DOPAMET Film-coated tablet Ref.[28245] Active ingredients: Alphamethyldopa

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Methyldopa is an antihypertensive agent indicated for the treatment of hypertension.

4.2. Posology and method of administration

General considerations

Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses.

Withdrawal of methyldopa is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.

Therapy with methyldopa may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually, as required. Following such previous antihypertensive therapy, methyldopa should be limited to an initial dose of not more than 500 mg daily and increased as required at intervals of not less than two days.

When methyldopa is given to patients on other antihypertensives the dose of these agents may need to be adjusted to effect a smooth transition.

When 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily.

Many patients experience sedation for two or three days when therapy with methyldopa is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first.

Posology

Adults

The recommended initial dose is 250mg orally two or three times daily for two days.
Adjustment intervals should be at least two days, until adequate response is obtained. The maximum recommended daily dosage is 3 g.

Elderly

Initial dose should be kept as low as possible not exceeding 250mg daily. A suggested starting dose would be 125 mg two times daily increasing slowly as required, but not to exceed a maximum daily dosage of 2g. Syncope in older patients may be related to an increased sensitivity and advanced atherosclerotic vascular disease. This may be avoided by lower doses.

Paediatric population

Initial dosage is based on 10 mg/kg bodyweight daily in 2-4 oral doses. The daily dosage is then increased or decreased until an adequate response is achieved. The maximum dosage is 65mg/kg or 3.0g daily, whichever is less.

4.9. Overdose

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastro-intestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distension, flatus, diarrhea, nausea and vomiting).

If ingestion is recent, emesis may be induced or gastric lavage performed. There is no specific antidote. Methyldopa is dialyzable. Treatment is symptomatic. Infusions may be helpful to promote urinary excretion. Special attention should be directed towards cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity. Administration of sympathomimetic agents may be indicated. When chronic overdosage is suspected methyldopa should be discontinued.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

PVC-Al blisters in packs of 30 &100, boxes of 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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