Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CAPTOPRIL (UNII: 9G64RSX1XD) (CAPTOPRIL - UNII:9G64RSX1XD)
GLENVIEW PHARMA INC.
CAPTOPRIL
CAPTOPRIL 12.5 mg
ORAL
PRESCRIPTION DRUG
Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/ agranulocytosis (see WARNINGS). Captopril 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 is 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. Heart Failure: 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
Captopril Tablets, USP for oral administration are available as: 12.5 mg tablets in bottles of 100 (NDC 69158-003-00) The 12.5 mg Captopril tablet is white, round, flat, bevelled-edge with a bisect bar on one side and 'W 902' on the other side; 25 mg tablets in bottles of 100 (NDC 69158-004-00) The 25 mg Captopril tablet is white, round, flat, bevelled-edge with a quadrisect bar on one side and 'W 903' on the other side; 50 mg tablets in bottles of 100 (NDC 69158-005-00) The 50 mg Captopril tablet is a white, round, flat, bevelled-edge with a bisect bar on one side and 'W 904' on the other side; Bottle contains desiccant. All captopril tablets are white and may exhibit a slight sulfurous odor. Dispense in a tight container as defined in the USP. Storage Store at 20 o to 25 o C (68 o to 77 o F). Excursions permitted to 15 o to 30 o C (59 o to 86 o F). [See USP Controlled Room Temperature] Keep bottles tightly closed (protect from moisture). Distributed By: Glenview Pharma Inc., 6404 N Fairfield Ave Chicago, IL 60645 REV: 09-2014
Abbreviated New Drug Application
CAPTOPRIL- CAPTOPRIL TABLET GLENVIEW PHARMA INC. ---------- RX ONLY WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE CAPTOPRIL TABLETS, USP 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 tablets, USP are 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. Molecular formula C9H15NO3S [MW 217.29] and has the following structural formula: Captopril 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 scored tablet, for oral administration, contains 12.5 mg, 25 mg, or 50 mg of captopril. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, anhydrous lactose, colloidal silicon dioxide, talc and palmitic acid. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The mechanism of action of captopril has 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 prevents the conversion of angiotensin I to angiotensin II by inhibition o Læs hele dokumentet