TRIAMTERENE AND HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide capsule

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:

Preferred Pharmaceuticals Inc.

INN (International Name):

TRIAMTERENE

Composition:

TRIAMTERENE 37.5 mg

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 capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is

Product summary:

Triamterene and Hydrochlorothiazide Capsules, USP contain 37.5 mg triamterene and 25 mg hydrochlorothiazide, and are available in size # 4 white opaque/white opaque capsules imprinted with Logo “LANNETT” on the cap and “1632” on the body. They are supplied as follows: Bottles of 30, NDC 68788-6802-3 Bottles of 60, NDC 68788-6802-6 Bottles of 90, NDC 68788-6802-9 Bottles of 100, NDC 68788-6802-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA Revised 04/11, Revision 1 10-582 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Each triamterene and hydrochlorothiazide capsule for oral use contains
triamterene 37.5 mg and
hydrochlorothiazide 25 mg. Hydrochlorothiazide is a
diuretic/antihypertensive agent and triamterene is
an antikaliuretic agent.
Hydrochlorothiazide is slightly soluble in water. It is soluble in
dilute ammonia, dilute aqueous sodium
hydroxide, and dimethylformamide. It is sparingly soluble in methanol.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1, 2,
4-benzothiadiazine-7- sulfonamide 1,1-dioxide,
and its structural formula is:
Molecular Formula: C H CIN O S M.W. 297.74
At 50°C, triamterene is practically insoluble in water (less than
0.1%). It is soluble in formic acid,
sparingly soluble in methoxyethanol, and very slightly soluble in
alcohol.
Triamterene is 2, 4, 7-triamino-6-phenylpteridine and its structural
formula is:
Molecular Formula: C
H N M.W. 253.26
Inactive ingredients consist of lactose monohydrate, pregelatinized
starch, sodium starch glycolate,
polysorbate 80, citric acid anhydrous, povidone, and magnesium
stearate. The capsule shell consists of
7
8
3
4
2
12
11
7
titanium dioxide and gelatin. The capsule imprinting ink consists of
shellac glaze in ethanol, iron oxide
black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue
# 2 Aluminum Lake, FD&C
Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow #
10 Aluminum Lake.
Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution
Test 3 as published in the
current USP monograph for triamterene and hydrochlorothiazide
capsules.
CLINICAL PHARMACOLOGY
The triamterene and hydrochlorothiazide capsule is a
diuretic/antihypertensive drug product that
combines natriuretic and antikaliuretic effects. Each component
complements the action of the other.
The hydrochlorothiazide component blocks the reabsorption of sodium
and chloride ion