Dopamet

Dopamet
Methyldopa

Composition
Each Film coated tablet contains: L - α - Methyldopa 250 mg

Mode of action
The antihypertensive effect of methyldopa is probably due to its metabolism to alphamethylnoradrenaline, which lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neutrotransmission, and/or reduction of plasma rennin-activity.

Indications
Hypertension.

Contra indications
Dopamet is contra-indicated in accute hepatitis and cirrhosis of the liver.
The preparation should be used with caution in patients with a history of liver disease.
Known hypersensitive to methyldopa.
On therapy with monoamine oxidase (MAD) inhibitors.

Side effects
The most common side effects is drowsiness, which will disappear on continued administration. Serious side effects ofalpha-methyldopa are rare.
Central nervous system: drowsiness, headache, lassitude, dizziness, cerebrovascular and mental disturbances.
Cardiovascular system: bradycardia, angina attack, orthostatic hypotension (dose reduction may be necessary), oedema due to water and salt retention (disappears on diuretic administration).
Gastrointestinal tract: nausea, vomiting, constipation, flatus, diarrhea and dryness of the mucous membranes have been reported.
Abnormal liver function tests have been reported:

• Endocrine: Hyperprolactinemia.
• Hematologic: Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia, positive test for antinuclearantibody, LE Cells, and rheumatoid factor, positive coombs test.
• Hypersensitivity: Myocarditis, pericarditis, vasculitis, lupus-like syndrome, drug related fever, eosinophilia.
• Others : Allergic reactions with skin rash, impotence, arthalgia, myalgia have been reported.

Precautions
It should be known that the positive Coomb test, haemolytic anaemia and disturbance of liver function could be occur during the therapy of alpha-methyldopa.
In the initial treatment of methydopa, blood test (such as hematocrit, haemoglobin and erythrocyte count) should be done for a standard or comparison related to any anaemia. Periodical blood count test should be also done during the treatment of methyldopa in order to diagnose any haemolytic anaemia.
It will be useful to make a direct Coomb Test before and 6 until 12 months after treatment. If the Coomb Test is positive and haemolytic anaemia occurs due to methyldopa, the therapy should be discontinued.
Severe necrotic liver disease is rare but has been reported.
Periodical liver function test should be done especially 6 until 12 weeks from the start of the treatment or when there is an idiopathic fever.
Use of alpha-methyldopa in pregnancy or may become pregnant or intend to nurse requires that anticipated benefits be weighed against possible risks.

Dosage
The initial dose is ½ - 1 tablet daily. Adjustment of the dose to meet the required blood pressure reducing effect must be made gradually, for example, by increasing the dose by ½ - 1 tablet at intervals of 2 - 3 days. If needed, the dose may be increased to 4 -8 tablets (1-2 g) daily. No additional effect is obtained by exceeding a dose of 2.5 g of methyldopa over 24 hours. When the dose is 1 g or over during 24 hours, it is an advantage to divide the dose up into 3 - 4 single doses. In the case of reduced renal function, the dose should be increased with caution, i.e. ½ tablet (125mg) at a time.

Drug interaction

• When methyldopa is used with other antihypertensive drugs, potentiation of antihypertensive effect may occur. Patients should be followed carefully to detect side reactions or unusual manifestation of drug idiosyncracy.
• Patients may require reduced doses of anaesthetic when on methyldopa. If hypotension does occur during anaesthesia, it usually can be controlled by vasopressors.The adrenergic receptors remain sensitive during treatment with methyldopa.
• When methyldopa and lithium are given concomitantly the patient should be carefully
  monitored for symptoms of lithium toxicity.
  Read the circular for lithium preparations.
• Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate.This may adversely affect blood pressure control in patients treated with methyldopa. Co administration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended.
• Monoamine oxidase (MAO) inhibitors.

Presentation
Dopamet Film coated tablet: available in boxes
containing 10 strips @ 10 film coated tablets.
Reg.No.:DKL7205503517A1

Storage
Store in a cool (15°C – 25°C), dry place and away from light

HARUS DENGAN RESEP DOKTER

Manufactured by
PT Actavis Indonesia, Jakarta
(Group of Actavis, Iceland)

Share this :