VERAPAMIL HYDROCHLORIDE (Page 5 of 5)

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; eg, intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in the 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 judgment and experience of the treating physician.

OVERDOSAGE

Overdose with verapamil may lead to pronounced hypotension, bradycardia, and conduction system abnormalities (eg, junctional rhythm with AV dissociation and high degree AV block, including asystole). Other symptoms secondary to hypoperfusion (eg, 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 verapamil hydrochloride extended-release tablets), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the sustained-release formulation. Verapamil is known to decrease gastrointestinal transit time.

In overdose, verapamil hydrochloride extended-release tablets 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 solutions 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 g/hr for more than 24 hr) 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

Essential hypertension

The dose of verapamil hydrochloride extended-release tablets should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCl, verapamil hydrochloride extended-release tablets, given in the morning. Lower initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (eg, the elderly or small people). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of verapamil hydrochloride extended-release tablets are evident within the first week of therapy.

If adequate response is not obtained with 180 mg of verapamil hydrochloride extended-release tablets, the dose may be titrated upward in the following manner:

240 mg each morning,
180 mg each morning plus
180 mg each evening; or
240 mg each morning plus
120 mg each evening,
240 mg every 12 hours.

When switching from immediate-release verapamil hydrochloride tablets to verapamil hydrochloride extended-release tablets, the total daily dose in milligrams may remain the same.

HOW SUPPLIED

Verapamil hydrochloride extended-release tablets, USP 180 mg are supplied as light blue, oval shaped, scored, film coated tablets debossed with C 75 on one side and plain on other side.

NDC Number Size

NDC 71205-607-30

bottle of 30

NDC 71205-607-60

NDC 71205-607-90

bottle of 60

bottle of 90

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] and protect from light and moisture. Dispense in tight, light-resistant containers.

Manufactured for :
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827
Toll free number : 1-877-977-0687

Manufactured by:
Cadila Pharmaceuticals Limited
1389, Dholka, District — Ahmedabad,
Gujarat State, INDIA

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Revised March 2020

OETA1155

PRINCIPAL DISPLAY PANEL — 180 mg Tablet Bottle Label

NDC 71205-607-30

Verapamil Hydrochloride
Extended-Release
Tablets, USP

180 mg

Meets Dissolution Test 3

30 Tablets

Rx only

71205-607-30
(click image for full-size original)
VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-607(NDC:75834-158)
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color BLUE (LIGHT BLUE) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code C;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-607-30 30 TABLET in 1 BOTTLE None
2 NDC:71205-607-60 60 TABLET in 1 BOTTLE None
3 NDC:71205-607-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206173 05/15/2019
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-607), RELABEL (71205-607)

Revised: 09/2021 Proficient Rx LP

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