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Indapamide Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Indapamide safely and effectively. Before taking Indapamide please consult with your doctor. See full prescribing information for Indapamide.

Indications And Usage

Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

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Contraindications

Anuria. Known hypersensitivity to indapamide or to other sulfonamide-derived drugs.

Adverse Reactions

Most adverse effects have been mild and transient. The clinical adverse reactions listed in Table 1 represent data from Phase II/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%; 2) a cumulative incidence less than 5%. Reactions are counted regardless of relation to drug. TABLE 1: Adverse Reactions from Studies of 1.25 mg Incidence ≥ 5% Incidence < 5%OTHER All other clinical adverse reactions occurred at an incidence of < 1%. 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% of patients given indapamide 1.25 mg compared to 5% 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% of patients receiving indapamide 1.25 mg, 61% of patients receiving indapamide 5 mg, and 80% 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% 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% of patients receiving indapamide 1.25 mg. TABLE 2: Adverse Reactions from Studies of 2.5 mg and 5 mg Incidence ≥ 5% Incidence < 5% 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% 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% of patients receiving indapamide 2.5 mg q.d. and 7% 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% of patients receiving indapamide 2.5 mg, 72% of patients receiving indapamide 5 mg, and 44% 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% 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 (< 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.

Drug Interactions

Drug Interactions Other Antihypertensives Indapamide may add to or potentiate the action of other antihypertensive drugs. In limited controlled trials that compared the effect of indapamide combined with other antihypertensive drugs with the effect of the other drugs administered alone, there was no notable change in the nature or frequency of adverse reactions associated with the combined therapy. Lithium See WARNINGS. Post-Sympathectomy Patient The antihypertensive effect of the drug may be enhanced in the post-sympathectomized patient. Norepinephrine Indapamide, like the thiazides, may decrease arterial responsiveness to norepinephrine, but this diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

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