Methyldopa 500 mg/1
methyldopa · TABLET · Rising Pharma Holdings, Inc.
Methyldopa is a tablet containing methyldopa at 500 mg/1, taken oral. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- Methyldopa
- Generic Name
- methyldopa
- NDC Code (Product)
64980-572- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA070076
- Marketing Start
- 09/16/2024
Recall History
Teva Pharmaceuticals USA
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Hypertension.
Dosage & Administration
DOSAGE & ADMINISTRATION Adults : Initiation of Therapy : The usual starting dosage of methyldopa tablets is 250 mg two to three times a day in the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than 2 days, until an adequate response is achieved. To minimize the sedation, start dosage increases in the evening. By adjustment of dosage, morning hypotension may be prevented without sacrificing control of afternoon blood pressure. When methyldopa tablets are given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When methyldopa tablets are given with anti-hypertensives other than thiazides, the initial dosage of methyldopa tablets should be limited to 500 mg daily in divided doses; when methyldopa tablets are added to a thiazide, the dosage of thiazide need not be changed. Maintenance of Therapy : The usual daily dosage of methyldopa tablets is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 g. Once an effective dosage range is attained, a smooth blood pressure response…
Warnings
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% 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 i…
Contraindications
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.
Drug Interactions
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. Patients may require reduced doses of anesthetics when on methyldopa. If hypotension does occur during anesthesia, 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. Coadministration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended. Monoamine oxidase (MAO) inhibitors: See CONTRAINDICATIONS .
Adverse Reactions
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 listed in order of decreasing severity. Cardiovascular : Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus hypersensitivity, orthostatic hypotension (decrease daily dosage), edema or weight gain, bradycardia. Digestive : Pancreatitis, colitis, vomiting, diarrhea, sialadenitis, sore or “black” tongue, nausea, constipation, distension, flatus, dryness of mouth. Endocrine : Hyperprolactinemia. Hematologic : Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia; positive tests for antinuclear antibody, LE cells, and rheumatoid factor, positive Coombs test. Hepatic : Liver disorders including hepatitis, jaundice, abnormal liver function tests (see WARNINGS ). Hypersensitivity : Myocarditis, pericarditis, vasculitis, lupus…
Frequently Asked Questions
What is Methyldopa used for?
Methyldopa contains methyldopa. It is a tablet taken oral. Consult your doctor for specific uses.
Is Methyldopa a controlled substance?
Methyldopa is not classified as a controlled substance by the DEA.
What is the generic name for Methyldopa?
The generic name for Methyldopa is methyldopa. There are no other listed brand versions of methyldopa.
What is the NDC code for Methyldopa 500 mg/1?
The NDC (National Drug Code) for Methyldopa 500 mg/1 is 64980-572, listed by Rising Pharma Holdings, Inc..
Other Methyldopa Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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