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looking ahead to [1%:<7 hrs), pharmacokinetic data are not available and dosage adjustment may be required. Use in patients with impaired hepatic function Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects (see OVERDOSAGE ) should be carried out. Use in patients with attenuated (decreased) neuromuscular transmission It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne's muscular dystrophy, prolongs recovery from the neuromuscular blocking agent vecuronium, and causes a worsening of myasthenia gravis. It may be necessary to decrease the dosage of verapamil when it is administered to patients with attenuated neuromuscular transmission. Use in patients with impaired renal function About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by hemodialysis. Until further data are available, verapamil should be administered cautiously to patients with impaired renal function. These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage (see OVERDOSAGE ). Information for patients Covera-HS tablets should be swallowed whole; do not break, crush, or chew. The medication in the Covera-HS tablet is released slowly through an outer shell that does not dissolve. The patient should not be concerned if they occasionally observe this outer shell in their stool as it passes from the body. Drug-Drug Interactions Drug interactions: Effects of other drugs on verapamil pharmacokinetics In vitro metabolic studies indicate that verapamil is metabolized by cytochrome P450 CYP3A4, CYP1A2, and CYP2C. Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g., erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g., rifampin) have caused a lowering of plasma levels of verapamil. HMG-CoA reductase inhibitors The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs. Alcohol Verapamil may increase blood alcohol concentrations and prolong its effects. Aspirin In a few reported cases, co-administration of verapamil with aspirin has led to increased bleeding times greater than observed with aspirin alone. Grapefruit juice Grapefruit juice may significantly increase concentrations of verapamil. Grapefruit juice given to nine healthy volunteers increased S- and R- verapamil AUC 0 12 by 36% and 28%, respectively. Steady state C max and C min of S-verapamil increased by 57% and 16.7%, respectively, with grapefruit juice compared to control. Similarly, C max and C min of R-verapamil increased by 40% and 13%, respectively. Grapefruit juice did not affect half-life, nor was there a significant change in AUC 0 12 ratio R/S compared to control. Grapefruit juice did not cause a significant difference in the PK of norverapamil. This increase in verapamil plasma concentration is not expected to have any clinical consequences. Beta-blockers Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction and/or cardiac contractility. The combination of sustained-release verapamil and beta-adrenergic blocking agents has not been studied. However, there have been reports of excessive bradycardia and AV block, including complete heart block, when the combination has been used for the treatment of hypertension. For hypertensive patients, the risks of combined therapy may outweigh the potential benefits. The combination should be used only with caution and close monitoring. Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil. A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together. Digitalis Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. However, chronic verapamil treatment can increase serum digoxin levels by 50% to 75% during the first week of therapy, and this can result in digitalis toxicity. In patients with hepatic cirrhosis, the influence of verapamil on digoxin kinetics is magnified. Verapamil may reduce total body clearance and extrarenal clearance of digitoxin by 27% and 29%, respectively. Maintenance and digitalization doses should be reduced when verapamil is administered, and the patient should be reassessed to avoid over- to under-digitalization. Whenever over-digitalization is suspected, the daily dose of digitalis should be reduced or temporarily discontinued. On discontinuation of verapamil use, the patient should be reassessed to avoid under-digitalization. In previous clinical trials with other verapamil formulations related to the control of ventricular response in digitalized patients who had atrial fibrillation or atrial flutter, ventricular rates below 50/min at rest occurred in 15% of patients, and asymptomatic hypotension occurred in 5% of patients. Antihypertensive agents Verapamil administered concomitantly with oral antihypertensive agents (e.g., vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta-blockers) will usually have an additive effect on lowering blood pressure. Patients receiving these combinations should be appropriately monitored. Concomitant use of agents