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this may CLTC 100 MR Generic Name: chlortetracycline hydrochloride Dosage Form: FOR ANIMAL USE ONLY CLTC 100 MR (chlortetracycline hydrochloride) TYPE A MEDICATED ARTICLE Active Drug Ingredient: Chlortetracycline hydrochloride . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 g/lb CAUTION: For use in manufacturing medicated animal feeds only. CAUTION : Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety. Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions seek prompt medical treatment if such reactions are suspected. Directions for Use For premix quantities less than 1 lb. Mix the proper amount of premix with at least 10 lb of feed ingredients to make a preblend. Add the preblend to the remaining feed ingredients and mix thoroughly. Indications for Use Use Level of CLTC lb of CLTC 100 MR/ton CALVES Milk Replacers or Starter Feeds For calves (up to 250 lb) for the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline. 10 mg/lb body weight daily Limit use to 5 days 20 1 Calves (up to 250 lb) for increased rate of weight gain and improved feed efficiency 0.1 mg/lb body weight daily 0.2 1 CALVES Hand Fed Feed Calves (250-400 lb) for increased rate of weight gain and improved feed efficiency 25-70 mg/head/day 0.25-0.7 2 WARNING: At 10 mg/lb use level, withdraw 10 days before slaughter. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. 1 Calf weighing 100 lb consuming 1 lb of dry starter feed or 1 lb of milk replacer mixed with one gallon of water. 2 Based on consumption of 2 lb of resulting feed per head per day. STORE IN A DRY, COOL PLACE FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS. NOT FOR HUMAN USE. RESTRICTED DRUG (CALIFORNIA) USE ONLY AS DIRECTED. CLTC is a registered trademark of Phibro Animal Health for chlortetracycline. Phibro Animal Health, Inc., Ridgefield Park, NJ 07660. Net Weight 50 lb (22.7 kg) NADA #92-287, Approved by FDA 101-8033-05 CLTC 100 MR chlortetracycline hydrochloride powder Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-6300 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORTETRACYCLINE HYDROCHLORIDE (CHLORTETRACYCLINE) CHLORTETRACYCLINE HYDROCHLORIDE 100 g in 0.45 kg Inactive Ingredients Ingredient Name Strength DEXTROSE Packaging # Item Code Package Description 1 NDC:66104-6300-0 22.7 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA092287 02/16/1996 Labeler - Phibro Animal Health (006989008) Revised: 08/2009 Phibro Animal Health Print this page FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More growing old


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lack of awareness [50:<50 mL/minute. 1 (See Geriatric Use under Cautions.) Gender or Race Dosage adjustment not required. 1 Cautions for Aptiom Contraindications Known hypersensitivity to eslicarbazepine acetate or oxcarbazepine. 1 (See Sensitivity Reactions under Cautions.) Warnings/Precautions Sensitivity Reactions Serious Dermatologic Reactions Serious dermatologic reactions, including Stevens-Johnson syndrome (SJS), reported with eslicarbazepine acetate. 1 Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and SJS, have been reported in patients receiving oxcarbazepine or carbamazepine, which are chemically related to eslicarbazepine acetate. 1 13 Monitor patients for dermatologic reactions. 1 If a dermatologic reaction occurs, discontinue eslicarbazepine acetate unless reaction is clearly not drug related. 1 Do not use in patients who developed a previous dermatologic reaction to either oxcarbazepine or eslicarbazepine acetate. 1 (See Contraindications under Cautions.) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity DRESS, also known as multiorgan hypersensitivity, reported; may be fatal or life-threatening. 1 Clinical presentation is variable but typically presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement (e.g., hepatitis, nephritis, hematologic abnormalities, myocarditis, myositis sometimes resembling an acute viral infection); eosinophilia is often present. 1 Monitor patients for possible hypersensitivity reactions; immediately evaluate patients who develop possible signs and symptoms of DRESS. 1 Discontinue drug if another cause cannot be established. 1 Do not use eslicarbazepine acetate in patients with a prior DRESS reaction to either oxcarbazepine or eslicarbazepine acetate. 1 (See Contraindications under Cautions.) Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema, which can be fatal, reported. 1 Monitor patients for possible hypersensitivity reactions (e.g., breathing difficulties, swelling). 1 If such reactions occur, discontinue drug if cannot establish another cause. 1 Do not use eslicarbazepine acetate in patients with a prior anaphylactic-type reaction to either oxcarbazepine or eslicarbazepine acetate. 1 (See Contraindications under Cautions.) Other Warnings and Precautions Suicidality Risk Increased risk of suicidality (suicidal behavior or ideation) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%). 1 10 11 12 Increased suicidality risk was observed 1 week after initiation of anticonvulsant therapy and continued through 24 weeks. 1 10 11 Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions. 1 10 Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression. 1 10 11 12 Anxiety, agitation, hostility, insomnia, and mania may be precursors to emerging suicidality. 1 10 Balance risk of suicidality with risk of untreated illness. 1 10 Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality. 1 12 If suicidal thoughts or behavior emerges during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself. 1 12 (See Advice to Patients.) Hyponatremia Clinically important hyponatremia (serum sodium concentrations> <125 mEq/L) reported. 1 2 Hyponatremia is dose related and generally develops during the first 8 weeks of therapy, possibly as early as after 3 days. 1 Serious, life-threatening complications, which necessitated hospitalization and drug discontinuance, occurred in some patients. 1 Concurrent hypochloremia also was present. 1 Consider monitoring serum sodium and chloride concentrations during maintenance therapy, particularly in patients concurrently receiving other drugs known to decrease serum sodium concentrations (e.g., carbamazepine, desmopressin, diuretics). 1 25 Measure sodium and chloride concentrations in patients who develop symptoms of hyponatremia (e.g., nausea, vomiting, malaise, headache, lethargy, confusion, irritability, muscle weakness or spasms, obtundation, increase in seizure frequency or severity). 1 If hyponatremia occurs, dosage reduction or drug discontinuance may be necessary. 1 Neurologic Effects Adverse neurologic effects may occur; dizziness, disturbances in gait or coordination (e.g., ataxia, vertigo, balance disorder, nystagmus, abnormal coordination), somnolence and fatigue, cognitive dysfunction (e.g., memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, psychomotor retardation), and visual changes (e.g., diplopia, blurred vision, visual impairment) reported. 1 These effects are dose-related and generally occur during dosage titration. 1 Risk of some adverse neurologic effects (e.g., dizziness, disturbances in gait or coordination, visual changes) appears to be greater in patients 60 years of age. 1 Dizziness and diplopia occur more frequently during concurrent use of carbamazepine; dosage adjustment of eslicarbazepine acetate and/or carbamazepine may be necessary. 1 (See Specific Drugs under Interactions.) Caution patients about possible neurologic effects during therapy. 1 (See Advice to Patients.) Discontinuance of Therapy Abrupt withdrawal of anticonvulsants may result in increased seizure frequency and status epilepticus in patients with seizure disorders. 1 Withdraw eslicarbazepine acetate gradually. 1 Drug-induced Liver Injury Adverse hepatic effects, ranging from mild to moderate transaminase elevations (> 3 times the ULN) to rare cases with concomitant elevations of total bilirubin (>2 times the ULN) reported. 1 Manufacturer recommends baseline liver function tests. 1 Discontinue eslicarbazepine acetate in patients with jaundice or other evidence of substantial liver injury (i.e., laboratory evidence). 1 Abnormal Thyroid Function Tests Dose-dependent decreases in serum thyroid hormone concentrations (free and total triiodothyronine [T 3 ] and thyroxine [T 4 ]) observed. 1 These changes were not associated with other abnormal thyroid function test results suggesting hypothyroidism. 1 Clinical evaluation of abnormal thyroid test results is recommended. 1 Specific Populations Pregnancy Category C. 1 North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients and caregivers); NAAED registry information also available on the website . 