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Lozol

Last reviewed on RxList: 2/2/2017
Lozol Side Effects Center

Last reviewed on RxList 12/21/2016

Lozol (indapamide) is an oral antihypertensive/diuretic (water pill) used to treat fluid retention (edema) in people with congestive heart failure. Lozol is also used to treat high blood pressure (hypertension). Lozol is a discontinued brand name and is available as generic indapamide. Common side effects of Lozol (indapamide) include:

  • dizziness,
  • headache, or
  • skin rash.

Lozol (indapamide) may cause dehydration. Tell your doctor if you have symptoms of dehydration including fast or irregular heartbeat, unusual dry mouth, thirst, muscle cramps or pain, unusual decreased urination, or weakness.

The adult starting dose of indapamide for hypertension is 1.25 mg as a single daily dose. Dose may be increased gradually to 5 mg if the response is not satisfactory. The adult starting dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning. Dose may be increased to 5 mg if the response is not satisfactory. Indapamide may interact with lithium, baclofen, other blood pressure medications, steroids, oral insulin or diabetes medicine, aspirin and other salicylates, ACE inhibitors, NSAIDs (nonsteroidal anti-inflammatory drugs), amiodarone, chloroquine, cisapride, clarithromycin, disopyramide, dofetilide, droperidol, erythromycin, haloperidol, pentamidine, pimozide, procainamide, quinidine, sotalol, or thioridazine. Tell your doctor all medications you are taking. During pregnancy, indapamide should be used only when prescribed. Diuretics (water pills) are not usually recommended to treat high blood pressure caused by pregnancy. It is unknown if this medication passes into breast milk or may harm a nursing infant. Consult your doctor before breastfeeding.

Our Lozol (indapamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lozol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • dry mouth, thirst, nausea, vomiting;
  • feeling weak, drowsy, restless, or light-headed;
  • fast or uneven heartbeat; or
  • muscle pain or weakness.

Less serious side effects may include:

  • dizziness;
  • headache; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lozol (Indapamide)

Lozol Professional Information

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 entire FDA prescribing information for Lozol (Indapamide)

Related Resources for Lozol

Read the Lozol User Reviews »

© Lozol Patient Information is supplied by Cerner Multum, Inc. and Lozol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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