Clarityne

Loratadine.

Clarityne tablet contains micronized loratadine.
Each 5 mL of syrup contains 5 mg of micronized loratadine.
Excipients/Inactive Ingredients: Tablet: Cornstarch, lactose and magnesium stearate.
Syrup: Propylene glycol, glycerin, citric acid monohydrate, sugar, peach flavor, purified water and sodium benzoate (as preservative).

Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H₁-receptor antagonistic activity.

Relief of symptoms associated with allergic rhinitis eg, sneezing, nasal discharge (rhinorrhoea) and itching, as well as ocular itching and burning.
Nasal and ocular signs and symptoms are relieved rapidly after oral administration.

Adults and Children ≥12 years old: 1 tablet once daily.
Children 6-12 years old: Body Weight >30 kg: 1 tablet once daily or 2 teaspoons of syrup (10 mg) once daily.
Body Weight <30 kg: 5 ml syrup once daily.
Children 2-6 years old: Body Weight >30 kg: 10 mg syrup once daily.
Body Weight <30 kg: 5 ml syrup once daily.

Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 160 mg produced no adverse effects.
In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.
Treatment: Consider standard measures to remove any unabsorbed drug in the stomach eg, adsorption by activated charcoal administered as a slurry with water. The administration of gastric lavage should be considered. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible, the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and therefore may be valuable for their action in rapid dilution of bowel content. It is not known whether loratadine is dialysable. After emergency treatment, the patient should continue to be medically monitored.

Patients who have shown hypersensitivity or idiosyncrasy to any of the components of Clarityne.

Safety and efficacy of Clarityne in children <2 years have not yet 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 5 mg or 5 mL once daily, or 10 mg or 10 mL every other day is recommended.

Safe use of Clarityne during pregnancy has not been established; therefore, use only if potential benefit justifies potential risk to foetus.
Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue the drug.

Clarityne has no clinically significant sedative properties at the daily recommended dose of 10 mg. Most commonly reported side effects include fatigue, headache, somnolence, dry mouth, GI disorders eg, nausea, gastritis and also allergic symptoms eg, rash.
During the marketing of Clarityne products, alopecia, anaphylaxis, abnormal hepatic function, tachycardia and palpitation have been reported rarely.
Similarly, the incidence of adverse effects associated with syrup has been comparable to that of placebo. In controlled paediatric clinical trials, the incidence of treatment-related headache, sedation and nervousness, which were rarely reported events, was similar to that of placebo.

When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Increase in plasma concentration of loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be co-administered with caution until definitive interaction studies can be completed.
Drug/Laboratory Test Interactions: Clarityne should be discontinued approximately 48 hrs prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

Protect from excessive moisture.
Tablet: Store below 25°C.
Syrup: Store below 30°C.

Antihistamines & Antiallergics

R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.

P₂