"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)./"...
INNOPRAN XL® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers.
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 montherapy) 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
INNOPRAN XL should be administered once daily at bedtime and should be taken consistently either on an empty stomach or with food. Initiate dosing at 80 mg and titrate to 120 mg daily as needed for blood pressure control. Doses above 120 mg have no additional effects on blood pressure [see Clinical Studies]. The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.
Dosage Forms And Strengths
INNOPRAN XL Extended-Release Capsules are supplied as capsules containing either 80 mg, or 120 mg of propranolol hydrochloride imprinted with “InnoPran XL”. In addition, the 80 mg strength is a gray/white capsule imprinted with “80” and 2 segmented bands, while the 120 mg strength is a gray/off-white capsule imprinted with “120” and 3 segmented bands.
Storage And Handling
INNOPRAN XL (propranolol hydrochloride) Extended Release Capsules are supplied as capsules containing either 80 mg, or 120 mg propranolol hydrochloride imprinted with “InnoPran XL”.
Store at 25°C (77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] in a tightly closed container.
Manufactured for: Akrimax Pharmaceuticals, LLC Cranford, NJ 07016 By: Aptalis Pharmatech, Inc. Vandalia, OH 45377. Marketed and distributed by: Akrimax Pharmaceuticals, LLC Cranford, NJ 07016 Innopran XL®, a Diffucaps ® Drug Delivery Product Manufactured By Aptalis Pharmatech, Inc. Revised: Nov 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/23/2013
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