Long-Acting, Non-Sedating Antihistamine
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.
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.
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.
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
CLARITYNE Products are contraindicated in patients who have shown
hypersensitivity or idiosyncrasy to their components.
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
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
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.
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
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.
Store between 2° and 30°C.
Blister pack tablets should be protected from excessive moisture.
Keep out of reach of children.