| Summary Product Information |
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| Route of Administration |
Dosage Form |
Product Strength |
| Oral |
Tablet |
125 mg, 250 mg, 500 mg |
| Indications and Clinical Use |
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Methyldopa tablets are indicated for the treatment of arterial hypertension. Methyldopa is one of the drugs of choice for treating hypertension in pregnant women. However; due to side effects, it is rarely used, especially in the elderly, except for very resistant hypertension.
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Patients who are hypersensitive to this drug or to any ingredient in the formulation
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Active hepatic disease such as acute hepatitis or active cirrhosis
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Previous liver disorder or hemolytic anemia with methyldopa therapy
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Concurrent MAOI therapy
Hematologic
It is recommended to perform a complete blood count and direct coombs' test prior to and periodically while on methyldopa therapy. 10 to 20% of patients on prolonged methyldopa therapy develop a positive direct Coombs' test, usually 6 to 12 months after starting therapy. Patients with positive Coombs's test should be evaluated for hemolytic anemia. If hemolytic anemia exists, methlydopa must be discontinued and therapy should not be restarted. The anemia should resolve within several weeks after discontinuation of methyldopa. If not, corticosteroid therapy may be indicated. The positive coomb's test may take weeks to months to return to normal after stopping methyldopa therapy.
Hepatic
Use methyldopa with caution in patients with a history of liver disease. Fever, sometimes associated with eosinophilia or abnormal liver function tests has occurred within 3 weeks of initiating therapy. Jaundice with or without fever has also occured, usually after 2 to 3 months of therapy. Hepatic necrosis has been reported rarely. It is recommended to check liver function tests prior to and periodically while on methyldopa therapy, especially during the first 6 to 12 weeks or if the patient develops an unexplained fever. Discontinue methyldopa if unexplained fever or jaundice occurs, or if liver function tests are abnormal.
Renal
Lower doses may be required in patients with renal dysfunction . Methyldopa is removed during hemodialysis resulting in hypertension. A supplement dose is recommended after hemodialysis .Special Populations
Pregnant Women
Methyldopa is the most extensively used antihypertensive in pregnancy and is the initial drug of choice for the treatment of chronic hypertension in pregnant women. Neonates born to women on methyldopa therapy may have decreased systolic blood pressure for the first 2 to 3 days. There have also been reports of tremors. No substantial adverse effects have been detected in long-term follow up of children exposed in utero.
Nursing Women
Methyldopa is excreted in the breast milk. However; the amount is not clinically significant. The American Academy of Pediatriacs considers methyldopa to be compatible with breast-feeding.
Pediatrics (birth to 16 years old)
There are no well controlled trials in pediatric patients. Recommended dosages are based on published literature reports of methyldopa therapy in hypertensive pediatric patients.
Geriatrics
Methyldopa is rarely indicated in the elderly as there are better alternatives for treating hypertension in this age group. If methyldopa is used, start with lower doses since it has been associated with higher incidences of CNS sided effects, postural hypertension and syncope in the elderly.
Monitoring and Laboratory Tests
Obtain a complete blood count, direct Coombs' test and liver function tests prior to initiating therapy and periodically while on therapy .
Occupational Hazards
Methyldopa may cause sedation, especially in the first 2 to 3 days of initiating therapy. Advise patients to avoid activities that require mental alertness until they know how methyldopa affects them.
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