Full Prescribing Info
Contents
Loratadine.
Description
Each Carin tablet contains 10 mg of Loratadine.
Pharmacodynamics
Pharmacology: Pharmacodynamics: Loratadine is a non-sedative histamine H1 receptor antagonist with anti-allergic properties. It binds selectively to peripheral histamine H1 receptors with a lower affinity to brain H1 receptors. It is a long-acting antihistamine with little anti-muscarinic activity.
Pharmacokinetics: Loratadine is rapidly and almost completely absorbed after oral administration. Loratadine is about 98% bound to plasma proteins. It crosses the placental barrier and is detected in the human breast milk. Loratadine is extensively and rapidly metabolized in the liver to form a major metabolite, descarboethoxyloratadine. Descarboethoxyloratadine has potent histamine H1 blocking activity. Loratadine and its metabolites are excreted in the urine and faeces.
Indications/Uses
Loratadine is indicated for the relief of symptoms with allergic rhinitis e.g. sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. It is also indicated for the relief of signs and symptoms of chronic urticaria and other allergic dermatological disorders.
Dosage/Direction for Use
Adults and Children ≥ 12 years: 1 tablet (10 mg) once daily.
Children 6 - 12 years: 1 tablet (10 mg) once daily.
Children 2 - 5 years: half tablet (5 mg) once daily.
Not recommended for children under 2 years of age.
Patients with severe liver impairment: An initial dose of 5 mg once daily or 10 mg every other day is recommended.
Overdosage
Nausea, vomiting, drowsiness, hypotension, tachycardia and ataxia have been reported in overdosage. Treatment of overdosage should be supportive and symptomatic. This may include induction of emesis, gastric lavage to decrease absorption and the use of saline cathartics to enhance elimination.
Contraindications
Carin tablets are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to any of its components.
Special Precautions
Patients with severe liver impairment should be given a lower initial dose because they may have reduced clearance of Loratadine.
Use in Pregnancy and Lactation: The safe use of Loratadine during pregnancy has not been established. Therefore, Loratadine should only be given if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Loratadine is excreted in the breast milk, so nursing mothers are advised not to take the drug.
Use In Pregnancy & Lactation
Pregnancy and Lactation: The safe use of Loratadine during pregnancy has not been established. Therefore, Loratadine should only be given if the potential benefit justifies the potential risk to the fetus.
Breast Feeding: Loratadine is excreted in the breast milk, so nursing mothers are advised not to take the drug.
Adverse Reactions
Adverse effects reported are fatigue, dizziness, dry mouth, headache, sedation, nausea and pruritus. Somnolence, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
Drug Interactions
When administered concomitantly with alcohol, Loratadine has no potentiating effects as measured by psychomotor performance studies. Co-administration with drugs that inhibit or are metabolized by hepatic cytochromes P450, 3A4 and 2D6 may elevate the plasma concentrations of either drug. Increased plasma concentrations of Loratadine has been reported when used concomitantly with ketoconazole, erythromycin and cimetidine.
Storage
Store below 25°C in a cool dry place.
Protect from excessive moisture.
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Tab 10 mg (white to off-white, oval-shaped, with a break line on one side and plain on the other side) x 50 x 10's.
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