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METHYLDOPA is a brand name for Methyldopa, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: METHYLDOPA (methyldopa tablets) is indicated: • For the treatment of arterial hypertension. May be employed in a general treatment program in conjunction with a diuretic and/or other antihypertensive drugs as needed for proper response in patients with hypertension of various severity. • As the initial agent in the…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 6
1 Adverse Reaction Overview 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. Blood and lymphatic system disorders: hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia, bone marrow depression, eosinophilia.
Cardiac disorders: bradycardia, aggravation of angina pectoris, myocarditis, pericarditis, congestive heart failure, prolonged carotid sinus hypersensitivity, atrioventricular block. Endocrine disorders: hyperprolactinemia. Gastrointestinal disorders: nausea, vomiting, distention, constipation, flatus, diarrhea, mild dryness of mouth, sore or black·tongue, pancreatitis, sialadenitis, colitis, glossodynia.
General disorders and administration site conditions: asthenia or weakness, edema (and weight gain) usually relieved by the use of a diuretic (Discontinue methyldopa if edema progresses or if signs of heart failure appear), drug-related fever.
Hepatobiliary disorders: liver disorders including hepatitis, jaundice. METHYLDOPA (Methy ldopa Tablets) Page 12 of 26 Unclassified / Non classifié Musculoskeletal and connective tissue disorders: mild arthralgia, myalgia. Nervous system disorders: sedation, headache, dizziness, lightheadedness, symptoms of cerebrovascular insufficiency (may be due to lowering of blood pressure), paresthesias, parkinsonism, Bell's palsy, decreased mental acuity, involuntary choreoathetotic movements, toxic encephalopathy.
Psychiatric disorders: psychic disturbances including nightmares and reversible mild psychoses or depression, decreased libido. Reproductive system and breast disorders: breast enlargement, gynecomastia, lactation, impotence, amenorrhea.
Respiratory, thoracic, and mediastinal disorders: nasal stuffiness. Skin and subcutaneous tissue disorders: dermatologic reactions including eczema and lichenoid eruptions, lupus-like syndrome, toxic epidermal necrolysis, angioedema, urticaria.
4 Geriatrics 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Special Populations ..........................................................................................
11 8 ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview .............................................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................
12 9 DRUG INTERACTIONS.................................................................................................. 1 Serious Drug Interactions ................................................................................. 4 Drug-Drug Interactions.....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions..................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
14 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics............................................................................................. 16 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS.............................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Vascular disorders: orthostatic hypotension (decrease daily dosage), vasculitis. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Laboratory Test Findings: abnormal liver function tests, positive Coombs test, rise in BUN, positive tests for antinuclear antibody, LE cells and rheumatoid factor.
16 PART II: SCIENTIFIC INFORMATION ........................................................................................ 17 13 PHARMACEUTICAL INFORMATION..............................................................................
17 14 CLINICAL TRIALS.......................................................................................................... 17 15 MICROBIOLOGY ..........................................................................................................
17 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 18 PATIENT MEDICATION INFORMATION ...................................................................................
19 METHYLDOPA (Methy ldopa Tablets) Page 4 of 26 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS METHYLDOPA (methyldopa tablets) is indicated: • For the treatment of arterial hypertension. May be employed in a general treatment program in conjunction with a diuretic and/or other antihypertensive drugs as needed for proper response in patients with hypertension of various severity.
• As the initial agent in the treatment of hypertension in those patients for which treatment should not be […]