TRIAMTERENE AND HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Bryant Ranch Prepack

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide 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 useful in the treat

Descriptif du produit:

Capsules containing 37.5 mg triamterene and 25 mg hydrochlorothiazide are available for oral administration as white capsules with single black ink bands imprinted GG 606 in black ink and supplied as: NDC 0781-2074-01 bottles of 100 NDC 0781-2074-10 bottles of 1000 Capsules containing 50 mg triamterene and 25 mg hydrochlorothiazide are available for oral administration as opaque red cap/opaque red body, body and cap imprinted GG 580 in white ink, filled with yellow powder and supplied as: NDC 0781-2715-01 bottles of 100 NDC 0781-2715-10 bottles of 1000 NDC 0781-2715-13 unit dose packages of 100 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from moisture. Protect from light. Dispense in a tight, light-resistant container. 08-2011M 7379 Sandoz Inc. Princeton, NJ 08540

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
BRYANT RANCH PREPACK
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULES, USP
DESCRIPTION
Triamterene is an antikaliuretic agent and hydrochlorothiazide is a
diuretic/antihypertensive agent.
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 with a chemical
formula of C
H N and a molecular
weight of 253.27. The structural formula for triamterene is:
TRIAMTERENE
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-2_H_-1,2,
4-benzothiadiazine-7-sulfonamide 1,1-dioxide
with a chemical formula of C H ClN O S and a molecular weight of
297.75. The structural formula
for hydrochlorothiazide is:
HYDROCHLOROTHIAZIDE
Each capsule, for oral administration, contains 37.5 mg triamterene
and 25 mg hydrochlorothiazide or 50
mg triamterene and 25 mg hydrochlorothiazide.
The 37.5 mg triamterene and 25 mg hydrochlorothiazide capsule inactive
ingredients include: citric
acid, corn starch, glycine, anhydrous lactose, magnesium stearate,
Polysorbate 80, povidone, and
sodium starch glycolate. The capsule shells and imprinting inks
contain: D & C Yellow #10 Aluminum
Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD &
C Red #40 Aluminum
Lake, gelatin, pharmaceutical glaze, propylene glycol, synthetic black
iron oxide, and titanium dioxide.
The 37.5 mg triamterene and 25 mg hydrochlorothiazide capsule meets
USP _Dissolution Test 3_.
The 50 mg triamterene and 25 mg hydrochlorothiazide capsule inactive
ingredients include: lactose
monohydrate, magnesium stearate, povidone, corn starch. The capsule
shells and imprinting inks contain:
D&C Red # 40, gelatin, titanium dioxide, pharmaceutical glaze,
propy