METHYLDOPA Film coated tablets Ref.[7784] Active ingredients: Alphamethyldopa

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT

Therapeutic indications

Treatment of moderate to severe hypertension.

Posology and method of administration

Adults

250mg 2-3 times daily for 2 days, adjusted at intervals of 2 days until adequate response is obtained. Maximum dose 3g daily (increase evening dose first). Usual effective dose 500mg to 2g daily.

Elderly

Initial dose should be kept as low as possible not exceeding 250mg daily. An appropriate starting dose would be 125mg twice daily, increased slowly as required but not exceeding a maximum daily dosage of 2g.

Children

10mg/kg bodyweight daily in 2-4 divided doses. The dosage is increased or decreased until adequate response is achieved. Maximum recommended daily dose is 65mg/kg bodyweight or 3g whichever is less.

Overdose

Symptoms of overdose may include acute hypotension, sedation, weakness, bradycardia, dizziness, gastrointestinal disturbances, light-headedness, constipation, distension, flatus, diarrhoea, nausea and vomiting.

Stomach emptied by aspiration, lavage and emesis may be induced if ingestion is recent. There is no specific antidote. Methyldopa is dialyzable. Treatment is symptomatic. Intravenous infusion may be given to promote urinary excretion and pressor agents such as metaraminol or noradrenaline given. Special care is needed with cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity. When chronic overdosage is suspected, methyldopa should be discontinued.

Shelf life

Shelf life: 30 months in Blister strips.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Aluminium/PVC (opaque) blister strips of 14 tablets in cartons containing 28 or 56 tablets.

Special precautions for disposal and other handling

No special instruction necessary.

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