Biomedicine Sckivs Pharmaceuticals Nig. Ltd
3 Anionwu Street Odoakpu. P.O.Box 7846 Onitsha, Nigeria
Tel: 234-0803-507-8844; 803-619-3742

Brand Name



Manufactured by: Bharat Parenterals Ltd. VilI. Haripura, Ta. savli, Dist. Vadodara, Gujarat, India.

Therapeutic Class

Antihypertensives, Others

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-9133): Each mm coated tablet contains: Methyldopa BP eq, to Anhydrous Methyldopa 250 mg Pack Size: PRESENTATION: Alu- PVC Blister of 10 x 10 Tablets in a carton.


DESCRIPTION: Methyldopa is an antihypertensive and is the L-isomer of alpha-methyldopa. It is levo-3-(3,4-dihydroxyphenyl)-2-methylalanme sesquihydrate, Methyldopa IS supplied as tablets for oral administration containing 250 mg and 500 mg of methyldopa. The amount of methyldopa is calculated on the anhydrous basis. Its molecular formula is C10H13NO4,1




CONTRAINDICATIONS: Methyldopa is contraindicated inpatients: - with active hepatic diseases, such as acute hepatitis and active cirrhosis. - with liver disorders previously associated with methyldopa therapy. - with hypersensitivity to any component of this product. - on therapy with monoamine oxidase (MAO) inhibitors


WARNINGS: It is important to recognize that a positive Coomb's test, haemolytic anaemia, and liver disorders may occur with methyldopa therapy. The rare occurrences of haemolytic anaemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed. PRECAUTIONS: General: Methyldopa should be used with caution in patients with a history of previous liver disease or dysfunction. Some patients taking methyldopa experience clinical oedema or weight gain which may be controlled by use of a diuretic. Methyldopa should not be continued if edema progresses or signs of heart failure appear. Rarely, involuntary choreoathetotic movements have been observed during therapy with methyldopa in patients with severe bilateral cerebrovascular disease. If these movements occur, stop therapy.


DRUG INTERACTIONS: 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 manifestations of drug idiosyncrasy. When methyldopa and lithium are given concomitantly, the patient should be carefully monitored for symptoms of lithium toxicity. Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sui fate or ferrous gluconate. Drug Laboratory Test Interactions: Methyldopa may interfere with measurement of: urinary uric acid by the phosphotung state method, serum creatinine by the alkaline picrate method, and SGOT by colorimetric methods. Interference with spectrophotometric methods for SGOT analysis has not been reported. Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of a tumorigenic effect was seen when methyldopa was given for two years to mice at doses up to 1800 mg/kg/day or to rats at doses up to 240 mg/kg/day. Methyl dopa was not mutagenic in the Ames Test and did not increase chromosomal aberration or sister chromatid exchanges in Chinese hamster ovary cells. These in vitro studies were carried out both with and without exogenous metabolic activation. Fertility was unaffected when methyldopa was given to male and female rats at 100 mg/kg/day, Nursing Mothers: Methyldopa appears in breast milk. Therefore, caution should be exercised when methyldopa is given to a nursing woman. Paediatric Use: There are no well-controlled clinical trials in paediatric patients

Adverse Effects

ADVERSE REACTIONS: Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia or weakness may be noted as early and transient symptoms. However, significant adverse effects due to methyldopa have been infrequent and this agent usually is well tolerated. The following adverse reactions have been reported and within each category, are used in order of decreasing severity. Cardiovascular: Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus hypersensitivity, orthostatic hypotension (decrease daily dosage), oedema or weight gain, bradycardia. Digestive: Pancreatitis, colitis, vomiting, diarrhoea, sialadenitis, sore or black tongue, nausea, constipation, distension, flatus, dryness of mouth. Endocrine: Hyperprolactinemia. Haematologic: Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, haemolytic anaemia; positive tests for antinuclear antibody, LE cells and rheumatoid factor, positive Coomb's test. Hepatic: Liver disorders including hepatitis, jaundice, abnormal liver function tests. Hypersensitivity: Myocarditis, pericarditis, vasculitis, lupus-like syndrome, drug-related fever, eosinophilia. Nervous system: Involuntary choreoathetotic movements, symptoms of cerebrovascular insufficiency, psychic disturbances including nightmares and reversible mild psychoses or depression, headache, sedation, asthenia or weakness, dizziness, light-headedness, paraesthesias. Metabolic: Rise in BUN. Musculoskeletal: Arthralgia with or without joint swelling; myalgia. Respiratory: Nasal stuffiness. Skin: Toxic epidermal necrolysis, rash. Urogenital: Amenorrhea, breast enlargement, gynecomastia, lactation, impotence, decreased libido

Dosage & Administration

DOSAGE AND ADMINISTRATION: Adults: Antihypertensive: Initial: Oral, 250 mg two or three times a day for two days, the dosage then being adjusted, preferably at intervals of not less than two days, until the desired response is obtained. Maintenance: Oral, 500mg to 2 grams a day, divided into two to four doses. Note: Geriatric patients may be once sensitive to the effects of the usual adult dose and may require a lower dose to prevent syncope. Usual adult prescribing limits: 3 grams a day Paediatric Patients: Initial dosage is based on 10 mg/kg of body weight daily in two to four heaved. The maximum dosage is 65 mg/kg or 3g daily, whichever is less. OVERDOSAGE: Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distention, flatus, diarrhoea, nausea, vomiting). In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.

Storage/Handling Recommendations

STORAGE: Keep out of reach of children. Store in a dry place, below 30

Review Date

2018-01-10 08:54:38