LORADIN

Loratadine

Description:

Loradin is a preparation of Loratadine. Loratadine is a long acting tricyclic antihistamine with selective peripheral H1- receptor antagonistic activity and no central sedative or anticholinergic effect.

Composition:

Each tablet contains Loratadine INN 10 mg.

Indications:

Loradin tablets provide fast effective relief from the symptoms of hay fever, allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning, nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loradin is also associated with idiopathic chronic urticaria. In children over 2 years, Loradin is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria nettle rash.

Dosage & administration:

Adult & children over 12 years of age: One Loradin 10 mg tablet once daily (usually in the morning).

Children:

2-12 years (body weight more than 30 Kg): 10 mg Loradin once daily.

2-12 years (body weight less than 30 Kg): 5 mg Loradin once daily.

Below 2 years of age: Safety and efficacy of Loradin have not been established.

Contraindication:

Loradin is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

Side-effects:

During controlled clinical studies, the incidence of adverse events including sedation and anticholinergic effects observed with placebo. Fatigue, nausea and headache were reported rarely. Scientific studies showed that Loratadine does not cause drowsiness. It does not affect performance and ability to drive or tasks requiring concentration.

Precautions:

Patients with liver impairment and renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10 mg every other day).

Use during pregnancy and lactation:

Use in Pregnancy: There is no experience of the use of Loratadine in human pregnancy, hence it should not be used during pregnancy.

Use in Lactation: Loratadine is excreted in breast milk, so it should not be administered to lactating mother.

Liver & renal impairment: Patients with liver impairment and renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10 mg every other day).

Drug Interaction:

When administered concurrently with alcohol, Loratadine has no potentiating effect as measured by psychomotor performance studies. Interactions with other drugs have not been reported.

Overdosage:

In the event of overdosage, treatment that should be started immediately is symptomatic and supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously, but not in the patients with impaired consciousness. Administration of activated charcoal as slurry with water may be attempted following emesis. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed.

Storage:

Loradin should be stored at below 30º C.

Packing:

Box containing 5 x 10's tablets in blister pack.