Clarityne

Clarityne

loratadine

Manufacturer:

Bayer

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Loratadine (micronised).
Description
Each tablet also contains the following inactive ingredients: Cornstarch, lactose and magnesium stearate.
Each 5-mL syrup also contains the following inactive ingredients: Propylene glycol, glycerin, citric acid monohydrate, sodium benzoate, sugar, peach flavour, sodium benzoate 0.1% w/v (preservative) and purified water.
Action
Long-acting, nonsedating antihistamine.
Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
Indications/Uses
Relief of symptoms associated with allergic rhinitis eg, sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning.
Nasal and ocular signs and symptoms are relieved rapidly after oral administration.
Relief of symptoms and signs of chronic urticaria and other allergic dermatological disorders.
Dosage/Direction for Use
Adults and Children ≥12 years: 1 tab (10 mg) or two 5-mL spoonfuls (10 mg) once daily.
Children 6-12 years: Body weight >30 kg: 1 tab (10 mg) once daily or two 5-mL spoonfuls (10 mg) syrup once daily; ≤30 kg: ½ tab (5 mg) once daily or one 5-mL spoonful (5 mg) syrup once daily.
Children 2-6 years: Body weight >30 kg: Two 5-mL spoonfuls (10 mg) syrup once daily; ≤30 kg: One 5-mL spoonful (5 mg) syrup once daily.
Overdosage
Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 160 mg produced no adverse effects.
Treatment: In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.
The patients should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240-360 mL of water. If emesis does not occur within 15 min, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children.
Following emesis, adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. 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. Loratadine is not cleared by hemodialysis to any appreciable extent. After emergency treatment, the patient should continue to be medically monitored.
Contraindications
Patients who have shown hypersensitivity or idiosyncrasy to any of the components of Clarityne.
Special Precautions
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.
Use in pregnancy & lactation: Safe use of Clarityne during pregnancy has not been established; therefore, use only if the potential benefit justifies the potential risk to the fetus.
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.
Use in children: Safety and efficacy of Clarityne in children <2 years have not yet been established.
Use In Pregnancy & Lactation
Safe use of Clarityne during pregnancy has not been established; therefore, use only if the potential benefit justifies the potential risk to the fetus.
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.
Adverse Reactions
Clarityne has no clinically significant sedative properties at the daily recommended dose of 10 mg.
Most commonly reported adverse effects include fatigue, headache, somnolence, dry mouth, gastrointestinal disorders eg, nausea, gastritis, and also allergic symptoms eg, rash.
During the marketing of Clarityne tablet, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
Similarly, the incidence of adverse effects associated with Clarityne syrup has been comparable to that of placebo. In controlled pediatric clinical trials, the incidence of treatment-related headache, sedation and nervousness, which were rarely reported events, was similar to that of placebo.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Increase in plasma concentrations of loratadine has been reported with concomitant use of ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic).
Drug/Laboratory Test: 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.
Storage
Store below 30°C. Protect tablets from excessive moisture.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Tab 10 mg x 500's. Syr 5 mg/5 mL x 100 mL.
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