1 Lactation Distributed into milk. 1 Discontinue nursing or the drug. 1 Pediatric Use Safety and efficacy not established in patients <18 years of age; not FDA-labeled for use in pediatric patients. 1 23 However, pharmacokinetics, efficacy, and tolerability have been studied in a limited number of pediatric patients 2 17 years of age with partial-onset seizures. 22 23 Geriatric Use Insufficient experience in patients 65 years of age to establish efficacy in this population. 1 Patients 60 years of age appear to have a greater risk of adverse neurologic effects. 1 (See Neurologic Effects under Cautions.) Although pharmacokinetics do not appear to be affected by age independently (see Absorption: Special Populations, under Pharmacokinetics), consider greater frequency of renal impairment and concomitant medical conditions and medications when selecting dosage in geriatric patients. 1 Dosage adjustment is necessary if Cl cr> <50 mL/minute. 1 Hepatic Impairment Pharmacokinetics not affected by moderate hepatic impairment; dosage adjustment not necessary in patients with mild or moderate hepatic impairment. 1 Not studied in patients with severe hepatic impairment; use not recommended. 1 Renal Impairment Eslicarbazepine and other metabolites are primarily eliminated by renal excretion. 1 (See Absorption: Special Populations, under Pharmacokinetics.) Dosage adjustment not necessary in patients with mild renal impairment. 1 However, dosage adjustment is recommended in patients with moderate or severe renal impairment (Cl cr> <50 mL/minute). 1 (See Renal Impairment under Dosage and Administration.) Repeated hemodialysis removes eslicarbazepine and other metabolites from systemic circulation in patients with end-stage renal disease. 1 Common Adverse Effects Dizziness, 1 2 3 4 somnolence, 1 2 3 4 nausea, 1 2 3 4 vomiting, 1 2 3 4 headache, 1 2 3 4 diplopia, 1 2 3 4 fatigue, 1 3 vertigo, 1 2 4 ataxia, 1 blurred vision, 1 3 tremor. 1 Interactions for Aptiom Moderate inhibitor of CYP2C19; may induce CYP3A4. 1 8 Does not appear to inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2D6, 2E1, 3A4, nor to induce CYP1A2 or phase II hepatic enzymes involved in glucuronidation or sulfation. 1 8 Mild activation of UGT1A1-mediated glucuronidation observed in vitro. 1 Autoinduction of metabolism not observed. 1 Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes Potential pharmacokinetic interactions (e.g., decreased eslicarbazepine exposure) with inducers of CYP3A4; higher dosages of eslicarbazepine acetate may be necessary. 1 8 Potential pharmacokinetic interactions (e.g., decreased substrate concentrations) with concomitant use of CYP3A4 substrates; higher dosages of the CYP3A4 substrate may be necessary. 1 27 Potential pharmacokinetic interactions (e.g., increased substrate concentrations) with concomitant use of CYP2C19 substrates. 1 27 Drugs associated with Hyponatremia Possible increased risk of hyponatremia during concomitant use of other drugs associated with hyponatremia; consider monitoring sodium and chloride concentrations during concurrent therapy. 1 25 Specific Drugs Drug Interaction Comments Carbamazepine Decreased AUC of eslicarbazepine by 25 47%; 1 8 19 pharmacokinetics of carbamazepine not substantially affected 1 8 19 Increased risk of adverse neurologic effects (e.g., diplopia, dizziness); 1 8 19 increased risk of hyponatremia 1 25 Adjust dosage of eslicarbazepine acetate and/or carbamazepine based on efficacy and tolerability; 1 consider monitoring sodium and chloride concentrations 1 25 Clobazam Eslicarbazepine exposure generally not substantially affected 1 Possible increased clobazam exposure; 1 19 however, clearance of clobazam not affected in a pharmacokinetic analysis 8 No dosage adjustments necessary 1 8 19 Contraceptives, oral Dosage-dependent decreases in ethinyl estradiol and levonorgestrel concentrations; possible reduced contraceptive efficacy 1 8 Additional or nonhormonal methods of birth control recommended during eslicarbazepine acetate therapy and for at least 1 menstrual cycle following discontinuance 1 8 Desmopressin Increased risk of hyponatremia 1 25 Consider monitoring sodium and chloride concentrations 1 25 Digoxin No clinically important effect on digoxin AUC 1 8 19 Digoxin dosage adjustment not necessary 1 19 Diuretics Increased risk of hyponatremia 1 25 Consider monitoring sodium and chloride concentrations 1 25 Gabapentin Eslicarbazepine exposure generally not substantially affected 1 Systemic exposure of gabapentin not affected by eslicarbazepine acetate 1 8 No dosage adjustments necessary 1 8 19 HMG-CoA reductase inhibitors (statins) Rosuvastatin: Decreased AUC of rosuvastatin by 36 39% 1 25 Simvastatin: Decreased AUC of simvastatin (a CYP3A4 substrate) by 41 61% 1 8 25 26 Adjust dosage of rosuvastatin or simvastatin if clinically significant change in serum lipids observed 1 8 26 Lamotrigine Eslicarbazepine exposure generally not substantially affected 1 Systemic exposure of lamotrigine not affected by eslicarbazepine acetate 1 8 No dosage adjustments necessary 1 8 19 Levetiracetam Eslicarbazepine exposure generally not substantially affected 1 Systemic exposure of levetiracetam not affected by eslicarbazepine acetate 1 8 No dosage adjustments necessary 1 8 19 Metformin No clinically important effect on metformin exposure 1 8 Metformin dosage adjustment not necessary 1 Omeprazole Possible increased exposure of omeprazole (a CYP2C19 substrate) 1 Oxcarbazepine Eslicarbazepine is the S -enantiomer of the main active metabolite of oxcarbazepine; possible increased risk of adverse effects 1 6 7 8 Avoid concurrent use 1 Phenobarbital Possible decreased eslicarbazepine exposure; phenobarbital exposure not affected 1 8 19 Increased eslicarbazepine acetate dosage may be necessary 1 Phenytoin Possible decreased eslicarbazepine exposure and increased phenytoin exposure 1 8 19 Increased eslicarbazepine acetate dosage may be necessary 1 8 19 Monitor serum phenytoin concentrations; adjust phenytoin dosage based on clinical response and therapeutic drug monitoring 1 8 19 Primidone Possible decreased eslicarbazepine exposure 1 19 Increased eslicarbazepine acetate dosage may be necessary 1 Topiramate Systemic exposure of eslicarbazepine not substantially affected 1 24 Topiramate exposure decreased by 18% 1 8 19 24 No dosage adjustments necessary 1 8 19 24 Valproate Eslicarbazepine exposure generally not substantially affected 1 Systemic exposure of valproate not affected by eslicarbazepine acetate 1 8 No dosage adjustments necessary 1 8 19 Warfarin Decreased AUC of S -warfarin by 23%; no effect on R -warfarin 1 8 Monitor INR 1 8 Aptiom Pharmacokinetics Absorption Bioavailability Following oral administration, eslicarbazepine acetate is rapidly and extensively metabolized by hydrolytic first-pass metabolism to eslicarbazepine; plasma concentrations of the parent drug mostly undetectable. 1 4 6 7 8 Food Food does not affect the pharmacokinetics of eslicarbazepine acetate. 1 8 Plasma Concentrations Peak concentrations of eslicarbazepine occur 1-4 hours following oral administration of eslicarbazepine acetate. 1 8 Exhibits linear and dose-proportional pharmacokinetics at recommended dosages. 1 Steady-state eslicarbazepine concentrations attained 4 5 days after once-daily dosing. 1 Special Populations Pharmacokinetics not affected by moderate hepatic impairment (Child-Pugh score 7 9). 1 Mild renal impairment: Systemic exposure increased by 62%. 1 Moderate and severe renal impairment: Systemic exposure was 2- and 2.5-fold higher, respectively. 1 Pharmacokinetic profile similar in geriatric individuals with Cl cr> 60 mL/minute compared with younger healthy adults (18 40 years of age). 1 7 Distribution Extent Distributes into human milk. 1 Plasma Protein Binding <40% (independent of plasma concentration). 1 Elimination Metabolism Rapidly and extensively metabolized to eslicarbazepine via hydrolytic first-pass metabolism. 1 Eslicarbazepine accounts for 91% of systemic exposure; systemic exposure to minor active metabolites of R -licarbazepine and oxcarbazepine is 5 and 1%, respectively, while the inactive glucuronides of these metabolites account for approximately 3% of systemic exposure. 1 6 8 Elimination Route Eslicarbazepine and other metabolites primarily eliminated by renal excretion; over 90% of a dose is recovered in urine as unchanged eslicarbazepine (approximately two-thirds) or as glucuronide conjugates (approximately one-third). 1 Renal clearance of eslicarbazepine is substantially lower than GFR in healthy individuals with normal renal function, suggesting that renal tubular reabsorption occurs. 1 Half-life 13 20 hours (in patients with epilepsy). 1 Special Populations Clearance is reduced in patients with renal impairment and correlates with Cl cr . 1 Eslicarbazepine and other metabolites are cleared by repeated hemodialysis in patients with end-stage renal disease. 