Lozol Side Effects

Generic Name: indapamide

Please note - some side effects for Lozol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lozol - for the Consumer

Lozol

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lozol:

Back pain; diarrhea; dizziness or lightheadedness when siting up or standing; headache; infection; nervousness; pain; runny nose; trouble sleeping; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; drowsiness; fatigue; irregular heartbeat; muscle cramps; numbness of your hands or feet; pounding in the chest; rapid heartbeat; unusual tiredness; urination problems; weakness; yellowing of the skin or eyes.

Lozol Side Effects - for the Professional

Lozol

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 Lozol 2.5 mg or 5.0 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.

All other clinical adverse reactions occurred at an incidence of <1%.

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 eight weeks because of adverse reactions.

In controlled clinical trials of six to eight weeks in duration, 20% of patients receiving indapamide 1.25 mg, 61% of patients receiving indapamide 5.0 mg, and 80% of patients receiving indapamide 10.0 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.

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 six to eight weeks, the mean changes in selected values were as shown in the tables below.

No patients receiving indapamide 1.25 mg experienced hyponatremia considered possibly clinically significant (<125 mEq/L).

Indapamide had no adverse effects on lipids.

The following reactions have been reported with clinical usage of Lozol: 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.

Side Effects by Body System

General

Most adverse side effects are mild and transient.

Dermatologic

Dermatologic reactions, such as rashes, occur in less than 5% of patients, and comprise up to 36% of all adverse drug reactions associated with indapamide.

Metabolic

Metabolic abnormalities are common, but are rarely clinically significant. Hypokalemia occurs in 15% of patients, although clinically relevant hypokalemia is reported in only 1% and 3% of patients receiving 2.5 and 5.0 mg/day, respectively. Hyponatremia, hyperglycemia, and hyperuricemia are reported in 1% to 5% of patients but are rarely clinically relevant. Unlike the thiazides, indapamide has little or no adverse effect on the lipid profile.

Renal

Renal side effects are unusual, consisting primarily of azotemia.

A case of interstitial nephritis and an urticarial rash associated with indapamide has been reported.

Gastrointestinal

Gastrointestinal side effects include dyspepsia, constipation, diarrhea, flatulence, and dry mouth in less than 5% of patients.

Nervous system

Nervous system side effects include dizziness, lightheadedness, headache, and fatigue in 5% of patients.

Cardiovascular

Cardiovascular side effects are usually limited to postural hypotension. Indapamide does not affect the heart rate.

Musculoskeletal

A 71-year-old woman with a history of psychiatric problems and reflux esophagitis developed chest pain, finger numbness, sweating, and nausea while gardening. Her medications included indapamide, trifluoperazine, oxazepam, and ranitidine. Myocardial infarction was definitively ruled out by ECG and CPK isoenzyme analysis. Interesting laboratory values included a reduced serum sodium (117 mmol/L), elevated LDH and AST enzymes, and elevated CPK-MM isoenzymes. There was no history of muscular trauma, and thyroid function tests were normal. The hyponatremia and elevated CPK-MM fractions fell precipitously upon hydration with normal saline. A definite causal link between indapamide and rhabdomyolysis could not be made, but thiazide diuretics have been previously implicated in some cases of hypokalemia with subsequent muscle damage.

Musculoskeletal cramps are reported in about 5% of patients. A single case of skeletal muscle damage has been associated with indapamide.

Genitourinary

Decreased sexual libido is rare, with up to 88% of patients reporting no change and most of the remaining 12% reporting improvement of sexual libido during indapamide therapy.

Genitourinary side effects generally reflect the activity of the drug, with less than 5% of patients reporting polyuria and nocturia.

Hepatic

Hepatic side effects are rare, at least one case of hepatitis has been reported.

A case of reversible hepatitis associated with indapamide has been reported.

Hypersensitivity

Hypersensitivity reactions occur in less than 5% of patients. Cases of severe reactions including toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome have been reported. Patients with a sulfa allergy may react to indapamide.

Endocrine

Endocrine side effects include at least one case of indapamide-induced hyperparathyroidism. In one study, indapamide significantly reduced parathyroid hormone levels in all patients.

Hematologic

Hematologic side effects are rare, but have included at least one case of mild thrombocytopenia and mucosal bleeding from the tongue. Bleeding stopped promptly and platelet counts returned to normal following discontinuation of indapamide.

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