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Verelan

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Verelan

Indications
Dosage
How Supplied

INDICATIONS

Verelan (verapamil HCl) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

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:

  1. 180 mg in the morning.
  2. 240 mg in the morning.
  3. 360 mg in the morning.
  4. 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 on left and VERELAN above 120 mg on right side of the capsule 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 on left and VERELAN above 180 mg on right side of the capsule 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 on left and VERELAN above 240 mg on right side of the capsule 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 on left and VERELAN above 360 mg on right side of the capsule 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 1-800FDA-1088 or www.fda.gov/medwatch. Rxonly

Distributed by: Kremers Urban Pharmaceutical Inc. Princeton, NJ 08540, USA. Manufactured by: Alkermes Gaineville LLC Gaineville, GA 30504, USA. Rev. 06/2014

Last reviewed on RxList: 10/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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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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