1 Pharmacokinetics not substantially affected by gender or race. 1 Stability Storage Oral Tablets 20 25 C (may be exposed to 15 30 C). 1 Actions Exact mechanism of anticonvulsant action not fully elucidated; however, eslicarbazepine acetate, like carbamazepine and oxcarbazepine, is known to reduce excitability of rapidly firing neurons by inhibiting voltage-gated sodium channels. 1 4 6 7 9 27 Eslicarbazepine binds to voltage-gated sodium channels with a higher affinity for the inactivated state than for the resting state allowing selective inhibition of more rapidly firing neurons. 6 7 9 Eslicarbazepine is structurally similar to carbamazepine and is the S -enantiomer of racemic licarbazepine, the major metabolite of oxcarbazepine (10-monohydroxy derivative [MHD]). 6 7 8 29 Advice to Patients Importance of providing patient with a copy of manufacturer's patient information (medication guide) when therapy is initiated and each time the drug is dispensed. 1 Importance of taking only as prescribed. 1 Risk of suicidality (anticonvulsants, including eslicarbazepine acetate, may increase risk of suicidal thoughts or actions in about 1 in 500 people). 1 10 12 Importance of patients, family members, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one's life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions). 1 10 Importance of informing patients and caregivers about the risk of serious, potentially fatal skin reactions. 1 Importance of informing patients about the signs and symptoms that may signal a serious skin reaction and instructing patients to immediately consult with their clinician if a skin reaction occurs during treatment. 1 Risk of drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity. 1 Importance of advising patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their clinician immediately. 1 Importance of advising patients of life-threatening symptoms suggesting anaphylaxis or angioedema (e.g., swelling of the face, eyes, tongue; difficulty swallowing or breathing) that may occur. 1 Importance of instructing patients to immediately report such symptoms to their clinician. 1 Importance of advising patients that eslicarbazepine acetate can cause hyponatremia, particularly in patients receiving other drugs that can lower serum sodium concentrations. 1 Patients should be advised to promptly contact their clinician if they develop any symptoms of hyponatremia (e.g., nausea, tiredness, lack of energy, irritability, confusion, muscle weakness or spasms, increase in seizure frequency or severity). 1 Importance of advising patients of risk of adverse neurologic effects such as dizziness, gait disturbance, somnolence, fatigue, cognitive dysfunction, and visual disturbances. 1 These effects are more likely to occur during the dosage titration phase (compared with the maintenance phase). 1 Importance of advising patients not to drive, operate machinery, or engage in other hazardous activities until the effects of drug therapy are known. 1 Importance of advising patients not to discontinue eslicarbazepine acetate therapy without consulting with their clinician. 1 The drug should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. 1 Importance of informing women that eslicarbazepine acetate can substantially decrease the effectiveness of hormonal contraceptives. 1 8 Women of childbearing potential should be advised to use additional or alternative nonhormonal forms of contraception during therapy and for at least one menstrual cycle after discontinuance or until otherwise instructed by their clinician. 1 8 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of clinicians informing women about the existence of and encouraging enrollment in the pregnancy registry (see Pregnancy under Cautions). 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., kidney or liver disease) or history of suicidality, depression, or mood disorder. 1 Importance of informing patients of other important precautionary information. 1 (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. Eslicarbazepine Acetate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets 200 mg Aptiom (scored) Sunovion 400 mg Aptiom Sunovion 600 mg Aptiom (scored) Sunovion 800 mg Aptiom (scored) Sunovion AHFS DI Essentials. Copyright 2017, Selected Revisions April 23, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Sunovion Pharmaceuticals Inc. Aptiom (eslicarbazepine acetate) tablets prescribing information. Marlborough, MA; 2013 Nov. 2. Elger C, Halász P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia . 2009; 50:454-63. [PubMed 19243424] 3. Ben-Menachem E, Gabbai AA, Hufnagel A et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res . 2010; 89:278-85. [PubMed 20299189] 4. Gil-Nagel A, Lopes-Lima J, Almeida L et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand . 2009; 120:281-7. [PubMed 19832771] 5. Food and Drug Administration. Center for Drug Evaluation and Research: Application number 022416Orig1s000: Summary Review. From FDA website. 6. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics . 2007; 4:88-96. [PubMed 17199020] 7. Almeida L, Falcão A, Maia J et al. Single-dose and steady-state pharmacokinetics of eslicarbazepine acetate (BIA 2-093) in healthy elderly and young subjects. J Clin Pharmacol . 2005; 45:1062-6. [PubMed 16100301] 8. Bialer M, Soares-da-Silva P. Pharmacokinetics and drug interactions of eslicarbazepine acetate. Epilepsia . 2012; 53:935-46. [PubMed 22612290] 9. Bonifácio MJ, Sheridan RD, Parada A et al. Interaction of the novel anticonvulsant, BIA 2-093, with voltage-gated sodium channels: comparison with carbamazepine. Epilepsia . 2001; 42:600-8. [PubMed 11380566] 10. US Food and Drug Administration. FDA Alert: Information for healthcare professionals: suicidal behavior and ideation and antiepileptic drugs. Rockville, MD; 2008 Jan 31; updated 2008 Dec 16. From the FDA website. 11. US Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website. 12. US Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website. Accessed 2012 May 4. 13. Novartis Pharmaceuticals Corporation. Trileptal (oxcarbazepine) film-coated tablets and oral suspension prescribing information. East Hanover, NJ; 2014 Jul. 15. US Food and Drug Administration. Information for healthcare professionals: dangerous or even fatal skin reactions - carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics). Rockville, MD; 2007 Dec 12. From the FDA website. 16. Yip VL, Marson AG, Jorgensen AL et al. HLA genotype and carbamazepine-induced cutaneous adverse drug reactions: a systematic review. Clin Pharmacol Ther . 2012; 92:757-65. [PubMed 23132554] 18. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol . 2013; 149:1025-32. [PubMed 23884208] 19. Sunovion Pharmaceuticals Inc. Aptiom (eslicarbazepine acetate) - drug interactions evaluations. Marlborough, MA; 2014. 20. Halász P, Cramer JA, Hodoba D et al. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia . 2010; 51:1963-9. [PubMed 20662896] 21. Hufnagel A, Ben-Menachem E, Gabbai AA et al. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res . 2013; 103:262-9. [PubMed 22871333] 22. Almeida L, Minciu I, Nunes T et al. Pharmacokinetics, efficacy, and tolerability of eslicarbazepine acetate in children and adolescents with epilepsy. J Clin Pharmacol . 2008; 48:966-77. [PubMed 18508949] 23. Sunovion Pharmaceuticals Inc. Aptiom (eslicarbazepine acetate) - data relating to pediatric patients. Marlborough, MA; 2014. 24. Nunes T, Sicard E, Almeida L et al. Pharmacokinetic interaction study between eslicarbazepine acetate and topiramate in healthy subjects. Curr Med Res Opin . 2010; 26:1355-62. [PubMed 20377319] 25. Eisai Ltd. Zebinix 800mg tablets summary of product characteristics. Hertfordshire, UK; 2014 May 28. 26. Falcâo A, Pinto R, Nunes T et al. Effect of repeated administration of eslicarbazepine acetate on the pharmacokinetics of simvastatin in healthy subjects. Epilepsy Res . 2013; 106:244-9. [PubMed 23726291] 27. Anon. Eslicarbazepine acetate (Aptiom) for epilepsy. Med Lett Drugs Ther . 2014; 56:42. [PubMed 24869714] 28. Ben-Menachem E. Eslicarbazepine acetate: a well-kept secret?. Epilepsy Curr . 2010; 10:7-8. [PubMed 20126330] 29. Brown ME, El-Mallakh RS. Role of eslicarbazepine in the treatment of epilepsy in adult patients with partial-onset seizures. Therapeutics Clin Risk Manag . 2010; 6:103-9. Next Interactions Print this page Add to My Med List More about Aptiom (eslicarbazepine) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 10 Reviews Add your own review/rating Drug class: dibenzazepine anticonvulsants Consumer resources Aptiom Aptiom (Advanced Reading) Professional resources Aptiom (FDA) Eslicarbazepine Acetate (AHFS Monograph) Related treatment guides Seizures> ]} 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 C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 4 years Approval History FDA approved 2013 Manufacturer Sunovion Pharmaceuticals Inc. Drug Class Dibenzazepine anticonvulsants Related Drugs Seizures diazepam , levetiracetam , topiramate , Valium , Topamax , Keppra , primidone , Dilantin , oxcarbazepine , phenobarbital , phenytoin , Trileptal , pyridoxine , Vimpat , zonisamide , valproic acid , Mysoline , Vitamin B6 , lacosamide , Zonegran , Trokendi XR , Depakene , Luminal , More... Aptiom Rating 10 User Reviews 6.7 /10 10 User Reviews 6.7 Rate it! Aptiom Images Aptiom 400 mg (ESL 400 ) View all images} } surgical procedure


