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in order to [70:20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m 2 /day whether given intravenously or intramuscularly. (See Surface Area Nomogram .) For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m 2 every 24 hours for 5 days for patients with serum creatinine levels of 2 3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3 4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl. These regimens may be repeated at one month intervals. 12 Calcium Disodium Versenate, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that Calcium Disodium Versenate be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy. 14 18 Therapy of lead poisoning in adults and pediatric patients with Calcium Disodium Versenate is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug. Calcium Disodium Versenate is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients. Acutely ill individuals may be dehydrated from vomiting. Since edetate calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy. Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of Calcium Disodium Versenate should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Intravenous Administration Add the total daily dose of Calcium Disodium Versenate (1000 mg/m 2 /day) to 250 500 ml of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8 12 hours. Calcium Disodium Versenate injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride. Intramuscular Administration The total daily dosage (1000 mg/m 2 /day) should be divided into equal doses spaced 8 12 hours apart. Lidocaine or procaine should be added to the Calcium Disodium Versenate injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/ml (0.5%) can be obtained as follows: 0.25 ml of 10% lidocaine solution per 5 ml concentrated Calcium Disodium Versenate; 1 ml of 1% lidocaine or procaine solution per ml of concentrated Calcium Disodium Versenate. When used alone, regardless of method of administration, Calcium Disodium Versenate should not be given at doses larger than those recommended. Diagnostic Test Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores. 7, 9,12,13,18 These procedures have advantages and disadvantages that should be reviewed in current references. Edetate calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated. Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. How is Calcium Disodium Versenate Supplied Calcium Disodium Versenate injection, 5 mL ampul containing 200 mg of edetate calcium disodium per ml (1000 mg per ampul), in boxes containing 5 ampuls (NDC 99207-240-05 ). Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Rx Only This product is non-returnable. REFERENCES 1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylenediamine tetraacetate treatment of lead-poisoned children. J Pharmacol Exp Therapeu 1986; 239: 829 835. 2. The Pharmacological Basis of Therapeutics, 7th edition, Goodman and Gilman, editors. MacMillan Publishing Company, New York, 1985, pp. 1619 1622. 3. Hammond PB, Aronson AL, Olson WC. The mechanism of mobilization of lead by ethylenediaminetetraacetate. J Pharmacol Exp Therapeu 1967; 157: 196 206. 4. Van deVyver FL, D'Haese PC, Visser WJ, et al. Bone lead in dialysis patients. Kidney Intl 1988; 33: 601 607. 5. Cory-Slecta DA, Weiss B, Cox C. Mobilization and redistribution of lead over the course of calcium disodium ethylenediamine tetraacetate chelation therapy. J Pharmacol Exp Therapeu 1987; 243: 804 813. 6. Chisolm JJ. Mobilization of lead by calcium disodium edetate. Am J Dis Child 1987; 141: 1256 1257. 7. Drug Evaluations, 6th Edition, American Medical Association, Saunders, Philadelphia, 1986, pp. 1637 1639. 8. Centers for Disease Control: Preventing lead poisoning in young children. Atlanta, GA, Department of Health and Human Services, 1985 Jan. 9. Finberg L, Rajagopal V. Diagnosis and treatment of lead poisoning in children. J Family Med 1985 April: 3 12. 10. Schardein JL, Sakowski R, Petrere J, et al. Teratogenesis studies with EDTA and its salts in rats. Toxicol Appl Pharmacol 1981; 61: 423 428. 11. Swenerton H, Hurley LS. Teratogenic effects of a chelating agent and their prevention by zinc. Science 1971; 173: 62 64. 12. American Hospital Formulary Service, Drug Information, 1988, pp. 1695 1698. 13. Markowitz ME, Rosen JF. Assessment of lead stores in children: Validation of an 8-hour CaNa 2 EDTA (Calcium Disodium Versenate) provocative test. J Pediatrics 1984; 104: 337 341. 14. Piomelli S, Rosen JF, Chisolm JJ, et al. Management of childhood lead poisoning. J Pediatrics 1984; 105: 523 532. 15. Sachs HK, Blanksma LA, Murray EF, et al. Ambulatory treatment of lead poisoning: Report of 1,155 cases. Pediatrics 1970; 46: 389. 16. Chisolm JJ. The use of chelating agents in the treatment of acute and chronic lead intoxication in childhood. J Pediatrics 1968; 73: 1. 17. Coffin R, Phillips JL, Staples WI, et al. Treatment of lead encephalopathy in children. J Pediatrics 1966; 69: 198 206. 18. Chisolm JJ. Increased lead absorption and acute lead poisoning. Current Pediatric Therapy 12, Gillis and Kagan, editors, WB Saunders, Philadelphia, 1986, pp. 667 671. Manufactured for: Medicis, The Dermatology Company Scottsdale, AZ 85256 By: CP Pharmaceuticals, Ltd . Wrexham LL13 9UF, U.K. Product of UK 106055/1 Rev. 10/12 PRINCIPAL DISPLAY PANEL - 5 mL Ampule Carton NDC 99207-240-05 5 ampuls per carton Calcium Disodium Versenate (edetate calcium disodium injection, USP) 1000 mg/5 mL (200 mg/mL) For intravenous or intramuscular administration only MEDICIS Calcium Disodium Versenate edetate calcium disodium injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-240 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EDETATE CALCIUM DISODIUM (EDETIC ACID) EDETATE CALCIUM DISODIUM 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER Packaging # Item Code Package Description 1 NDC:99207-240-05 5 AMPULE in 1 CARTON 1 5 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA008922 06/21/2013 Labeler - Medicis Pharmaceutical Corp (182837492) Establishment Name Address ID/FEI Operations CP Pharmaceuticals Ltd 226503308 MANUFACTURE(99207-240) Revised: 07/2013 Medicis Pharmaceutical Corp Next Interactions Print this page Add to My Med List More about Calcium Disodium Versenate (edetate calcium disodium) Side Effects During Pregnancy Dosage Information Drug Interactions Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antidotes Consumer resources Calcium Disodium Versenate Professional resources Calcium Disodium Versenate (AHFS Monograph) Related treatment guides Lead Poisoning, Mild Lead Poisoning, Severe]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Valeant Pharmaceuticals International, Inc. Drug Class Antidotes Related Drugs antidotes naltrexone , atropine , naloxone , acetylcysteine , leucovorin Lead Poisoning, Mild n/a Lead Poisoning, Severe Chemet , succimer , More... Calcium Disodium Versenate Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } keep at bay


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a hearth [35 C:2%) were somnolence (10.7%), dizziness (7.1%), paresthesia (7.1%), asthenia (7.1%), nausea (6.3%), and headache (2.7%). While the incidence of these adverse reactions was generally higher than in Table 1 (experience encompassing the standard, much slower infusion rates), e.g., somnolence (1.7%), dizziness (5.2%), paresthesia (0.9%), asthenia (0%), nausea (3.2%), and headache (4.3%), a direct comparison between the incidence of adverse reactions in the 2 cohorts cannot be made because of differences in patient populations and study designs. Ammonia levels have not been systematically studied after IV valproate, so that an estimate of the incidence of hyperammonemia after IV Depacon cannot be provided. Hyperammonemia with encephalopathy has been reported in 2 patients after infusions of Depacon. Epilepsy The data described in the following section were obtained using Depakote (divalproex sodium) tablets. Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, Depakote (divalproex sodium) was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the Depakote-treated patients (6%), compared to 1% of placebo-treated patients. Table 2 lists treatment-emergent adverse reactions which were reported by 5% of Depakote-treated patients and for which the incidence was greater than in the placebo group, in the placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures. Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to Depakote alone, or the combination of Depakote and other antiepilepsy drugs. Table 2. Adverse Reactions Reported by 5% of Patients Treated with Depakote During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures Body System/Reaction Depakote (%) (n = 77) Placebo (%) (n = 70) Body as a Whole Headache 31 21 Asthenia 27 7 Fever 6 4 Gastrointestinal System Nausea 48 14 Vomiting 27 7 Abdominal Pain 23 6 Diarrhea 13 6 Anorexia 12 0 Dyspepsia 8 4 Constipation 5 1 Nervous System Somnolence 27 11 Tremor 25 6 Dizziness 25 13 Diplopia 16 9 Amblyopia/Blurred Vision 12 9 Ataxia 8 1 Nystagmus 8 1 Emotional Lability 6 4 Thinking Abnormal 6 0 Amnesia 5 1 Respiratory System Flu Syndrome 12 9 Infection 12 6 Bronchitis 5 1 Rhinitis 5 4 Other Alopecia 6 1 Weight Loss 6 0 Table 3 lists treatment-emergent adverse reactions which were reported by 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of Depakote monotherapy treatment of complex partial seizures. Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to Depakote alone, or the combination of valproate and other antiepilepsy drugs. Table 3. Adverse Reactions Reported by 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures 1 1 Headache was the only adverse reaction that occurred in 5% of patients in the high dose group and at an equal or greater incidence in the low dose group. Body System/Reaction High Dose (%) (n = 131) Low Dose (%) (n = 134) Body as a Whole Asthenia 21 10 Digestive System Nausea 34 26 Diarrhea 23 19 Vomiting 23 15 Abdominal Pain 12 9 Anorexia 11 4 Dyspepsia 11 10 Hemic/Lymphatic System Thrombocytopenia 24 1 Ecchymosis 5 4 Metabolic/Nutritional Weight Gain 9 4 Peripheral Edema 8 3 Nervous System Tremor 57 19 Somnolence 30 18 Dizziness 18 13 Insomnia 15 9 Nervousness 11 7 Amnesia 7 4 Nystagmus 7 1 Depression 5 4 Respiratory System Infection 20 13 Pharyngitis 8 2 Dyspnea 5 1 Skin and Appendages Alopecia 24 13 Special Senses Amblyopia/Blurred Vision 8 4 Tinnitus 7 1 The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures: Body as a Whole: Back pain, chest pain, malaise. Cardiovascular System: Tachycardia, hypertension, palpitation. Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess. Hemic and Lymphatic System: Petechia. Metabolic and Nutritional Disorders: SGOT increased, SGPT increased. Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia. Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder. Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis. Skin and Appendages: Rash, pruritus, dry skin. Special Senses: Taste perversion, abnormal vision, deafness, otitis media. Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency. Mania Although Depacon has not been evaluated for safety and efficacy in the treatment of manic episodes associated with bipolar disorder, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of Depakote (divalproex sodium) tablets. Body as a Whole: Chills, neck pain, neck rigidity. Cardiovascular System: Hypotension, postural hypotension, vasodilation. Digestive System: Fecal incontinence, gastroenteritis, glossitis. Musculoskeletal System: Arthrosis. Nervous System: Agitation, catatonic reaction, hypokinesia, reflexes increased, tardive dyskinesia, vertigo. Skin and Appendages: Furunculosis, maculopapular rash, seborrhea. Special Senses: Conjunctivitis, dry eyes, eye pain. Urogenital: Dysuria. Migraine Although Depacon has not been evaluated for safety and efficacy in the prophylactic treatment of migraine headaches, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of Depakote (divalproex sodium) tablets. Body as a Whole: Face edema. Digestive System: Dry mouth, stomatitis. Urogenital System: Cystitis, metrorrhagia, and vaginal hemorrhage. Post-Marketing Experience The following adverse reactions have been identified during post approval use of Depakote. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome. Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration. Neurologic: Paradoxical convulsion, parkinsonism There have been several reports of acute or subacute cognitive decline and behavioral changes (apathy or irritability) with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation. There have been reports of acute or subacute encephalopathy in the absence of elevated ammonia levels, elevated valproate levels, or neuroimaging changes. The encephalopathy reversed partially or fully after valproate discontinuation. Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness. Hematologic: Relative lymphocytosis, macrocytosis, leucopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria. Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion. There have been rare reports of Fanconi's syndrome occurring chiefly in children. Metabolism and nutrition: Weight gain. Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology. Genitourinary: Enuresis and urinary tract infection. Special Senses: Hearing loss. Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis. Drug Interactions Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), may increase the clearance of valproate. For example, phenytoin, carbamazepine, and phenobarbital (or primidone) can double the clearance of valproate. Thus, patients on monotherapy will generally have longer half-lives and higher concentrations than patients receiving polytherapy with antiepilepsy drugs. In contrast, drugs that are inhibitors of cytochrome P450 isozymes, e.g., antidepressants, may be expected to have little effect on valproate clearance because cytochrome P450 microsomal mediated oxidation is a relatively minor secondary metabolic pathway compared to glucuronidation and beta-oxidation. Because of these changes in valproate clearance, monitoring of valproate and concomitant drug concentrations should be increased whenever enzyme inducing drugs are introduced or withdrawn. The following list provides information about the potential for an influence of several commonly prescribed medications on valproate pharmacokinetics. The list is not exhaustive nor could it be, since new interactions are continuously being reported. Drugs for which a potentially important interaction has been observed Aspirin A study involving the co-administration of aspirin at antipyretic doses (11 to 16 mg/kg) with valproate to pediatric patients (n = 6) revealed a decrease in protein binding and an inhibition of metabolism of valproate. Valproate free fraction was increased 4-fold in the presence of aspirin compared to valproate alone. The β-oxidation pathway consisting of 2-E-valproic acid, 3-OH-valproic acid, and 3-keto valproic acid was decreased from 25% of total metabolites excreted on valproate alone to 8.3% in the presence of aspirin. Caution should be observed if valproate and aspirin are to be co-administered. Carbapenem Antibiotics A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics (for example, ertapenem, imipenem, meropenem this is not a complete list) and may result in loss of seizure control. The mechanism of this interaction is not well understood. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates [see Warnings and Precautions (5.12) ] . Estrogen-Containing Hormonal Contraceptives Estrogen-containing hormonal contraceptives may increase the clearance of valproate, which may result in decreased concentration of valproate and potentially increased seizure frequency. Prescribers should monitor serum valproate concentrations and clinical response when adding or discontinuing estrogen containing products. Felbamate A study involving the co-administration of 1,200 mg/day of felbamate with valproate to patients with epilepsy (n = 10) revealed an increase in mean valproate peak concentration by 35% (from 86 to 115 mcg/mL) compared to valproate alone. Increasing the felbamate dose to 2,400 mg/day increased the mean valproate peak concentration to 133 mcg/mL (another 16% increase). A decrease in valproate dosage may be necessary when felbamate therapy is initiated. Rifampin A study involving the administration of a single dose of valproate (7 mg/kg) 36 hours after 5 nights of daily dosing with rifampin (600 mg) revealed a 40% increase in the oral clearance of valproate. Valproate dosage adjustment may be necessary when it is co-administered with rifampin. Drugs for which either no interaction or a likely clinically unimportant interaction has been observed Antacids A study involving the co-administration of valproate 500 mg with commonly administered antacids (Maalox, Trisogel, and Titralac - 160 mEq doses) did not reveal any effect on the extent of absorption of valproate. Chlorpromazine A study involving the administration of 100 to 300 mg/day of chlorpromazine to schizophrenic patients already receiving valproate (200 mg BID) revealed a 15% increase in trough plasma levels of valproate. Haloperidol A study involving the administration of 6 to 10 mg/day of haloperidol to schizophrenic patients already receiving valproate (200 mg BID) revealed no significant changes in valproate trough plasma levels. Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate. Effects of Valproate on Other Drugs Valproate has been found to be a weak inhibitor of some P450 isozymes, epoxide hydrase, and glucuronosyltransferases. The following list provides information about the potential for an influence of valproate co-administration on the pharmacokinetics or pharmacodynamics of several commonly prescribed medications. The list is not exhaustive, since new interactions are continuously being reported. Drugs for which a potentially important valproate interaction has been observed Amitriptyline/Nortriptyline Administration of a single oral 50 mg dose of amitriptyline to 15 normal volunteers (10 males and 5 females) who received valproate (500 mg BID) resulted in a 21% decrease in plasma clearance of amitriptyline and a 34% decrease in the net clearance of nortriptyline. Rare postmarketing reports of concurrent use of valproate and amitriptyline resulting in an increased amitriptyline level have been received. Concurrent use of valproate and amitriptyline has rarely been associated with toxicity. Monitoring of amitriptyline levels should be considered for patients taking valproate concomitantly with amitriptyline. Consideration should be given to lowering the dose of amitriptyline/nortriptyline in the presence of valproate. Carbamazepine/carbamazepine-10,11-Epoxide Serum levels of carbamazepine (CBZ) decreased 17% while that of carbamazepine-10,11-epoxide (CBZ-E) increased by 45% upon co-administration of valproate and CBZ to epileptic patients. Clonazepam The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures. Diazepam Valproate displaces diazepam from its plasma albumin binding sites and inhibits its metabolism. Co-administration of valproate (1,500 mg daily) increased the free fraction of diazepam (10 mg) by 90% in healthy volunteers (n = 6). Plasma clearance and volume of distribution for free diazepam were reduced by 25% and 20%, respectively, in the presence of valproate. The elimination half-life of diazepam remained unchanged upon addition of valproate. Ethosuximide Valproate inhibits the metabolism of ethosuximide. Administration of a single ethosuximide dose of 500 mg with valproate (800 to 1,600 mg/day) to healthy volunteers (n = 6) was accompanied by a 25% increase in elimination half-life of ethosuximide and a 15% decrease in its total clearance as compared to ethosuximide alone. Patients receiving valproate and ethosuximide, especially along with other anticonvulsants, should be monitored for alterations in serum concentrations of both drugs. Lamotrigine In a steady-state study involving 10 healthy volunteers, the elimination half-life of lamotrigine increased from 26 to 70 hours with valproate co-administration (a 165% increase). The dose of