DISAL- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dogs - DISAL Tablets are indicated for the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute non-inflammatory tissue edema. In cases of edema involving cardiac insufficiency, the continued use of heart stimulants such as digitalis or its glycosides is indicated. The rationale for efficacious use of diuretic therapy is determined by the clinical pathology producing the edema. Animal reproductive studies have shown that furosemide may cause fetal abnormality and the drug is contraindicated in pregnant animals. Furosemide is contraindicated in anuria, furosemide hypersensitivity, hepatic coma, or during electrolytic imbalances. Monitor serum electrolytes, BUN and CO2 frequently. Monitor serum potassium levels and watch for signs of hypocalcemia. Corticosteroids cause an additive potassium-depletion effect.

Product summary:

DISAL Tablets are available in 12.5 mg and 50 mg strength and supplied in bottles containing 500 tablets. NDC 0010-6738-01 12.5 mg – 500 tablets NDC 0010-6739-01 50 mg – 500 tablets

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DISAL- FUROSEMIDE TABLET
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
DISAL®
(FUROSEMIDE TABLETS)
Approved by FDA under NADA # 129-034
DISAL®
(FUROSEMIDE TABLETS)
DISAL is not USP for dissolution.
For use in dogs only.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Furosemide is a potent loop diuretic which is a derivative of
anthranilic acid. The
structure is:
Chemical Name: 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid.
Furosemide is pharmacodynamically characterized by the following:
1) It is administered orally. It is easily absorbed from the
intestinal tract and begins to
act in 30 to 60 minutes after oral administration.
2) Is a loop diuretic which inhibits reabsorption of sodium and
chloride at the ascending
loop of Henle in the kidneys, enhancing water excretion.
3) A dose-response relationship and a ratio of minimum to maximum
effective dose
range greater than tenfold.
4) A high degree of efficacy, low inherent toxicity and a high
therapeutic index.
ACTIONS:
1, 2
3
1
The therapeutic efficacy of DISAL Tablets is from the activity of the
intact and unaltered
molecule throughout the nephron, inhibiting the reabsorption of sodium
not only in the
proximal and distal tubule but also in the ascending limb of the loop
of Henle. The
prompt onset of action is a result of the drug's rapid absorption and
a poor lipid
solubility. The low lipid solubility and a rapid renal excretion
minimize the possibility of its
accumulation in tissues and organs or crystalluria. DISAL Tablets have
no inhibitory
effect on carbonic anhydrase or aldosterone activity in the distal
tubule. The drug
possesses diuretic activity either in the presence of acidosis or
alkalosis.
INDICATIONS:
Dogs - DISAL Tablets are indicated for the treatment of edema
(pulmonary congestion,
ascites) associated with cardiac insufficiency and acute
non-inflammatory tissue edema.
In cases of edema involving cardiac insufficiency, the continued use
of heart stimulants
such as digitalis o