Clinical medicine profile
Indapamide
Thiazide-like Diuretic [EPC]
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Hypersensitivity to the active substance or excipients.
- Additional absolute contraindications are indication- and product-specific — consult SmPC.
Precautions
- WARNINGS Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide.
- This occurred primarily in elderly females.
- (See PRECAUTIONS , Geriatric Use .) This appears to be dose related.
- Also, a large case-controlled pharmacoepidemiology study indicates that there is an increased risk of hyponatremia with indapamide 2.5 mg and 5 mg doses.
- Hyponatremia considered possibly clinically significant (< 125 mEq/L) has not been observed in clinical trials with the 1.25 mg dosage (see PRECAUTIONS ).
- Thus, patients should be started at the 1.25 mg dose and maintained at the lowest possible dose.
- (See DOSAGE AND ADMINISTRATION .) 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE & ADMINISTRATION Hypertension : The adult starting indapamide dose for hypertension is 1.25 mg as a single daily dose taken in the morning. If the response to 1.25 mg is not satisfactory after 4 weeks, the daily dose may be increased to 2.5 mg taken once daily. If the response to 2.5 mg is not satisfactory after 4 weeks, the daily dose may be increased to 5.0 mg taken once daily, but adding another antihypertensive should be considered. Edema of Congestive Heart Failure : The adult starting indapamide dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning. If the response to 2.5 mg is not satisfactory after one week, the daily dose may be increased to 5.0 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. In general, doses of 5.0 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. There is minimal clinical trial experience in patients with doses greater than 5.0 mg once a day.
Pediatric Use : Safety and effectiveness of indapamide in pediatric patients have not been established.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- INDICATIONS Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs.
- Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
- Usage in Pregnancy : The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below).
- Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
- Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy.
- Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS below).
- Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose
- use of diuretics to lower intravascular volume in this case is illogical and unnecessary.
- There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women.
- If this edema produces discomfort, increased recumbency will often provide relief.
- In rare instances, this edema may cause extreme discomfort which is not relieved by rest.
- In these cases, a short course of diuretics may provide relief and may be appropriate.
Adverse effects
- ADVERSE REACTIONS 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 (426patients given 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%
- a cumulative incidence less than 5%.
- Reactions are counted regardless of relation to drug.
- TABLE 1: Adverse Reaction from Studies of 1.25mg 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%.
- 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 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.
- 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.
Drug interactions
Open multi-drug checker ↗- Drug combinations to be avoided
- nonantiarrhythmic drugs causing wave burst arrhythmia such erythromycin, halofantrine, pentamidine, terfenadine and vincamine.
Mechanism & disposition
It inhibits Na+ reabsorption in the cortical segment of the distal tubule and to a lesser degree K+ and Mg2+.
Read complete mechanism
It inhibits Na+ reabsorption in the cortical segment of the distal tubule and to a lesser degree K+ and Mg2+. Its vascular effect is manifested by an increase in arterial compliance and a decrease in total peripheral and arteriolar resistance, without altering heart rate.
Product-specific
Product-specific
See product SmPC
of 14 C-labeled indapamide and metabolites is biphasic with a terminal
of indapamide in whole blood is approximately 14 hours. Indapamide is preferentially and reversibly taken up by the erythrocytes in the peripheral blood. The whole blood/plasma ratio is approximately 6:1 at the time of peak concentration and decreases to 3.5:1 at eight hours. Fro...
Pregnancy, lactation & diet
Pregnancy : Teratogenic Effects : Reproduction studies have been performed in rats, mice and rabbits at doses up to 6,250 times the therapeutic human dose and have revealed no evidence of impaired fertility or harm to the fetus due to indapamide. Postnatal development in rats and mice was unaffected by pretreatment of parent animals during gestation. There are, however, no adequate and well-controlled studies in pregnant women. Moreover, diuretics are known to cross the placental barrier and appear in cord blood. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There may be hazards associated with this use such as fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because most drugs are excreted in human milk, if use of this drug is deemed essential, the patient should stop nursing.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| Indapamide | Afya Index / Retail Reference | slow release tabs 1.5mg 28's | KES 4,015.00afya_index_book |
| Indapamide | distributed by Metro | controlled release tabs 1.5mg 10 x 10's | Unavailable |
| Indicontin CR | Afya Index / Retail Reference | slow release tabs 1.5mg 28's | KES 479.00afya_index_book |
| InduricSR | Afya Index / Retail Reference | slow releasetabs 1.5mg 30's | KES 1,072.00afya_index_book |
| NATRILIX SR | DAIMA BIASHARA / Wholesale Import | 1.5MG TABS * 30`S | KES 1,241.63Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.