FDA label a371e86a-6242-4bf2-a741-c77f3570f3a9

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 Hydralazine In a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Signs and symptoms usually regress when the drug is discontinued, but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .) Hydrochlorothiazide Thiazides should be used with caution in patients with severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte imbalance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs. Sensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

ADVERSE REACTIONS Adverse reactions are usually reversible upon reduction of dosage or discontinuation of hydralazine HCl and hydrochlorothiazide. Whenever adverse reactions are moderate or severe, it may be necessary to discontinue the drug. Hydralazine : The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent Digestive: Constipation, paralytic ileus. Cardiovascular : Hypotension, paradoxical pressor response, edema. Respiratory: Dyspnea. Neurologi c: Peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: Difficulty in urination. Hematologic: Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions : Rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other: Nasal congestion, flushing, lacrimation, conjunctivitis. Hydrochlorothiazide: 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 systems and are listed in decreasing order of severity and not frequency. Digestive: Pancreatitis, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, anorexia. Cardiovascular : Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics). Neurologic : Vertigo, dizziness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, restlessness. Musculoskeletal : Muscle spasm. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia. Metabolic : Hyperglycemia, glycosuria, hyperuricemia. Hypersensitive Reactions : Necrotizing angitis, Stevens-Johnson syndrome, respiratory distress including pneumonitis and pulmonary edema, purpura, urticaria, rash, photosensitivity.