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Basic Drug Info
Drug Name:Methyldopa
Manufacturer:IVAX Pharmaceuticals, Inc.
Other Info:



Clinical Trials:


Indications and Usage
Hypertension.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications
Methyldopa is contraindicated in patients:- with active hepatic disease, such as acute hepatitis and active cirrhosis.- with liver disorders previously associated with methyldopa therapy (see WARNINGS).- with hypersensitivity to any component of this product.- on therapy with monoamine oxidase (MAO) inhibitors.
Liver diseases -- Pathological processes of the LIVER.

Acute Hepatitis --

Cirrhosis --

Liver Cirrhosis -- Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

It is important to recognize that a positive Coombs test, hemolytic anemia, and liver disorders may occur with methyldopa therapy.

The rare occurrences of hemolytic anemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed.

Read this section carefully to understand these reactions.With prolonged methyldopa therapy, 10 to 20 percent of patients develop a positive direct Coombs test which usually occurs between 6 and 12 months of methyldopa therapy.

Lowest incidence is at daily dosage of 1 g or less.

This on rare occasions may be associated with hemolytic anemia, which could lead to potentially fatal complications.

One cannot predict which patients with a positive direct Coombs test may develop hemolytic anemia.Prior existence or development of a positive direct Coombs test is not in itself a contraindication to use of methyldopa.

If a positive Coombs test develops during methyldopa therapy, the physician should determine whether hemolytic anemia exists and whether the positive Coombs test may be a problem.

For example, in addition to a positive direct Coombs test there is less often a positive indirect Coombs test which may interfere with cross matching of blood.Before treatment is started, it is desirable to do a blood count (hematocrit, hemoglobin, or red cell count) for a baseline or to establish whether there is anemia.

Periodic blood counts should be done during therapy to detect hemolytic anemia.

It may be useful to do a direct Coombs test before therapy and at 6 and 12 months after the start of therapy.If Coombs-positive hemolytic anemia occurs, the cause may be methyldopa and the drug should be discontinued.

Usually the anemia remits promptly.

If not, corticosteroids may be given and other causes of anemia should be considered.

If the hemolytic anemia is related to methyldopa, the drug should not be reinstituted.When methyldopa causes Coombs positivity alone or with hemolytic anemia, the red cell is usually coated with gamma globulin of the IgG (gamma G) class only.

The positive Coombs test may not revert to normal until weeks to months after methyldopa is stopped.Should the need for transfusion arise in a patient receiving methyldopa, both a direct and an indirect Coombs test should be performed.

In the absence of hemolytic anemia, usually only the direct Coombs test will be positive.

A positive direct Coombs test alone will not interfere with typing or cross matching.

If the indirect Coombs test is also positive, problems may arise in the major cross match and the assistance of a hematologist or transfusion expert will be needed.Occasionally, fever has occurred within the first 3 weeks of methyldopa therapy, associated in some cases with eosinophilia or abnormalities in one or more liver function tests, such as serum alkaline phosphatase, serum transaminases (SGOT, SGPT), bilirubin and prothrombin time.

Jaundice, with or without fever, may occur with onset, usually within the first 2 or 3 months of therapy.

In some patients the findings are consistent with those of cholestasis.

In others the findings are consistent with hepatitis and hepatocellular injury.Rarely, fatal hepatic necrosis has been reported after use of methyldopa.

These hepatic changes may represent hypersensitivity reactions.

Periodic determinations of hepatic function should be done, particularly during the first 6 to 12 weeks of therapy or whenever an unexplained fever occurs.

If fever, abnormalities in liver function tests, or jaundice appear, stop therapy with methyldopa.

If caused by methyldopa, the temperature and abnormalities in liver function characteristically have reverted to normal when the drug was discontinued.

Methyldopa should not be reinstituted in such patients.Rarely, a reversible reduction of the white blood cell count with a primary effect on the granulocytes has been seen.

The granulocyte count returned promptly to normal on discontinuance of the drug.

Rare cases of granulocytopenia have been reported.

In each instance, upon stopping the drug, the white cell count returned to normal.

Reversible thrombocytopenia has occurred rarely.
Branded Drugs
The following US Branded drugs contain Methyldopa


ALDOCLOR-150 -- MERCK AND CO INC

ALDOCLOR-250 -- MERCK AND CO INC

METHYLDOPA AND CHLOROTHIAZIDE -- PAR PHARMACEUTICAL INC

ALDORIL 15 -- MERCK AND CO INC

ALDORIL 25 -- MERCK AND CO INC

ALDORIL D30 -- MERCK AND CO INC

ALDORIL D50 -- MERCK AND CO INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- CLONMEL HEALTHCARE LTD

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- IVAX PHARMACEUTICALS INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- MYLAN PHARMACEUTICALS INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- PAR PHARMACEUTICAL INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- PARKE DAVIS DIV WARNER LAMBERT CO

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- PUREPAC PHARMACEUTICAL CO

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- SANDOZ INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- TEVA PHARMACEUTICALS USA INC

METHYLDOPA AND HYDROCHLOROTHIAZIDE -- WATSON LABORATORIES INC

ALDOMET -- MERCK AND CO INC

ALDOMET -- MERCK RESEARCH LABORATORIES DIV MERCK CO INC


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