FDA label 3e2d7ee3-b000-4827-a9df-852ad7767c5f

WARNING: 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 reevaluated as conditions in each patient warrant.

WARNINGS Methyclothiazide Methyclothiazide shares with other thiazides the propensity to deplete potassium reserves to an unpredictable degree. There have been isolated reports that certain nonedematous individuals developed severe fluid and electrolyte derangements after only brief exposure to normal doses of thiazide and nonthiazide diuretics. Thiazides should be used with caution in patients with renal disease or significant impairment of renal function, since azotemia may be precipitated and cumulative drug effects may occur. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Deserpidine Deserpidine differs slightly in chemical structure from reserpine; however, its actions, indications, cautions, and adverse reactions are common to the class of rauwolfia alkaloids. Reserpine may cause mental depression. Recognition of depression may be difficult because this condition may often be disguised by somatic complaints (Masked Depression). The drug should be discontinued at first signs of depression such as despondency, early morning insomnia, loss of appetite, impotence, or self-deprecation. Drug-induced depression may persist for several months after drug withdrawal and may be severe enough to result in suicide.

ADVERSE REACTIONS Adverse reactions are usually reversible upon reduction of dosage or discontinuation of ENDURONYL tablets. Whenever adverse reactions are moderate or severe, it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Consequently, the reactions are categorized by organ system and are listed in decreasing order of severity and not frequency. Methyclothiazide Body as a Whole Headache, cramping, weakness. Cardiovascular System Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics). Digestive System Pancreatitis, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, nausea, gastric irritation, constipation, anorexia. Hemic and Lymphatic System Aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, thrombocytopenia. Hypersensitivity Reactions Anaphylactic reactions, necrotizing angiitis (vasculitis, cutaneous vasculitis), Stevens-Johnson syndrome, respiratory distress (including pneumonitis and pulmonary edema), fever, purpura, urticaria, rash, photosensitivity. Metabolic and Nutritional Disorders Hyperglycemia, hyperuricemia, electrolyte imbalance (see PRECAUTIONS ), hypercalcemia. Nervous System Vertigo, dizziness, paresthesias, muscle spasm, restlessness. Special Senses Transient blurred vision, xanthopsia. Urogenital System Glycosuria. Deserpidine Body as a Whole Headache. Cardiovascular System Arrhythmias (particularly when used concurrently with digitalis or quinidine), syncope, angina-like symptoms, bradycardia, fluid retention. Digestive System Vomiting, diarrhea, nausea, anorexia, dryness of mouth, hypersecretion, increased motility, increased salivation. Hemic and Lymphatic System Thrombocytopenic purpura. Metabolic and Nutritional Disorders Weight gain. Musculoskeletal System Muscular aches. Nervous System Rare parkinsonian syndrome and other extrapyramidal tract symptoms, dizziness, paradoxical anxiety, depression, nervousness, nightmares, dull sensorium, drowsiness, decreased libido. Respiratory System Asthma in asthmatic patients, dyspnea, epistaxis, nasal congestion. Skin and Appendages Rash, pruritus, flushing of skin. Special Senses Deafness, optic atrophy, glaucoma, uveitis, conjunctival injection. Urogenital System Nonpuerperal lactation, impotence, dysuria, gynecomastia, breast engorgement.