Loratadine Contraindications and Precautions
- neonates
- asthma
- breast-feeding
- driving or operating machinery
- hepatic disease
- infants
- pregnancy
- renal disease
- renal failure
- renal impairment
Loratadine Contraindications and Precautions
Loratadine is contraindicated in any individual hypersensitive to the drug or any of the ingredients of the specific drug formulation.
Use antihistamines with caution in patients with asthma. The anticholinergic activity of H1-antagonists may result in thickened bronchial secretions in the respiratory tract thereby aggravating an acute asthmatic attack. However, these anticholinergic effects do not preclude the use of H1-antagonists in all asthmatic patients, particularly if the above respiratory symptom is not a primary component of the illness. Because loratadine possesses only weak anticholinergic properties, it would not be expected to adversely affect the respiratory status of most asthmatic patients.
Loratadine may cause drowsiness or somnolence in individual patients; therefore patients receiving this loratadine should be advised to avoid driving or operating machinery until the effects of the drug are known.
Loratadine and its metabolite are excreted into breast milk. Concentrations in the breast milk and serum are equivalent. Infants, particularly those that are premature, are at higher risk for adverse effects. Breast-feeding should be avoided during loratadine therapy.
Loratadine is classified as pregnancy category B. Animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women. Loratadine should be used during pregnancy only when the benefits of therapy outweigh the risks. Self-medication with loratadine (OTC formulations) during pregnancy is not recommended. Pregnant patients should see their health care professional for a proper diagnosis and for treatment recommendations.
The safety and effectiveness of loratadine have not been established in infants less than 2 years of age. Antihistamines generally should not be used in neonates due to the possibility of paradoxical CNS stimulation or seizures.
Loratadine is extensively metabolized in the liver by the hepatic microsomal CYP450 system. Loratadine should be used cautiously in those with hepatic disease and initial dosage adjustments should be made according to the manufacturer’s guidelines (see Dosage).
The AUC and Cmax of loratadine and its metabolite are elevated in the presence of significant renal impairment (CrCl < 30 ml/min) associated with renal disease or renal failure. Loratadine should be used cautiously in those with renal failure or impairment and initial dosage adjustments should be made according to the manufacturer’s guidelines (see Dosage).
[ Last revised: 12/29/2002 8:40:00 PM ]
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