Vetacortyl (Canada)

Company: Vétoquinol

Sterile Suspension of Methylprednisolone Acetate, USP

VETERINARY USE ONLY

DIN 02011689

ACTIVE INGREDIENTS: per mL

PRESERVATIVES: per mL

PRESENTATION: Vial of 5 mL.

Properties

Methylprednisolone, an anti-inflammatory steroid, is the 6-methyl derivative of prednisolone. Exceeding prednisolone in anti-inflammatory potency and having less tendency than prednisolone to induce sodium and water retention, methylprednisolone offers the advantage over older corticosteroids of affording equally satisfactory anti-inflammatory effect with the use of lower doses and with an enhanced split between anti-inflammatory and mineralocorticoid activities.

The low water solubility of the molecule induces a long acting effect. Its duration of action is of about three weeks. In blood, methylprednisolone acetate is hydrolysed with release of the active fraction: methylprednisolone (MPS). MPS is characterized by its glucocorticoid action:

- Anti-inflammatory activity, involution of the lymphoid organs five times more important than the cortisol or hydrocortisone.

- Immunologic action interfering with the hypersensitivity reactions or changing the tissue response to these reactions.

- Action on the metabolism of carbohydrates: increase of glycemia and liver glycogenesis.

- Action on water-mineral metabolism: inhibition of the vitamin D activity, depletion of serum Ca.

Vetacortyl Indications

Musculoskeletal conditions: As with other adrenal steroids, methylprednisolone acetate has been found useful in alleviating the pain and lameness associated with acute localised arthritic conditions and generalized arthritic conditions. It has been used successfully to treat rheumatoid arthritis, traumatic arthritis, osteoarthritis, periostitis, synovitis, tenosynovitis, bursitis and myositis of horses; traumatic arthritis, osteoarthritis and generalized arthritic conditions of dogs. Remission of musculo-skeletal conditions may be permanent, or symptoms may recur, depending on the cause and extent of structural degeneration.

Allergic conditions: This preparation is especially beneficial in relieving pruritus and inflammation associated with allergic dermatitis, acute moist dermatitis, dry eczema, urticaria, bronchial asthma, pollen sensitivities and otitis externa in dogs: allergic dermatitis and moist and dry eczema in cats. Onset of relief may begin within a few hours to a few days following injection and may persist for a few days to six weeks. Symptoms may be expected to recur if the cause of the allergic reaction is still present, in which case retreatment may be indicated.

Other conditions: In certain conditions where it is desired to reduce inflammation, vascularization, fibroblastic infiltration and scar tissue, the use of methylprednisolone acetate should be considered. Snakebite of dogs also is an indication for the use of this suspension because of its antitoxemic, antishock and anti-inflammatory activity. It is particularly effective in reducing swelling and preventing sloughing. Its employment in the treatment of such conditions is recommended as a supportive measure to standard procedures and time-honoured treatments and will give comfort to the animal and hasten complete recovery.

Warnings

This drug is not to be administered to horses that are to be slaughtered for use in food.

Vetacortyl Cautions

Not for intravenous use. While using Vetacortyl, care should be taken to ensure that the suppression of the inflammatory process is not masking signs of infection and hence causing an overgrowth of microorganisms. Patients should be monitored for signs of infection. Should an infection occur, it should be brought under control by using appropriate antibiotics and discontinuing therapy with Vetacortyl, if necessary. Continued and prolonged use of corticosteroids is discouraged.

Contra-indications

Systemic therapy with methylprednisolone acetate, as with other corticoids, is contraindicated in animals with arrested tuberculosis, peptic ulcer and Cushing’s syndrome. The presence of active tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, predisposition to thrombophlebitis, hypertension or congestive heart failure necessitates carefully controlled use of corticosteroids.

Intrasynovial, or other injections of corticosteroids for local effect, are contraindicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following injection may indicate that the condition has become septic. Appropriate antibacterial therapy should be instituted immediately.

Vetacortyl Dosage And Administration

A) Systemic Administration

Following intramuscular injection of methylprednisolone acetate, a prolonged systemic effect results. The dose varies with the size of the animal patient, the severity of the condition under treatment and the animal’s response to therapy.

