METHYLDOPA (methyldopa)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Hepatic cirrhosis
Pheochromocytoma
Severe hepatic disease

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Autoimmune hemolytic anemia
Depression
Hypotension
Porphyria

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Angina
Chronic heart failure
Disease of liver
Edema
Kidney disease with reduction in glomerular filtration rate (GFr)
Parkinsonism
Severe cerebrovascular disease

There are 14 severe adverse reactions.

More Frequent	Less Frequent
Peripheral edema	Altered mental status Drug fever

Rare/Very Rare
Acute pancreatitis Autoimmune hemolytic anemia Cholestasis Colitis Drug-induced hepatitis Granulocytopenic disorder Hepatocellular damage Leukopenia Myocarditis Systemic lupus erythematosus Thrombocytopenic disorder

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Drowsy Headache disorder Xerostomia	Abnormal sexual function Diarrhea Erectile dysfunction Libido changes Nasal congestion Nausea Orthostatic hypotension

Rare/Very Rare
Hyperprolactinemia Paresthesia Sinus bradycardia Vomiting

Reproduction studies in mice, rabbits, and rats using oral methyldopa in dosages of 1000, 200, and 100 mg/kg, respectively, have not revealed evidence of harm to the fetus. These dosages are 16.6, 3.3,

and 1.7 times, respectively, the maximum daily human dosage when compared on the basis of body weight and 1.4, 1.1,

and 0.2 times, respectively, the maximum daily human dosage when compared on the basis of body surface area. Methyldopa has been used for many years in the management of hypertension in pregnant women, and the drug is generally considered safe for mother and fetus when used in association with careful prenatal management.

Uteroplacental blood flow and fetal hemodynamics have been reported to be stable during therapy with the drug. Although no teratogenic effects have been reported, the possibility that methyldopa may cause fetal injury (e.g., secondary to reduced placental blood flow or fetotoxicity) cannot be excluded. In neonates born to women treated with methyldopa, systolic blood pressure may be decreased during the first 2-3 days after delivery; in some neonates, tremors have also been reported.

Studies to date, including a long-term follow-up study, of children born to women who received methyldopa during pregnancy have not revealed evidence of substantial adverse effects of the drug on the offspring; however, in the longest follow-up study, treatment with methyldopa was associated with a smaller head circumference (without an apparent effect on intelligence quotient) in male offspring of those women whose therapy was initiated between 16 and 20 weeks' gestation. At 4 years of age, the developmental delay commonly seen in children born to hypertensive mothers was less evident in those whose mothers received methyldopa during pregnancy than in those whose mothers were untreated. Children born to mothers receiving methyldopa scored consistently higher on indices of intellectual and motor development than children born to untreated hypertensive mothers; however, these differences were not apparent by 7.5

years of age. Methyldopa should be used during pregnancy only when clearly needed. In addition, excessive reduction in blood pressure should be avoided, and a conservative approach to treatment generally should be followed. (See Hypertension during Pregnancy under Uses: Hypertension.)

Since methyldopa is distributed into milk, the drug should be used with caution in nursing women; the possibility of adverse effects on a nursing infant cannot be excluded. The extent to which methyldopa distributes into milk has not been clearly established, but the amount of drug a nursing infant would ingest is believed to be too small to be clinically important; however, if a woman receiving methyldopa breastfeeds, the infant (particularly if preterm) should be monitored for potential systemic effects of the drug (e.g., decreased respiration, blood pressure, or alertness).

No enhanced Geriatric Use information available for this drug.