lamotrigine should be reduced when co-administered with valproate. Serious skin reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with concomitant lamotrigine and valproate administration. See lamotrigine package insert for details on lamotrigine dosing with concomitant valproate administration. Phenobarbital Valproate was found to inhibit the metabolism of phenobarbital. Co-administration of valproate (250 mg BID for 14 days) with phenobarbital to normal subjects (n = 6) resulted in a 50% increase in half-life and a 30% decrease in plasma clearance of phenobarbital (60 mg single-dose). The fraction of phenobarbital dose excreted unchanged increased by 50% in presence of valproate. There is evidence for severe CNS depression, with or without significant elevations of barbiturate or valproate serum concentrations. All patients receiving concomitant barbiturate therapy should be closely monitored for neurological toxicity. Serum barbiturate concentrations should be obtained, if possible, and the barbiturate dosage decreased, if appropriate. Primidone, which is metabolized to a barbiturate, may be involved in a similar interaction with valproate. Phenytoin Valproate displaces phenytoin from its plasma albumin binding sites and inhibits its hepatic metabolism. Co-administration of valproate (400 mg TID) with phenytoin (250 mg) in normal volunteers (n = 7) was associated with a 60% increase in the free fraction of phenytoin. Total plasma clearance and apparent volume of distribution of phenytoin increased 30% in the presence of valproate. Both the clearance and apparent volume of distribution of free phenytoin were reduced by 25%. In patients with epilepsy, there have been reports of breakthrough seizures occurring with the combination of valproate and phenytoin. The dosage of phenytoin should be adjusted as required by the clinical situation. Propofol The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression. Rufinamide Based on a population pharmacokinetic analysis, rufinamide clearance was decreased by valproate. Rufinamide concentrations were increased by]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only Pregnancy Category Risk depends on usage N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer AbbVie Inc. Drug Class Fatty acid derivative anticonvulsants Related Drugs fatty acid derivative anticonvulsants Depakote , divalproex sodium , valproic acid , Depakote ER , Depakene , Depakote Sprinkles Epilepsy gabapentin , Lyrica , Neurontin , lamotrigine , levetiracetam , Lamictal , Keppra , Depakote , More... Seizure Prevention clonazepam , diazepam , Klonopin , lamotrigine , topiramate , Valium , Topamax , Lamictal , More... Seizures diazepam , levetiracetam , topiramate , Valium , Topamax , Keppra , primidone , Dilantin , More... Depacon Rating No Reviews - Be the first! No Reviews - Be the first! 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high-quality [2:<12 years old). One PK study was conducted in 9 full-term neonates (mean age: 7 days and mean gestational age: 38.8 weeks). The study results show that neonates had comparable plasma lidocaine and prilocaine concentrations and blood methemoglobin concentrations as those found in previous pediatric PK studies and clinical trials. There was a tendency towards an increase in methemoglobin formation. However, due to assay limitations and very little amount of blood that could be collected from neonates, large variations in the above reported concentrations were found. Special Populations: No specific PK studies were conducted. The half-life may be increased in cardiac or hepatic dysfunction. Prilocaine's half-life also may be increased in hepatic or renal dysfunction since both of these organs are involved in prilocaine metabolism. Clinical Studies Lidocaine and prilocaine cream application in adults prior to IV cannulation or venipuncture was studied in 200 patients in four clinical studies in Europe. Application for at least 1 hour provided significantly more dermal analgesia than placebo cream or ethyl chloride. Lidocaine and prilocaine cream was comparable to subcutaneous lidocaine, but was less efficacious than intradermal lidocaine. Most patients found lidocaine and prilocaine cream treatment preferable to lidocaine infiltration or ethyl chloride spray. Lidocaine and prilocaine cream was compared with 0.5% lidocaine infiltration prior to skin graft harvesting in one open label study in 80 adult patients in England. Application of lidocaine and prilocaine cream for 2 to 5 hours provided dermal analgesia comparable to lidocaine infiltration. Lidocaine and prilocaine cream application in children was studied in seven non-US studies (320 patients) and one US study (100 patients). In controlled studies, application of lidocaine and prilocaine cream for at least 1 hour with or without presurgical medication prior to needle insertion provided significantly more pain reduction than placebo. In children under the age of seven years, lidocaine and prilocaine cream was less effective than in older children or adults. Lidocaine and prilocaine cream was compared with placebo in the laser treatment of facial port-wine stains in 72 pediatric patients (ages 5 to 16). Lidocaine and prilocaine cream was effective in providing pain relief during laser treatment. Lidocaine and prilocaine cream alone was compared with lidocaine and prilocaine cream followed by lidocaine infiltration and lidocaine infiltration alone prior to cryotherapy for the removal of male genital warts. The data from 121 patients demonstrated that lidocaine and prilocaine cream was not effective as a sole anesthetic agent in managing the pain from the surgical procedure. The administration of lidocaine and prilocaine cream prior to lidocaine infiltration provided significant relief of discomfort associated with local anesthetic infiltration and thus was effective in the overall reduction of pain from the procedure only when used in conjunction with local anesthetic infiltration of lidocaine. Lidocaine and prilocaine cream was studied in 105 full term neonates (gestational age: 37 weeks) for blood drawing and circumcision procedures. When considering the use of lidocaine and prilocaine cream in neonates, the primary concerns are the systemic absorption of the active ingredients and the subsequent formation of methemoglobin. In clinical studies performed in neonates, the plasma levels of lidocaine, prilocaine, and methemoglobin were not reported in a range expected to cause clinical symptoms. Local dermal effects associated with lidocaine and prilocaine cream application in these studies on intact skin included paleness, redness and edema and were transient in nature (see ADVERSE REACTIONS ). The application of lidocaine and prilocaine cream on genital mucous membranes for minor, superficial surgical procedures (eg, removal of condylomata acuminata) was studied in 80 patients in a placebo-controlled clinical trial (60 patients received lidocaine and prilocaine cream and 20 patients received placebo). Lidocaine and prilocaine cream (5 to 10 g) applied between 1 and 75 minutes before surgery, with a median time of 15 minutes, provided effective local anesthesia for minor superficial surgical procedures. The greatest extent of analgesia, as measured by VAS scores, was attained after 5 to 15 minutes' application. The application of lidocaine and prilocaine cream to genital mucous membranes as pretreatment for local anesthetic infiltration was studied in a double-blind, placebo-controlled study in 44 female patients (21 patients received lidocaine and prilocaine cream and 23 patients received placebo) scheduled for infiltration prior to a surgical procedure of the external vulva or genital mucosa. Lidocaine and prilocaine cream applied to the genital mucous membranes for 5 to 10 minutes resulted in adequate topical anesthesia for local anesthetic injection. Individualization of Dose: The dose of lidocaine and prilocaine cream that provides effective analgesia depends on the duration of the application over the treated area. All pharmacokinetic and clinical studies employed a thick layer of lidocaine and prilocaine cream (1 to 2 g/10 cm 2 ). The duration of application prior to venipuncture was 1 hour. The duration of application prior to taking split thickness skin grafts was 2 hours. A thinner application has not been studied and may result in less complete analgesia or a shorter duration of adequate analgesia. The systemic absorption of lidocaine and prilocaine is a side effect of the desired local effect. The amount of drug absorbed depends on surface area and duration of application. The systemic blood levels depend on the amount absorbed and patient size (weight) and the rate of systemic drug elimination. Long duration of application, large treatment area, small patients, or impaired elimination may result in high blood levels. The systemic blood levels are typically a small fraction (1/20 to 1/36) of the blood levels that produce toxicity. Table 2 below gives maximum recommended doses, application areas and application times for infants and children. TABLE 2 LIDOCAINE AND PRILOCAINE CREAM MAXIMUM RECOMMENDED DOSE, APPLICATION AREA, AND APPLICATION TIME BY AGE AND WEIGHT* For Infants and Children Based on Application to Intact Skin Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight. * These are broad guidelines for avoiding systemic toxicity in applying lidocaine and prilocaine cream to patients with normal intact skin and with normal renal and hepatic function. ** For more individualized calculation of how much lidocaine and prilocaine may be absorbed, physicians can use the following estimates of lidocaine and prilocaine absorption for children and adults: The estimated mean ( SD) absorption of lidocaine is 0.045 ( 0.016) mg/cm 2 /hr. The estimated mean ( SD) absorption of prilocaine is 0.077 ( 0.036) mg/cm 2 /hr. Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine cream Maximum Application Area** Maximum Application Time 0 up to 3 months or> <5 kg 1 g 10 cm 2 1 hour 3 up to 12 months and> 5 kg 2 g 20 cm 2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm 2 4 hours 7 to 12 years and > 20 kg 20 g 200 cm 2 4 hours An I.V. antiarrhythmic dose of lidocaine is 1 mg/kg (70 mg/70 kg) and gives a blood level of about 1 μg/mL. Toxicity would be expected at blood levels above 5 μg/mL. Smaller areas of treatment are recommended in a debilitated patient, a small child or a patient with impaired elimination. Decreasing the duration of application is likely to decrease the analgesic effect. Indications and Usage for DermacinRx Prikaan Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS ). CONTRAINDICATIONS Lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product. Warnings Application of lidocaine and prilocaine cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see Individualization of Dose ). Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive. Studies in laboratory animals (guinea pigs) have shown that lidocaine and prilocaine cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream only in the external auditory canal, showed no abnormality. Lidocaine and prilocaine cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible. Methemoglobinemia: Lidocaine and prilocaine cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents. Very young patients or patients with glucose-6-phosphate dehydrogenase deficiencies are more susceptible to methemoglobinemia. Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia. There have been reports of significant methemoglobinemia (20 to 30%) in infants and children following excessive applications of lidocaine and prilocaine cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents. Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required. Physicians are cautioned to make sure that parents orother caregivers understand the need for careful application of lidocaine and prilocaine cream, to ensure that the doses and areas of application recommended in Table 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia. Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of lidocaine and prilocaine cream, provided the test results can be obtained quickly. PRECAUTIONS General: Repeated doses of lidocaine and prilocaine cream may increase blood levels of lidocaine and prilocaine. Lidocaine and prilocaine cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients. Lidocaine and prilocaine cream should not be applied to open wounds. Care should be taken not to allow lidocaine and prilocaine cream to come in contact with the eye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of lidocaine and prilocaine cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, lidocaine and prilocaine cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine. Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of lidocaine and prilocaine cream on intradermal injections of live vaccines has not been determined. Information for Patients: When lidocaine and prilocaine cream is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned. Lidocaine and prilocaine cream should not be applied near the eyes or on open wounds. Drug Interactions: Lidocaine and prilocaine cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition (see Methemoglobinemia subsection of WARNINGS ). Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised (see WARNINGS ). Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Long-term studies in animals designed to evaluate the carcinogenic potential of lidocaine and prilocaine have not been conducted. Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals. In the animal studies reported below, doses or blood levels are compared with the Single Dermal Administration (SDA) of 60 g of lidocaine and prilocaine cream to 400 cm 2 for 3 hours to a small person (50 kg). The typical application of lidocaine and prilocaine cream for one or two treatments for venipuncture sites (2.5 or 5 g) would be 1/24 or 1/12 of that dose in an adult or about the same mg/kg dose in an infant. Chronic oral toxicity studies of ortho -toluidine, a metabolite of prilocaine, in mice (450 to 7200 mg/m 2 ; 60 to 960 times SDA) and rats (900 to 4,800 mg/m 2 ; 60 to 320 times SDA) have shown that ortho -toluidine is a carcinogen in both species. The tumors included hepatocarcinomas/adenomas in female mice, multiple occurrences of hemangiosarcomas/hemangiomas in both sexes of mice, sarcomas of multiple organs, transitional-cell carcinomas/papillomas of urinary bladder in both sexes of rats, subcutaneous fibromas/fibrosarcomas and mesotheliomas in male rats, and mammary gland fibroadenomas/adenomas in female rats. The lowest dose tested (450 mg/m 2 in mice, 900 mg/m 2 in rats; 60 times SDA) was carcinogenic in both species. Thus the no-effect dose must be less than 60 times SDA. The animal studies were conducted at 150 to 2,400 mg/kg in mice and at 150 to 800 mg/kg in rats. The dosages have been converted to mg/m 2 for the SDA calculations above. Mutagenesis: The mutagenic potential of lidocaine HCl has been tested in a bacterial reverse (Ames) assay in Salmonella, an in vitro chromosomal aberration assay using human lymphocytes an in vivo micronucleus test in mice. There was no indication of mutagenicity or structural damage to chromosomes in these tests. Ortho -toluidine, a metabolite of prilocaine, at a concentration of 0.5 μg/mL, was genotoxic in Escherichia coli DNA repair and phage-induction assays. Urine concentrates from rats treated with ortho -toluidine (300 mg/kg orally; 300 times SDA) were mutagenic when examined in Salmonella typhimurium in the presence of metabolic activation. Several other tests on ortho -toluidine, including reverse mutations in five different Salmonella typhimurium strains in the presence or absence of metabolic activation and a study to detect single strand breaks in DNA of V79 Chinese hamster cells, were negative. Impairment of Fertility: See Use in Pregnancy . Use in Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies with lidocaine have been performed in rats and have revealed no evidence of harm to the fetus (30 mg/kg subcutaneously; 22 times SDA). Reproduction studies with prilocaine have been performed in rats and have revealed no evidence of impaired fertility or harm to the fetus (300 mg/kg intramuscularly; 188 times SDA). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine and prilocaine cream should be used during pregnancy only if clearly needed. Reproduction studies have been performed in rats receiving subcutaneous administration of an aqueous mixture containing lidocaine HCl and prilocaine HCl at 1:1 (w/w). At 40 mg/kg each, a dose equivalent to 29 times SDA lidocaine and 25 times SDA prilocaine, no teratogenic, embryotoxic or fetotoxic effects were observed. Labor and Delivery : Neither lidocaine nor prilocaine are contraindicated in labor and delivery. Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered. Nursing Mothers: Lidocaine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when lidocaine and prilocaine cream is administered to a nursing mother since the milk:plasma ratio of lidocaine is 0.4 and is not determined for prilocaine. Pediatric Use: Controlled studies of lidocaine and prilocaine cream in children under the age of seven years have shown less overall benefit than in older children or adults. These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures. Lidocaine and prilocaine cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS ). When using lidocaine and prilocaine cream in young children, especially infants under the age of 3 months, care must be taken to insure that the caregiver understands the need to limit the dose and area of application, and to prevent accidental ingestion (see DOSAGE AND ADMINISTRATION and Methemoglobinemia ). In neonates (minimum gestation age: 37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited (see TABLE 2 in Individualization of Dose ). Studies have not demonstrated the efficacy of lidocaine and prilocaine cream for heel lancing in neonates. Geriatric Use: Of the total number of patients in clinical studies of lidocaine and prilocaine cream, 180 were age 65 to 74 and 138 were 75 and over. No overall differences in safety or efficacy were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Plasma levels of lidocaine and prilocaine in geriatric and non-geriatric patients following application of a thick layer of lidocaine and prilocaine cream are very low and well below potentially toxic levels. However, there are no sufficient data to evaluate quantitative differences in systemic plasma levels of lidocaine and prilocaine between geriatric and non-geriatric patients following application of lidocaine and prilocaine cream. Consideration should be given for those elderly patients who have enhanced sensitivity to systemic absorption (see PRECAUTIONS ). After intravenous dosing, the elimination half-life of lidocaine is significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours). (See CLINICAL PHARMACOLOGY ). Adverse Reactions Localized Reactions: During or immediately after treatment with lidocaine and prilocaine cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of lidocaine and prilocaine cream have been reported. The relationship to lidocaine and prilocaine cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 lidocaine and prilocaine cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to lidocaine and prilocaine cream. Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine and prilocaine cream. In patients treated with lidocaine and prilocaine cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%. In clinical studies on genital mucous membranes involving 378 lidocaine and prilocaine cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%). Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Systemic (Dose Related) Reactions: Systemic adverse reactions following appropriate use of lidocaine and prilocaine cream are unlikely due to the small dose absorbed (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY ). Systemic adverse effects of lidocaine and/or prilocaine are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. OVERDOSAGE Peak blood levels following a 60 g application to 400 cm 2 of intact skin for 3 hours are 0.05 to 0.16 μg/mL for lidocaine and 0.02 to 0.10 μg/mL for prilocaine. Toxic levels of lidocaine (>5 μg/mL) and/or prilocaine (>6 μg/mL) cause decreases in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to direct depressant effects of these local anesthetic agents on the cardiovascular system. In the absence of massive topical overdose or oral ingestion, evaluation should include evaluation of other etiologies for the clinical effects or overdosage from other sources of lidocaine, prilocaine or other local anesthetics. Consult the package inserts for parenteral Xylocaine (lidocaine HCl) or Citanest (prilocaine HCl) for further information for the management of overdose. DermacinRx Prikaan Dosage and Administration Adult Patients-Intact Skin A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site. Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours. Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm 2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream. Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose . Adult Female Patients-Genital Mucous Membranes For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes. Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream. Pediatric Patients-Intact Skin The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight: Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream Maximum Application Area Maximum Application Time 0 up to 3 months or <5 kg 1 g 10 cm 2 1 hour 3 up to 12 months and> 5 kg 2 g 20 cm 2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm 2 4 hours 7 to 12 years and > 20 kg 20 g 200 cm 2 4 hours Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION ). Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS ). When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful. Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS ). When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose ). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose ). Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose ). INSTRUCTIONS FOR APPLICATION: To measure 1 gram of lidocaine and prilocaine cream, the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of the diagram shown below. Use the number of strips that equals your dose, like the examples in the table below. Dosing Information 1 gram = 1 strip 2 grams = 2 strips 2.5 grams = 2.5 strips For adult and pediatric patients, apply ONLY as prescribed by your physician. If your child is below the age of 3 months or small for their age, please inform your doctor before applying lidocaine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children. When applying lidocaine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with lidocaine and prilocaine cream. Lidocaine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place. If using a protective covering, your doctor will remove it, wipe off the lidocaine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure. The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering. Precautions Do not apply near eyes or open wounds. Keep out of the reach of children. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying lidocaine and prilocaine cream, remove the cream and contact the child's physician at once. How is DermacinRx Prikaan Supplied Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following: NDC 0591-2070-30 30 gram/tube packed individually, in a child-resistant tube. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. NOT FOR OPHTHALMIC USE. Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Rx only Keep out of the reach of children. For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: IGI Laboratories Inc. Buena, NJ 08310 USA DermacinRx Prikaan (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP and Frame Style Transparent Dressing) Packaged in the USA by: PureTek Corporation San Fernando, CA 91340 For questions or information call toll-free: 877-921-7873 visit: dermacinrx.com Rev. 36744 DermacinRx Prikaan lidocaine and prilocaine kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69621-873 Packaging # Item Code Package Description 1 NDC:69621-873-00 1 KIT in 1 PACKAGE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 TUBE 90 g Part 1 of 1 LIDOCAINE AND PRILOCAINE lidocaine and prilocaine cream Product Information Item Code (Source) NDC:0591-2070 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (LIDOCAINE) LIDOCAINE 25 mg in 1 g PRILOCAINE (PRILOCAINE) PRILOCAINE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength PEG-55 HYDROGENATED CASTOR OIL CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) WATER SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:0591-2070-30 1 TUBE in 1 CARTON 1 30 g in these days


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lack of understanding [18:] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Nonsteroidal anti-inflammatory agents Related Drugs Pain tramadol , acetaminophen , Tylenol , naproxen , oxycodone , More... Rheumatoid Arthritis Humira , hydroxychloroquine , Plaquenil , sulfasalazine , leflunomide , Enbrel , More... Gout, Acute naproxen , ibuprofen , Aleve , Advil , colchicine , Medrol , More... Osteoarthritis prednisone , naproxen , Cymbalta , aspirin , ibuprofen , meloxicam , More... Nalfon Rating 1 User Review 8.5 /10 1 User Review 8.5 Rate it! Nalfon Images Nalfon 600 MG (NALFON ) View larger images good deal


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the entirety [1%:] Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Estramustine Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Hormones / antineoplastics Mitotic inhibitors Related Drugs hormones / antineoplastics anastrozole , tamoxifen , letrozole , Evista , Arimidex , raloxifene mitotic inhibitors Taxol , Taxotere , paclitaxel , Abraxane , docetaxel , etoposide Prostate Cancer estradiol , Premarin , Estrace , bicalutamide , Casodex , Eligard , Xtandi , Zytiga , leuprolide , Taxotere , Lupron Depot , conjugated estrogens , docetaxel , Firmagon , Trelstar , enzalutamide , Zoladex , abiraterone , degarelix , Menest , flutamide , flax , Delestrogen , More... profitable


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fighters Sugar Substitutes Posted under Health Guides . Updated 3 March 2016. +Related Content Sugar substitutes are substances used to sweeten foods and beverages instead of sucrose (sugar). You ll find a variety of foods on the market that contain sugar substitutes; some advertise this fact but for others you need to look closely at the ingredient list. Some products that contain sugar substitutes are: diet soda, sugar-free syrup, gum, ice cream, fruit cups, yogurt, pudding, and more. There are different kinds of sugar substitutes that include artificial sweeteners, stevia, and sugar alcohols. There are some benefits to using sugar substitutes. Benefits of sugar substitutes: Have few or no calories Do not cause your blood sugar to go up as much as regular sugar does Do not cause tooth decay or cavities What are artificial sweeteners? Artificial sweeteners are chemicals that are generally much sweeter than sugar, so a smaller amount of them is needed to have the same sweetness as sugar. They typically provide very little to no calories and have no nutrients in them. Examples of artificial sweeteners include: Saccharin (Sweet N Low , SugarTwin ) Acesulfame K (Sunett , Sweet One ) Sucralose (Splenda ) Aspartame (NutraSweet , Equal ) Products containing aspartame have a warning label because they are NOT safe for use by people that have the hereditary disease Phenylketonuria (PKU). Pregnant women may be advised by their doctor to avoid saccharin due to the unknown long-term effects. What is stevia? Stevia is the common name for sweeteners such as PureVia and Truvia that are found naturally in the stevia rebaudiana plant. Unlike other sugar substitutes, stevia originates from a plant rather than being a manmade chemical. However, chemicals are used in the processing of stevia. Stevia sweeteners provide zero calories and are one of the most recently approved sugar substitutes by the FDA. Stevia sweeteners can be found in packets and in a variety of drinks and foods. If you are trying to avoid sugar substitutes, it is important to note that stevia sweetened products may say naturally sweetened so it s always a good idea to check out the ingredients, too! What is monk fruit extract? Monk fruit extract, or norbu, is the main ingredient in the sweeteners of Monk Fruit in the Raw and Nectresse . Monk fruit extract is made from the monk fruit, a fruit regional to Southeast Asia. The juices of this fruit are extremely sweet, so can be used in very small quantities to sweeten foods and beverages without adding calories. Monk fruit extract is made by taking the juices from the monk fruit plant by squeezing the liquid from the seeds and the pulp of the fruit. Just like stevia, products that say naturally sweetened may have monk fruit extract in them. What are sugar alcohols? Sugar alcohols are carbohydrates found in plant products. In order to use sugar alcohols as a sweetener, they are altered in a laboratory environment to make them usable in sugar-free and reduced-sugar foods. They are usually 25-100% as sweet as sugar and they provide 1.5 3 calories/gram when compared to sugar (which provides 4 calories/gram). Sugar alcohols can cause gas and loose stools since they are not completely digested by the body. Therefore, foods that contain sugar alcohols include the label excess consumption may have a laxative effect. It is also important to note that sugar alcohols, despite their low calorie count, are still carbohydrates so can still have a small impact on blood sugar levels. Sugar alcohols are used in anything from candy to gum to bakery goods and ice cream. Examples of sugar alcohols include: Sorbitol Mannitol Zylitol Isomalt Lactitol Maltitol Erythritol Are sugar substitutes safe? The U.S. Food and Drug Administration (FDA) consider sugar substitutes to be safe food additives . The FDA has also set an acceptable daily intake (ADI) for each sweetener which is an amount