Tablet: Each tablet contains: Loratadine (micronized) 10 mg.
List of excipients: Available upon request.
Syrup: Each 5 mL of syrup contains: Loratadine (micronized) 5 mg.
List of excipients: Available upon request.
Long-Acting, Non-sedating Antihistamine.
Tablet: Loratadine (Claritin) tablet and syrup contain loratadine, a tri-cyclic antihistamine with selective peripheral H1-receptor antagonistic activity, which is currently used for the relief of symptoms associated with allergic rhinitis, and urticaria and other dermatologic disorders.
Syrup: Loratadine (Claritin) syrup contains loratadine, a tri-cyclic antihistamine with selective peripheral H1-receptor antagonistic activity, which is currently used for the relief of symptoms associated with perennial and/or seasonal allergic rhinitis and allergic skin disorders.
Tablet: Loratadine (Claritin) 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, urticaria and other dermatologic disorders. Nasal and ocular signs and symptoms are relieved rapidly after oral administration.
Syrup: Loratadine (Claritin) is indicated for the relief of symptoms associated with perennial and/or seasonal allergic rhinitis and allergic skin disorders.
Method of Administration: Oral use.
Dosage Regimen: Tablet: Adults and Children 6 years of age and over with a body weight greater than 30 kg: Loratadine (Claritin) Tablet: One tablet [10 mg] once daily.
Syrup: Adults and Children 12 years of age and over: Loratadine (Claritin) Syrup: Two teaspoonfuls, 10 mL once daily.
Children 2 to 12 years of age: Body weight >30 kg - 10 mL (10 mg), (two teaspoonfuls), Loratadine (Claritin) Syrup once daily.
Body weight ≤30 kg - 5 mL (5 mg), (one teaspoonful), Loratadine (Claritin) Syrup once daily.
Children 1 to 2 years of age: One-half teaspoonful - 2.5 mL (2.5 mg) Loratadine (Claritin) Syrup once daily.
Additional information on special populations: Patients with severe hepatic impairment: Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 mL (5 mg) is recommended.
Missed dose: Take the missed dose as soon as remembered but once daily only.
Signs and Symptoms of Overdose: Intake of loratadine above the labeled dose increases the risk of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.
If taken more than the recommended dosage: In the event of overdosage, general symptomatic and supportive measures should be instituted and maintained for as long as necessary.
Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.
There is no information to indicate that abuse or dependence occurs with loratadine.
Hypersensitivity to the active substance, metabolites or to any of the excipients.
The product should be administered with caution in patients with liver impairment.
Effects on ability to drive or use machines: In clinical trials, loratadine had no or negligible influence on the ability to drive and use machines.
When to consult a doctor: If undesirable effects listed in Adverse Reactions are experienced.
Pregnancy: A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of loratadine during pregnancy.
Lactation: Loratadine is excreted in breast milk. The product is not recommended for use in breast-feeding women.
Fertility: There are no data available on male and female fertility.
Summary of the safety profile: Loratadine has no clinically significant sedative properties at the recommended dosage.
In clinical trials, in a range of indications including Allergic Rhinitis (AR) and Chronic Idiopathic Urticaria (CIU), the most frequently reported adverse effects were headache, somnolence, fatigue and dry mouth, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
At the recommended dose, loratadine had no clinically significant sedative properties.
In addition, other adverse reactions reported very rarely during the post-marketing period are listed in the following table in order of decreasing seriousness of loratadine: See table.
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Drug Interactions: Increase in plasma concentrations of this drug has been reported with 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.
Laboratory Interactions: The administration of loratadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Pediatric population: Interaction studies have only been performed in adults.
Store at temperatures not exceeding 30°C.
Tablet: Protect from excessive moisture.
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Claritin syr 5 mg/5 mL
(grape flavor) 60 mL x 1's
Claritin tab 10 mg
100's;5's
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