INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MICRO DEXAMETHASONE PHOSPHATE INJECTION 4 mg/1 mL C/A

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MICRO DEXAMETHASONE PHOSPHATE INJECTION 4 mg/1 mL C/A

COMPOSITION:
Each 1 mL contains 4,0 mg
dexamethasone phosphate as the disodium salt with sodium metabisulphite 0,1 % m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Dexamethasone phosphate is a glucocorticoid and acts by controlling the rate of protein synthesis. It forms a steroid-receptor complex with receptor proteins, moves into the nucleus where it binds the chromatin and thus directs the genetic apparatus to transcribe RNA. It has a biological half-life in plasma of about 190 minutes. It has little or no effect on sodium and water retention.

INDICATIONS:
Coriticosteroids are used where their anti-inflammatory and immunosuppressive effects are desirable, including intensive treatment during shorter periods.

CONTRA-INDICATIONS:
Dexamethasone phosphate is contra-indicated in a patient that has hypersensitivity to corticosteroids, tuberculosis, psychoses, severe psychoneuroses, acute infection, peptic ulcer or osteoporosis.
The safety in pregnancy and lactation has not been established.

WARNINGS:
MICRO DEXAMETHASONE PHOSPHATE INJECTION should not be administered intrathecally or subconjuctivally.
Toxic effects may result from withdrawal or from continued use or large doses. Dexamethasone phosphate should be used with extreme caution in the presence of congestive heart failure, hypertension, in patients with diabetes mellitus, epilepsy, glaucoma, ocular herpes simplex, infectious diseases, chronic renal failure, uraemia and in elderly patients.

DOSAGE AND DIRECTIONS FOR USE:
Usual adult dosage ranges from 0,5 to 20 mg daily depending on the severity of the disorder.
Dexamethasone phosphate may be administered by slow intravenous injection or intramuscularly. In the treatment of cerebral oedema caused by malignancy, an initial intravenous dose of 10 mg is usually given, followed by 4 mg intramuscularly, every 6 hours. A response is usually obtained after 12 to 24 hours and dosage may be reduced after 2 to 4 days.
The injection may also be given by intra-articular, intralesional, intramuscular or soft tissue injection. For intra-articular injection, dose equivalent to 0,8 to 4 mg (depending on the size of the joint), are given.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Dexamethasone phosphate has little or no effect on sodium and water retention. Oedema, hypertension and an increased excretion of potassium with the possibility of hypokalaemic alkalosis may occur. In extreme cases, cardiac failure may be induced.
Excessive metabolic effects may lead to mobilisation of calcium and phosphorous, with osteoporosis and spontaneous fractures, nitrogen depletion and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased. Increased appetite is reported.
The effect on tissue repair is manifest in delayed wound healing and increased susceptibility to all kinds of infection: including sepsis, fungal and viral infections have been reported, especially if patients are given antibiotics concomitantly. Infections may also be masked.
Acute adrenal insufficiency may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma. Growth retardation in children has been reported. Large doses may produce symptoms typical of hyperactivity of the adrenal cortex, with moon-face, sometimes with hirsutism, buffalo hump, flushing, increased bruising, striae and acne, sometimes leading to a fully developed Cushing’s syndrome. Sudden cessation of administration is dangerous.
Other side-effects include: amenorrhoea, hyperhidrosis, skin thinning, ocular changes, including development of cataract, mental and neurological disturbances, intracranial hypertension, acute pancreatitis and aseptic necrosis of bone. Increase in the coagulability of blood may lead to thrombo-embolic complications. Peptic ulceration and muscular weakness have been reported. Muscle weakness and wasting occur less frequently.
Precautions:
Patients with active or doubtfully quiescent tuberculosis should not be given corticosteroids. Similarly, patients already receiving corticosteroid therapy are more susceptible to infection, the symptoms of which, moreover, may be masked until an advanced stage has been reached. Warnings have recently been issued about the risks of chickenpox and severe herpes zoster being increased in patients receiving systematic corticosteroids, and patients should avoid close personal contact with either infection.
During long courses of corticosteroid therapy, patients should be examined regularly and, in particular, checked for hypertension, glycosuria, hypokalaemia, gastric discomfort and mental changes.
Sodium intake may need to be reduced and potassium supplements may be necessary. Monitoring of the fluid intake and output, and daily weight records may give early warning of fluid retention.
Back pain may signify osteoporosis.
Children are at special risk from raised intracranial pressure.
Infection should be treated as an emergency.
Rapid intravenous injection of massive doses of corticosteroids, may sometimes cause cardiovascular collapse and injections should therefore be given slowly or by infusion. High doses should not be used for prolonged treatement.
Interactions:
Concurrent administration of barbiturates, carbamazepine, phenytoin, primidone or rifampicin may enhance the metabolism and reduce the effects of corticosteroids. Concurrent administration of corticosteroids with potassium depleting diuretics, such as thiazides or furosemide, may cause excessive potassium loss. There may be an increased incidence of gastro-intestinal bleeding and ulceration when corticosteroids are given with nonsteroidal anti-inflammatory drugs. Reponse to anticoagulants may be altered by corticosteroids and requirements of antidiabetic agents and antihypertensives may be increased. Corticosteroids may decrease serum concentrations of salicylates and may decrease the effect of antimuscarinics in myasthenia gravis.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless light yellow solution, in a 1 mL clear colourless, type 1, glass ampoule.

PRESENTATION:
10 or 100 x 1 mL clear colourless, type 1, glass ampoules packed in containers.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
32/21.5.1/0512

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MICRO HEALTHCARE (Pty) Ltd
10 Lindley Street
BETHLEHEM
9701
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1998

New addition to this site: September 2005
Source: Pharmaceutical Industry Website

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