TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

State of Florida DOH Central Pharmacy

INN (International ime):

TRIAMTERENE

Sastav:

TRIAMTERENE 37.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 trea

Proizvod sažetak:

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. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light. Dispense in a tight, light-resistant container. This product was Manufactured By: Sandoz Inc. Princeton, NJ 08540 And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

TRIAMTERENE AND HYDROCHLOROTHIAZIDE - TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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.
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.
This product complies with dissolution test #3.
CLINICAL PHARMACOLOGY
Triamterene and hydrochlorothiazide is a diuretic/antihypertensive
drug product that combines
natriuretic and antikaliuretic effects. Each component complements the
action of the other.
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11
7
7
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3
4
2
The triamterene component of triamterene and hydrochlorothiazide
capsule exerts its diuretic effect on
the distal renal tubule to inhibit the reabsorption of sodium in
exchange for pota