that attenuate alpha-adrenergic function with verapamil may result in a reduction in blood pressure that is excessive in some patients. Such an effect was observed in one study following the concomitant administration of verapamil and prazosin. Antiarrhythmic agents Disopyramide Until data on possible interactions between verapamil and disopyramide are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration. Flecainide A study in healthy volunteers showed that the concomitant administration of flecainide and verapamil may have additive effects on myocardial contractility, AV conduction, and repolarization. Concomitant therapy with flecainide and verapamil may result in additive negative inotropic effect and prolongation of atrioventricular conduction. Quinidine In a small number of patients with hypertrophic cardiomyopathy (IHSS), concomitant use of verapamil and quinidine resulted in significant hypotension. Until further data are obtained, combined therapy of verapamil and quinidine in patients with hypertrophic cardiomyopathy should probably be avoided. The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy. Other agents Nitrates Verapamil has been given concomitantly with short- and long-acting nitrates without any undesirable drug interactions. The pharmacologic profile of both drugs and clinical experience suggest beneficial interactions. Cimetidine The interaction between cimetidine and chronically administered verapamil has not been studied. Variable results on clearance have been obtained in acute studies of healthy volunteers; clearance of verapamil was either reduced or unchanged. Lithium Increased sensitivity to the effects of lithium (neurotoxicity) has been reported during concomitant verapamil-lithium therapy; lithium levels have been observed sometimes to increase, sometimes to decrease, and sometimes to be unchanged. Patients receiving both drugs must be monitored carefully. Carbamazepine Verapamil therapy may increase carbamazepine concentrations during combined therapy. This may produce carbamazepine side effects such as diplopia, headache, ataxia, or dizziness. Rifampin Therapy with rifampin may markedly reduce oral verapamil bioavailability. Phenobarbital Phenobarbital therapy may increase verapamil clearance. Cyclosporine Verapamil therapy may increase serum levels of cyclosporine. Theophylline Verapamil may inhibit the clearance and increase the plasma levels of theophylline. Inhalation anesthetics Animal experiments have shown that inhalation anesthetics depress cardiovascular activity by decreasing the inward movement of calcium ions. When used concomitantly, inhalation anesthetics and calcium channel blocking agents, such as verapamil, should each be titrated carefully to avoid excessive cardiovascular depression. Neuromuscular blocking agents Clinical data and animal studies suggest that verapamil may potentiate the activity of neuromuscular blocking agents (curare-like and depolarizing). It may be necessary to decrease the dose of verapamil and/or the dose of the neuromuscular blocking agent when the drugs are used concomitantly. Telithromycin Hypotension and bradyarrhythmias have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class. Clonidine Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with verapamil. Monitor heart rate in patients receiving concomitant verapamil and clonidine. Carcinogenesis, mutagenesis, impairment of fertility An 18-month toxicity study in rats, at a low multiple (6-fold) of the maximum recommended human dose, not the maximum tolerated dose, did not suggest a tumorigenic potential. There was no evidence of a carcinogenic potential of verapamil administered in the diet of rats for two years at doses of 10, 35, and 120 mg/kg/day or approximately 1, 3.5, and 12 times, respectively, the maximum recommended human daily dose (480 mg/day or 9.6 mg/kg/day). Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate with or without metabolic activation. Studies in female rats at daily dietary doses up to 5.5 times (55 mg/kg/day) the maximum recommended human dose did not show impaired fertility. Effects on male fertility have not been determined. Pregnancy Pregnancy Category C Reproduction studies have been performed in rabbits and rats at oral doses up to 1.5 (15 mg/kg/day) and 6 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, however, this multiple of the human dose was embryocidal and retarded fetal growth and development, probably because of adverse maternal effects reflected in reduced weight gains of the dams. This oral dose has also been shown to cause hypotension in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery. Labor and delivery It is not known whether the use of verapamil during labor or delivery has immediate or delayed adverse effects on the fetus, or whether it prolongs the duration of labor or increases the need for forceps delivery or