TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Zydus Pharmaceuticals (USA) Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This  fixed  combination  drug  is  not  indicated  for  the  initial  therapy  of  edema  or  hypertension  except  in  individuals  in  whom  the  development  of  hypokalemia  cannot  be  risked. - Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). Triamterene and hydrochlorothiazide tablets, USP may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets, USP may enhance the actions of these drugs, dosage adjustments may be necessary. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mot

Product summary:

Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg are yellowish green to green colored, spotted, round shaped, flat, uncoated tablets debossed with '856' on one side and breakline on the other side and are supplied as follows: NDC 68382-856-01 in bottles of 100 tablets with child-resistant closure NDC 68382-856-05 in bottles of 500 tablets NDC 68382-856-10 in bottles of 1000 tablets NDC 68382-856-77 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Triamterene and Hydrochlorothiazide Tablets USP, 75 mg/50 mg are light yellow to yellow colored, round shaped, flat, uncoated tablets debossed with '857' on one side and breakline on the other side and are supplied as follows: NDC 68382-857-01 in bottles of 100 tablets with child-resistant closure NDC 68382-857-05 in bottles of 500 tablets NDC 68382-857-10 in bottles of 1000 tablets NDC 68382-857-77 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Store  at  20º  to  25º  C  (68º  to  77º  F)  [See  USP  Controlled  Room  Temperature].   Protect  from  light.   Dispense in a tight, light-resistant container as defined in the USP. Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088. Manufactured  by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India Distributed  by: Zydus  Pharmaceuticals (USA)  Inc. Pennington, NJ 08534 Rev.: 11/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene a
potassium-conserving
diuretic, with the natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide Tablet USP, 37.5 mg/25 mg
contains:
Triamterene, USP
..............................................................................37.5
mg
Hydrochlorothiazide, USP
................................................................25 mg
Each Triamterene and Hydrochlorothiazide Tablet USP, 75 mg/50 mg
contains:
Triamterene, USP
.............................................................................75
mg
Hydrochlorothiazide, USP
................................................................50 mg
Each triamterene and hydrochlorothiazide tablet, USP intended for oral
administration
contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP
and 75 mg
triamterene USP with 50 mg hydrochlorothiazide USP. In addition, each
tablet contains
the following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, D&C
Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate and
microcrystalline
cellulose. Additionally, the 37.5 mg/25 mg tablets contain FD&C Blue
No. 1 Aluminum
Lake.
Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is
soluble in formic
acid. It is sparingly soluble in methoxyethanol. It is very slightly
soluble in acetic acid,
alcohol and dilute mineral acids. It is practically insoluble in
water, benzene, ether,
chloroform and dilute alkali hydroxides. Its molecular weight is
253.26. Its structural
formula is:
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2_H_-1,2,4,
benzothiadiazine-7-sulfonamide
1,1-dioxide. Hydrochlorothiazide, USP is very slightly soluble in
water. It is freely soluble
in sodium hydroxide solution, n-butylamine and dimethyl formamide. It
is sparingly
soluble in methanol. It is