VERAPAMIL HCl EXTENDED-RELEASE TABLETS USP, Rx only

/VERAPAMIL HCl EXTENDED-RELEASE TABLETS USP, Rx only
VERAPAMIL HCl EXTENDED-RELEASE TABLETS USP, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

VERAPAMIL HCl EXTENDED-RELEASE TABLETS USP, Rx only

ID:

98a3ef97-b447-4bfc-b284-13acd00bda5b

Code:

34391-3

DESCRIPTION


id: ec08fba4-bed6-4b6b-988e-8a986a30fd65
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Verapamil hydrochloride is chemically designated as Benzeneacetonitrile, α-[3-[[2-(3,4- dimethoxyphenyl)ethyl]-methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)-monohydrochloride and has the following structural formula: C27H38N2O4●HCl M.W. 491.07 Verapamil hydrochloride is a white or practically white crystalline powder, practically odorless with a bitter taste. It is soluble in water, methanol, and chloroform. Each extended-release tablet, for oral administration, contains 240 mg, 180 mg or 120 mg verapamil hydrochloride. In addition to verapamil hydrochloride the tablets contain the following inactive ingredients: sodium alginate, microcrystalline cellulose, povidone, magnesium stearate. The coating for verapamil 240 mg tablets contains: hydroxypropyl cellulose, hypromellose, titanium dioxide, polyethylene glycol, D&C Yellow No. 10 Aluminum lake. The coating for verapamil 180 mg tablets contains: hypromellose, titanium dioxide, polyethylene glycol, FD & C Yellow No. 6 Aluminum lake, polysorbate 80. The coating for verapamil 120 mg tablets contains: hypromellose, titanium dioxide, polyethylene glycol, polydextrose powder, triacetin, synthetic yellow iron oxide. All three strengths: 120 mg, 180 mg, and 240 mg meet USP Drug Release Test #2.

CLINICAL PHARMACOLOGY


id: 8494dae8-60b9-46d7-8d46-32be16a016d3
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Verapamil HCl 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: a5724868-a954-42ef-9198-0a812190f5f9
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Verapamil HCl Extended-Release Tablets are indicated for the management of essential hypertension.

CONTRAINDICATIONS


id: 669f4f5f-c88d-40b6-8ed5-0ab17936388d
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS


id: a87bc95c-17bf-4c0a-be4c-c23e7b25f4c1
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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 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%
Dizziness 3.3%
Nausea 2.7%
Hypotension 2.5%
Headache 2.2%
Edema 1.9%
CHF/Pulmonary Edema 1.8%
Fatigue 1.7%
Dyspnea 1.4%
Bradycardia (HR < 50/min) 1.4%
AV block – total (1°,2°,3°) 1.2%
2°and 3° 0.8%
Rash 1.2%
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 atrial flutter, ventricular rates below 50/min 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, maculas, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme. Special Senses: blurred vision, tinnitus. Urogenital: gynecomastia, impotence, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation.

OVERDOSAGE


id: 30542b9d-3e96-403e-8bf4-a392d6f44853
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdose with verapamil may lead to pronounced hypotension, bradycardia, and conduction system abnormalities (e.g., junctional rhythm with AV dissociation and high degree AV block, including asystole). Other symptoms secondary to hypoperfusion (e.g., metabolic acidosis, hyperglycemia, hyperkalemia, renal dysfunction, and convulsions) may be evident. Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially extended-release verapamil), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the extended-release formulation. Verapamil is known to decrease gastrointestinal transit time. In overdose, tablets of verapamil extended-release have occasionally been reported to form concretions within the stomach or intestines. These concretions have not been visible on plain radiographs of the abdomen, and no medical means of gastrointestinal emptying is of proven efficacy in removing them. Endoscopy might reasonably be considered in cases of massive overdose when symptoms are unusually prolonged. Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium injections may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. Continued treatment with large doses of calcium may produce a response. In a few reported cases, overdose with calcium channel blockers that was initially refractory to atropine became 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.

HOW SUPPLIED


id: 2d80ad35-605f-4c55-ae95-d39ca7d01471
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Verapamil Hydrochloride Extended-Release Tablets USP 240 mg NDC 21695-868-90 are supplied as ivory, capsule-shaped, scored, film-coated tablets debossed with “7300” on one side, on the other side, packaged in bottles of 90. Store between 20˚ to 25˚ C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. You may report side effects to FDA at 1-800-FDA-1088 TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. D 4/2010 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL


id: 9e71e003-e636-458f-bfd5-c4244812c1fc
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4