other obstetric intervention. Such adverse experiences have not been reported in the literature, despite a long history of use of verapamil in Europe in the treatment of cardiac side effects of beta-adrenergic agonist agents used to treat premature labor. Nursing mothers Verapamil is excreted in human milk. Because of the potential for adverse reactions in nursing infants from verapamil, nursing should be discontinued while verapamil is administered. Pediatric use Safety and effectiveness in pediatric patients have not been established. Geriatric use Clinical studies of Covera-HS did not include sufficient numbers of subjects under age 65 to determine whether they responded differently from older subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Animal pharmacology and/or animal toxicology In chronic animal toxicology studies, verapamil caused lenticular and/or suture line changes at 30 mg/kg/day or greater, and frank cataracts at 62.5 mg/kg/day or greater in the beagle dog but not in the rat. Development of cataracts due to verapamil has not been reported in man. Adverse Reactions Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered Covera-HS occurred at rates greater than 2.0% or occurred at lower rates but appeared drug-related in clinical trials in hypertension and angina: Placebo n=261 % All doses studied n=572 % * Constipation was typically mild, easily manageable, and the incidence usually diminished within about one week. At a typical once-daily dose of 240 mg, the observed incidence was 7.2%. Constipation 2.7 11.7 * Headache 7.3 6.6 Upper respiratory infection 4.6 5.4 Dizziness 2.7 4.7 Fatigue 3.8 4.5 Edema 3.1 3.0 Nausea 1.9 2.1 AV block (1 ) 0.0 1.7 Elevated liver enzymes (see WARNINGS ) 0.8 1.4 Bradycardia 0.4 1.4 Paresthesia 0.0 1.0 Flushing 0.3 0.8 Hypotension 0.0 0.7 Postural hypotension 0.3 0.4 In previous experience with other formulations of verapamil, the following reactions occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug related in clinical trials in 4,954 patients. Constipation 7.3% Dyspnea 1.4% Dizziness 3.3% Bradycardia Nausea 2.7% (HR> < 50/min) 1.4% Hypotension 2.5% AV Block Headache 2.2% total (1 ,2 ,3 ) 1.2% Edema 1.9% AV Block CHF/Pulmonary 2 and 3 0.8% Edema 1.8% Rash 1.2% Fatigue 1.7% Flushing 0.6% Elevated liver enzymes (see WARNINGS ) The following reactions, reported with orally administered verapamil in 2% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: angina pectoris, AV block (2 & 3 ), atrioventricular dissociation, CHF, pulmonary edema, chest pain, claudication, myocardial infarction, palpitations, purpura (vasculitis), syncope. Digestive system: diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia. Hemic and lymphatic: ecchymosis or bruising. Nervous system: cerebrovascular accident, confusion, equilibrium disorders, insomnia, muscle cramps, psychotic symptoms, shakiness, somnolence, extrapyramidal symptoms. Skin: arthralgia and rash, exanthema, hair loss, hyperkeratosis, macules, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme. Special senses: blurred vision, tinnitus. Urogenital: gynecomastia, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation, impotence. Other: allergy aggravated, dyspnea. Treatment of acute cardiovascular adverse reactions The frequency of cardiovascular adverse reactions that require therapy is rare; hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately; e.g., intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine HCl or dobutamine HCl may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgement and experience of the treating physician. Overdosage Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially sustained-release verapamil products), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the sustained-release formulations. Verapamil is known to decrease gastrointestinal transit time. Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride. Verapamil cannot be removed by hemodialysis. Clinically significant hypotensive reactions or high degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including cardiopulmonary resuscitation. Covera-HS Dosage and Administration Covera-HS should be administered once daily at bedtime. Clinical trials explored dose ranges between 180 mg and 540 mg given at bedtime and found effects to persist throughout the dosing interval. Covera-HS tablets should be swallowed whole and not chewed, broken, or crushed. For both hypertension and angina, the dose of Covera-HS should be individualized by titration. Initiate therapy with 180 mg of Covera-HS. If an adequate response is not obtained with 180 mg of Covera-HS, the dose may be titrated upward in the following manner: a) 240 mg each evening b) 360 mg each evening (2 180 mg) c) 480 mg each evening (2 240 mg) When Covera-HS is administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect. The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of