Verapamil Hydrochloride (Page 3 of 3)

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 hydrochloride 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 verapamil occurred at rates greater than 1% 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 (HR<50/min) 1.4%
Nausea 2.7% AV block total (1°, 2°, 3°) 1.2 % 1.2%
Hypotension 2.5% 2° and 3° 0.8%
Headache 2.2% Rash 1.2%
Edema 1.9% Flushing 0.6%
CHF,Pulmonary edema 1.8%
Fatigue 1.7%
Elevated liver enzymes (see WARNINGS)

In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50 at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.

The following reactions, reported in 1% 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, atrioventricular dissociation, 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, paresthesia, 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.

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 hydrochloride (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine hydrochloride, metaraminol bitartrate, or methoxamine hydrochloride) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine hydrochloride or dobutamine hydrochloride may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

OVERDOSAGE

Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially the extended-release formulation), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the extended-release formulation. 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.

DOSAGE AND ADMINISTRATION

The dose of verapamil must be individualized by titration. The usefulness and safety of dosages exceeding 480 mg/day have not been established; therefore, this daily dosage should not be exceeded. Since the half-life of verapamil increases during chronic dosing, maximum response may be delayed.

Angina: Clinical trials show that the usual dose is 80 mg to 120 mg three times a day. However, 40 mg three times a day may be warranted in patients who may have an increased response to verapamil (e.g., decreased hepatic function, elderly, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately eight hours after dosing. Dosage may be increased at daily (e.g., patients with unstable angina) or weekly intervals until optimum clinical response is obtained.

Arrhythmias: The dosage in digitalized patients with chronic atrial fibrillation (see PRECAUTIONS) ranges from 240 to 320 mg/day in divided (three times a day or four times a day) doses. The dosage for prophylaxis of PSVT (non-digitalized patients) ranges from 240 to 480 mg/day in divided (three times a day or four times a day) doses. In general, maximum effects for any given dosage will be apparent during the first 48 hours of therapy.

Essential hypertension: Dose should be individualized by titration. The usual initial monotherapy dose in clinical trials was 80 mg three times a day (240 mg/day). Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect. Consideration should be given to beginning titration at 40 mg three times per day in patients who might respond to lower doses, such as the elderly or people of small stature. The antihypertensive effects of verapamil are evident within the first week of therapy. Upward titration should be based on therapeutic efficacy, assessed at the end of the dosing interval.

HOW SUPPLIED

Verapamil Hydrochloride Tablets USP, 40 mg light peach film-coated tablets, debossed with WATSON 404 are available in bottles of 100.

Verapamil Hydrochloride Tablets USP, 80 mg white, scored film-coated tablets, debossed with WATSON 343 are available in bottles of 100, 500, and 1000.

Verapamil Hydrochloride Tablets USP, 120 mg white, scored film-coated tablets, debossed with WATSON 345 are available in bottles of 100, 500, and 1000.

Bottles of 100 are supplied with child-resistant closures.

Dispense in a tight, light-resistant container with child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Revised: November 2014

PRINCIPAL DISPLAY PANEL

verapamil hcl 120mg
(click image for full-size original)

VERAPAMIL HYDROCHLORIDE verapamil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0937(NDC:0591-0345)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VERAPAMIL HYDROCHLORIDE (VERAPAMIL) VERAPAMIL HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code WATSON;345
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-0937-1 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070994 10/01/1986
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-0937)

Revised: 01/2022 RedPharm Drug, Inc.

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