TRIAMTERENE AND HYDROCHLOROTHIAZIDE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Blenheim Pharmacal, Inc.

INN (mednarodno ime):

TRIAMTERENE

Sestava:

TRIAMTERENE 37.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske 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 tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - Triamterene and hydrochlorothiazide tablets are 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 tablets may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets 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

Povzetek izdelek:

Triamterene and Hydrochlorothiazide Tablets, USP are available as follows: The 37.5 mg/25 mg tablets are green round tablets debossed with MYLAN on one side of the tablet and TH above the score and 1 below the score on the other side. They are available as follows: NDC 0378-1352-01 bottles of 100 tablets NDC 0378-1352-05 bottles of 500 tablets The 75 mg/50 mg tablets are yellow round tablets debossed with MYLAN on one side of the tablet and TH above the score and 2 below the score on the other side. They are available as follows: NDC 0378-1355-01 bottles of 100 tablets NDC 0378-1355-05 bottles of 500 tablets 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 using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED JANUARY 2011 TRHCT:R4

Status dovoljenje:

New Drug Application

Lastnosti izdelka

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE TABLET
BLENHEIM PHARMACAL, INC.
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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
blocks the renal tubular absorption of
sodium and chloride ions. This natriuresis and diuresis is accompanied
by a secondary loss of
potassium and bicarbonate. Onset of hydrochlorothiazide's diuretic
effect occurs within 2 hours and the
peak action takes place in 4 hours. Diuretic activity persists for
approximately 6 to 12 hours.
The exact mechanism of hydrochlorothiazide's antihypertensive action
is not known although it may
relate to the excretion and redistribution of body sodium.
Hydrochlorothiazide does not affect normal
blood pressure.
Following oral administration, peak hydrochlorothiazide plasma levels
are attained in approximately 2
hours. It is excreted rapidly and unchanged in the urine.
Well controlled studies have demonstrated that doses of
hydrochlorothiazide as low as 25 mg given
once daily are effective in treating hypertension, but the
dose-response has not been clearly established.
TRIAMTERENE
Triamterene is a potassium-conserving (antikaliuretic) diuretic with
relatively weak natriuretic
properties. It exerts its diuretic effect on the distal renal tubule
to inhibit the reabsorption of sodium in
exchange for potassium and hydrogen. With this action, triamterene
increases sodium excretion and
reduces the excessive loss of potassium and hydrogen associated with
hydrochlorothiazide.
Triamterene is not a competitive antagonist of the mineralocorticoids
and its potassium-conserving
effect is observed in patients with Addison's disease, i.e., without
aldosterone. Triamterene's onset and
duration of activity is similar to hydrochlorothiazide