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Logo LENASONE INJECTION 4 mg/mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LENASONE INJECTION 4 mg/mL

COMPOSITION:
Each 1 mL ampoule contains 5,26 mg
betamethasone disodium phosphate equivalent to 4 mg betamethasone base, sodium metabisulphite 0,32% m/v and phenol 0,5% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 –Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
As for corticosteroids, Lenasone (betamethasone) 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.

INDICATIONS:
As substitution therapy in the treatment of adrenal insufficiency states.
In patients with known or suspected adrenal insufficiency prior to surgery, or if shock, severe trauma or other stress conditions occur.
Lenasone (betamethasone) is used for the symptomatic relief of inflammatory conditions and as immunosuppressant.

CONTRA-INDICATIONS:
Hypersensitivity to corticosteroids. Tuberculosis. Ocular herpes simplex. Primary glaucoma. Acute psychosis and psychoneurosis. Systemic infection. Peptic ulcer. Osteoporosis.

WARNINGS:
Lenasone (betamethasone) Injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Lenasone (betamethasone) should be used with extreme caution in the presence of congestive heart failure, hypertension, in patients with diabetes mellitus, chronic renal failure, uraemia and in elderly patients.

DOSAGE AND DIRECTIONS FOR USE:
Lenasone (betamethasone) is administered intravenously, intramuscularly, subcutaneously, intrasynovially or intralesionally.
Lenasone (betamethasone) Injection is not to be administered intramuscularly to patients with idiopathic thrombocytopenic purpura.
Intravenously, 1 to 2 mL Lenasone (betamethasone) (4 to 8 mg betamethasone base) as an initial dosage, administered slowly (1 minute). This initial dosage may be repeated at 3 to 4 hourly intervals. If necessary up to 5 mL (20 mg) may be administered at once. Once improvement has been obtained a dose of 0,5 to 1 mL (2 to 4 mg) is generally adequate.
Lenasone (betamethasone) may be given orally once the patient has attained the desired improvement.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Lenasone (betamethasone) may cause hypokalemic alkalosis. Increase susceptibility to infection (e.g. sepsis fungal and viral) and delayed wound healing. Cardiac failure. Peptic ulcerations with haemorrhage and perforation.
Glycosuria. Osteoporosis and spontaneous fractures. Increased appetite.
Posterior subcapsular cataract. Atrophy of the adrenal cortex and acute adrenal insufficiency during prolonged treatment. Inhibition or arrest of growth in children. Cushing syndrome. Amenorrhoea. Behavioural disturbances, including mental and neurological disturbances. Intracranial hypertension.
Thrombo-embolic complications. Lymphocytopenia. Myopathy. Hyperglycaemia with accentuation or precipitation of the diabetic state. Insulin requirements of diabetic patients are increased. Infections may be masked by anti-inflammatory properties of Lenasone (betamethasone).
Hyperhydrosis and aseptic necrosis of bone may occur. Live vaccines should not be given to patients receiving high doses of Lenasone (betamethasone).
Patients receiving long courses of Lenasone (betamethasone) should be regularly checked for hypertension glycosuria, hypokalaemia, gastric discomfort and mental changes. Sodium intake may need to be reduced and potassium supplements given. Daily mass records may indicate fluid retention and back pain may signify osteoporosis. Children are at special risk from raised intracranial pressure. Infections should be treated as an emergency.
Large doses should be given by infusion to prevent cardiovascular collapse.
Concurrent administration of barbiturates phenytoin or rifampicin may enhance the metabolism and reduce the effects of Lenasone (betamethasone).
Response to anti-coagulants may be reduced or enhanced. Concurrent administration of Lenasone (betamethasone) with potassium depleting diuretics may cause excessive potassium loss.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless to slight straw coloured solution in clear ampoules.

PRESENTATION:
Ampoules of 1 mL each, boxes of 10 ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
X/21.5.1/361

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
FEBRUARY 1991 12-198/1-95
  Tradepak PE

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