they feel is safe to have each day. It is measured in milligrams per pound of body weight per day . These amounts, listed in the table below, are higher than the amount most people usually have in a day. Sugar substitutes have never been shown to increase the risk of other diseases. Even though they might not be bad for you, the most nutrient dense foods and drinks (such as fruits, vegetables, milk and water) don t contain sugar substitutes. Sweetener ADI* In milligrams (mg) per pound (lb) Estimated ADI equivalent in packets of sweetener for a person weighing 150lbs Average sweetness compared to sugar Aspartame (NutraSweet , Equal ) 22.7 mg per lb 97.4 packets 220 times sweeter Saccharin (Sweet N Low , SugarTwin ) 2.3 mg per lb 8.6 packets 200-700 times sweeter Acesulfame K (Sunett , Sweet One ) 6.8 mg per lb 20.4 packets 200 times sweeter Sucralose (Splenda ) 2.3 mg per lb 68.2 packets 600 times sweeter Stevia (Good & Sweet , PureVia , Truvia ) Not yet established n/a 200-300 times sweeter Monk Fruit Extract (Monk Fruit in the Raw and Nectresse ) Not yet established n/a 100-250 times sweeter *FDA-established acceptable daily intake (ADI) limit per pound of body weight Information adapted from mayoclinic.com Are there any other ways to make my food taste sweet (without adding sugar substitutes)? There are other ways to make your foods more flavorful without adding sugar substitutes. Try adding spices such as nutmeg and cinnamon to yogurt, cooked cereals, cookies, or coffee. You can also experiment with flavors such as vanilla and cocoa powder in pudding and baked goods. Sugar substitutes can be used as a safe alternative to sugar. It s important that we use them in moderation and eat mostly foods without added sugar or sugar substitutes. Tags: nutrition , sugar to intensify


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1st Baron Verulam [25:<70 mcg/dL, respectively. 111 h May be most effective when administered early in the course of acute poisoning; administration should be accompanied by appropriate supportive measures. a Not a substitute for control of the lead hazard, a including effective measures to eliminate or reduce further lead exposure. b Patients should not be treated prophylactically with any chelating agent. a Consult most recent AAP and CDC recommendations for information regarding chelation therapy. a Has been reported to be useful in poisonings caused by alkyl lead compounds (e.g., tetraethyl lead). a However, chelation therapy has not been found to be clinically efficacious and experts recommend supportive therapy, with sedation, as necessary, for treatment of tetraethyl lead toxicity. h Has been used parenterally as an aid in the diagnosis of suspected lead poisoning (the edetate calcium disodium mobilization or provocation test) a b when adequacy of patient s response to chelation therapy is uncertain. a However, AAP and other experts state these tests are obsolete and have the potential for increased lead toxicity associated with administration of edetate calcium disodium alone, unreliability of the test, and expense. 111 g Calcium Disodium Versenate Dosage and Administration General Chelation therapy can increase lead absorption from the GI tract; therefore, remove patient from lead poisoning source once it has been identified. 103 113 b Ensure that patient resides in lead-free environment during and after therapy. 103 113 Various dosage regimens have been recommended in lead poisoning management; a total dose of edetate calcium disodium depends on patient s response to, and tolerance of the selected agent, a as well as severity of lead toxicity. h Subsequent course(s) of therapy may be required based on clinical symptoms and blood lead concentrations. h Consult published protocols and specialized references for dosages of chelating agents, the method and sequence of administration, and specific information on precautions associated with chelation therapy. a Maintain adequate hydration to ensure renal excretion of chelating agents. 111 Prior to initiating therapy, ensure that adequate urine flow is established. b g Administration Administer by slow IV infusion or by IM injection. a b Should not be given orally since edetate calcium disodium enhances absorption of lead present in the GI tract; in addition, orally administered drug is poorly absorbed from the GI tract and is considered ineffective. a Manufacturer states that IM injection is preferred route of administration for patients with lead encephalopathy and cerebral edema and may be preferred in young children. b However, most experts, including AAP and CDC, recommend administration by slow IV infusion whenever possible, 101 103 111 g h and AAP states that clinical experience suggests slow IV infusion is safe and more appropriate for children than IM injection. 111 IV Infusion For solution and drug compatibility information, see Compatibility under Stability. Administer by slow IV infusion as a single daily dose or in divided-dose infusions. a h When administered by continuous IV infusion, interrupt infusion for 1 hour before obtaining a blood lead concentration to avoid falsely elevated blood lead concentrations. 101 Dilution Prior to administration, dilute with 250 500 mL b of 0.9% sodium chloride or 5% dextrose injection a b to provide a final concentration of> <0.5%. 111 g h Rate of Administration Rapid IV infusions may increase risk of severe and potentially fatal adverse effects (e.g., increased intracranial pressure and cerebral edema). 109 111 Administer slowly over several hours (e.g., 4 hours); 111 manufacturer recommends slow IV infusion over 8 12 hours. b 111 May also be administered as a continuous infusion over 24 hours. g IM Administration When administered alone, daily dosage usually given in equally divided doses at 8 12 hour intervals. a b When administered in conjunction with dimercaprol, daily dosage usually given in equally divided doses at 4-hour intervals. a Dilution To minimize pain at the injection site, add 0.25 mL of 10% lidocaine hydrochloride injection to 5 mL of edetate calcium disodium injection or, alternatively, add 1 mL of 1% lidocaine hydrochloride or 1 mL of 1% procaine hydrochloride injection to each mL of edetate calcium disodium injection to provide a final lidocaine or procaine hydrochloride concentration of 5 mg/mL (0.5%). a b (See Local Effects under Cautions.) Dosage Dosage same for IV and IM administration. 109 (See Possible Prescribing and Dispensing Errors under Cautions.) Pediatric Patients Lead Poisoning Consult most recent published protocols, including those from AAP and CDC, and specialized references for combination therapy dosage recommendations. a b Encephalopathy, Symptoms Suggestive of Encephalopathy, or Blood Lead Concentration> 70 mcg/dL IV or IM 1500 mg/m 2 or 50 75 mg/kg daily for 5 days; initiate administration 4 hours after initial IM administration of dimercaprol and immediately after second IM dose of dimercaprol. 111 h Other experts recommend 1 1.5 g/m 2 or 25 75 mg/kg daily for 5 days. g h Decision to repeat therapy should be based on clinical symptoms and blood lead concentrations. h If additional chelation therapy required, allow >2 4 days without treatment to elapse to allow redistribution of lead and to prevent depletion of essential metals before initiating a second 5-day course of therapy. 111 a b g Asymptomatic Patients with Blood Lead Concentration 45 70 mcg/dL IV or IM 1 g/m 2 or 25 mg/kg daily for 5 days. 111 b g Decision to repeat therapy should be based on clinical symptoms and blood lead concentrations. 111 h Allow 10 14 days without treatment to elapse to allow reequilibration before assessing blood lead concentrations and restarting therapy. h Adults Lead Poisoning Consult most recent published protocols, including those from AAP and CDC, and specialized references for combination therapy dosage recommendations. a b Encephalopathy, Symptoms Suggestive of Encephalopathy, or Blood Lead Concentration >100 mcg/dL IV or IM 1.5 g/m 2 or 50 75 mg/kg daily for 5 days; initiate administration 4 hours after initial IM administration of dimercaprol and immediately after second IM dose of dimercaprol. h Other experts recommend 1 1.5 g/m 2 or 25 75 mg/kg daily for 5 days. g h Asymptomatic Patients with Blood Lead Concentration <70 mcg/dL IV or IM Manufacturer recommends 1 g/m 2 daily for 5 days. b However, most experts do not recommend chelation therapy in adult, asymptomatic patients with blood lead concentration> <70 mcg/dL. h Prescribing Limits Pediatric Patients Lead Poisoning Encephalopathy, Symptoms Suggestive of Encephalopathy, or Blood Lead Concentration> 70 mcg/dL IV or IM Maximum 1.5 g/m 2 or 75 mg/kg daily. g h Asymptomatic Patients with Blood Lead Concentration 45 70 mcg/dL IV or IM Maximum 1 g/m 2 or 25 50 mg/kg daily. 