Flucort Injection (Canada)

Description

The active ingredient of FLUCORT Injection is flumethasone which occurs as a white to creamy white, odorless, crystalline powder. The appearance of FLUCORT Injection is a clear, colourless to slightly yellowish, mobile liquid.

Experimental Studies

The acetate of flumethasone has been reported to have approximately 700 times the activity of hydrocortisone in the rat liver glycogen disposition assay^1,2.

Veterinary experimental studies utilizing eosinophil depression in normal dogs and blood glucose levels and eosinophil depression in normal cattle as parameters of drug activity in comparison tests involving prednisone and dexamethasone, suggest anti-inflammatory and gluconeogenic potencies for flumethasone of the following approximate order: Four times that of dexamethasone. Sixty to eighty times that of prednisone.

Clinical evidence of drug potency obtained during evaluation of the compound further substantiates the above experimental findings.

Flucort Injection Indications

FLUCORT Injection is recommended for various rheumatic, allergic, dermatologic and other disease states which are known to be responsive to the anti-inflammatory corticoids.

Bovine Indications

1. Ketosis.

2. Musculoskeletal conditions due to the inflammation of muscles or joints and accessory structures where permanent structural changes do not exist such as, arthritis, myositis, sprains or muscular soreness.

*3. Supportive therapy in milk fever, acute mastitis, metritis, shipping fever, pneumonia and founder.

Equine Indications

1. Musculoskeletal conditions due to inflammation where permanent structural defects do not exist such as bursitis, carpitis, osselets, tendinitis, myositis, sprains and muscular soreness.

*2. Supportive therapy in laminitis, fatigue, heat exhaustion and distemper (strangles).

Canine Indications

1. Musculoskeletal conditions due to inflammation of muscles or joints and accessory structures where permanent structural changes do not exist, such as, arthritis, osteoarthritis, disc syndrome, sprains and muscular soreness.

2. Acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions. The drug has proven useful in otitis externa in conjunction with topical medication for similar reasons.

3. In allergic states such as hives, urticaria, insect bites and asthmatic conditions.

4. Shock and shock-like states due to trauma, hemorrhage or endotoxins.³

*5. Supportive therapy prior to or following surgical procedures.

*6. Supportive therapy in various disease conditions such as distemper, hepatitis, cystitis, tracheobronchitis and tonsillitis.

Feline Indications

1. Musculoskeletal conditions due to inflammation of muscles or joints and accessory structures where permanent structural changes do not exist, such as, arthritis, sprains and muscular soreness.

2. Acute and chronic dermatoses of varying etiology to help control the pruritus, irritation and inflammation associated with these conditions.

3. For appetite stimulation in combination with the B-complex vitamins.

In human medicine various corticosteroids have been used for their remissive or palliative effect in a number of disease entities. These diseases include acute and chronic leukemia; various auto-immune disorders such as hemolytic anemia, idiopathic thrombocytopenic purpura, and systemic lupus erythrematosus; ulcerative colitis, nephrosis, asthmatic conditions and pulmonary emphysema.⁴ The use of corticosteroids as therapy in these human disease states suggests that they may prove of value in their counterparts in animals when encountered.

*When FLUCORT Injection is used as supportive therapy, it does not replace the need for standard, primary therapy.

Flucort Injection Dosage And Administration

FLUCORT Injection is recommended for parenteral administration using various routes depending on the animal species under treatment. Injection should be accomplished slowly with the drug at or near body temperature.

The intravenous injection of the compound may be indicated when a rapid method of administration is desired such as in toxemias or shock or shock-like states.

The following recommended dosages should be used as therapeutic guides. Each animal should be treated on an individual basis and dosage adjusted according to the response noted.

Dosage of FLUCORT Injection:

Bovine: 1.25 to 5.0 mg daily by intravenous or intramuscular injection. If necessary, the dose may be repeated.

Equine: 1.25 to 2.5 mg daily by intravenous or intramuscular injection. If necessary, the dose may be repeated.

Canine: 0.0625 to 0.25 mg daily by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated. Intralesional dosages in the dog have ranged from 0.125 to 1.0 mg, depending on the size and location of the lesion under treatment.

Feline: 0.03125 to 0.125 mg by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated.

If desired, therapy with FLUCORT Injection may be substituted for other corticoids by the appropriate adjustment of dose levels.

Flucort Injection Cautions

The usual precautions and contraindications for adrenocorticoid hormones are applicable with this compound. The close observation of animals under treatment with this drug is necessary since the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, etc., may not be readily observed. Under clinical and experimental trials, few side effects have been noted but, if they occur, the veterinarian should be prepared to take the necessary steps to correct them.

Continuous therapy with FLUCORT Injection especially at high dose levels, may result in suppression of adrenal cortical function. In such cases, a temporary suspension of the therapy and stimulation of the adrenal cortex by the use of ACTH may be advisable. Following prolonged therapy with the drug it is recommended that the drug be withdrawn gradually. If such animals are later subjected to stressful situations (trauma, surgery, etc.) it is advisable to institute a temporary course of therapy with FLUCORT Injection.

FLUCORT Injection may be administered to animals with bacterial diseases provided that specific and appropriate anti-bacterial therapy with antibiotic or chemotherapeutic drugs is administered simultaneously. It should be borne in mind that FLUCORT Injection like cortisone, through its anti-inflammatory action, may mask the usual signs of an infection such as pyrexia, inappetence, lassitude, etc. In the course of therapy with FLUCORT Injection should the question of determining the presence of an infectious disease arise, the drug should be withheld temporarily until a diagnosis or re-diagnosis establishes the facts.

Warning

Treated animals must not be slaughtered for use in food for at least 4 days after the latest treatment with this drug.

Storage

Store at room temperature.

REFERENCES

1. Stafford, R.O.; Barnes, I.E.; Bowman, B.J.; and Meinziger, M.M. PROC. SOC. EXP. BIOL. MED., 89, 371-374, 1955.

2. Ringler, I.; West, D.; Dulin, W.E.; and Boland, E.W. METABOLISM, 13, 37-44, 1964.

3. Lillehei, R.C.; Longerbeam, J.K.; Bloch, J.H.; and Mannox, W.G. CLIN. PARMACOL. THER. 5, 63-101, 1964.

4. “A Decade of Anti-Inflammatory Steroids, from Cortisone to Dexamethasone.” ANN. N.Y. ACAD. SCIENCE, 82, 797-1014, 1959.

© Wyeth 2006. All Rights Reserved.

Wyeth Animal Health, Division of Wyeth Canada, Guelph, Ontario N1K 1E5

Trademarks used under license

NAC No.: 11983711