Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Preferred Pharmaceuticals Inc.
TRIAMTERENE
TRIAMTERENE 37.5 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Baca dokumen lengkapnya