CAPTOPRIL AND HYDROCHLOROTHIAZIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Rising Pharma Holdings, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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 a white, round, biconvex tablet debossed with ‘R over 27’ on one side of the tablet and quadrisect scored on the other side. They are available as follows: Bottles of 90 tablets - NDC 16571-827-09 The 25 mg/25 mg tablets are supplied as a peach, round, biconvex tablet debossed with ‘R over 28’ on one side of the tablet and quadrisect scored on the other side. They are available as follows: Bottles of 90 tablets - NDC 16571-828-09 The 50 mg/15 mg tablets are supplied as a white, capsule-shaped, biconvex tablet debossed with ‘R ’ to the left of the partial score and ‘29 ’ to the right of the partial score on one side of the tablet and partially scored on the other side. They are available as follows: Bottles of 90 tablets - NDC 16571-829-09 The 50 mg/25 mg tablets are supplied as a peach, capsule-shaped, biconvex tablet debossed with R to the left of the partial score and 30 to the right of the partial score on one side of the tablet and partially scored on the other side. They are available as follows: Bottles of 90 tablets - NDC 16571-830-09 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. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 12/2022 200640 PIR83001-00

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CAPTOPRIL AND HYDROCHLOROTHIAZIDE - CAPTOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
RISING PHARMA HOLDINGS, INC.
----------
BOXED WARNING
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 with
characteristic sulfide-like
odor; it is freely soluble in water, ethanol, methanol, chloroform,
isopropyl alcohol and
methylene chloride and soluble in ethyl acetate. It dissolves in
dilute solution of alkali
hydroxide.
Hydrochlorothiazide, USP is a white or almost white, almost odorless
crystalline powder.
Very slightly soluble in water, sparingly soluble in Ethanol and
Methanol, soluble in
Acetone. Freely soluble in N,N-Dimethylformamide, in n-Butylamine and
in diluted
solutions of alkali hydroxides. Practically insoluble in Ether, in
Chloroform and in diluted
mineral acids.
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