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For the treatment of hypertension.
Posology
Use in Adults
Initial dosage: Usually 250 mg two or three times a day, for two days.
Adjustment: Usually adjusted at intervals of not less than two days, until an adequate response is obtained. The maximum recommended daily dosage is 3 g.
Many patients experience sedation for two or three days when therapy is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first.
Withdrawal of methyldopa is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure.
Patients with renal impairment:
Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses.
Other antihypertensives:
Methyldopa therapy may be initiated in most patients already on treatment with other antihypertensive agents by terminating these other antihypertensive medications gradually if 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.
Paediatric population:
Initial dosage is based on 10 mg/kg body weight daily in 2-4 oral doses. The daily dose is then increased or decreased until an adequate response is obtained. The maximum dosage is 65 mg/kg or 3.0 g daily, whichever is less.
Older people:
The initial dose in elderly patients should be kept as low as possible, not exceeding 250 mg daily; an appropriate starting dose in the elderly would be 125 mg twice daily, increasing slowly as required, but not to exceed a maximum daily dosage of 2 g.
Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.
Method of administration
For oral administration.
Methyldopa is contra-indicated in patients with:
- Depression
- Active hepatic disease such as acute hepatitis and active cirrhosis
- Hypersensitivity (including hepatic disorders associated with previous methyldopa therapy) to methyldopa or to any of the other ingredients listed in section 6.1
- Therapy with monoamine oxidase inhibitors (MAOIs)- with a catecholamine-secreting tumour such as phaeochromocytoma or paraganglioma
- Porphyria.
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