Each tablet contains Loratadine 10 mg.
Pharmacology: Pharmacodynamics: Loratadine is a cyproheptadine derivative, structurally related to azatadine. It exhibits potent, long-acting H1-antihistamine activity with no central sedative or anticholinergic effects. In man, nasal and other signs and symptoms of allergic rhinitis are relieved rapidly after oral administration.
Pharmacokinetics: Loratadine is well absorbed and is almost totally metabolised. It has a distribution half-life of one hour and an elimination half-life of 15.3 hours.
Approximately 81% of the 14C labelled dose is excreted in the urine (40%) and faeces (41%) over a 10 day period. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Pharmacokinetics in healthy adult volunteers and healthy geriatric volunteers are comparable. Steady state levels of loratadine are reached after the fifth dose.
Lotin is indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching. Nasal signs and symptoms are relieved rapidly after oral administration.
Adults (including the elderly) and children 12 years of age and over: One 10 mg tab once daily.
Lotin is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components. Not for use in children under 12 years of age.
Safe use of this product during pregnancy has not been established.
Effects on Ability to Drive and Use Machines: Lotin has no clinically significant sedative effect at recommended dosage.
Lotin should not be administered during pregnancy. There is no experience of the use of loratadine in human pregnancy. In animal studies loratadine was not teratogenic, but at high doses some embryotoxic effects were observed. Since loratadine is excreted in breast milk, it should not be administered to lactating women.
During controlled studies, the incidence of adverse effects associated with Lotin treatment was comparable to that associated with placebo. Lotin has no clinically significant sedative or anticholinergic properties. Other events, fatigue, nausea and headache, were reported rarely. Tachycardia and syncope have been reported rarely. Spontaneous adverse events reported rarely, include: Alopecia, anaphylaxis, abnormal hepatic function and supraventricular tachyarrhythmias.
Interactions with Other Medicaments and Other Forms of Interaction: When administered concurrently with alcohol, Lotin has no potentiating effects as measured by psychomotor performance studies. Loratadine is metabolised by hepatic cytochromes P450 3A4 and 2D6. Concomitant therapy with drugs which inhibit or are metabolised by either system may therefore elevate plasma concentrations of either drug and adverse reactions might result. Studies indicate that cimetidine, which inhibits both enzymes, and erythromycin or ketoconazole, which inhibit P450 3A4, each increased loratadine concentrations, although no adverse effects, clinical or electro-cardiographic, were observed. Other drugs known to inhibit either P450 3A4 or P450 2D6 are quinidine, fluconazole or fluoxetine.
Incompatibilities: None known.
Special Precautions for Storage: None.
Shelf-life: 36 months.
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
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