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treatments By the third week of January, many New Year s diets have been broken, and it s time for some sound advice on achieving a quality lifestyle instead. Ninety-five percent of all women don t have the ideal body type portrayed by the media, and up to 60 percent of all women and girls eat in a dysfunctional fashion. Men and women both experience pressure to achieve an unrealistic physical ideal, while the $30 billion diet industry profits from our national preoccupation with size. This year, choose to celebrate Healthy Weight Week and focus on feeling positive. Accept and enjoy your remarkable body just as it is! Here are some suggestions: Stop dieting Instead of dieting, start eating normally. What s normal eating? Eating when you re hungry, listening to your body and stopping when you feel full. If dieting leaves you unsatisfied and frustrated, try eating regular meals (typically three) at the same time each day and snacking once or twice if you re hungry. Focus on the total person You are more than individual body parts. Instead of focusing on particular physical features, remember that you are a unique person with a range of special gifts and talents. Do you have a knack with computers? Do you enjoy singing in a choir? Find time for the activities that make you feel good about yourself. Enjoy your body The greatest lifestyle improvement is for sedentary people to become active. Treat your body well. Instead of exercising to reach a target weight, savor the joy of movement for its own sake. Spend a few minutes walking with a friend each day or look for small opportunities to become more active: Take the stairs instead of the elevator or deliberately park as far as possible from the entrance to a store. Have fun being physical without worrying about weight. Practice positive thinking Positive thinking is an essential part of healthy living, directly affecting our physical and mental well-being. Can t take a compliment? Practice by complimenting yourself each day. Focus on your achievements, skills and lifestyle choices. Establish a support network of positive thinkers, and avoid those who remain focused on physical appearances. Accept who you are, and be proud of who you are! Respect others One of the best ways to celebrate Healthy Weight Week is to respect all people, regardless of size. Think positively about yourself, and remember to think positively about others. Accept each other at any size; compliment behavior, ideas and character instead of appearance and develop more self-acceptance, self-appreciation and self-respect. Related Articles Related Content from Our Sponsors Read more articles by this author Hot Topics Today 1 PTSD Patients Show Heightened Sensitivity to Deviant Sounds 2 Developing the Evidence Base for Mindfulness Therapies 3 Dominant Hand May Begin in Womb 4 Why Empaths and Sensitives Must Take Special Care of Their Energies 5 5 Types of People Who Are Naturally Attracted to Each Other Most Popular News PTSD Patients Show Heightened Sensitivity to Deviant Sounds Dominant Hand May Begin in Womb Developing the Evidence Base for Mindfulness Therapies Bipolar or Depression? Heart Test May Help Tell the Difference Avatar Therapy May Ease Schizophrenia Symptoms Join Over 195,000 Subscribers to Our Weekly Newsletter Find a Therapist Enter ZIP or postal code it's critical


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Photo :Entero VU
searching for Entero VU Generic Name: Barium Suspension (BA ree um) Brand Name: Digibar 190, E-Z-Cat Dry, E-Z-Dose, E-Z-HD, E-Z-Paque, ...show all 19 brand names. Entero VU, Liquid E-Z-Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Polibar ACB, Readi-Cat, Readi-Cat 2, Tagitol V, Varibar Honey, Varibar Nectar, Varibar Thin Honey, Varibar Thin Liquid, VoLumen Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Uses of Entero VU: It is used before an x-ray or an alike test. What do I need to tell my doctor BEFORE I take Entero VU? If you have an allergy to barium or any other part of Entero VU (barium suspension). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have had any of these health problems: Blockage, hole, bleeding, injury, burn, or blood flow problems in the GI (gastrointestinal) tract; slow-moving GI (gastrointestinal) tract; or a problem called toxic megacolon. If you have had a recent hole in the GI (gastrointestinal) tract, GI surgery, or radiation to the pelvic area. If you have trouble swallowing or have inhaled food, liquids, saliva, or vomit into your lungs. If you are not able to break down fructose. This is not a list of all drugs or health problems that interact with this medicine. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Entero VU with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Slideshow Prednisone: 12 Things You Should Know What are some things I need to know or do while I take Entero VU? Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor. This medicine prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Entero VU. To prevent hard stools (constipation) or bowel block from this medicine, your doctor may have you use a laxative like milk of magnesia or lactulose after using Entero VU. Follow what your doctor has told you. Talk with your doctor. Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor. If you are 65 or older, use Entero VU with care. You could have more side effects. Some products are not approved for use in children. Talk with the doctor. Some products have sorbitol in them. Very bad health problems like low blood sugar, bleeding, and kidney failure have happened when people who are not able to break down fructose took a product with sorbitol in it. Talk with the doctor. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Entero VU) best taken? Use Entero VU as ordered by your doctor. Read all information given to you. Follow all instructions closely. Follow what your doctor has told you to do. Shake well before use. Most of the time, this medicine is taken by mouth. Take as you have been told by your doctor. Some brands of Entero VU are to be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you need to take your brand with food. Some products may be used as an enema. If you are using this medicine as an enema, it will be given rectally by your doctor. What do I do if I miss a dose? Call your doctor to find out what to do. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Very hard stools (constipation). Very bad belly pain. Shortness of breath. Very bad dizziness or passing out. A heartbeat that does not feel normal. Flushing. Fast or slow heartbeat. Feeling agitated. Feeling confused. Blue or gray skin color. Feeling very tired or weak. Pale skin. Ringing in ears. Sweating a lot. Chest pain or pressure. Coughing up blood. Swelling, warmth, numbness, change of color, or pain in a leg or arm. Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight. What are some other side effects of Entero VU? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Upset stomach or throwing up. Loose stools (diarrhea). Stomach cramps. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Entero VU? Most of the time, Entero VU (barium suspension) will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take Entero VU or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Entero VU. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Entero VU (barium sulfate) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: non-iodinated contrast media Consumer resources Entero VU oral and rectal Entero VU (Advanced Reading) Other brands: Volumen , Readi-Cat , Esobar , Readi-Cat 2 , ... +27 more Professional resources Entero VU (FDA) Other Formulations Entero-H oral and rectal Related treatment guides Computed Tomography} Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Entero VU Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Non-iodinated contrast media Related Drugs Computed Tomography barium sulfate , iodixanol , Visipaque , Volumen , iopromide , Tomocat , Readi-Cat , CheeTah , Readi-Cat 2 , Esobar , Ultravist , Liquid E-Z Paque , Sitzmarks , E-Z-Paque , Entrobar , Intropaste , Anatrast , Prepcat , ioflupane I 123 , More...} } huge