111 h Adults Lead Poisoning Encephalopathy, Symptoms Suggestive of Encephalopathy, or Blood Lead Concentration >100 mcg/dL IV or IM Maximum 1.5 g/m 2 or 75 mg/kg daily. g h Asymptomatic Patients with Blood Lead Concentration <70 mcg/dL IV or IM Maximum 1 g/m 2 daily. b Special Populations Hepatic Impairment No specific dosage recommendations for hepatic impairment. b Renal Impairment Reduce dosage in patients with pre-existing mild renal disease; b some experts recommend maximum 50 mg/kg daily in patients with renal impairment. g Immediately discontinue administration if urine flow stops during therapy. b Lead Poisoning Lead Nephropathy IV or IM Dosage regimens may be repeated at monthly intervals until lead excretion is reduced toward normal. b Table 1. Dosage for Treatment of Lead Poisoning in Adults with Lead Nephropathyb S cr Recommended Dosage 2 1 g daily for 5 days 2 3 500 mg every 24 hours for 5 days 3 4 500 mg every 48 hours for 3 doses> 4 500 mg once weekly Geriatric Patients No specific geriatric dosage recommendations. b Cautions for Calcium Disodium Versenate Contraindications Anuria. b Active renal disease. b Hepatitis. b Warnings/Precautions Warnings Possible Prescribing and Dispensing Errors Ensure accuracy of prescription. c d Similarity in names of edetate calcium disodium (Versenate ) and edetate disodium (Endrate ; no longer commercially available in the US) has resulted in errors and adverse reactions, including fatalities. c d Fatalities reported when edetate disodium has been administered instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for chelation therapies or other nonapproved uses. c When prescribing, use full product name; do not use the abbreviation EDTA when prescribing, dispensing, or administering edetate calcium disodium. c Fatality Risk Risk of potentially fatal toxic effects, including renal tubular necrosis, which may result in fatal nephrosis; follow recommended dosage schedule and do not exceed recommended daily dosage. a b (See Prescribing Limits under Dosage and Administration and see Renal Effects under Cautions.) Potentially fatal increase in intracranial pressure with rapid IV infusion in patients with lead encephalopathy; administer by slow IV infusion or IM injection. a b Major Toxicities Renal Effects Potential for dose-dependent nephrotoxicity, a b including renal tubular necrosis, proteinuria, and microscopic hematuria. b (See Fatality Risk under Cautions.) Rarely, changes in distal renal tubules and glomeruli, glycosuria, presence of large renal epithelial cells in urinary sediment, increased urinary frequency, and urgency may occur. a Immediately discontinue therapy at first sign of renal toxicity (i.e., increasing proteinuria, increased number of erythrocytes, or if large renal epithelial cells are present). b Hydropic degeneration of proximal renal tubular cells may occur; cells usually recover following discontinuance of therapy. 109 b Adequate diuresis prior to initiation of therapy may reduce drug-induced renal damage; monitor urine flow throughout therapy and stop therapy if anuria or severe oliguria develops. a b Administer IV fluids prior to first dose to establish urine flow, particularly in acutely ill patients at risk of dehydration from vomiting; a b however, avoid excess fluid in patients with concurrent encephalopathy. b Drug may produce same signs of renal damage as lead poisoning (e.g., proteinuria, microscopic hematuria). a General Precautions Cardiovascular Effects Possible ECG changes (e.g., inversion of the T wave); monitor for cardiac rhythm irregularities and ECG changes during therapy. a b Other Therapeutic Measures Chelation therapy should not be a substitute for effective measures to eliminate or reduce further lead exposure. b (See Lead Poisoning under Uses.) Parenteral chelation therapy may increase absorption of lead in the GI tract; consider bowel decontamination as an adjunct to chelation therapy. 111 h Laboratory Monitoring Monitor serum electrolyte concentrations and hepatic function before and daily during each course of therapy in severe cases of lead poisoning and after the second and fifth day of therapy in moderate cases of lead poisoning. b Monitor renal function (e.g., BUN determinations) before and periodically during each course of therapy to detect renal impairment. a Perform urinalyses and urinary sediment determinations daily during therapy in severe cases of lead poisoning and after the second and fifth day of therapy in moderate cases of lead poisoning. b Discontinue therapy immediately at the first sign of renal toxicity, including increasing proteinuria, an increased number of erythrocytes, or presence of large renal epithelial cells. a b Hepatic Effects Potential for reduced alkaline phosphatase levels (possibly due to reduced serum zinc levels and increased serum AST and ALT concentrations); usually return to normal within 48 hours after cessation of therapy. b Metabolic Effects Possible zinc deficiency b or hypercalcemia. b Local Effects Possible thrombophlebitis with IV infusion of concentrations >0.5%; dilute drug before IV infusion to avoid thrombophlebitis. a Possible injection site pain following IM administration; concomitant administration of a local anesthetic may minimize pain. b Specific Populations Pregnancy Category B. b e If drug is indicated, maternal benefit appears to outweigh fetal risk; e however, only use drug during pregnancy if clearly needed. b Lactation Not known whether edetate calcium disodium is distributed into human milk; b however, breastfeeding is contraindicated in women receiving edetate calcium disodium because maternal lead poisoning itself creates a risk of exposing nursing infant to the toxic lead. e Pediatric Use Edetate calcium disodium has been used in the management of lead poisoning in all age groups, including pediatric patients. a Lead encephalopathy occurs more often in pediatric patients, in whom encephalopathy may be incipient and overlooked and results in high mortality rate. b Hepatic Impairment Contraindicated in patients with hepatitis. b (See Contraindications.) Renal Impairment Contraindicated in patients with active renal disease. b (See Contraindications.) Use with extreme caution and in reduced dosage in patients with mild renal disease. 109 b Common Adverse Effects Injection site pain. b Interactions for Calcium Disodium Versenate Specific Drugs Drug Interaction Insulin, zinc-containing preparations Interference with action of insulin due to chelation of zinc b Steroids Potential increased renal toxicity b Calcium Disodium Versenate Pharmacokinetics Absorption Bioavailability Poorly absorbed from the GI tract. b Well absorbed following IM or sub-Q administration. a Onset Following IV administration, urinary excretion of chelated lead begins within about 1 hour; peak excretion of chelated lead occurs within 24 48 hours. a Distribution Extent Distributed primarily into the extracellular fluid; a b in blood, all drug found in plasma. b Does not appear to penetrate erythrocytes. a b Does not enter CSF in any appreciable quantity; a approximately 5% of the plasma concentration is found in spinal fluid. b g Elimination Metabolism Does not undergo metabolism. a b Elimination Route Rapidly excreted by glomerular filtration into the urine unchanged or as metal chelates. a Within 1 hour following IV administration, approximately 50% of drug is excreted; over 95% is excreted within 24 hours. a b Half-life IV administration: 20 60 minutes. a b IM administration: 1.5 hours. a Special Populations Excretion rate not affected by changes in urine flow and/or pH; however, impaired renal function with reduced glomerular filtration delays drug excretion and may increase nephrotoxicity. a Stability Storage Parenteral Injection 15 30 C. a b Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Incompatible with dextrose 10%, invert sugar 10% in water, invert sugar 10% in sodium chloride 0.9%, Ringer s injection, lactated Ringer s injection, and sodium lactate (1/6) M. HID Drug Compatibility HID Admixture Compatibility Incompatible Amphotericin B Hydralazine HCl Actions Forms a stable chelate with divalent and trivalent metals (e.g., lead, zinc, cadmium, manganese, iron, mercury) that can displace calcium in the edetate calcium disodium molecule; b the chelate then can be excreted in urine. a Does not cause substantial changes in serum or total body calcium concentrations following IV administration of large doses because edetate calcium disodium is saturated with calcium. a Theoretically, 1 g of edetate calcium disodium sequesters 620 mg of lead; however, an average of only 3 5 mg of lead is excreted in urine following parenteral administration of 1 g in patients with acute lead poisoning or high concentrations of lead in soft tissues. a Orally administered edetate calcium disodium increases excretion of lead in urine and may enhance absorption of lead. a Parenterally administered edetate calcium disodium chelates and greatly increases urinary excretion of zinc and, to a much lesser extent, cadmium, manganese, iron, and copper. a b Increases excretion of uranium, plutonium, yttrium, and some other heavier radioactive isotopes to a limited extent. a Mercury readily displaces calcium from edetate calcium disodium in vitro; however, patients with mercury poisoning do not respond to the drug. a Advice to Patients Importance of identifying source of lead poisoning and then removing patient from that source. 111 a b h Importance of patient residing in an environment that is lead-free during and after therapy. 103 113 Importance of patients notifying physician immediately if urine output stops for a period of 12 hours. b Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. b Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. b Importance of informing patients of other important precautionary information. b (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Edetate Calcium Disodium Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection 200 mg/mL Calcium Disodium Versenate Graceway AHFS DI Essentials. Copyright 2017, Selected Revisions June 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 100. Centers for Disease Control. Preventing lead poisoning in young children: a statement by the Centers for Disease Control. J Pediatr . 1978; 93:709-20. [PubMed 212543] 101. Piomelli S, Rosen JF, Chisolm JJ Jr et al. Management of childhood lead poisoning. J Pediatr . 1984; 105:523-32. [PubMed 6481529] 102. Pincus D, Saccar CV. Lead poisoning. Am Fam Physician . 1979; 19:120-4. [PubMed 110123] 103. US Department of Health and Human Services. Preventing lead poisoning in young children: a statement by the Centers for Disease Control October 1991. Atlanta, GA: Centers for Disease Control, Center for Environmental Health. 104. Agency for Toxic Substances and Disease Registry and CDC Center for Environmental Health and Injury Control. Childhood lead poisoning United States: report to Congress by the Agency for Toxic Substances and Disease Registry. MMWR Morb Mortal Wkly Rep . 1988; 37:481-5. [PubMed 3135478] 105. Agency for Toxic Substances and Disease Registry. The nature and extent of lead poisoning in children in the United States: a report to Congress. Atlanta, GA: US Department of Health and Human Services, Public Health Service; 1988 Jul. 106. American Academy of Pediatrics Committee on Environmental Hazards and Committee on Accident and Poison Prevention. Statement on childhood lead poisoning. Pediatrics . 