Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CAPTOPRIL (UNII: 9G64RSX1XD) (CAPTOPRIL - UNII:9G64RSX1XD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
CAPTOPRIL
CAPTOPRIL 25 mg
ORAL
PRESCRIPTION DRUG
Captopril and Hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. Treatment may, therefore, be initiated with Captopril and Hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION). In using Captopril and Hydrochlorothiazide, consideration shou
Dispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED MARCH 2006 CPHZ:R7
Abbreviated New Drug Application
CAPTOPRIL AND HYDROCHLOROTHIAZIDE - CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, Captopril and Hydrochlorothiazide should be discontinued as soon as possible. SEE WARNINGS: CAPTOPRIL: FETAL/NEONATAL MORBIDITY AND MORTALITY. DESCRIPTION Captopril and hydrochlorothiazide tablets, USP for oral administration combines two antihypertensive agents: captopril and hydrochlorothiazide. Catopril, the first of a new class of antihypertensive agents, is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Hydrochlorothiazide is a benzothiadiazide (thiazide) diuretic-antihypertensive. 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. Hydrochlorothiazide, USP is a white crystalline powder slightly soluble in water but freely soluble in sodium hydroxide solution. Captopril is designated chemically as 1-[(2S)-3-Mercapto-2-methylpropionyl]-L-proline; Hydrochlorothiazide is 6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Their structural formulas are: Captopril and Hydrochlorothiazide Tablets, USP are available for oral administration in four combinations of captopril with hydrochlorothiazide: 25 mg with 15 mg, 25 mg with 25 mg, 50 mg with 15 mg, and 50 mg with 25 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate. The 25 mg/25 mg and 50 mg/25 mg tablets also contain the coloring agent FD&C Yellow #6 Aluminum Lake. CLINICAL PHARMACOLOGY Pročitajte cijeli dokument