Indapamide

DOSAGE & ADMINISTRATION

25 mg as a single daily dose taken in the morning. 5 mg taken once daily. 0 mg taken once daily, but adding another antihypertensive should be considered. 5 mg as a single daily dose taken in the morning. 0 mg taken once daily. If the antihypertensive response to indapamide is insufficient, indapamide may be combined with other antihypertensive drugs, with careful monitoring of blood pressure.

It is recommended that the usual dose of other agents be reduced by 50% during initial combination therapy. As the blood pressure response becomes evident, further dosage adjustments may be necessary. 0 mg and larger have not appeared to provide additional effects on blood pressure or heart failure, but are associated with a greater degree of hypokalemia.

0 mg once a day.

ADVERSE REACTIONS

Most adverse effects have been mild and transient. 25 mg). 0 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.

25mg Incidence ≥ 5% Incidence < 5%* 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 Nervousness Dizziness Hypertonia RESPIRATORY SYSTEM Cough RHINITIS Pharyngitis Sinusitis SPECIAL SENSES Conjunctivitis *OTHER All other clinical adverse reactions occurred at an incidence of <1%.

25 mg compared to 5% of the patients given placebo discontinued treatment in the trials of up to eight weeks because of adverse reactions. 4 mEq/L. 25 mg group, about 40% of those patients who reported hypokalemia as a laboratory adverse event returned to normal serum potassium values without intervention.

25 mg. 0 mg Incidence ≥ 5% Incidence < 5% CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR Headache Lightheadedness Dizziness Drowsiness Fatigue, weakness, loss of energy, lethargy, tiredness, or malaise Vertigo Insomnia Depression Muscle cramps or spasm, or numbness of the extremities Blurred Visoin 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.

WARNINGS

Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide. This occurred primarily in elderly females. ) This appears to be dose related. 5 mg and 5 mg doses. 25 mg dosage (see PRECAUTIONS ).

25 mg dose and maintained at the lowest possible dose. ) 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.

CONTRAINDICATIONS

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