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Isoptin

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Isoptin SR

Isoptin SR

INDICATIONS

ISOPTIN SR (verapamil HCl) is indicated for the management of essential hypertension.

DOSAGE AND ADMINISTRATION

Essential Hypertension

The dose of ISOPTIN SR should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCl, ISOPTIN SR, 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 (e.g., the elderly or small people etc.). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of ISOPTIN SR are evident within the first week of therapy.

If adequate response is not obtained with 180 mg of ISOPTIN SR, the dose may be titrated upward in the following manner:

  1. 240 mg each morning,
  2. 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening
  3. 240 mg every twelve hours.

When switching from immediate release ISOPTIN to ISOPTIN SR, the total daily dose in milligrams may remain the same.

HOW SUPPLIED

ISOPTIN® SR 240 mg tablets are supplied as light green, capsule shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side and “ST” on the other side. ISOPTIN® SR 180 mg tablets are supplied as light pink, oval shaped, scored, film-coated tablets containing 180 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side, and “SK” on the other side. The ISOPTIN® SR 120 mg tablets are supplied as light violet, oval shaped, film-coated tablets containing 120 mg of verapamil hydrochloride. The tablet is embossed with “p” on one side and “SC” on the other side.

240 mg (light green)- Bottle of 100-NDC # 10631-490-01
                               Bottle of 500- NDC # 10631-490-05
180 mg (light pink)- Bottle of 100- NDC # 10631-489-01
120 mg (light violet)- Bottle of 100- NDC # 10631-488-01

Storage

Store at 25 ° C (77 ° F); excursions permitted to 15 °–30 ° C (59 °– 86 ° F) [see USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, USA Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA. October 2011

Last reviewed on RxList: 12/16/2011
This monograph has been modified to include the generic and brand name in many instances.

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Isoptin SR - User Reviews

Isoptin SR User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

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