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Photo :Valchlor (Topical application)
draw back Valchlor (Topical application) Generic Name: mechlorethamine (Topical application route) me-klor-ETH-a-meen Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Pricing & Coupons Commonly used brand name(s) In the U.S. Valchlor Available Dosage Forms: Gel/Jelly Pharmacologic Class: Alkylating Agent Chemical Class: Nitrogen Mustard Slideshow A Joint Effort: A Provider's Guide To Orthopedic Pain Options Uses For Valchlor Mechlorethamine topical is used to treat a type of skin cancer called mycosis fungoides-type T-cell lymphoma in patients who have received previous skin treatment. It belongs to the group of cancer medicines called alkylating agents. Mechlorethamine interferes with the growth of cancer cells, which are eventually destroyed. This medicine is available only with your doctor's prescription. Before Using Valchlor In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of mechlorethamine topical in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mechlorethamine topical in the elderly. However, elderly patients are more likely to have unwanted skin reactions, which may require caution in patients using this medicine. Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Proper Use of Valchlor It is very important that you use this medicine only as directed by your doctor . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This medicine is only for use on the skin . Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away using soap and water for at least 15 minutes. Remove contaminated clothing. Check with your doctor if any irritation continues after washing the area with soap and water. To use: Take the tube out of the refrigerator. Apply the medicine right away or within 30 minutes. Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Place the medicine in the original box and return it to the refrigerator. Allow the treated areas to dry for 5 to 10 minutes before covering with clothing. Do not bandage or wrap the treated skin. Avoid fire, flames, and smoking until the medicine has dried. Wash your hands with soap and water after touching and applying the medicine. Caregivers must wear disposable nitrile gloves when applying this medicine. Wash your hands with soap and water after removing the gloves. Moisturizers are permitted on the treated areas 2 hours before or 2 hours after applying the medicine. This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For topical dosage form (gel): For T-cell lymphoma skin cancer: Adults Apply once a day to the affected skin area. Children Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Storage Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store in the refrigerator. Do not freeze. Keep this medicine away from food in the refrigerator. Throw empty tube and used disposable gloves in the trash can. Make sure children and pets do not have contact with the tube and gloves. Discard any unused medicine after 60 days. Precautions While Using Valchlor It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine. Do not get this medicine in your eyes. If eye contact occurs, you may have pain, burning, swelling, redness, sensitivity to light, or blurred vision. The medicine can cause permanent eye injury. If you get this medicine in your eye, rinse the eye right away for at least 15 minutes with water or an eye wash solution and call your doctor. Avoid getting this medicine in your nose or mouth. It may cause pain, redness, or ulcers. If this occurs, rinse your nose or mouth right away for at least 15 minutes with water and call your doctor. This medicine may cause unwanted skin reactions, including non-melanoma skin cancer. Contact your doctor right away if you have redness, swelling, itching, ulcers, or blisters on the skin. Valchlor Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Blistering, crusting, irritation, itching, or reddening of the skin cracked, dry, scaly skin pain, swelling, tenderness, or warmth on the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Darkening of the skin Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Valchlor (mechlorethamine topical) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical antineoplastics Consumer resources Valchlor Professional resources Valchlor (AHFS Monograph) Valchlor Gel (FDA) Related treatment guides Mycosis Fungoides} 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 Manufacturer Actelion Pharmaceuticals US, Inc. Drug Class Topical antineoplastics Related Drugs Mycosis Fungoides prednisone , methotrexate , dexamethasone , Decadron , Deltasone , Trexall , Sterapred , vinblastine , Dexasone , Adcetris , brentuximab , Dexpak Taperpak , Prednicot , Baycadron , Sterapred DS , Velban , Dexacen-4 , More... Valchlor Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Related Questions & Answers Would like to know what specific drug class each of the following 12 drugs fall under... Thank you!? Read more questions} }


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Photo :Radiation and Chemotherapy Together Boost Lung Cancer Survival
dollars (*this news item will not be available after 12/26/2017) Wednesday, September 27, 2017 TUESDAY, Sept. 26, 2017 (HealthDay News) -- Combining radiation therapy with chemotherapy has substantially extended survival for many people with lung cancer, two new studies report. About 32 percent of non-small cell lung cancer patients who received chemoradiation therapy were still alive five years following treatment, a survival rate double that of previous estimates, according to results from a long-term clinical trial. Further, a small second clinical trial of people with lung cancer that had already spread to other parts of the body showed that radiation therapy added to chemo dramatically slowed the time until these cancers progressed further. The two studies show that radiation therapy and chemotherapy work well together, and that radiation also might help patients who are undergoing newer forms of cancer treatment like targeted therapy and immunotherapy, said Dr. Benjamin Movsas, a radiation oncologist with the Henry Ford Hospital in Detroit. "Instead of becoming less important, radiation therapy is becoming more important," Movsas said. Both studies were presented Sunday at the American Society of Radiation Oncology's annual meeting, in San Diego. Findings presented at meetings are typically viewed as preliminary until they've been published in a peer-reviewed journal. Chemotherapy's advantage is that it can attack cancer anywhere in the body, even cancer cells doctors haven't found, Movsas said. "It goes around the entire body through the bloodstream," he said. "If there are residual cancer cells that may have spread from the initial site, this is a way to address those." But chemotherapy often can't kill off a solid tumor completely. Focused radiation can step in and destroy those clumps of cancer cells, acting in conjunction with chemo, explained Movsas, who was not involved with the studies. The first presentation involved long-term results from a major chemoradiation therapy trial that started in 2006. The study involved more than 500 patients treated at 185 hospitals in the United States and Canada. They all had inoperable stage 3 lung cancer that had not spread to other parts of the body. The researchers reported that the overall five-year survival rate from this combination therapy was 32 percent, more than twice as high as previous estimates. "That's the new benchmark for stage 3 lung cancer. About one-third of patients are alive at five years," said principal investigator Dr. Jeffrey Bradley. He's director of the S.L. King Center for Proton Therapy at the Washington University School of Medicine in St. Louis. "A third of patients are alive at five years -- that's as close to cure as you can get," Movsas said. "For me, that's a real step forward and a very, very promising result." The second study looked into whether radiation therapy could be added to chemo to control cancer that had spread into other parts of the body such as the brain, liver, bone and pancreas. For this clinical trial, researchers used radiation therapy on 14 patients whose lung cancer had spread to six or fewer sites elsewhere in the body. Beam radiation targeted both the main tumor and the new cancer sites. Patients were recruited between April 2014 and July 2016. Thirty-one cancerous lesions were treated with radiation in the 14 patients. People who received chemoradiation experienced a remission nearly triple that of a 15-person control group who got just chemotherapy -- 9.7 months compared with 3.5 months, said lead researcher Dr. Puneeth Iyengar. Only four of those who received radiation therapy have had renewed progression of their cancer, compared with 10 out of 