- Dogs and Cats: The average dose for dogs is 20 mg. In accordance with the size of the dog and severity of the condition under treatment, the dose may range from 2 mg in miniature breeds to 40 mg in medium breeds, and even as high as 120 mg in extremely large breeds or dogs with severe involvement.

The average dose for cats is 10 mg with a range up to 20 mg. Injection may be made at weekly intervals or in accordance with the severity of the condition and clinical response.

- Horses: The usual intramuscular dose for horses is 200 mg repeated as necessary. For maintenance therapy in chronic conditions, initial doses should be reduced gradually until the smallest effective (i.e. individualized) dose is established.

When treatment is to be withdrawn after prolonged and intensive therapy, the dose should be reduced gradually.

B) Local Administration

Methylprednisolone acetate, a slightly soluble ester of methylprednisolone, is capable of producing a more prolonged local anti-inflammatory effect than equimolar doses of hydrocortisone acetate. Following intrasynovial or intratendinous injection, relief from pain may be experienced within 12 to 24 hours. The duration of relief varies, but averages three to four weeks with a range of one to five or more weeks. Injections have been well tolerated with no resulting post-injection “flare-ups”.

Intrasynovial or intratendinous injection is recommended as an adjuvant to general therapeutic measures to effect suppression of inflammation in one or a few peripheral structures when (1) the disease is limited to one or a few peripheral structures; (2) the disease is widespread with one or a few peripheral structures actively inflamed; (3) systemic therapy with other corticoids or corticotrophin controls all but a few of the more actively involved structures; (4) systemic therapy with cortisone, hydrocortisone or corticotrophin is contraindicated; (5) joints show early but actively progressing deformity (to enhance the effect of physiotherapy and corrective procedures); and (6) surgical or other orthopedic corrective measures are to be or have been done.

The action of methylprednisolone acetate injected intrasynovially appears to be well localized since significant metabolic effects characteristic of systemic administration of adrenal steroids have not been observed. In a few instances, mild and transient improvement of structures other than those injected have been reported. No other systemic effects have been noted. However, it is possible that mild systemic effects may occur following intrasynovial administration, and this possibility is greater the larger the number of structures injected and the higher the total dose employed.

- Procedure: The anatomy of the area to be injected should be reviewed in order to assure that the suspension is properly placed and to determine that large blood vessels or nerves are avoided. The injection site is located where the synovial cavity is most superficial. The area is prepared for aseptic injection of the medication, by the removal of hair and cleansing of the skin with alcohol. A sterile 18- to 21-gauge needle for horses, 20- to 22-gauge needle for dogs, on a dry syringe is quickly inserted into the synovial space and a small amount of synovial fluid withdrawn. If there is an excess of synovia and more than 1 mL of suspension is to be injected, it is well to aspirate a volume of fluid comparable to that which is to be injected. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the proper amount of suspension which is then injected. In some animals, a transient pain is elicited immediately upon injection into the affected cavity. This pain varies from mild to severe and may last for a few minutes up to 12 hours. After injection, the structure may be moved gently a few times to aid mixing of the synovial fluid and the suspension. The site may be covered with a small sterile dressing.

Areas not suitable for injection are those that are anatomically inaccessible, such as spinal joints and those like the sacroiliac joints which are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the synovial space. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. Local therapy does not alter the underlying disease process, and whenever possible, comprehensive therapy including physiotherapy and orthopedic correction should be employed.

The single intrasynovial dose depends on the size of the part, which corresponds to the size of the animal. The interval between repeated injections depends on the duration of relief obtained.

- Horses: The average initial dose for a large synovial space in horses is 120 mg with a range from 40 to 240 mg. Smaller spaces will require a correspondingly lesser dose. The intratendinous dose in horses ranges from 80 to 400 mg, depending on the size of the tendon. Subcutaneous infiltration in the treatment of periostitis consists of multiple injections of 10 to 120 mg in numerous sites over the inflamed area.

- Dogs: The average initial dose for a large synovial space in dogs is 20 mg. Smaller spaces will require a correspondingly lesser dose.

Storage

keep between 15°C and 25°C. Keep from freezing.

Vétoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

432501 0912 A

NAC No.: 12340656