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Verelan (Verapamil Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Essential Hypertension

The dose of Verelan should be individualized by titration. The usual daily dose of sustained-release verapamil, Verelan, in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of Verelan are evident within the first week of therapy.

If adequate response is not obtained with 120 mg of Verelan, the dose may be titrated upward in the following manner:

(a) 180 mg in the morning.

(b) 240 mg in the morning.

(c) 360 mg in the morning.

(d) 480 mg in the morning.

Verelan sustained-release capsules are for once-a-day administration. When switching from immediate-release verapamil to Verelan capsules, the same total daily dose of Verelan capsules can be used.

As with immediate-release verapamil, dosages of Verelan capsules should be individualized and titration may be needed in some patients.

Sprinkling the Capsule Contents on Food

Verelan pellet filled capsules may also be administered by carefully opening the capsule and sprinkling the pellets on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any pellet/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a Verelan capsule is not recommended.

HOW SUPPLIED

Verelan ® (verapamil hydrochloride) sustained-release pellet filled capsules are supplied in four dosage strengths:

120 mg - Two-piece, size 2 hard gelatin capsule (yellow cap/yellow body), printed with SCHWARZ above 2490 and VERELAN above 120 mg in black ink, supplied as follows:
NDC 0091-2490-23 - Bottle of 100s
180 mg - Two-piece, size 1 elongated hard gelatin capsule (light grey cap/yellow body), printed with SCHWARZ above 2489 and VERELAN above 180 mg in black ink, supplied as follows:
NDC 0091-2489-23 - Bottle of 100s
240 mg - Two-piece, size 0 hard gelatin capsule (dark blue cap/yellow body), printed with SCHWARZ above 2491 and VERELAN above 240 mg in black ink, supplied as follows:
NDC 0091-2491-23 - Bottle of 100s
360 mg - Two-piece, size 00 hard gelatin capsule (lavender cap/yellow body), printed with SCHWARZ above 2495 and VERELAN above 360 mg in black ink, supplied as follows:
NDC 0091-2495-23 - Bottle of 100s

Store at controlled room temperature 20°-25°C (68°-77°F). [See USP]. Avoid excessive heat. Brief digressions above 25°C, while not detrimental, should be avoided. Protect from moisture. Dispense in tight, light-resistant container as defined in USP.

Call your doctor for medical advice about side effects. You may report side effects to UCB, Inc. at 1-800-477-7877 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

R x only

Manufactured for:
UCB, Inc.

Smyrna, GA 30080

Verelan® is a registered trademark of Alkermes Pharma Ireland Limited
by:
Alkermes Gainesville LLC
Gainesville, GA 30504, USA

U.S. Patent No.: 4,863,742

CP0187F Rev. 09/2011

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