DYRENIUM- triamterene capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

WellSpring Pharmaceutical Corporation

INN (nume internaţional):

TRIAMTERENE

Compoziție:

TRIAMTERENE 50 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

DYRENIUM- TRIAMTERENE CAPSULE
WELLSPRING PHARMACEUTICAL CORPORATION
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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,
Sodium Lauryl Sulfate NF,
Titanium Dioxide USP and Silicon Dioxide NF.
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 prod