15 patients in the chemo-only group, Iyengar said. He's an assistant professor of radiation oncology at the University of Texas Southwestern Medical Center in Dallas. The chemoradiation patients didn't have any cancer recurrences (failures) "within the areas that were irradiated, whereas a multitude of patients [in the control group] failed in areas that would have gotten radiation had they been in that arm of the trial," Iyengar said. "Clearly, local [radiation] treatment improved the control of the disease and also delayed the time to progression," Iyengar concluded. Movsas called these results a "paradigm shift" in the way radiation therapy can help treat patients with advanced lung cancer. "This is really changing the way we are thinking about patients with lung cancer that has spread to certain areas," Movsas said. In both clinical trials, chemoradiation therapy had side effects similar to those produced by chemotherapy alone, Movsas added. "Overall, it was pretty well-tolerated," he said. SOURCES: Benjamin Movsas, M.D., radiation oncologist, Henry Ford Hospital, Detroit; Jeffrey Bradley, M.D., director, S.L. King Center for Proton Therapy, Washington University School of Medicine in St. Louis; Puneeth Iyengar, M.D., Ph.D., assistant professor, radiation oncology, University of Texas Southwestern Medical Center, Dallas; Sept. 24, 2017 presentations, American Society of Radiation Oncology meeting, San Diego HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Cancer Chemotherapy Lung Cancer Radiation Therapy Recent Health News a protracted


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Photo :Multivitamin Side Effects
coming back from Multivitamin Side Effects Overview Side Effects Professional Interactions Reviews More Drug Images Support Group Q & A Compare Alternatives Applies to multivitamin: oral elixir, oral tablet, oral tablet extended release Other dosage forms: oral tablet oral capsule, oral liquid, oral solution, oral tablet, oral tablet disintegrating oral capsule, oral tablet injection injectable, injection solution, oral capsule, oral capsule extended release, oral elixir, oral liquid, oral tablet, oral tablet disintegrating, oral tablet extended release, sublingual liquid oral liquid, oral solution What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. What are some other side effects of this drug? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Upset stomach or throwing up. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Some side effects of multivitamin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA . Next Professional Print this page More about multivitamin Side Effects Drug Images Drug Interactions Compare Alternatives Support Group En Español 54 Reviews Add your own review/rating Drug class: vitamin and mineral combinations Consumer resources Multivitamins Multivitamins Capsules and Tablets Folic Acid and Cyanocobalamin Folic Acid, Cyanocobalamin, and Pyridoxine L-Methylfolate, Methylcobalamin, and N-Acetylcysteine ... +11 more Other brands: Folic Acid XTRA , Folbic , Vitamins , Folbee , ... +28 more Professional resources Levomefolate, Calcium Acetylcysteine and Mecobalamin Algal (FDA) ... +7 more Related treatment guides Dietary Supplementation Hyperhomocysteinemia Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Manufacturer Pfizer Inc. Drug Class Vitamin and mineral combinations Related Drugs Dietary Supplementation biotin , multivitamin , Fish Oil , ascorbic acid , Coenzyme Q10 , Lovaza , CoQ10 , calcium citrate , Zinc , More... Hyperhomocysteinemia multivitamin , Deplin , Folic Acid XTRA , Folbic , Folbee , l-methylfolate , MTX Support , Renal Caps , More... Multivitamin Rating 54 User Reviews 6.2 /10 54 User Reviews 6.2 Rate it! Multivitamin Images Multivitamin systemic (077 ) View all images together with your


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Photo :CNJ-016 Injection
keen about [16:65 yrs of age) has not been established for VIGIV. Renal Insufficiency Use VIGIV with caution in patients with pre-existing renal insufficiency and in patients at increased risk of developing renal insufficiency [see 5.8 Acute Renal Dysfunction/Failure ]. CNJ-016 Injection Description VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear to opalescent liquid. VIGIV is manufactured from plasma collected from healthy, screened donors with high titers of anti-vaccinia antibody (meeting minimum potency specifications) that is purified by an anion-exchange column chromatography method (, ). The plasma donors were boosted with vaccinia vaccine prior to donating plasma used in the production of the product. Each plasma donation used for the manufacture of VIGIV is tested for the presence of hepatitis B virus (HBV) surface antigen (HBsAg) and antibodies to human immunodeficiency viruses (HIV) 1/2 and hepatitis C virus (HCV) using FDA-licensed serological tests. Plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid Testing (NAT) for HIV-1 and HCV and found to be negative. A NAT for HBV was also performed on all Source Plasma used and found to be negative; however, the significance of a negative result has not been established. The Source Plasma has also been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 and the limit for B19 in the manufacturing pool is set not to exceed 10 4 IU of B19 DNA per mL. The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as HBV, HCV and HIV ( 7 ). Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses ( 8 ). In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non lipid enveloped viruses. The inactivation and reduction of known enveloped and non enveloped model viruses were validated in laboratory studies as summarized in Table 2 . Table 2 Virus Reduction Values (Log 10) Obtained through Validation Studies * The PRV was retained by the 0.1 μm pre-filter during the virus validation. Since manufacturing employs a 0.1 μm pre-filter before the 20N filter, the claim of 5.6 reduction is considered applicable. Enveloped Enveloped Non-Enveloped Genome RNA DNA RNA DNA Virus HIV-1 BVDV PRV Vaccinia HAV EMC MMV PPV Family retro flavi herpes pox picorna parvo Size (nm) 80 100 50 70 120 200 220 450 long x 140 260 wide 25 30 30 20 25 18 24 Anion Exchange Chromatography (partitioning) Not evaluated 2.3 n.e. 3.4 n.e. 20N Filtration (size exclusion) 4.7 3.5 5.6 * n.e. n.e. 4.8 n.e. 4.1 Solvent/Detergent (inactivation) 4.7 7.3 5.5 3.7 Not evaluated Total Reduction (log 10 ) 9.4 10.8 11.1 3.7 7.1 7.5 Abbreviations: HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2 BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV) PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general EMC: encephalomyocarditis virus; model for HAV and for small non-enveloped viruses in general MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general PPV: porcine parvovirus; model for human parvovirus B19 and for small non-enveloped viruses in general n.e.: not evaluated The product potency (as determined by a plaque reduction neutralization test) is expressed in arbitrary units (U) by comparison to the FDA reference standard. Each vial contains approximately 40 to 70 mg/mL total protein and 50,000 units of vaccinia antibody neutralizing activity. The product contains 40 mcg/mL of Immune globulin A (IgA). CNJ-016 Injection - Clinical Pharmacology Mechanism of Action VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known. Pharmacodynamics Two phase 2, double-blind pharmacodynamic studies were conducted in which 82 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV. In the first study, the efficacy of 9,000 Units per kg of VIGIV on the immunologic and local response to Dryvax was evaluated. A total of 32 healthy subjects were randomized to receive single IV infusions of either VIGIV (9,000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9,000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4. In a second study, 50 healthy subjects were randomized to receive a single IV infusion of either VIGIV (9,000 Units per kg), VIGIV (24,000 Units per kg), or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The effect of VIGIV on the immunologic response to Dryvax was determined by measuring vaccinia antibody titer (vaccinia IgG) in plasma and comparing titer levels across all three treatment arms. In addition, the effect of VIGIV on the local response (tissue) to Dryvax was assessed by evaluating the size of the pox reaction, as well as the area of erythema and induration following vaccination. VIGIV (9,000 Units per kg and 24,000 Units per kg) reduced the local and immunological response to vaccinia vaccination when it was administered 4 days prior to vaccination compared to vaccination alone. This is consistent with the hypothesis that VIGIV can neutralize vaccinia virus in vivo [see 14 CLINICAL STUDIES ] . In addition, infusions