Desloratadine
Regulatory sources consulted
- EMA EPAR EMEA/H/C/002310
- AEMPS CIMA 00160065
- https://www.ema.europa.eu/en/medicines/human/EPAR/dasselta
- https://cima.aemps.es/cima/dochtml/ft/00160065/FT_00160065.html
- AEMPS CIMA · nº registro 00160065 ↗
- EMA EPAR · EMEA/H/C/002310 ↗
- RxNorm rxcui 275635 ↗
Approved indications
- Relief of symptoms associated with allergic rhinitis and urticaria.
Contraindications
Absolute
- Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Clinical warnings
- Should be administered with caution in patients with a medical or family history of seizures. — EMA SPC
Adverse events
Common (≥1%)
fatigue · dry mouth · headache
Rare but serious
hypersensitivity reactions · anaphylaxis · angioedema · seizures · tachycardia · palpitations · elevated liver enzymes
Pregnancy and lactation
Pregnancy: As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy. Lactation: Desloratadine has been detected in breastfed newborns/infants of treated women. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.