"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Verelan® PM (verapamil hydrochloride extended-release capsules) for oral use 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
THE CONTENTS OF THE Verelan PM CAPSULE SHOULD NOT BE CRUSHED OR CHEWED. Verelan PM CAPSULES ARE TO BE SWALLOWED WHOLE OR THE ENTIRE CONTENTS OF THE CAPSULE SPRINKLED ONTO APPLESAUCE.
Administer Verelan PM once daily at bedtime. Clinical trials studied doses of 100 mg, 200 mg, 300 mg and 400 mg. The usual daily dose of extended-release Verelan PM in clinical trials has been 200 mg given by mouth once daily at bedtime. In rare instances, initial doses of 100 mg a day may be warranted in patients who have an increased response to verapamil [e.g. patients with impaired renal function, impaired hepatic function, elderly, low-weight patients, etc. (see Use in Specific Populations)]. Base upward titration on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of Verelan PM are evident within the first week of therapy.
If an adequate response is not obtained with 200 mg of Verelan PM, the dose may be titrated upward in the following manner:
- 300 mg each evening
- 400 mg each evening (2 × 200 mg)
When Verelan PM is administered at bedtime, office evaluation of blood pressure during morning and early afternoon hours is essentially a measure of peak effect. The usual evaluation of trough effect, which sometimes might be needed to evaluate the appropriateness of any given dose of Verelan PM, would be just prior to bedtime.
Sprinkling The Capsule Contents On Food
Verelan PM capsules may also be administered by carefully opening the capsule and sprinkling the pellets onto one tablespoonful of applesauce. Swallow the applesauce immediately without chewing and follow 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. Use any pellet/applesauce mixture immediately and do not store for future use. Absorption of the pellets sprinkled onto other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules. Subdividing the contents of a Verelan PM capsule is not recommended.
Dosage Forms And Strengths
Extended-release capsules controlled onset:
100 mg, 200 mg, 300 mg.
100 mg: white opaque cap imprinted SCHWARZ/4085 and amethyst body imprinted 100 mg.
200 mg: amethyst opaque cap imprinted SCHWARZ/4086 and amethyst body imprinted 200 mg.
300 mg: lavender opaque cap imprinted SCHWARZ/4087 and amethyst body imprinted 300 mg.
Storage And Handling
Verelan PM (verapamil hydrochloride) extended-release pellet filled capsules are supplied in three dosage strengths:
|100 mg:||Two piece size 2 hard gelatin capsule, white opaque cap imprinted SCHWARZ/4085 and amethyst body imprinted with 100 mg. Product identification printed in black ink, supplied as follows: NDC 0091-4085-01 Bottle of 100s|
|200 mg:||Two piece size 0 hard gelatin capsule, amethyst opaque cap imprinted SCHWARZ/4086 and amethyst body imprinted with 200 mg. Product identification printed in black ink, supplied as follows: NDC 0091-4086-01 Bottle of 100s|
|300 mg:||Two piece size 00 hard gelatin capsule, lavender opaque cap imprinted SCHWARZ/4087 and amethyst body imprinted 300 mg. Product identification printed in black ink, supplied as follows: NDC 0091-4087-01 Bottle of 100s|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Protect from moisture.
Dispense in tight, light-resistant container as defined in USP.
Distributed by: Kremers Urban Pharmaceuticals Inc., Princeton, NJ 08540, USA. Manufactured by: Alkermes Gainesville LLC Gainesville, GA 30504, USA. Printed in USA Material Code: Rev. 10/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/27/2014
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