CAPTOPRIL AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

CAPTOPRIL

Composition:

CAPTOPRIL 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 should be give

Product summary:

Captopril and Hydrochlorothiazide Tablets, USP are available containing 25 mg or 50 mg of captopril, USP with 15 mg or 25 mg of hydrochlorothiazide, USP providing the following available combinations: 25 mg/15 mg, 25 mg/25 mg, 50 mg/15 mg or 50 mg/25 mg. The 25 mg/15 mg tablets are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with M 81 on one side and is quadrisected on the reverse side. They are available as follows: NDC 0378-0081-01 bottles of 100 tablets The 25 mg/25 mg tablets are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with M 83 on one side and is quadrisected on the reverse side. They are available as follows: NDC 0378-0083-01 bottles of 100 tablets The 50 mg/15 mg tablets are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with M 84 on one side and is partially bisected on both sides. They are available as follows: NDC 0378-0084-01 bottles of 100 tablets The 50 mg/25 mg tablets are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with M 86 on one side and is partially bisected on both sides. They are available as follows: NDC 0378-0086-01 bottles of 100 tablets Dispense in a tight, light-resistant 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 Controlled Room Temperature.] Protect from moisture. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 4/2020 CPHZ:R8

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPTOPRIL AND HYDROCHLOROTHIAZIDE- CAPTOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
MYLAN PHARMACEUTICALS INC.
----------
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. Captopril, 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 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 (corn) and sodium lauryl sulfate. The 25 mg/25
mg and 50 mg/25 mg tablets also
contain FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
CAPTOPRIL
_MECHANISM OF