DISAL- furosemide injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Ladda ner Produktens egenskaper (SPC)
13-04-2023

Aktiva substanser:

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

Tillgänglig från:

Boehringer Ingelheim Animal Health USA Inc.

INN (International namn):

FUROSEMIDE

Sammansättning:

FUROSEMIDE 50 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION

Terapeutiska indikationer:

Dogs and Horses: DISAL Injection is an effective diuretic-saluretic for use in the treatment of acute noninflammatory tissue edema in dogs and horses, and for use in the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency in the dog. 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 in either dogs or horses 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 bitches, mares and stallions at stud. 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.

Produktsammanfattning:

DISAL Injection, 50 mg/mL is supplied in 100 mL multi-dose vials. NDC 0010-6737-01 – 100 mL

Bemyndigande status:

New Animal Drug Application

Produktens egenskaper

                                DISAL- FUROSEMIDE INJECTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
DISAL® (FUROSEMIDE INJECTION) 50 MG/ML
Approved by FDA under NADA # 131-538
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) Administered intramuscularly, it begins to act in about 30 minutes,
and diuretic
response is produced. When administered intravenously, the response is
in about 5
minutes.
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.
EACH ML CONTAINS: 50 mg furosemide as a monoethanolamine salt,
myristyl-gamma-
picolinium chloride 0.02%, EDTA sodium 0.1%, sodium sulfite 0.1% with
sodium chloride
0.2% in water for injection, pH adjusted with sodium hydroxide and/or
hydrochloric acid.
ACTIONS:
The therapeutic efficacy of DISAL Injection 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
1 2
3
1
accumulation in tissues and organs or crystalluria. Furosemide has 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 and Horses: DISAL Injection is an effective diuretic-saluretic
                                
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