Verapamil Hydrochloride Tablets USP

/Verapamil Hydrochloride Tablets USP
Verapamil Hydrochloride Tablets USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Verapamil Hydrochloride Tablets USP

ID:

57c103e0-d723-0031-b263-f02d7b8fc35b

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg or 120 mg of verapamil hydrochloride. Verapamil hydrochloride is not chemically related to other cardioactive drugs. The structural formula of verapamil hydrochloride is: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)-, monohydrochloride, (±)− Verapamil hydrochloride is a white or practically white, crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water, methanol, and chloroform. The inactive ingredients are anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach, 80 mg light peach and 120 mg peach); hydroxypropyl cellulose and titanium dioxide (40 mg white, 80 mg white and 120 mg white).

CLINICAL PHARMACOLOGY


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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells.

INDICATIONS AND USAGE


id: 0cde513f-f9f0-4c10-9c43-e1dbcd57735f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Verapamil Hydrochloride Tablets are indicated for the treatment of the following: Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory Bypass Tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential Hypertension

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Verapamil Hydrochloride Tablets are contraindicated in: 1. Severe left ventricular dysfunction (see WARNINGS) 2. Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. Second-or-third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) 5. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). (see WARNINGS) 6. Patients with known hypersensitivity to verapamil hydrochloride.

ANIMAL PHARMACOLOGY AND/OR ANIMAL TOXICOLOGY


id: a88d9888-3baf-4bb7-b6d9-0e68c0fe3ab4
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

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


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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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  
 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%       2° and 3°  0.8%
 CHF,Pulmonary edema  1.8%  Rash  1.2%
 Fatigue  1.7%  Flushing  0.6%
 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. Skin:  arthralgia and rash, exanthema, hair loss, hyperkeratosis, maculae, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme. Special senses: blurred vision, tinnitus. Urogenital: gynecomastia, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation, impotence.

OVERDOSAGE


id: e5c8a0b9-554b-4fa6-b994-c12f85d369e9
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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 injection 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 fixed 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


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The dose of verapamil hydrochloride 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.

Verapamil HCL 120mg Tablet


id: 5fa992ea-3eb6-4d1b-f50a-7346a608b43c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4