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Lozol

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Lozol

Side Effects
Interactions

SIDE EFFECTS

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 (indapamide) 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.

TABLE 1: Adverse Reactions from Studies of 1.25 mg

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%.

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.

TABLE 2: Adverse Reactions from Studies of 2.5 mg and 5.0 mg

table 2
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 six to eight 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) Potassium Sodium Chloride Serum Uric Acid (mg/dL) BUN (mg/dL)
Indapamide
1.25 mg (n=255-257) – 0.28 – 0.63 – 2.60 0.69 1.46
Placebo
(n=263-266) 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 5.0 mg
  Serum Electrolytes (mEq/L) Potassium Sodium Chloride Serum Uric Acid (mg/dL) BUN (mg/dL)
Indapamide 2.5 mg (n=76) – 0.4 – 0.6 – 3.6 0.7 – 0.1
Indapamide 5.0 mg (n=81) – 0.6 – 0.7 – 5.1 1.1 1.4

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

Read the Lozol (indapamide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Other Antihypertensives

Lozol (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.

Read the Lozol Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/16/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Lozol - User Reviews

Lozol User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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