Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CAPTOPRIL (UNII: 9G64RSX1XD) (CAPTOPRIL - UNII:9G64RSX1XD)
AMICI PHARMACEUTICALS LLC
ORAL
PRESCRIPTION DRUG
Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digital
Captopril Tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of captopril, USP. The 12.5 mg tablets are white to off-white, arc diamond shaped tablets with bisect on one side and “131” on the other side. They are available as follows: Bottles of 100 Tablets NDC 69292-522-01 Bottles of 1000 Tablets NDC 69292-522-10 The 25 mg tablets are white to off-white, arc diamond shaped tablets with quadrisect on one side and “132” on the other side. They are available as follows: Bottles of 100 Tablets NDC 69292-524-01 Bottles of 1000 Tablets NDC 69292-524-10 The 50 mg tablets are white to off-white, arc diamond shaped tablets with bisect on one side and “133” on the other side. They are available as follows: Bottles of 100 Tablets NDC 69292-526-01 Bottles of 1000 Tablets NDC 69292-526-10 The 100 mg tablets are white to off-white, capsule shaped tablets with bisect on one side and “134” on the other side. They are available as follows: Bottles of 100 Tablets NDC 69292-528-01 Bottles of 500 Tablets NDC 69292-528-50 Bottles contain a desiccant-charcoal canister. All captopril tablets are white and may exhibit a slight sulfurous odor.
Abbreviated New Drug Application
CAPTOPRIL- CAPTOPRIL TABLET AMICI PHARMACEUTICALS LLC ---------- CAPTOPRIL TABLETS, USPRX ONLY WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL TABLETS AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY DESCRIPTION Captopril is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline [MW 217.29] and has the following structure: Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. MECHANISM OF ACTION The mechanism of action of captopril tablets have not yet been fully elucidated. Its beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. However, there is no consistent correlation between renin levels and response to the drug. Renin, an enzyme synthesized by the kidneys, is released into the circulation where it acts on a plasma globulin substrate to produce angiotensin I, a relatively inactive decapeptide. Angiotensin I is then converted by angiotensin converting enzyme (ACE) to angiotensin II, a potent endogenous vasoconstrictor substance. Angiotensin II also stimulates aldosterone secretion from the adrenal cortex, thereby contributing to sodium and fluid retention. Captopril tablets prevent the conversion of angiotensin I to angiotensin II by inhibition of ACE, a peptidyldipeptide carboxy hydrolase. This inhibition has been demonstrated in both healt Прочитайте повний документ