PRETIN Tablet

For

- Seasonal allergic rhinitis

-Perennial allergic rhinitis

- Sneezing, rhinorrhea & itching

- Ocular itching and burning

- Chronic urticaria & other allergic dermatologic disorders

Dosage and Administration

Adult and children above 12 years of age: 10mg once a day.

Children:

6-12 years: 10mg once a day.

2-5 years: 5mg once a day.

Safety and efficacy of Loratadine in children below 2 years of age have not yet been established.

In patients who have hypersensitivity or idiosyncrasy to its component.

Potentially life threatening effects: No effects of this kind have been encountered.

Acute overdose: No cases of acute overdose have been reported.

Severe or irreversible adverse effects: No effects of this degree of severity have been reported.

Symptomatic adverse effects: Clinical trials suggest a very low rate of adverse effects, comparable to placebo, in particular for CNS effects (including sedation) and anticholinergic activity.

The lack of sedation by loratadine was further confirmed by special psychomotor studies such as the driving performance test.

There are no reports of potentially hazardous interactions with other drugs to date.

Psychomotor performance studies show that unlike other H1-receptor antagonists, loratadine does not potentiate the effect of alcohol when administered concomitantly with it.

Pregnancy

It should be used only if the potential benefit justifies the potential risk to the fetus.

(See the package insert about the details.)

Lactation

Loratadine is excreted in breast milk. So lactating mothers are advised not to take the drug.

Neonates: The drug is not normally used in neonates

Children: There are no special precautions required for young children over 2 years. But the safety and efficacy of loratadine in children below 2 years of age have not yet been established.

Loratadine binds selectively to peripheral H1 histamine receptors with a lower affinity to brain H1 receptors. In vitro, loratadine displays a threefold greater affinity for H1 receptor sites in guinea-pig lungs compared to those in the cerebral cortex. It is therefore relatively free of CNS side effects, including sedation, as demonstrated by a relative lack of activity in assays of CNS function in animals. It also possesses antiallergic properties shown in vitro and in animal studies. Loratadine inhibits mediator release from human basophils in vitro, but only at relatively high concentrations.