DYRENIUM- triamterene capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ)

Available from:

Concordia Pharmaceuticals Inc.

INN (International Name):

TRIAMTERENE

Composition:

TRIAMTERENE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Dyrenium may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy . 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. Diuretics are indicated in pregnancy (however, see PRECA

Product summary:

Capsules: 50 mg in bottles of 100, and 100 mg in bottles of 100.

Authorization status:

New Drug Application

Summary of Product characteristics

DYRENIUM - TRIAMTERENE CAPSULE
CONCORDIA PHARMACEUTICALS INC.
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DYRENIUM (TRIAMTERENE USP) CAPSULES 50 MG AND 100 MG POTASSIUM-
SPARING DIURETIC
WARNINGS
Abnormal elevation of serum potassium levels (greater than or equal to
5.5
mEq/liter) can occur with all potassium-sparing agents, including
Dyrenium.
Hyperkalemia is more likely to occur in patients with renal impairment
and diabetes
(even without evidence of renal impairment), and in the elderly or
severely ill. Since
uncorrected hyperkalemia may be fatal, serum potassium levels must be
monitored
at frequent intervals especially in patients receiving Dyrenium, when
dosages are
changed or with any illness that may influence renal function.
DESCRIPTION
Each capsule for oral use, with opaque red cap and body, contains
Triamterene USP, 50
or 100 mg, and is imprinted with the product name, DYRENIUM, strength
(50 mg or 100
mg) and WPC 002 (for the 50-mg strength) and WPC 003 (for the 100-mg
strength).
Inactive ingredients consist of D&C Red No. 33, FD&C Yellow No. 6,
Gelatin NF, Lactose
NF, Magnesium Stearate NF, and Titanium Dioxide USP.
Triamterene is 2,4,7-triamino-6-phenyl-pteridine:
Its molecular weight is 253.27. At 50°C, triamterene is slightly
soluble in water. It is
soluble in dilute ammonia, dilute aqueous sodium hydroxide and
dimethylformamide. It is
sparingly soluble in methanol.
CLINICAL PHARMACOLOGY
Triamterene has a unique mode of action; it inhibits the reabsorption
of sodium ions in
exchange for potassium and hydrogen ions at that segment of the distal
tubule under
the control of adrenal mineralocorticoids (especially aldosterone).
This activity is not
directly related to aldosterone secretion or antagonism; it is a
result of a direct effect on
®
the renal tubule.
The fraction of filtered sodium reaching this distal tubular exchange
site is relatively
small, and the amount which is exchanged depends on the level of
mineralocorticoid
activity. Thus, the degree of natriuresis and diuresis produced by
inhibition of the
exchange mechanism is