Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ)
GlaxoSmithKline LLC
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 25 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. DYAZIDE is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. DYAZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. DYAZIDE may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since DYAZIDE 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 treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical conseque
Capsules containing 25 mg hydrochlorothiazide and 37.5 mg triamterene supplied as follows: Patient-Pak unit-of-use bottles of 100 NDC 0007-3650-22. Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Dispense in a tight, light-resistant container. Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709 Trademarks are owned by or licensed to the GSK group of companies. ©2020 GSK group of companies or its licensor. August 2020 DYZ:76PI
New Drug Application
DYAZIDE- HYDROCHLOROTHIAZIDE AND TRIAMTERENE CAPSULE GLAXOSMITHKLINE LLC ---------- DYAZIDE (HYDROCHLOROTHIAZIDE/TRIAMTERENE) CAPSULES DESCRIPTION Each capsule of DYAZIDE (hydrochlorothiazide and triamterene) for oral use, with opaque red cap and opaque white body, contains hydrochlorothiazide 25 mg and triamterene 37.5 mg, and is imprinted with the product name DYAZIDE and SB. 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: 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: Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycine, lactose, magnesium stearate, microcrystalline cellulose, povidone, polysorbate 80, sodium starch glycolate, titanium dioxide, and trace amounts of other inactive ingredients. Capsules of DYAZIDE meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules. CLINICAL PHARMACOLOGY DYAZIDE 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 tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, c Læs hele dokumentet