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WARNINGS WARNINGS Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide. This occurred primarily in elderly females. (See PRECAUTIONS: Geriatric Use .) This appears to be dose related. Also, a large case-controlled pharmacoepidemiology study indicates that there is an increased risk of hyponatremia with indapamide 2.5 mg and 5 mg doses. Hyponatremia considered possibly clinically significant (125 mEq/L) has not been observed in clinical trials with the 1.25 mg dosage (see PRECAUTIONS ). Thus, patients should be started at the 1.25 mg dose and maintained at the lowest possible dose. (See DOSAGE AND ADMINISTRATION .) Hypokalemia occurs commonly with diuretics (see ADVERSE REACTIONS: Hypokalemia ), and electrolyte monitoring is essential, particularly in patients who would be at increased risk from hypokalemia, such as those with cardiac arrhythmias or who are receiving concomitant cardiac glycosides. In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy.
ADVERSE REACTIONS ADVERSE REACTIONS Most adverse effects have been mild and transient. The clinical adverse reactions listed in Table 1 represent data from Phase II and III placebo-controlled studies (306 patients given indapamide 1.25 mg). The clinical adverse reactions listed in Table 2 represent data from Phase II placebo-controlled studies and long-term controlled clinical trials (426 patients given indapamide 2.5 mg or 5 mg). The reactions are arranged into two groups: 1) a cumulative incidence equal to or greater than 5 percent; 2) a cumulative incidence less than 5 percent. Reactions are counted regardless of relation to drug. TABLE 1: Adverse Reactions from Studies of 1.25 mg * OTHER All other clinical adverse reactions occurred at an incidence of greater then 1percent. Incidence less than 5 percent Incidence greater then 5 percent * BODY AS A WHOLE Headache Asthenia Infection Flu Syndrome Pain Abdominal Pain Back Pain Chest Pain GASTROINTESTINAL SYSTEM Constipation Diarrhea Dyspepsia Nausea METABOLIC SYSTEM Peripheral Edema CENTRAL NERVOUS SYSTEM Dizziness Nervousness Hypertonia RESPIRATORY SYSTEM Rhinitis Cough Pharyngitis Sinusitis SPECIAL SENSES Conjunctivitis Approximately 4 percent of patients given indapamide 1.25 mg compared to 5 percent of the patients given placebo discontinued treatment in the trials of up to 8 weeks because of adverse reactions. In controlled clinical trials of 6 to 8 weeks in duration, 20 percent of patients receiving indapamide 1.25 mg, 61 percent of patients receiving indapamide 5 mg, and 80 percent of patients receiving indapamide 10 mg had at least one potassium value below 3.4 mEq/L. In the indapamide 1.25 mg group, about 40 percent of those patients who reported hypokalemia as a laboratory adverse event returned to normal serum potassium values without intervention. Hypokalemia with concomitant clinical signs or symptoms occurred in 2 percent of patients receiving indapamide 1.25 mg. TABLE 2: Adverse Reactions from Studies of 2.5 mg and 5 mg Incidence less then 5 percent Incidence greater then 5 percent CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR Headache Lightheadedness Dizziness Drowsiness Fatigue, weakness, loss of energy, lethargy, tiredness, or malaise Vertigo Insomnia Muscle cramps or spasm, or numbness of the extremities Depression Blurred Vision Nervousness, tension, anxiety, irritability, or agitation GASTROINTESTINAL SYSTEM Constipation Nausea Vomiting Diarrhea Gastric irritation Abdominal pain or cramps Anorexia CARDIOVASCULAR SYSTEM Orthostatic hypotension Premature ventricular contractions Irregular heart beat Palpitations GENITOURINARY SYSTEM Frequency of urination Nocturia Polyuria DERMATOLOGIC/HYPERSENSITIVITY Rash Hives Pruritus Vasculitis OTHER Impotence or reduced libido Rhinorrhea Flushing Hyperuricemia Hyperglycemia Hyponatremia Hypochloremia Increase in serum urea nitrogen (BUN) or creatinine Glycosuria Weight loss Dry mouth Tingling of extremities Because most of these data are from long-term studies (up to 40 weeks of treatment), it is probable that many of the adverse experiences reported are due to causes other than the drug. Approximately 10 percent of patients given indapamide discontinued treatment in long-term trials because of reactions either related or unrelated to the drug. Hypokalemia with concomitant clinical signs or symptoms occurred in 3 percent of patients receiving indapamide 2.5 mg q.d. and 7 percent of patients receiving indapamide 5 mg q.d. In long-term controlled clinical trials comparing the hypokalemic effects of daily doses of indapamide and hydrochlorothiazide, however, 47 percent of patients receiving indapamide 2.5 mg, 72 percent of patients receiving indapamide 5 mg, and 44 percent of patients receiving hydrochlorothiazide 50 mg had at least one potassium value (out of a total of 11 taken during the study) below 3.5 mEq/L. In the indapamide 2.5 mg group, over 50 percent of those patients returned to normal serum potassium values without intervention. In clinical trials of 6 to 8 weeks, the mean changes in selected values were as shown in the tables below. Mean Changes From Baseline After 8 Weeks Of Treatment - 1.25 mg Serum Electrolytes (mEq/L) Serum Uric Acid (mg/dL) BUN (mg/dL) Potassium Sodium Chloride Indapamide 1.25 mg (n 255 to 257) 0.28 0.63 2.60 0.69 1.46 Placebo (n 263 to 266) 0.00 0.11 0.21 0.06 0.06 No patients receiving indapamide 1.25 mg experienced hyponatremia considered possibly clinically significant (less then 125 mEq/L). Indapamide had no adverse effects on lipids. Mean Changes from Baseline after 40 Weeks of Treatment - 2.5 mg and 5 mg Serum Electrolytes (mEq/L) Serum Uric Acid (mg/dL) BUN (mg/dL) Potassium Sodium Chloride Indapamide 2.5 mg (n 76) 0.4 0.6 3.6 0.7 0.1 Indapamide 5 mg (n 81) 0.6 0.7 5.1 1.1 1.4 The following reactions have been reported with clinical usage of indapamide: jaundice (intrahepatic cholestatic jaundice), hepatitis, pancreatitis and abnormal liver function tests. These reactions were reversible with discontinuance of the drug. Also reported are erythema multiforme, Stevens-Johnson Syndrome, bullous eruptions, purpura, photosensitivity, fever, pneumonitis, anaphylactic reactions, agranulocytosis, leukopenia, thrombocytopenia and aplastic anemia. Other adverse reactions reported with antihypertensive/diuretics are necrotizing angiitis, respiratory distress, sialadenitis, xanthopsia.