TRIAMTERENE HYDROCHLOROTHIAZIDE- triamterene and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

TRIAMTERENE

Composition:

TRIAMTERENE 37.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 developmen

Product summary:

Triamterene and hydrochlorothiazide tablets, USP for oral administration are available as: 37.5 mg/25 mg: round, green, partial scored tablets, debossed GG 165 on one side and plain on the reverse side and supplied as: NDC 0781-1123-01 bottles of 100 NDC 0781-1123-05 bottles of 500 NDC 0781-1123-10 bottles of 1000 75 mg/50 mg: round, yellow, scored tablets, debossed GG 172 on one side and plain on the reverse side and supplied as: NDC 0781-1008-01 bottles of 100 NDC 0781-1008-05 bottles of 500 NDC 0781-1008-10 bottles of 1000 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMTERENE HYDROCHLOROTHIAZIDE- TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TABLET
BLENHEIM PHARMACAL, INC.
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLETS, USP
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.
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. No predictable
antihypertensive effect has been
demonstrated with triamterene.
Triamterene is rapidly absorbed following oral administration. Peak
plasma levels are achieved within
one hour after dosing. Triamterene is primarily metabolized to the
sulfate conjugate of
hydroxytriamterene. Both the plasma and urine levels of this
metabolite greatly exceed triamterene
levels.
The amount of triamterene added to 50 mg of hydrochlorothiazide in
triamterene and
hydrochlorothiazide tablets 75 mg/50 mg was determined from
steady-state dose response evaluations
in which various doses of liquid preparations of triamterene were
administered to hypertensive persons
who developed hypokalemia with hydrochlorothiazide (50 mg given once
daily). Single daily doses of
75 mg triamterene resulted in greater increases in serum potassium
than lower doses (25 mg and 50 mg),
while doses greater than 75 mg of triamterene resulted in no
additional elevations in ser