1987; 79:457-65. [PubMed 3822655] 107. Markowitz ME, Rosen JF. Assessment of lead stores in children: validation of an 8-hour CaNa 2 EDTA provocative test. J Pediatrics . 1984; 104:337-2. 108. Weinberger HL, Post EM, Schneider T et al. An analysis of 248 initial mobilization tests performed on an ambulatory basis. Am J Dis Child . 1987; 141:1266-70. [PubMed 3120575] 109. 3M Pharmaceuticals. Calcium disodium Versenate (edetate calcium disodium injection) prescribing information. Northridge, CA; 1997 Aug. 110. Markowitz ME, Rosen JF, Bijur PE. Effects of iron deficiency on lead excretion in children with moderate lead intoxication. J Pediatr . 1990; 116:360-4. [PubMed 2106578] 111. Committee on Drugs, American Academy of Pediatrics. Treatment guidelines for lead exposure in children. Pediatrics . 1995; 96:155-60. [PubMed 7596706] 112. Schwartz J, Landrigan PJ, Feldman RG et al. Threshold effect in lead-induced peripheral neuropathy. J Pediatr . 1988; 112:12-17. [PubMed 2826742] 113. Committee on Environmental Health, American Academy of Pediatrics. Lead poisoning: from screening to primary prevention. Pediatrics . 1993; 92:176-83. [PubMed 8516071] a. AHFS Drug Information 2007. McEvoy GK, ed. Edetate Calcium Disodium. Bethesda, MD: American Society of Health-System Pharmacists; 2007. From AHFS Drug Information website. b. Graceway Pharmaceuticals. Calcium disodium Versenate (edetate calcium disodium injection) prescribing information. Lake Forest, IL; July 2004. c. FDA Public Health Advisory: Edetate disodium (marketed as Endrate and generic products); 2008. From FDA website. d. MMWR. Deaths associated with hypocalcemia from chelation therapy - Texas, Pennsylvania, and Oregon, 2003-2005. March 2006: 55(08): 204-207. Centers for Disease Control. From CDC website. e. Briggs GC, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005: 536-538. f. . American Academy of Pediatrics, Committee on Environmental Health. Lead exposure in children: prevention, detection, and management. Pediatrics. 2005; 116:1036-46. g. Howland, MA. Edetate Calcium Disodium (CaNa 2 EDTA). In: Flomenbaum NE, Goldfrank LR, Hoffman RS et al, eds. Goldfrank s toxicologic ermergencies. 8th ed. New York: McGraw-Hill; 2006:1331-3. h. Henretig FM. Lead. In: Flomenbaum NE, Goldfrank LR, Hoffman RS et al, eds. Goldfrank s toxicologic emergencies. 8th ed. New York: McGraw-Hill; 2006:1308-24. HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:608. Next Interactions Print this page Add to My Med List More about Calcium Disodium Versenate (edetate calcium disodium) Side Effects During Pregnancy Dosage Information Drug Interactions Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antidotes Consumer resources Calcium Disodium Versenate Professional resources Calcium Disodium Versenate (FDA) Edetate Calcium Disodium (AHFS Monograph) Related treatment guides Lead Poisoning, Mild Lead Poisoning, Severe ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Valeant Pharmaceuticals International, Inc. Drug Class Antidotes Related Drugs Lead Poisoning, Mild n/a Lead Poisoning, Severe Chemet , succimer , More... 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of issues of safety Deoxycholic Acid Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pronunciation (dee ox i KOE lik AS id) Index Terms ATX-101 Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Solution, Subcutaneous: Kybella: 20 mg/2 mL (2 mL) [contains benzyl alcohol] Slideshow Drug Treatments for Rheumatoid Arthritis - What Are Your Options? Brand Names: U.S. Kybella Pharmacologic Category Lipolytic Pharmacology Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue. Absorption Rapid after subcutaneous injection Metabolism Not metabolized to any significant extent Excretion Feces (as intact drug) Time to Peak 18 minutes Duration of Action Post treatment deoxycholic plasma levels return to endogenous range within 24 hours Protein Binding 98% Use: Labeled Indications Submental convexity/fullness: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations of use: The safe and effective use for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. Contraindications Presence of infection at the injection sites Dosing: Adult Submental convexity/fullness: SubQ: Inject into submental subcutaneous fat tissue at an area-adjusted dose of 2 mg/cm 2 (maximum per treatment: 50 injections spaced 1 cm apart [0.2 mL each; total 10 mL]). Maximum number of treatments: 6 treatments spaced at 1-month intervals. Dosing: Renal Impairment There are no dosage adjustments provided in the manufacturer's labeling. Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, doses administered are ~3% of total body acid pool and are unlikely to be affected by hepatic impairment. Reconstitution Do not dilute. Administration Subcutaneous: Prior to each treatment, palpate the submental area to ensure sufficient submental fat in the target treatment area. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites; do not inject outside the defined parameters. Using a large bore needle, draw 1 mL into a sterile 1 mL syringe. Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL into the preplatysmal fat next to each of the marked injection sites by advancing the needle perpendicular to the skin. Inject into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer; avoid injection into the postplatysmal fat. Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied. Ice/cold packs, topical and/or injectable local anesthesia (eg, lidocaine) may be used. Discard any remaining solution after use. Storage Store intact vials at 20 C to 25 C (68 F to 77 F); excursions are permitted between 15 C and 30 C (59 F and 86 F). Drug Interactions Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy Anticoagulants: May enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy Adverse Reactions Frequency not always defined. Cardiovascular: Hypertension (3%), presyncope, syncope Central nervous system: Paresthesia (14%), headache (8%), neuropathy (4%, marginal mandibular) Dermatologic: Injection site pruritus (12%), skin tightness (5% injection site), skin discoloration at injection site, urticaria at injection site Gastrointestinal: Dysphagia (2%), nausea (2%) Hematologic & oncologic: Lymphadenopathy Local: Injection site reaction (96%), swelling at injection site (20% to 87%), bruising at injection site (72%), hematoma at injection site (72%), pain at injection site (16% to 70%), injection site numbness (42% to 66%), erythema at injection site (27%), induration at injection site (23%), injection site nodule (13%), warm sensation at injection site (4%), bleeding at injection site Neuromuscular & skeletal: Neck pain Respiratory: Oropharyngeal pain (3%) Warnings/Precautions Concerns related to adverse effects: Bruising/bleeding: Injection site hematoma or bruising has been reported. Dysphagia: Dysphagia has occurred in the setting of administration site reactions (eg, pain, swelling, and submental area induration). All occurrences resolved spontaneously (median 34 days; range 1 to 81 days). Nerve injury: Marginal mandibular nerve injury (eg, asymmetric smile or facial muscle paresis) has been reported. All injuries resolved spontaneously (median 44 days; range 1 to 298 days). Do not inject into or in close proximity to the marginal mandibular branch of the facial nerve. Disease-related concerns: Bleeding abnormalities: Use with caution in patients with bleeding abnormalities or who are currently taking antiplatelet or anticoagulant therapy. Excessive bleeding or bruising in treatment area may occur. Dysphagia: Avoid use in patients with current or prior history of dysphagia; condition may be exacerbated. Other warnings/precautions: Administration: For subcutaneous use only. Do not inject into or in close proximity (1 to 1.5 cm) of salivary glands, lymph nodes, or muscles. To avoid injury to the marginal mandibular nerve, do not inject above the inferior border of the mandible; do not inject within a region defined by a 1 to 1.5 cm line below the inferior border (from the angle of the mandible to the mentum); and only inject within the target submental fat treatment area. Appropriate use: Screen patients for other causes of submental convexity/fullness (eg, thyromegaly, cervical adenopathy). Use caution in patients with prior submental surgical or aesthetic treatments; changes in anatomy or landmarks, presence of scar tissue may impact safe administration or aesthetic result. Carefully consider use in patients with excessive skin laxity or prominent platysmal bands or other conditions for which reduction of submental fat may be aesthetically undesirable. Monitoring Parameters Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury. Pregnancy Considerations Adverse events have been observed in some animal reproduction studies. Pregnant women and women of reproductive potential not using effective contraception were excluded from initial studies (McDiarmid, 2014; Rzany, 2014). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience injection site bleeding, pain, or area that feels hard or numb, or headache. Have patient report immediately to prescriber facial weakness, uneven smile, severe injection site irritation, or difficulty swallowing (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about deoxycholic acid Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 3 Reviews Add your own review/rating Drug class: miscellaneous uncategorized agents Consumer resources Deoxycholic acid Deoxycholic acid Subcutaneous (Advanced Reading) Professional resources Deoxycholic Acid (AHFS Monograph) Other brands: Kybella Related treatment guides Submental Fullness} Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Deoxycholic acid Rating 3 User Reviews 6.3 /10 3 User Reviews 6.3 Rate it! Drug Class Miscellaneous uncategorized agents Related Drugs miscellaneous uncategorized agents Accutane , isotretinoin , anagrelide , Esbriet , Claravis Submental Fullness Kybella , More...} } motivated


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