Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A sterile solution containing Dexamethasone Sodium Phosphate 2 mg/ml and benzyl alcohol (20 mg/ml) as preservative.

Uses

Dexamethasone is a synthetic corticosteroid with a potent anti-inflammatory action: Duphacort Q can be used for:

1.Intravenous therapy in cases where emergency treatment is indicated, particularly shock and circulatory collapse, fog fever, acute mastitis and burns.

2.Acetonaemia (ketosis) in cattle. Duphacort Q has a marked glucogenic action.

3.Inflammatory conditions in all species: Duphacort Q will suppress inflammation and is indicated in the treatment of arthritis, laminitis (excluding horses), dermatitis, etc.

Dosage and administration

By intravenous or intramuscular injection.

Normal aseptic precautions should be observed.

Dosage:
Horses and cattle:	1 ml per 25 kg bodyweight
Dogs and cats:	1 ml per 10 kg bodyweight

e.g.
Horses	500 kg	- 20 ml
Cattle	400 kg	- 16 ml
Dogs	10 kg	- 1 ml
Cats	5 kg	- 0.5 ml

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Cattle must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 21 days from the last treatment. Milk must not be taken for human consumption during treatment. Milk for human consumption may be taken from cows only after 48 hours from the last treatment.

Do not use in horses intended for human consumption.

Systemic corticosteroid therapy is generally contraindicated in patients with renal disease and diabetes mellitus.

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.

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. a gradual reduction of dosage (for further discussion see standard texts).

Systemically acting 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).

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.

Gastrointestinal ulceration has been reported in animals treated with corticosteroids and gastrointestinal tract 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.

Use of the product in horses could induce laminitis and therefore careful observations during treatment should be made.

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

Pharmaceutical precautions

Store below 25°C. Keep out of the reach of children.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material.

Legal category

POM-V

Packaging Quantities

Multidose vials of 50 ml.

Further information

Nil

Marketing authorisation number

Vm 2000/4009