Dexadreson Solution for injection
A clear aqueous solution for injection. Each ml contains 2 mg Dexamethasone as Sodium phosphate. Benzylalcohol 15.6 mg is included as a preservative.
This preparation contains the sodium phosphate ester of dexamethasone, a fluoro-methyl derivative of prednisolone, which is a potent glucocorticoid with minimal mineralocorticoid activity. Dexamethasone has ten to twenty times the anti-inflammatory activity of prednisolone.
Following intramuscular injection this soluble ester of dexamethasone is rapidly absorbed and hydrolysed to the parent alcohol giving a prompt response which is maintained for approximately 48 hours.
Dexadreson may be used whenever a parenteral corticosteroid preparation giving a medium duration of activity is indicated. It can be used as an anti-inflammatory and anti-allergic agent in horses, cattle, pigs, dogs and cats and for the treatment of primary ketosis in cattle. The product can also be used to induce parturition in cattle and as supportive therapy in cases of shock in horses. Dexadreson is suitable for intravenous use in the horse and is thus of particular benefit in cases needing emergency treatment.
Dexadreson may be administered by intravenous or intramuscular injection in horses, and by intramuscular injection in cattle, pigs, dogs and cats. The product may also be given by intra-articular injection in horses. Normal aseptic technique should be observed. To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate administration of the correct dose.
For the treatment of inflammatory or allergic conditions
The following average doses are advised. However the actual dose used should be determined by the severity of the signs and the length of time for which they have been present.
Horses, cattle, pigs
1.5 ml/50 kg
0.5 ml/10 kg
Doses may be repeated once at 24–48 hour intervals if required.
For the treatment of primary ketosis in cattle (acetonaemia)
A dose of 5–10 ml is advocated dependent on the size of the cow and the duration of the signs. Care should be taken not to overdose Channel Island breeds. Larger doses will be required if the signs have been present for some time or if relapsed animals are being treated. In most early cases a single dose will effect a cure but the dose may be repeated at 48 hour intervals if necessary.
As supportive treatment in cases of shock in horses
Intravenous doses of 4–6 mg/kg can be administered.
For the induction of parturition
To avoid foetal oversize and mammary oedema in cattle.
A single intramuscular injection of 10 ml after day 260 of pregnancy.
Parturition will normally occur within 48–72 hours. If calving does not occur within these periods the dose may be repeated.
For the treatment of arthritis, bursitis or tenosynovitis
By intra-articular injection in the horse.
These quantities are not specific and are quoted purely as a guide. Injections into joint spaces or bursae should be preceded by the removal of an equivalent volume of synovial fluid. Strict asepsis is essential.
Except in emergency situations, the product should not be used in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure, osteoporosis and in viral infections during the viraemic stage.
Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result.
During therapy effective doses suppress the hypothalamo-pituitreal-adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. dosing to coincide with the time of the endogenous cortisol peak (i.e. in the morning with regard to dogs and the evening re cats) and a gradual reduction of dosage (for further discussion see standard texts).
Systematically administered corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use. Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis).
Apart from the use to induce parturition in cattle, corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion.
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.
Gastro-intestinal 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 animals with spinal cord trauma.
Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.
Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
During a course of treatment the situation should be reviewed frequently by close veterinary supervision.
If the product is used for induction of parturition in cattle, a high incidence of retained placentae may be experienced and possible subsequent metritis and/or subfertility.
Care should be taken when the product is used for the treatment of laminitis in horses, where there is the possibility that such treatment could worsen the condition. The use of the product in horses for other conditions could induce laminitis and careful observation during the treatment period should be made.
Use of the product in lactating cows may cause a reduction in milk yield.
Because corticosteroids can reduce the immunoresponse to vaccination, the product should not be used in combination with vaccines.
Care should be taken to avoid accidental self-injection.
If accidental self–injection occurs, seek medical attention and show the label to the doctor. Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water. Seek medical attention if irritation persists. Wash hands after use.
Cattle: Meat – 7 days; Milk - 60 hours
Pigs: Meat - 2 days
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
For animal treatment only. Keep out of the reach and sight of children.
Do not store above 25°C. Protect from light. Keep container in outer carton.
Following withdrawal of the first dose, use the product within 28 days. When the vial is broached for the first time, use the in-use shelf life which is specified on the packaging to calculate the date on which any remaining product should be discarded. This discard date should be written in the space provided on the label. Discard unused material.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.