CAPTOPRIL AND HYDROCHLOROTHIAZIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

CAPTOPRIL (UNII: 9G64RSX1XD) (CAPTOPRIL - UNII:9G64RSX1XD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Verfügbar ab:

Physicians Total Care, Inc.

INN (Internationale Bezeichnung):

CAPTOPRIL

Zusammensetzung:

CAPTOPRIL 25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

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