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A diuretic-saluretic for prompt relief of edema.
ANADA 200-293, Approved by FDA

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Furosemide Injection 5% is a chemically distinct diuretic and saluretic pharmacodynamically characterized by the following:
1) A high degree of efficacy, low-inherent toxicity and a high therapeutic index. 2) A rapid onset of action of comparatively short duration. 3) A pharmacological action in the functional area of the nephron, i.e., proximal and distal tubules and the ascending limb of the loop 4) A dose-response relationship and a ratio of minimum to maximum effective dose range greater than tenfold. The intravenous route produces the most rapid diuretic response. The CAS Registry Number is 54-31-9. Furosemide Injection 5%, a diuretic, is an anthranilic acid derivative with the following structural formula: Generic name: Furosemide (except in United Kingdom-furosemide). Chemical name: 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.
The therapeutic efficacy of Furosemide Injection 5% 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. Furosemide Injection 5% 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.
Dogs, Cats & Horses:
Furosemide Injection 5% is an effective diuretic possessing a wide therapeutic range. Pharmacologically it promotes the rapid
removal of abnormally retained extracellular fluids. The rationale for the efficacious use of diuretic therapy is determined by the
clinical pathology producing the edema. Furosemide Injection 5% is indicated for the treatment of edema, (pulmonary congestion,
ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
The continued use of heart stimulants, such as digitalis or its glycosides is indicated in cases of edema involving cardiac
Furosemide Injection 5% is indicated for the treatment of physiological parturient edema of the mammary gland and associated
Furosemide Injection 5% is a highly effective diuretic-saluretic which if given in excessive amounts may result in dehydration and
electrolyte imbalance. Therefore, the dosage and schedule may have to be adjusted to the patient's needs. The animal should be
observed for early signs of electrolyte imbalance, and corrective measures administered. Early signs of electrolyte imbalance are:
increased thirst, lethargy, drowsiness or restlessness, fatigue, oliguria, gastro-intestinal disturbances and tachycardia. Special
attention should be given to potassium levels. Furosemide Injection 5% may lower serum calcium levels and cause tetany in rare
cases of animals having an existing hypocalcemic tendency.
Although diabetes mellitus is a rarely reported disease in animals, active or latent diabetes mellitus may on rare occasions be
exacerbated by Furosemide Injection 5%. While it has not been reported in animals the use of high doses of salicylates, as in
rheumatic diseases, in conjunction with Furosemide Injection 5% may result in salicylate toxicity because of competition for renal
excretory sites.
Transient loss of auditory capacity has been experimentally produced in cats following intravenous injection of excessive doses of
Furosemide Injection 5% at a very rapid rate.
Electrolyte balance should be monitored prior to surgery in patients receiving Furosemide Injection 5%. Imbalances must be
corrected by administration of suitable fluid therapy.
Furosemide Injection 5% is contraindicated in anuria. Therapy should be discontinued in cases of progressive renal disease if
increasing azotemia and oliguria occur during the treatment. Sudden alterations of fluid and electrolyte imbalance in an animal with
cirrhosis may precipitate hepatic coma, therefore observation during period of therapy is necessary. In hepatic coma and in states of
electrolyte depletion, therapy should not be instituted until the basic condition is improved or corrected. Potassium supplementation
may be necessary in cases routinely treated with potassium-depleting steroids.
Furosemide Injection 5% is a highly effective diuretic and if given in excessive amounts as with any diuretic may lead to excessive
diuresis which could result in electrolyte imbalance, dehydration and reduction of plasma volume enhancing the risk of circulatory
collapse, thrombosis, and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte
imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may
precipitate digitalis toxicity. Caution should be exercised in animals administered potassium-depleting steroids.
It is important to correct potassium deficiency with dietary supplementation. Caution should be exercised in prescribing enteric-
coated potassium tablets.
There have been several reports in human literature, published and unpublished, concerning nonspecific small-bowel lesions
consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts.
These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or
certain other oral diuretics. These small-bowel lesions may have caused obstruction, hemorrhage, and perforation. Surgery was
frequently required, and deaths have occurred. Available information tends to implicate enteric-coated potassium salts, although
lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only
when indicated and should be discontinued immediately if abdominal pain, distension, nausea, vomiting, or gastro-intestinal bleeding
Human patients with known sulfonamide sensitivity may show allergic reactions to Furosemide Injection 5%, however, these
reactions have not been reported in animals.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of
tubocurarine. Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Furosemide
Injection 5% and it is advisable to discontinue Furosemide Injection 5% for one day prior to any elective surgery.
Milk taken from animals during treatment and for 48 hours (four milkings) after the last treatment must not be
used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.
HORSES: Do not use in horses intended for food.
The usual dosage of Furosemide Injection 5% is 1 to 2 mg/lb. body weight (approximately 2.5 to 5 mg/kg). The lower dosage is
suggested for cats. Administer once or twice daily at 6- to 8-hour intervals either intravenously or intramuscularly. A prompt diuresis
usually ensues from the initial treatment. Diuresis may be initiated by the parenteral administration of Furosemide Injection 5%.
The dosage should be adjusted to the individual's response. In severe edematous or refractory cases, the dose may be doubled or
increased by increments of 1 mg per pound body weight. The established effective dose should be administered once or twice daily.
The daily schedule of administration can be timed to control the period of micturition for the convenience of the client or veterinarian.
Mobilization of the edema may be most efficiently and safely accomplished by utilizing an intermittent daily dosage schedule, i.e.,
every other day or 2 to 4 consecutive days weekly.
Diuretic therapy should be discontinued after reduction of the edema, or maintained after determining a carefully programmed
dosage schedule to prevent recurrence of edema. For long-term treatment, the dose can generally be lowered after the edema has
once been reduced. Re-examination and consultations with client will enhance the establishment of a satisfactorily programmed
dosage schedule. Clinical examination and serum BUN, CO2 and electrolyte determinations should be performed during the early
period of therapy and periodically thereafter, especially in refractory cases. Abnormalities should be corrected or the drug temporarily
Administer intramuscularly or intravenously 1/4 to 1/2 mL per 10 pounds body weight. Administer one or twice daily, permitting a 6- to
8-hour interval between treatments. In refractory or severe edematous cases the dosage may be doubled or increased by increments
of 1 mg per pound body weight as recommended in preceding paragraphs. “Dosage and Administration”.
The individual dose is 250 to 500 mg (5 to 10 mL) administered intramuscularly or intravenously once or twice daily at 6- to 8-hour
intervals until desired results are achieved. The veterinarian should evaluate the degree of edema present and adjust dosage
schedule accordingly. Do not use in horses intended for food.
The individual dose administered intramuscularly or intravenously is 500 mg (10 mL) once daily or 250 mg (5 mL) twice daily at 12-
hour intervals. Treatment not to exceed 48 hours postparturition.
Milk taken from animals during treatment and for 48 hours (four milkings) after the last treatment must not be used for food.
Cattle must not be slaughtered for food within 48 hours following last treatment.

