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Brand Names: Claritin, Claritin-D, Claritine, Clarityn, Clarityne, Fristamin, Lomilan, Symphoral, Roletra, Rinolan, AllergyX, Alavert, Claritin-D, Clarinase
Generic Name: Loratadine
Clarityne is the european name for Claritin.
Each CLARITYNE! Tablet -contains 10 mg of 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 flavor and purified water. Preservative: Sodium Benzoate 0.1% w/v.
Loratadine is a potent long-active 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:
- One tablet [10 mg] once daily.
- CLARITYNE Syrup: Two 5 ml spoonful [10 mg] once daily.
Children 2 to 12 years of age:
Body Weight > 30 kg
- 10 ml [10 mg], (two 5 ml spoonful) CLARITYNE Syrup once daily.
Body Weight 30 kg
- 5 ml [5 mg], (one 5 ml spoonful) CLARITYNE 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 co administered with caution until definitive interaction studies can be completed.
Loratadine is metabolised by hepatic cytochromes P450 3A4 and 2D6. Concomitant therapy with drugs which inhibit or are metabolised by either system may therefore elevate plasma concentrations of loratadine.
Studies indicate that cimetidine at 300 mg four times daily for 10 days, which inhibits both enzymes, and erythromycin at 500 mg three times daily for 10 days or ketoconazole at 200 mg every 12 hours for 10 days, which inhibit P450, 3A4, each increased loratadine concentrations, although no adverse effects, clinical or electrocardiographic, were observed. (Ref; Clinical Pharmacology & Therapeutics September 1995: 269-278 and Br J Clin Pharmacol 2000 Dec; 50 (4581-589)
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 placebo.
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 recommended. Efficacy of CLARITYNE has not been established in children younger than 2 years of age. However, the pharmacokinetic profile of loratadine in children 1 to 2 years of age after the administration of a single 2.5 mg dose of CLARITYNE Syrup is similar to that in older children and adults, therefore, use only if the potential benefit justifies the potential risk.
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.
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 symtomatic and supportive.
Consider standard measure to remove any unabsorbed drug in the stomach, such as adsorbtion by activated charcoal administered as 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.
Tablet - Store between r and 30° C. Syrup - Store up to 25° C.
Keep out of reach of children.
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