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Clarityne
Long-Acting, Non-Sedating Antihistamine

DESCRIPTION

Each CLARITYNE Tablet contains 10 mg micronized loratadine and the inactive ingredients corn starch, lactose and magnesium stearate.


Each 5 ml of CLARITYNE Syrup contains 5 mg of micronized loratadine and the inactive ingredients propylene glycol, glycerin, citric acid monohydrate, sodium benzoate, sugar, peach flavour and purified water. Preservative: Sodium Benzoate 0.1% w/v.


ACTION

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

 

INDICATIONS AND USAGE

CLARITYNE Products are indicated for the relief of symptoms associated with allergic rhinitis, such as 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.

CLARITYNE Products are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.

DOSAGE AND ADMINISTRATION
Adults and Children 12 years of age and over:
CLARITYNE Tablet: One tablet (10 mg) once daily;

CLARITYNE Syrup: Two 5 ml spoonfuls (10 mg) once daily.


Children 6 to 12 years of age:
Body Weight >30 kg - One tablet (10 mg) once daily or two 5 ml spoonfuls (10 mg) syrup once daily.
Body Weight ≤30 kg - Half a tablet (5 mg) once daily or one 5 ml spoonful (5 mg) syrup once daily.


Children 2 to 6 years of age:
Body Weight >30 kg - Two 5 ml spoonfuls (10 mg) syrup once daily.

Body Weight ≤30 kg - One 5 ml spoonful (5 mg) syrup once daily.

 

DRUG INTERACTIONS

When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.

 

Increase in plasma concentrations 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 coadministered with caution until definitive interaction studies can be completed.


Drug/Laboratory Test Interactions: CLARITYNE Products should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.


ADVERSE REACTIONS

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, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.


During the marketing of CLARITYNE Tablets, alopecia, anaphylaxis, abnormal hepatic function, tachycardia and palpitations 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.


CONTRAINDICATIONS

CLARITYNE Products are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.


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.


Safety and efficacy of CLARITYNE Products in children younger than two years of age have not yet been established.


USAGE DURING PREGNANCY AND IN NURSING MOTHERS

Safe use of CLARITYNE Products during pregnancy has not been established; therefore, use only if the potential benefit justifies the potential risk to 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.


OVERDOSAGE

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, such as 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 of 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.


HOW SUPPLIED
CLARITYNE Tablets: In blister packs of 10's, 10 x 10's and 50 x 10's.

CLARITYNE Syrup: In bottles of 60 ml and 100 ml.


STORAGE

Store between 2 and 30C.

Blister pack tablets should be protected from excessive moisture.

Keep out of reach of children.

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