INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BETANOID 4 mg/mL Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BETANOID 4 mg/mL Injection

COMPOSITION:
Each 1 mL contains betamethasone sodium phosphate equivalent to betamethasone 4 mg
Sodium metabisulphite 0,32% m/v as anti-oxidant per 1 mL.

PHARMACOLOGICAL CLASSIFICATION:
A.21.5.1 - Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Betamethasone is a glucocorticoid and has the general properties of corticosteroids. It acts by controlling the rate of protein-synthesis. It forms a steroid-receptor complex with receptor proteins, moving into the nucleus where it binds the chromatin and regulates transcription of certain genes. In most examples transcription is enhanced, never the less glucocorticoids also decrease transcription of certain genes ie. pro-opiomelanocortin that encodes ACTH.
Betamethasone is rapidly distributed to all body tissues and plasmaprotein binding is high. It crosses the placenta and may be excreted in small amounts in breast milk.
Betamethasone is metabolised mainly in the liver but also in the kidney, and are excreted in the urine.

INDICATIONS:
Betanoid Injection is indicated as substitution therapy in the treatment of adrenal insufficiency states in patients with a known or suspected adrenal insufficiency prior to surgery or if shock, severe trauma or other stress conditions occur. Symptomatic treatment of inflammatory conditions responsive to corticosteroid therapy.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Patients with osteoporosis; psychosis; severe psychoneuroses; peptic ulcer; doubtfully quiescent or active tuberculosis and in patients suffering from acute viral infections including herpes zoster or herpes simplex ulceration of the eye.
Pregnancy and lactation. Patients should not be vaccinated with live vaccines while being treated with betamethasone.

WARNINGS:
Betanoid Injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use or large doses.

DOSAGE AND DIRECTIONS FOR USE:
Betamethasone is given intramuscularly or intravenously by injection or infusion, in doses equivalent to 4 mg to 20 mg betamethasone. It may also be given by local injection into soft tissue, in doses equivalent to 4 mg to 8 mg.
Dosage frequency and route of administration must be adjusted to the specific requirements of the patient, according to the disease the severity of the condition, the response obtained and the patients tolerance to the product.
Rapid intravenous injection of massive doses of corticosteroids may sometimes cause cardiovascular collapse and injections should therefore be given slowly or by infusion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Electrolyte disturbances are characterised by hypertension and oedema, because of the retention of sodium and water, and the increase in potassium, excretion may cause hypokalaemic alkalosis.
Increased susceptibility to all kinds of infection; sepsis; tuberculosis; fungal infections; viral infections and delayed wound healing have been reported.
Acute adrenal insufficiency may occur during prolonged therapy or on cessation and may be precipitated by stressful situations. Growth retardation has been reported in children. High doses during pregnancy may cause foetal or neonatal adrenal suppression.
Reversible Cushingoid symptoms may be produced with large doses. Due to the mobilisation of calcium and phosphorous, osteoporosis and spontaneous fractures, nitrogen depletion, and hyperglycaemia may occur.
Other side-effects reported were: amenorrhoea, hyperhidrosis, skin thinning, mental and neurological disturbances, intracranial hypertension, acute pancreatitis, muscle weakness and aseptic necrosis of bone. Increased coagulability of the blood may lead to thromboembolic complications.
Care should be taken in patents with congestive heart failure; hypertension; diabetes mellitus; epilepsy; glaucoma; infective diseases; chronic renal failure; uraemia and in elderly patients.
Patients with quiescent tuberculosis should be observed closely and should receive chemoprophylaxis if corticosteroid therapy is prolonged.

INTERACTIONS:

-	Simultaneous administration of barbiturates, carbamazepine, phenytoin, imidone, or rifampicin may reduce the effects of corticosteroids.
-	Excessive potassium loss may be due to concurrent administration of corticosteroids with potassium - depleting diuretics eg. furosemide.
-	When corticosteroids are given with non-steroidal anti-inflammatory agents, an increase incidence of gastro-intestinal bleeding and ulceration may occur.
-	Requirements of antidiabetics and antihypertensives may be increased.
-	Serum concentrations of salicylates may be decreased.
-	Antimuscarinic effects may be decreased in myasthenia gravis.
-	It interferes with assay procedures for endogenous substances.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is symptomatic and supportive. Doses must be reduced and the treatment slowly withdrawn.

IDENTIFICATION:
Clear, colourless liquid in a clear ampoule.

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

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

REGISTRATION NUMBER:
30/21.5.1/0324

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Quatromed Ltd
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 July 1997                Pro-Print PBE00828/6-97

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