Lorastine

/ Bayer

Adults and children over 12 years of age: 10 mg once daily (one tablet or 10 ml (10 mg) of the syrup once daily). The tablet or the syrup may be taken without regard to mealtime.
Children 2 to 12 years of age are dosed by weight: Body weight more than 30 kg: 10 mg once daily (one tablet or 10 ml (10 mg) of the syrup once daily).
Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily. The 10 mg strength tablet is not appropriate in children with a body weight less than 30 kg. Efficacy and safety of Lorastine in children under 2 years of age has not been established. Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 ml (5 mg) every other day is recommended. No dosage adjustments are required in the elderly or in patients with renal insufficiency.

Allergic rhinitis, urticaria.

Known hypersensitivity, newborn or premature babies, lactation, asthma or other lower respiratory tract conditions, narrow-angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction, concomitant use with monoamine oxidase inhibitor therapy.

Lorastine should be administered with caution in patients with severe liver impairment. Tablet This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Syrup This medicinal product contains sucrose; thus patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. The administration of Lorastine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%). In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2 % of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.
Immune system disorders: Anaphylaxis.
Nervous system disorders: Dizziness.
Cardiac disorders: Tachycardia, palpitation.
Gastrointestinal disorders: Nausea, dry mouth, gastritis.
Hepatobiliary disorders: Abnormal hepatic function.
Skin and subcutaneous tissue disorders: Rash, alopecia.
General disorders: and administration site conditions Fatigu.
For full details see prescribing information.

When administered concomitantly with alcohol, Lorastine has no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine, which may cause an increase in adverse events.
For full details see prescribing information.

Pregnancy: Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Lorastine during pregnancy is therefore not recommended.
Lactation: Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.

Overdose with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses. In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.