Loratadine
Regulatory sources consulted
- AEMPS-CIMA-FT-58518
- CredibleMeds.org
- Flockhart Table
- AEMPS CIMA · nº registro 58518 ↗
- RxNorm rxcui 28889 ↗
Approved indications
- Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Administration should be discontinued at least 48 hours before skin allergy tests, as antihistamines may prevent or reduce otherwise positive reactions. — AEMPS
Drug interactions
- ModerateKetoconazoleJ02AB02
Mechanism: Inhibition of CYP3A4, resulting in increased plasma concentrations of loratadine and its active metabolite. However, no clinically significant changes in the QTc interval have been observed.
Recommendation: Use with caution. Although the risk of cardiotoxicity is low, monitoring may be prudent in patients with additional risk factors.
AEMPS CIMA
- ModerateErythromycinJ01FA01
Mechanism: Inhibition of CYP3A4, increasing loratadine concentration. No clinically significant changes in the QTc interval have been observed.
Recommendation: Use with caution. Routine dose adjustment is not required.
AEMPS CIMA
Adverse events
Common (≥1%)
somnolence · headache · increased appetite · insomnia
Rare but serious
anaphylaxis · angioedema · convulsions · tachycardia · palpitations · abnormal liver function
Pregnancy and lactation
FDA category: N/A
Pregnancy: Use is not recommended. Lactation: Excreted in breast milk, use is not recommended.