of VIGIV of up to 24,000 Units per kg were well tolerated [see 6.1 Clinical Trials Experience ]. Pharmacokinetics A phase 1, double-blind study was conducted in which 60 healthy subjects were randomized to receive either 6,000 Units per kg or 9,000 Units per kg VIGIV. After intravenous administration of 6,000 Units per kg to 31 healthy subjects, a mean peak plasma concentration of 161 Units per mL was achieved within 2 hours. The half-life of VIGIV was 30 days (range of 13 to 67 days) and the volume of distribution was 6630 mL. Pharmacokinetic parameters were calculated based on antibody levels determined by an ELISA. The levels of vaccinia immune globulin remained in circulation for a prolonged period of time, with a mean half-life ranging from approximately 26 to 30 days. Maximum plasma concentrations (C max ) of VIGIV reached levels ranging from approximately 160 to 232 Units per mL in 1.8 to 2.6 hours. In addition, the drug had a large volume of distribution, as demonstrated by both non-compartmental and compartmental analyses. Non-compartmental analyses demonstrated that at the two dose levels studied, the drug exhibited dose-proportionality (AUC and C max values) ( Table 3 ). The pharmacokinetic parameters estimated by compartmental analysis were similar to those calculated by non-compartmental methods. Table 3 Non-compartmental Pharmacokinetic Parameters (mean ( SD)) of Vaccinia Immune Globulin Intravenous (Human) VIGIV (6,000 U/kg or 9,000 U/kg) from Measured Data Arithmetic Mean ( SD) Parameter 6,000 U/kg 9,000 U/kg AUC 0 - (U*h/mL) 58521 (16079) 78401 (17502) AUC 0-t (U*h/mL) 49405 (13246) 71541 (13173) C MAX (U/mL) 161 (40.0) 232 (40.9) T MAX (h) 1.84 (1.12) 2.61 (2.41) T (days) 30.0 (10.0) 26.2 (5.08) The plasma concentration of circulating VIGIV was also compared to a theoretical value obtained from a model of previously licensed Baxter Vaccinia Immune Globulin (VIG) product at day 5 after IV administration of VIGIV. Since Baxter VIG was administered IM and VIGIV is to be administered IV, the comparison was made at approximately five days to account for equilibration between the extravascular and intravascular compartments following IM injection. The binding capacity and neutralizing antibody activity of anti-vaccinia antibody in these subjects five days after intravenous administration of VIGIV (both 6,000 Units per kg and 9,000 Units per kg dosages) were at least as high as the theoretical values that would be achieved following the intramuscular administration of the comparator VIG (see Table 4 ). Five days represents the approximate time of peak serum anti-vaccinia antibody concentration following intramuscular administration of other Immune Globulin (Human) products. No historical pharmacokinetic data are available for the theoretical intramuscular comparator VIG. Table 4 Test of Non-inferiority * geometric mean (range) expressed as a percentage relative to the geometric mean of the simulated concentrations at Day 5 after 6,000 U/kg intramuscular administration observed levels simulated levels Dose VIGIV (U/kg) Plasma Levels, U/mL (Range * ) Ratio of Means % (97.5% Lower Confidence Interval Bound) VIGIV VIGIM 6,000 60.1 (36.1 84.6) 66.2 (42.3 94.9) 90.82 (86.94) 9,000 90.3 (63.4 133.8) 64.8 (47.6 87.2) 139.40 (135.27) Nonclinical Toxicology Immune globulins are normal constituents of the human body. Toxicology studies have not been performed with VIGIV as the product has been formulated with ingredients that are known to be non-toxic at the levels present in the final product. Animal Toxicology and/or Pharmacology The efficacy of VIGIV against vaccinia virus in a mouse-tail lesion model was assessed. A range of doses of VIGIV and a previously licensed VIG were compared for their ability to reduce pox formation in this model. Using this model, it was demonstrated that VIGIV exerted an in vivo protective effect against vaccinia infection when compared to a negative control. In addition, when using the mouse-tail lesion model with two different strains of vaccinia virus, it was observed that the protective effect of VIGIV appeared similar to that of the previously licensed VIG and a CBER reference standard. Since VIGIV is a product of human origin, secondary pharmacodynamics, safety pharmacology and pharmacodynamic drug interactions were not investigated in animals. Clinical Studies The pharmacokinetic, pharmacodynamic and safety profiles of VIGIV were evaluated in three clinical trials. In these clinical studies, VIGIV was shown to have an acceptable safety profile when administered as single infusions of 6,000 Units per kg, 9,000 Units per kg or 24,000 Units per kg to healthy subjects. For the phase 1 safety/pharmacokinetics study, see 12.3 Pharmacokinetics . Pharmacodynamic Effect of VIGIV on Immune and Local Responses to Dryvax In a phase 2, randomized, single center, double-blind study with three parallel treatment arms, the efficacy of 9,000 Units per kg of VIGIV on the immunologic and local response to the smallpox vaccine Dryvax was evaluated. Thirty-two healthy female and male subjects were randomized to receive single IV infusions of either VIGIV (9,000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9,000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4. In this study, the curves for antibody titre vs. time were similar between administration of VIGIV four days prior to vaccination with Dryvax and concurrent administration of VIGIV with Dryvax. Based on area under the effective time curve from Day 4 to 32 (AUEC 4-32 ) results, the administration of VIGIV four days prior to vaccination with Dryvax slightly reduced the pox reaction and erythema area by 4 to 9% and 8 to 12%, respectively, as compared to the concurrent administration of VIGIV with the Dryvax vaccine, or with Dryvax alone. In an additional phase 2, randomized, single center, double-blind, study with five parallel treatment arms, the efficacy of two different doses of VIGIV (9,000 Units per kg and 24,000 Units per kg) on the immunologic and local response to Dryvax was evaluated. Fifty healthy subjects were randomized to receive a single IV infusion of either VIGIV (9,000 Units per kg), VIGIV (24,000 Units per kg), or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The administration of VIGIV four days prior to vaccinia vaccination decreased the endogenous immune response to Dryvax in a dose-dependent manner. In addition, the mean pox reaction and erythema area diameters were smaller in size when 24,000 Units per kg of VIGIV was administered prior to vaccination with Dryvax compared to those when 9,000 Units per kg of VIGIV was administered prior to vaccination with Dryvax or to those from administration of Dryvax alone. These data are consistent with the hypothesis of vaccinia virus neutralization in vivo by VIGIV. REFERENCES Fulginiti VA, Winograd LA, Jackson M, Ellis P. Therapy of experimental vaccinal keratitis: Effect of idoxuridine and VIG. Arch Ophthal. 1965;74:539-44. Kahwaji J et al., Acute Hemolysis after High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clin J Am Soc Nephrol. 2009 December; 4: 1993 97. Daw Z, Padmore R, Neurath D, et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: A case series analysis. Transfusion 2008;48:1598-601. Bowman JM. Antenatal suppression of Rh alloimmunization. Clin Obst & Gynec. 1991;34:296-303. Bowman JM, Friesen AD, Pollock JM, Taylor WE. WinRho: Rh immune globulin prepared by ion exchange for intravenous use. Canadian Med Assoc J. 1980;123:1121-5. Friesen AD, Bowman JM, Price HW. Column ion-exchange preparation and characterization of an Rh immune globulin (WinRho) for intravenous use. Journal Appl Biochem. 1981;3:164-75. Horowitz B. Investigations into the application of tri(n-butyl)phosphate / detergent mixtures to blood derivatives. Curr Stud Hematol Blood Transfus. 