Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
DIRECT RX
RAMIPRIL
RAMIPRIL 5 mg
ORAL
PRESCRIPTION DRUG
1.1 Hypertension Ramipril capsules USP are 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 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 classe
Ramipril Capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of Ramipril Capsules USP are summarized below. Ramipril Capsules USP, 1.25 mg are: Size "4" capsules with yellow cap, imprinted with 'LUPIN' in black ink and yellow body imprinted with 'RAMIPRIL 1.25 mg' in black ink, containing white to off-white powder. NDC 68180-588-09 bottles of 90 NDC 68180-588-01 bottles of 100 NDC 68180-588-02 bottles of 500 Ramipril Capsules USP, 2.5 mg are: Size "4" capsules with orange cap, imprinted with 'LUPIN' in black ink and orange body imprinted with 'RAMIPRIL 2.5 mg' in black ink, containing white to off-white powder. NDC 68180-589-09 bottles of 90 NDC 68180-589-01 bottles of 100 NDC 68180-589-02 bottles of 500 Ramipril Capsules USP, 5 mg are: Size "4" capsules with red cap, imprinted with 'LUPIN' in black ink and red body imprinted with 'RAMIPRIL 5 mg' in black ink, containing white to off-white powder. NDC 68180-590-09 bottles of 90 NDC 68180-590-01 bottles of 100 NDC 68180-590-02 bottles of 500 Ramipril Capsules USP, 10 mg are: Size "4" capsules with light blue cap, imprinted with 'LUPIN' in black ink and light blue body imprinted with 'RAMIPRIL 10 mg' in black ink, containing white to off-white powder. NDC 68180-591-09 bottles of 90 NDC 68180-591-01 bottles of 100 NDC 68180-591-02 bottles of 500 Dispense in light-resistant, tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE DIRECT RX ---------- RAMIPRIL BOXED WARNING SECTION When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6). INDICATIONS & USAGE SECTION 1.1 Hypertension Ramipril capsules USP are 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 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 ca Olvassa el a teljes dokumentumot