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MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in evidence of significant drug-induced toxicity There were no drug-related tumongemc effects at any of the dosage levels Reproductive studies in animals did not show any impairment of fertility that was attributable to the drug PREGNANCY Pregnancy Category C Propranolol has been shown to be embryotoxic in There are no adequate and well-controlled studies in pregnant women Propranolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus NURSING MOTHERS Propranolol is excreted m human milk Caution should be exercised when propranolol is administered to a nursing mother PEDIATRIC USE Safety and effectiveness in children have not been established GENERAL Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance namely Hyponatremia hypochloremic alkalosis, and hypokalemia Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids Medication such as digitalis may also influence serum electrolytes Warning signs irrespective of cause are Dryness of mouth, thirst, weakness lethargy drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oiiguna tachycardia, and gastrointestinal disturbances such as nausea and Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or during concomitant use of corticosteroids or ACTH Interference with adequate oral electrolyte intake will also contribute to hypokalemia Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effect of digitalis (eg increased ventricular irritability) Hypokalemia may be avoided or treated by use of potassium supplements such as foods with a high potassium content Any chloride deficit is generally mud and usually does not require specific treatment, except under extraordinary circumstances (as in tiver or renal disease) Diiutionai hyponatremia may occur in edematous patients in hot weather, appropriate therapy is water restriction rather than administration of salt, except in rare instances when the hyponatremia is iife-threatening In actual salt depletion appropriate replacement is the therapy of choice Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving Insulin requirements m diabetic patients rnay be increased, decreased, or unchanged Thiazides may decrease serum PB! levels without signs of thyroid disturbance Caicium-gxcretioniSifeGreased by thiazides Pathologic changes m the parathyroid gland with hypercalceiTiia and hypophosphatemia have been observed m a few patients on prolonged thiazide therapy The common corriplications of hyperparathyroidism such as renal DRUG iNTERACtiONS' Thiazide drugs may increase the responsiveness to tubocuranne, The aniihypertensfve effects of thiazides may be enhanced m the postsympatheclomy PREGNANCY Pregnancy Category C Thiazides cross the placental barrier and appear m cord blood The use of thiazides in pregnancy requires that the anticipated benefit be weighed against possible hazards to the fetus These hazards include fetal or neonatal jaundice, thrombocytopenia and possibly other adverse reactions which have occurred m the adult NURSING mothers Thiazides appear m human milk If use of the drug is deemed essential the patient should stop nursing PEDIATRIC USE Safety and effectiveness in children have not been established Most adverse eMecfs have been mild and transient and have rarely required the withdrawal of Cardiovascular Bradycardia congestive heart failure, intensification of AV block, hypotension paresthesia of hands thrombocytopenic purpura, arterial insufficiency, usually of the Ceniral Nervous System Lightheadedness, mental depression manifested by insomnia, lassitude weakness, fatigue reversible mental depression progressing to catatonia, visual disturbances hailucir'ations, an acute reversible syndrome characterized by disorientation for time and place short-term memory loss emotional lability, slightly clouded sensorium, and Gastrointestinal Nausea vomiting, epigastric distress, abdominal cramping diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis Allergic Pharyngitis and agranulocytosis, erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress Hematologic Agranulocytosis, nonthrombocytopenic purpura thrombocytopenic Auto-Immune In extremely rare instances, systemic lupus erythematosus has been Miscellaneous Alopecia LE-like reactions, psoriasiform rashes, dry eyes, male impotence and Peyronies disease have been reported rarely Oculomucocutaneous reactions involving the skin, serous membranes, and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol Gastrointestinal Anorexia, gastric irritation, nausea vomiting, cramping, diarrhea, constipation. 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