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Lozol

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Lozol

Lozol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lozol (indapamide) is used to treat fluid retention (edema) in people with congestive heart failure. This medication is also used to treat high blood pressure (hypertension). It is an oral antihypertensive/diuretic. Lozol is a discontinued brand name. This medication is available in generic form. Common side effects include dizziness or headache.

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 (non-steroidal 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lozol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lozol Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Indapamide may cause too much body water and salts to be lost (dehydration). Prolonged diarrhea, vomiting, or excessive sweating can increase this risk. To prevent dehydration, drink plenty of fluids unless otherwise directed by your doctor. Tell your doctor promptly if you have any symptoms of dehydration, including: fast/irregular heartbeat, unusual dry mouth/thirst, muscle cramps/pain, unusual decreased urination, weakness.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lozol (Indapamide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lozol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Lozol - User Reviews

Lozol User Reviews

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Here is a collection of user reviews for the medication Lozol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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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