Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Vials of sterile, white freeze-dried powder containing 125 mg or 500 mg methylprednisolone (as the sodium succinate ester) presented with vials of solvent (Sterile Water for Injection) to produce a clear sterile solution for injection.

Uses

Corticosteroid: For administration to dogs and cats, as a glucocorticoid where a pharmacologically active, massive dose is required with a rapid onset of activity; for example in the treatment of overwhelming infections/toxicity, shock (as evidenced by collapse of peripheral circulation with clinical signs of pallor, weak and rapid pulse, shallow respiration) and spinal cord compression.

The use of relatively massive doses of Solu-Medrone V in cases of shock is well-established. The mechanism of action is believed to be twofold, being firstly a sustained rise in cardiac output with a concomitant decrease in peripheral vascular resistance and secondly the stabilisation of cellular and lysosomal membranes against endotoxic damage.

In the treatment of spinal cord compression, for instance as a consequence of an intervertebral disc rupture/protrusion or a road traffic accident, the mechanism of action of Solu-Medrone V is believed to include at least three mechanisms: 1) a facilitation of neuronal excitability and impulse conduction, 2) an improved spinal cord blood flow and 3) the preservation of spinal cord ultrastructure through a reduction of injury-induced free radical-catalysed lipid peroxidation.

Following the use of Solu-Medrone V at high dosage, there is no need for gradual tailing off, i.e. Solu-Medrone V therapy can be stopped as soon as clinical examination demonstrates a stable and improving patient state.

Dosage and administration

Reconstitution

Reconstitute aseptically by adding the contents of the solvent provided to the freeze-dried powder. Shake well to ensure contents are fully dissolved before use. Reconstituted solution should be used immediately.

Intramuscular or intravenous. Aseptic injection techniques should be practised. Where onset of activity is required within 30–180 minutes the intravenous route should be used; the required dose should be injected slowly over several minutes or given by intravenous infusion. For intravenous infusion, the initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline. Do not mix with calcium solutions.

When treating overwhelming infections/toxicity or shock, the dose should be 20 to 30 mg/kg methylprednisolone/kg bodyweight (0.32–0.48 ml product/kg); this may be repeated at 4–6 hours for 24–48 hours.

When treating spinal cord compression, the dose should be 30 mg/kg methylprednisolone/kg bodyweight (0.48 ml product/kg) and should be given within the first two hours of trauma for maximum clinical benefit. The need for conjunctive surgery or other medicinal treatment should be considered according to individual clinical status.

Contra-indications, warnings, etc

Vomiting may occur as a side effect of rapid intravenous treatment. Transient polydipsia, polyuria and hyperaesthesia are also possible side effects. A drop in systemic blood pressure may be produced by a high dose of methylprednisolone sodium succinate.

There are risks associated with the use, especially systemically, of corticosteroids during pregnancy. The safety of Solu-Medrone V in canine or feline pregnancy has not been established.

Systemic activity of corticosteroids in early pregnancy is known to have caused foetal abnormalities in laboratory animals and in late pregnancy may cause early parturition or abortion. Solu-Medrone V is indicated in life threatening conditions where it may be considered that, in pregnant animals, the clinical benefit may outweigh any possible risk.

Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, antibacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.

Except in cases of life threatening conditions, Solu-Medrone V is contra-indicated in cases where the patient is known or suspected to be suffering from Cushing's Syndrome, congestive heart failure, diabetes or severe chronic nephritis.

Gastrointestinal ulceration has been reported in animals treated with corticosteroids and g.i.t. ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

Concurrent administration of barbiturates, phenylbutazone, phenytoin or rifampicin may enhance the metabolism and reduce the effects of corticosteroids. Response to anti-coagulants may also be reduced by corticosteroids.

During a course of treatment, the situation should be reviewed frequently by close veterinary supervision.

Operator warning

Care should be taken to avoid accidental self-injection of this potent drug. In the event of contact with the eyes, flush with water or isotonic saline for 5-10 minutes. In the event of contact with the skin, wash with soap and water.

For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions

Do not store above 25°C. Do not freeze. Make up immediately before use. Any remaining reconstituted product should be discarded. Do not mix with calcium solutions.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Pack of single 125 mg or 500 mg vial, supplied with vial of Water for Injection as solvent.

Further information

Nil.

Marketing authorisation numbers

125 mg vial	Vm 00057/4242
500 mg vial	Vm 00057/4243
Water for Injection solvent	Vm 00057/4244