Covera-HS, would be just prior to bedtime. How is Covera-HS Supplied Covera-HS 180 mg tablets are lavender, round, film coated, with COVERA HS 2011 printed on one side, supplied as: NDC Number Size 0025-2011-31 bottle of 100 Covera-HS 240 mg tablets are pale yellow, round, film coated with COVERA HS 2021 printed on one side, supplied as: NDC Number Size 0025-2021-31 bottle of 100 Store at controlled room temperature 20 25 C (68 77 F) [see USP]. Dispense in tight, light-resistant containers. LAB-0267-8.0 October 2011 PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Label NDC 0025-2011-31 100 Tablets Rx only Covera-HS (verapamil hydrochloride) EXTENDED-RELEASE TABLETS 180 mg CONTROLLED-ONSET Pfizer Distributed by G.D. Searle LLC Division of Pfizer Inc, NY, NY 10017 PRINCIPAL DISPLAY PANEL - 240 mg Tablet Bottle Label NDC 0025-2021-31 100 Tablets Rx only Covera-HS (verapamil hydrochloride) EXTENDED-RELEASE TABLETS 240 mg CONTROLLED-ONSET Pfizer Distributed by G.D. Searle LLC Division of Pfizer Inc, NY, NY 10017 Covera-HS verapamil hydrochloride tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0025-2011 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength verapamil hydrochloride (verapamil) verapamil hydrochloride 180 mg Inactive Ingredients Ingredient Name Strength ferrosoferric oxide butylated hydroxytoluene cellulose acetate hydroxypropyl cellulose hypromelloses magnesium stearate polyethylene glycols polysorbate 80 povidone sodium chloride titanium dioxide FD&C BLUE NO. 2 D&C RED NO. 30 Aluminum Oxide Product Characteristics Color PURPLE (lavender) Score no score Shape ROUND Size 11mm Flavor Imprint Code COVERA;HS;2011 Contains Packaging # Item Code Package Description 1 NDC:0025-2011-31 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE 2 NDC:0025-2011-34 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020552 02/26/1996 Covera-HS verapamil hydrochloride tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0025-2021 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength verapamil hydrochloride (verapamil) verapamil hydrochloride 240 mg Inactive Ingredients Ingredient Name Strength ferrosoferric oxide butylated hydroxytoluene cellulose acetate hydroxypropyl cellulose hypromelloses magnesium stearate polyethylene glycols polysorbate 80 povidone sodium chloride titanium dioxide FD&C BLUE NO. 2 D&C YELLOW NO. 10 Aluminum Oxide Product Characteristics Color YELLOW (pale yellow) Score no score Shape ROUND Size 12mm Flavor Imprint Code COVERA;HS;2021 Contains Packaging # Item Code Package Description 1 NDC:0025-2021-31 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE 2 NDC:0025-2021-34 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020552 02/26/1996 Labeler - G.D. Searle LLC Division of Pfizer Inc (829077085) Establishment Name Address ID/FEI Operations Pfizer Pharmaceuticals LLC 193684656 MANUFACTURE Establishment Name Address ID/FEI Operations Recordati Industria Chimica e Farmaceutica SpA 338471447 API MANUFACTURE Establishment Name Address ID/FEI Operations Pfizer Pharmaceuticals LLC 829084545 MANUFACTURE Establishment Name Address ID/FEI Operations Abbott GmbH & Co KG 312532234 MANUFACTURE Establishment Name Address ID/FEI Operations Drug'On Pharma Switzerland AG 485106087 MANUFACTURE Establishment Name Address ID/FEI Operations Pfizer Pharmaceuticals LLC 829084552 MANUFACTURE Revised: 10/2011 G.D. Searle LLC Division of Pfizer Inc Next Interactions Print this page Add to My Med List More about Covera-HS (verapamil) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group 1 Review Add your own review/rating Drug class: calcium channel blocking agents Consumer resources Covera-HS (Advanced Reading) Professional resources Verapamil Hydrochloride (AHFS Monograph) Verapamil Sustained-Release Capsules (FDA) Other brands: Calan , Calan SR , Verelan , Isoptin SR , Verelan PM Related treatment guides Angina Arrhythmia Cluster Headaches High Blood Pressure ... +3 more ]} 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 Approval History Drug history at FDA Manufacturer Pfizer Inc. Drug Class Calcium channel blocking agents Group IV antiarrhythmics Related Drugs calcium channel blocking agents amlodipine , diltiazem , Norvasc , nifedipine , verapamil , Cardizem group IV antiarrhythmics diltiazem , verapamil , Cardizem , Cartia XT , Taztia XT Migraine Prevention atenolol , propranolol , nifedipine , verapamil , topiramate , Topamax , More... Cluster Headaches prednisone , verapamil , sumatriptan , Imitrex , indomethacin , cyproheptadine , More... Arrhythmia propranolol , amiodarone , verapamil , lidocaine , Inderal , Tikosyn , More... 4 more conditions... Covera-HS Rating 1 User Review 1 User Review Not Rated - Be the first! Covera-HS Images Covera-HS 180 mg (COVERA-HS 2011 ) View larger images} } to flamable


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