FDA label f9943f30-1081-4af6-9f9e-67c33beab308

WARNING This fixed-combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. It 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 Reserpine Reserpine may cause mental depression. Recognition of depression may be difficult because this condition may often be disguised by somatic complaints. 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. 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 Ser-Ap-Es. 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. Reserpine The following have been observed with rauwolfia preparations: Digestive: Vomiting, diarrhea, nausea, anorexia, dryness of mouth, hypersecretion. Cardiovascular: Arrhythmias (particularly when used concurrently with digitalis or quinidine), syncope, angina-like symptoms, bradycardia, edema. Respiratory : Dyspnea, epistaxis, nasal congestion. Neurologic: Rare parkinsonian syndrome and other extrapyramidal tract symptoms; dizziness; headache; paradoxical anxiety; depression; nervousness, nightmares; dull sensorium; drowsiness. Musculoskeletal: Muscular aches. Genitourinary: Pseudolactation, impotence, dysuria, gynecomastia, decreased libido, breast engorgement Metabolic: Weight gain. Special Senses: Deafness, optic atrophy, glaucoma, uveitis, conjunctival injection. Hypersensitive Reactions: Purpura, rash, pruritus. Hydralazine Digestive: Hepatitis, paralytic ileus, vomiting, diarrhea, nausea, constipation, anorexia. Cardiovascular: Angina pectoris, hypotension, paradoxical pressor response, tachycardia, palpitations, edema, flushing. Respiratory: Dyspnea, nasal congestion. Neurologic: Psychotic reactions characterized by depression, disorientation, or anxiety; peripheral neuritis, evidenced by paresthesia, numbness, and tingling; tremors; dizziness, headache. Musculoskeletal: Muscle cramps, arthralgia. Genitourinary: Difficulty in urination. Hematologic : Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis; lymphadenopathy; splenomegaly, eosinophilia. Special Senses: Conjunctivitis, lacrimation. Hypersensitive Reactions: Purpura, fever, urticaria, rash, pruritus, chills. Hydrochlorothiazide 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 angiitis, Stevens-Johnson syndrome, respiratory distress including pneumonitis and pulmonary edema, purpura, urticaria, rash, photosensitivity.