Indapamide
Regulatory sources consulted
- AEMPS-CIMA-FT-63368
- CredibleMeds.org
- clinical-knowledge
- AEMPS CIMA · nº registro 63368 ↗
- RxNorm rxcui 5764 ↗
Approved indications
- Essential hypertension.
Contraindications
Absolute
- Hypersensitivity to the active substance, to other sulfonamides or to any of the excipients.
- Severe renal impairment.
- Hepatic encephalopathy or severe hepatic impairment.
- Hypokalemia.
Clinical warnings
- Major warning · Risk of fluid and electrolyte imbalance (hyponatremia, hypokalemia) which can lead to hepatic encephalopathy, especially in patients with liver failure. — AEMPS CIMA
- Photosensitivity reactions have been reported. If they occur, it is recommended to stop treatment. — AEMPS CIMA
Drug interactions
- HighLithiumN05AN01
Mechanism: Decreased renal excretion of lithium, with risk of overdose.
Recommendation: Closely monitor plasma lithium levels. The combination is generally discouraged.
AEMPS CIMA
- ModerateSotalolC07AA07
Mechanism: Indapamide-induced hypokalemia increases the risk of ventricular arrhythmias (Torsades de Pointes) with QT-prolonging drugs.
Recommendation: Correct any hypokalemia before starting treatment. Monitor electrolytes and ECG.
AEMPS CIMA
Adverse events
Common (≥1%)
hypokalemia · maculopapular rash · hypersensitivity reactions
Rare but serious
pancreatitis · toxic epidermal necrolysis · Stevens-Johnson syndrome · hepatic encephalopathy
Pregnancy and lactation
FDA category: D
Use of indapamide is not recommended during pregnancy. Thiazide exposure during the third trimester may cause fetal or neonatal jaundice, thrombocytopenia. Indapamide is excreted in human milk, so breastfeeding is not recommended.