DEMADEX- torsemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TORSEMIDE (UNII: W31X2H97FB) (TORSEMIDE - UNII:W31X2H97FB)

Available from:

Physicians Total Care, Inc.

INN (International Name):

TORSEMIDE

Composition:

TORSEMIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials. DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. DEMADEX is contraindicated in patients with known hypersensitivity to DEMADEX or to sulfonylureas. DEMADEX is contraindicated in patients who are anuric.

Product summary:

DEMADEX for oral administration is available as white, scored tablets containing 10 mg, 20 mg of torsemide. The tablets are supplied in:  10 mg    Bottles of 30   NDC 54868-3835-0 20 mg   Bottles of 10   NDC 54868-4687-1 20 mg   Bottles of 30   NDC 54868-4687-0 20 mg   Bottles of 90   NDC 54868-4687-3 20 mg   Bottles of 100   NDC 54868-4687-2 Each tablet is debossed on the scored side with the logo BM and 102, 103, 104, or 105 (for 5 mg, 10 mg, 20 mg, or 100 mg, respectively). On the opposite side, the tablet is debossed with 5, 10, 20, or 100 to indicate the dose. Storage Store at 15° to 30°C (59° to 86°F). Rx only

Authorization status:

New Drug Application

Summary of Product characteristics

DEMADEX - TORSEMIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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DEMADEX (TORSEMIDE) TABLETS
DESCRIPTION
DEMADEX (torsemide) is a diuretic of the pyridine-sulfonylurea class.
Its chemical name is 1-
isopropyl-3-[(4-_m_-toluidino-3-pyridyl) sulfonyl]urea and its
structural formula is:
Its empirical formula is C
H N O S, its pKa is 7.1, and its molecular weight is 348.43.
Torsemide is a white to off-white crystalline powder. The tablets for
oral administration also contain
lactose NF, crospovidone NF, povidone USP, microcrystalline cellulose
NF, and magnesium stearate
NF.
CLINICAL PHARMACOLOGY
Mechanism of Action
Micropuncture studies in animals have shown that torsemide acts from
within the lumen of the thick
ascending portion of the loop of Henle, where it inhibits the Na /K
/2CI -carrier system. Clinical
pharmacology studies have confirmed this site of action in humans, and
effects in other segments of the
nephron have not been demonstrated. Diuretic activity thus correlates
better with the rate of drug
excretion in the urine than with the concentration in the blood.
Torsemide increases the urinary excretion of sodium, chloride, and
water, but it does not significantly
alter glomerular filtration rate, renal plasma flow, or acid-base
balance.
Pharmacokinetics and Metabolism
The bioavailability of DEMADEX tablets is approximately 80%, with
little intersubject variation; the
90% confidence interval is 75% to 89%. The drug is absorbed with
little first-pass metabolism, and the
serum concentration reaches its peak (C
) within 1 hour after oral administration. C
and area under
the serum concentration-time curve (AUC) after oral administration are
proportional to dose over the
range of 2.5 mg to 200 mg. Simultaneous food intake delays the time to
C
by about 30 minutes, but
overall bioavailability (AUC) and diuretic activity are unchanged.
Absorption is essentially unaffected
by renal or hepatic dysfunction.
The volume of distribution of torsemide is 12 liters to 15 liters in
normal adults or in patients with mild
to