Parenteral: Furosemide Injection 5%. Each mL contains: 50 mg furosemide as a diethanolamine salt preserved and stabilized with
myristyl-gamma-picolinium chloride 0.02%, EDTA sodium 0.1%, sodium metabisulphate 0.1% with sodium chloride 0.2% in Water
For Injection, USP, pH adjusted with sodium hydroxide.
Available in 50 mL multidose vials for dogs, cats, horses and cattle and 100 mL multidose vials for horses and cattle.
Acute Toxicity:
The following table illustrates low acute toxicity of Furosemide Injection 5% in three different species. (Two values indicate two
different studies.)
LD50 of Furosemide Injection 5% in mg/kg body weight
>1000 and >4640 >300 and >464 *NOTE: The lower value for the rat oral LD50 was obtained in a group of fasted animals; the higher figure is from a study performed
in fed rats.
Toxic doses lead to convulsions, ataxia, paralysis and collapse. Animals surviving toxic dosages may become dehydrated and
depleted of electrolytes due to the massive diuresis and saluresis.
Chronic Toxicity:
Chronic toxicity studies with Furosemide Injection 5% were done in a one-year study in rats and dogs. In a one-year study in rats,
renal tubular degeneration occurred with all doses higher than 50 mg/kg. A six-month study in dogs revealed calcification and
scarring of the renal parenchyma at all doses above 10 mg/kg.
Reproductive Studies:
Reproductive studies were conducted in mice, rats and rabbits. Only in rabbits administered high doses (equivalent to 10 to 25 times
the recommended average dose of 2 mg/kg for dogs, cats, horses, and cattle) of furosemide during the second trimester period did
unexplained maternal deaths and abortions occur. The administration of Furosemide Injection 5% is not recommended during the
second trimester of pregnancy.
Store between 15°C and 30°C (59°-86°F).
For Animal Use Only
Keep Out Of Reach Of Children
Iss. 12-01
NET CONTENTS: 50 mL and 100 mL
NAC No.: 10581590


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