Product Description.:
MYLAN, 507
tablet , film-coated , green , round round
This fixed combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static, but must be re-evaluated as conditions in each patient warrant.
DRUG DESCRIPTION
ALDORIL (Methyldopa-Hydrochlorothiazide) combines two antihypertensives: methyldopa and hydrochlorothiazide.
Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
ALDORIL is supplied as tablets in four strengths for oral use:
ALDORIL 15, contains 250 mg of methyldopa and 15 mg of hydrochlorothiazide.
ALDORIL 25, contains 250 mg of methyldopa and 25 mg of hydrochlorothiazide.
ALDORIL D30, contains 500 mg of methyldopa and 30 mg of hydrochlorothiazide.
ALDORIL D50, contains 500 mg of methyldopa and 50 mg of hydrochlorothiazide.
Each tablet contains the following inactive ingredients: calcium disodium edetate, calcium phosphate, cellulose, citric acid, colloidal silicon dioxide, ethylcellulose, guar gum, hydroxypropyl methylcellulose, magnesium stearate, propylene glycol, talc, and titanium dioxide. ALDORIL 15 and ALDORIL D30 also contain iron oxide.
INDICATIONS
Hypertension (see BOX WARNING).
SIDE EFFECTS
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.
Methyldopa
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.
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, distention, 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-like syndrome, drug-related fever, eosinophilia.
Nervous System/Psychiatric: Parkinsonism, Bell's palsy, decreased mental acuity, involuntary choreoathetotic movements, symptoms of cerebrovascular insufficiency, psychic disturbances including nightmares and reversible mild psychoses or depression, headache, sedation, asthenia or weakness, dizziness, lightheadedness, paresthesias.
