TRIAMTERENE AND HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

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 are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules 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 may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, dosage adjustments may be necessary. 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 no satisfactory evidence that they are u

Product summary:

Triamterene and Hydrochlorothiazide Capsules, USP are available containing 37.5 mg triamterene and 25 mg hydrochlorothiazide in opaque olive and opaque rich yellow capsules imprinted in black ink with MYLAN over 2537 on both body and cap. They are available as follows: NDC 0378-2537-01 bottles of 100 capsules NDC 0378-2537-10 bottles of 1000 capsules STORE AT CONTROLLED ROOM TEMPERATURE 15°–30°C (59°–86°F). PROTECT FROM LIGHT. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED FEBRUARY 2002 TMHZ:R4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DESCRIPTION
Each triamterene and hydrochlorothiazide capsule for oral
administration contains hydrochlorothiazide
25 mg and triamterene 37.5 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 ClN O S
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
Inactive ingredients consist of colloidal silicon dioxide,
croscarmellose sodium, gelatin, magnesium
stearate, microcrystalline cellulose, pharmaceutical glaze,
polyethylene glycol, polysorbate 80,
propylene glycol, silicon dioxide, sodium bicarbonate, sodium lauryl
sulfate, synthetic black iron
oxide, titanium dioxide, yellow iron oxide, D&C Yellow #10 Aluminum
Lake, FD&C Blue #1, FD&C
Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, and FD&C Red #40
Aluminum Lake.
Triamterene and Hydrochlorothiazide Capsules, USP 37.5 mg/25 mg meet
_USP Dissolution Test 3_.
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 ions, and thereby
increases the quantity of sodium traversing the distal tubule and the
volume of water excreted. A portion
of the additional sodium presented to the distal tubul