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Logo MICRO BETAMETHASONE 4 mg/ml INJECTION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MICRO BETAMETHASONE 4 mg/ml INJECTION

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

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 i.e. 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 is excreted in the urine.

INDICATIONS:
Betamethasone 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:
Betamethasone Injection should not be administered intrathecally or subconjuctivally. Toxic effects may result from withdrawal or from continued use or large doses.

DOSAGE AND DIRECTIONS FOR USE:
Betamethasone is given, intravenously, intramuscularly, intra-articularly, intralesionally or by 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 characterized 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 mat be produced with large doses. Due to mobilisation of calcium and phosphorus, osteoporosis and spontaneous fractures, nitrogen depletion, and hyperglycaemia may occur.
Other side-effects reported were; amenorrhoea, hyperhidrosis, skin thinning, ocular changes including development of cataract, mental and neurological disturbances, intracranial hypertension, acute pancreatitis, muscle weakness and aseptic necrosis of bone. Increased coagulability of the blood may lead to thrombo-embolic complications.
Care should be taken in patients with congestive heart failure; hypertension; diabetes mellitus; epilepsy; glaucoma; infective diseases; ocular herpes simplex, 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, primidone, or rifampicin may reduce the effect of corticosteroids.
- Excessive potassium loss may be due to concurrent administration of corticosteroids with potassium-depleting diuretics e.g. 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, containers of 10 or 100 x 1 mL ampoules.

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

REGISTRATION NUMBER:
32/21.5.1/0338

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:
July 1997

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

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