VERAPAMIL HYDROCHLORIDE (Page 5 of 5)

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:

a)
240 mg each morning,
b)
180 mg each morning plus
180 mg each evening; or
240 mg each morning plus
120 mg each evening,
c)
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

Product: 50090-4582

NDC: 50090-4582-0 30 TABLET in a BOTTLE

NDC: 50090-4582-4 90 TABLET in a BOTTLE

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

Revised March 2020

OETA1155

Storage

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.

VERAPAMIL HYDROCHLORIDE

Label ImageLabel Image
VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4582(NDC:75834-159)
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
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 19mm
Flavor Imprint Code C;77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4582-0 30 TABLET in 1 BOTTLE None
2 NDC:50090-4582-4 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 — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4582), REPACK (50090-4582)

Revised: 10/2021 A-S Medication Solutions

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