DYAZIDE- hydrochlorothiazide and triamterene capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

hydrochlorothiazide (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH), triamterene (UNII: WS821Z52LQ) (triamterene - UNII:WS821Z52LQ)

Tilgjengelig fra:

Cardinal Health

INN (International Name):

hydrochlorothiazide

Sammensetning:

hydrochlorothiazide 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Capsules containing 25 mg hydrochlorothiazide and 37.5 mg triamterene, in bottles of 1,000 capsules; in Patient-Pak™ unit-of-use bottles of 100. They are supplied as follows: NDC 0007-3650-22–in Patient-Pak™ unit-of-use bottles of 100. NDC 0007-3650-30–bottles of 1,000. 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. GlaxoSmithKline Research Triangle Park, NC 27709 DYAZIDE is a registered trademark of GlaxoSmithKline. ©2007, GlaxoSmithKline. All rights reserved. June 2007 DYZ:72PI Cardinal Health Zanesville OH 43701 I12600308

Autorisasjon status:

New Drug Application

Preparatomtale

DYAZIDE- HYDROCHLOROTHIAZIDE AND TRIAMTERENE CAPSULE
CARDINAL HEALTH
----------
DYAZIDE®
(HYDROCHLOROTHIAZIDE/TRIAMTERENE)
CAPS ULES
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, co