Tablets & Suspension
Long acting – non sedating – antihistamine
Each tablet contains 10 mg Loratadine.
Each spoon (5 ml) contains 5 mg Loratadine.
– Loraladine is a pctent long acting tricyclic antihistamine with selective
peripheral H1 receptor antagonistic activity.
Indications and usage:
-Loratadine is indicated for the symptomatic relief of hypersensitivity reactions including 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.
-loratadine is also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatological disorders.
– Loratadine is contra – indicated in patients who have shown sensitivity
or idiosyncrasy to their components.
– During controlled clinical studies, the incidence of adverse effects associated with 10 mg Loratadine treatment was comparable to that associated with placebo. In these trials, Loratadine showed no clinically significant sedative or anticholinergic properties since fatigue, sedation, headache and dry mouth were rarely reported events and frequency of these effects for both Loratadine and placebo was not statistically different. Nausea was also rarely reported.
– When administered concomitantly with alcohol, Loratadine has no pctentiating effects as measured by psychomotor perfomnance studies.
– Drug laboratory test interactions:
– Antihistamines should be discontinue about four days prior to skin testing procedures since these drugs may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Warnings and precautions:
– Safety and efficacy of Loratadine in children younger than 6 years of age have not yet been eslablished. The safe use of Loraladin during pregnancy has not been established and therefore, the compound should be used only if the potential benefit justifies the potential risk to fetus. Since Loraladine is excreted in breast milk, caution should be exercised when Loratadine is administered to a nursing woman.
Dosage and administration:
– Adults and children 12 years of age and over: 10 mg . once daily
– children: from 6 -12 years: 2 spoon (10ml.) once daily
– shake bottle well before use.
– Boxes of 10 tablets
– Bottles of 60 ml. & 100 rnt.
produced by :
MISR CO. FOR PHARM .IND S.A.E