TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Apotex Corp.

INN (इंटरनेशनल नाम):

TRIAMTERENE

रचना:

TRIAMTERENE 37.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, 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 consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. Triamterene and hydrochlorothiazide should not be used in the presence of elevated serum potassium levels (greater than or equal to 5.5 mEq/liter). If hyperkalemia develops, this drug should be discontinued, and a thiazide alone should be substituted. Triamterene and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents such as spironolactone, amiloride hydrochloride or other formulations containing triamterene. Concomitant potassium supplementation in the form of medication, potassium-containing salt substitute or potassium-enriched diets should also not be used. Triamterene and hydrochlorothiazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment. Triamterene and hydrochlorothiazide should not be used in patients who are hypersensitive to triamterene or hydrochlorothiazide or other sulfonamide-derived drugs.

उत्पाद समीक्षा:

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/ 25 mg are available for oral administration as green, oval biconvex tablets, scored and engraved “37.5” bisect “25” on one side, “APO” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-2656-1) Bottles of 500 (NDC 60505-2656-5) Bottles of 6,500 (NDC 60505-2656-7) Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval biconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-2657-1) Bottles of 500 (NDC 60505-2657-5) Bottles of 7,000 (NDC 60505-2657-7) Dispense with a child-resistant closure in a tight, light-resistant container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 37.5 mg/25 mg and 75 mg/50 mg Revised September 2020 Rev. 3

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
APOTEX CORP.
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TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, 37.5 MG/ 25 MG AND 75
MG/50
MG
DESCRIPTION
Triamterene and hydrochlorothiazide combines triamterene, a
potassium-conserving
diuretic, with the natriuretic agent, hydrochlorothiazide.
Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP
contains 37.5 mg
of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP.
Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP
contains 75 mg of
Triamterene, USP and 50 mg of Hydrochlorothiazide, USP.
Triamterene and hydrochlorothiazide tablets for oral administration
contains the
following inactive ingredients: lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, and sodium starch glycolate. In addition,
the 37.5 mg/25 mg
tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1
Aluminum Lake.
Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is
practically insoluble in
water, benzene, chloroform, ether and dilute alkali hydroxides. It is
soluble in formic acid
and sparingly soluble in methoxyethanol. Triamterene is very slightly
soluble in acetic
acid, alcohol and dilute mineral acids. The following is the
structural formula:
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2_H_ -1,2,4,
benzothiadiazine-7-sulfonamide
1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and
freely soluble in sodium
hydroxide solution, n-butylamine and dimethylformamide. It is
sparingly soluble in
methanol and insoluble in ether, chloroform and dilute mineral acids.
Its molecular weight
is 297.73. The following is the structural formula:
CLINICAL PHARMACOLOGY
Triamterene and hydrochlorothiazide is a diuretic, antihypertensive
drug product,
principally due to its hydrochlorothiazide component; the triamterene
component
reduces the excessive potassium loss which may occur with
hydrochlorothiazide use.
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide is a diuretic and antihypertensive agent. It
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