1989;56:83-96. Burnouf T. Value of virus filtration as method for improving the safety of plasma products. Vox Sang. 1996;70:235-6. How Supplied/Storage and Handling How Supplied NDC 60492-0173-1 The product is supplied as a 20 mL single dose vial containing 50,000 Units per vial. It is packaged in a shelf carton with 24 vials and a package insert. VIGIV does not contain latex. Storage and Handling Product may be stored frozen at or below 5 F ( -15 C) or refrigerated at 36 to 46 F (2 to 8 C); refer to label for appropriate storage conditions. Do not use after expiration date. If product is received frozen, use within 60 days of thawing at 2 to 8 C. Intravenous infusion should begin within 4 hours after entering the vial. Do not reuse or save VIGIV for future use. This product contains no preservative; therefore, partially used vials should be discarded. Discuss the risks and benefits of VIGIV with the patient before prescribing or administration. Inform patients of the potential for hypersensitivity reactions, especially in individuals with previous reactions to human immune globulin and in individuals deficient in IgA [see 4 CONTRAINDICATIONS and 5.1 Hypersensitivity ]. Advise patients to be aware of the following symptoms associated with allergic reactions: hives, rash, chest tightness, wheezing, shortness of breath, or feeling light headed or dizzy when they stand. Patients should be cautioned to seek medical attention immediately should they experience any one or more of the above mentioned symptoms, as well as other side effects including injection site pain, chills, fever, headache, nausea, vomiting, and joint pain. Advise patients that the maltose contained in VIGIV can interfere with some types of blood glucose monitoring systems. They must use only testing systems that are glucose-specific for monitoring blood glucose levels as the interference of maltose could result in falsely elevated glucose readings. This could lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia [see 5.2 Interference with Blood Glucose Testing ]. Advise patients that VIGIV may impair the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps, and varicella (i.e. chickenpox). Should the patient have been recently vaccinated, they should notify their treating physician [see 7.1 Live, Attenuated Vaccines ]. Inform patients that VIGIV is prepared from human plasma. Products made from human plasma may contain infectious agents such as viruses that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products [see 5.9 Transmission of Infectious Agents from Human Plasma ]. Manufactured by: Cangene Corporation, a subsidiary of Emergent BioSolutions Inc. 155 Innovation Drive Winnipeg, MB Canada R3T 5Y3 Principal Display Panel - Carton Label Principal Display Panel - Vial Label CNJ-016 vaccinia immune globulin (human) injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60492-0173 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMAN VACCINIA VIRUS IMMUNE GLOBULIN (HUMAN VACCINIA VIRUS IMMUNE GLOBULIN) HUMAN VACCINIA VIRUS IMMUNE GLOBULIN 1 [iU] in 1 mL Inactive Ingredients Ingredient Name Strength MALTOSE POLYSORBATE 80 Packaging # Item Code Package Description 1 NDC:60492-0173-2 24 VIAL, SINGLE-USE in 1 CARTON 1 NDC:60492-0173-1 12 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125109 05/02/2005 Labeler - Cangene Corporation (244844056) Revised: 03/2016 Cangene Corporation Next Interactions Print this page Add to My Med List More about CNJ-016 Injection (vaccinia immune globulin) Side Effects During Pregnancy Dosage Information Drug Interactions 0 Reviews Add your own review/rating]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Discontinued C Pregnancy Category Risk cannot be ruled out Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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avoided Aptensio XR Generic Name: methylphenidate (oral) (METH il FEN i date) Brand Name: Aptensio XR, Concerta, Cotempla XR-ODT, Metadate CD, Metadate ER, Methylin, QuilliChew ER, Quillivant XR, Ritalin Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons What is Aptensio XR (methylphenidate)? Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Methylphenidate may also be used for purposes not listed in this medication guide. Slideshow Adderall for Study - Does it Really Make You Smarter? What is the most important information I should know about Aptensio XR (methylphenidate)? Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect. Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes. Call your doctor right away if you have: signs of heart problems --chest pain, feeling light-headed or short of breath; signs of psychosis --paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems --unexplained wounds on your fingers or toes. What should I discuss with my healthcare provider before taking Aptensio XR (methylphenidate)? Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. You should not use methylphenidate if you are allergic to it, or if you have: glaucoma; a personal or family history of tics (muscle twitches) or Tourette's syndrome; or severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse). Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have: heart problems or a congenital heart defect; high blood pressure; or a family history of heart disease or sudden death. To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had: depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions; motor tics (muscle twitches) or Tourette's syndrome; blood circulation problems in the hands or feet; seizures or epilepsy; problems with the esophagus, stomach, or intestines; an abnormal brain wave test (EEG); or a history of drug or alcohol addiction. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Methylphenidate is not approved for use by anyone younger than 6 years old. How should I take Aptensio XR (methylphenidate)? Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended. Methylphenidate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. To prevent sleep problems, take this medicine in the morning. Some brands of methylphenidate should be taken at least 30 minutes before a meal. Extended-release methylphenidate can be taken with or without food. Follow the directions on your medicine label Do not crush, chew, or break an extended-release tablet . Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. To make swallowing easier, you may open the capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use. The chewable tablet must be chewed before you swallow it. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. To take the orally disintegrating tablet (Cotempla XR-ODT): Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. While using methylphenidate, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine. If you need surgery, tell the surgeon ahead of time that you are using methylphenidate. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat. Keep track of your medicine. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal. What should I avoid while taking Aptensio XR (methylphenidate)? Avoid drinking alcohol, especially if you take extended-release methylphenidate. Alcohol may cause the medicine to be released into the bloodstream too fast. Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Aptensio XR (methylphenidate) side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: signs of heart problems--chest pain, trouble breathing, feeling like you might pass out; signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; a seizure (convulsions); muscle twitches (tics); changes in your vision; or penis erection that is painful or lasts 4 hours or longer (rare). Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine. Common side effects may include: mood changes, feeling nervous or irritable, sleep problems (insomnia); fast heart rate, increased blood pressure; loss of appetite, weight loss; nausea, stomach pain; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Aptensio XR (methylphenidate)? Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs methylphenidate, and may increase side effects. Many drugs can interact with methylphenidate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using. Next Side Effects Print this page Add to My Med List More about Aptensio XR (methylphenidate) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 7 Reviews Add your own review/rating Drug class: CNS stimulants Consumer resources Aptensio XR (Advanced Reading) Other brands: Ritalin , Concerta , Ritalin LA , Methylin , ... +8 more Professional resources Aptensio XR (FDA) Methylphenidate Hydrochloride (AHFS Monograph) Related treatment guides ADHD Where can I get more information? Your pharmacist can provide more information about methylphenidate. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 17.01. Last reviewed: August 01, 2017 Date modified: December 03, 2017} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out 2 CSA Schedule High potential for abuse Approval History Drug history at FDA WADA Class Anti-Doping Classification Drug Class CNS stimulants Related Drugs ADHD Adderall , methylphenidate , Vyvanse , Ritalin , Strattera , Concerta , amphetamine / dextroamphetamine , Adderall XR , Focalin , atomoxetine , dexmethylphenidate , Focalin XR , lisdexamfetamine , Mydayis , Ritalin LA , Methylin , Quillivant XR , Daytrana , Metadate CD , QuilliChew ER , Ritalin-SR , Metadate ER , Cotempla XR-ODT , clonidine , More... Aptensio XR Rating 7 User Reviews 6.8 /10 7 User Reviews 6.8 Rate it! Aptensio XR Images Aptensio XR 10 mg (Aptensio XR 10 mg) View all images Help and Support Looking for answers? Ask a question or go join the Aptensio XR support group to connect with others who have similar interests.} } tremendous


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