Aerius 5 mg tablets- non-sedating long-acting antiallergic

Aerius is indicated for the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Aerius is also indicated for the relief of symptoms associated with chronic idiopathic urticaria such as the relief of itching and the size and number of
hives.

Dosage And Administration

Adults and adolescents (> 12 years of age): One Aerius 5 mg film-coated tablet once a day regardless of mealtime. For oral use.

Description And Actions

Each Aerius Tablet Contains 5.0Mg Of Desloratadine.

Desloratadine is a non-sedating long-acting hitamine antagonist with potent, selective peripheral H1-receptor antagonist activity. Desloratadine has demonstrated antiallergic, antihistaminic, and anti-inflammatory activity.

Drug Interactions

• No clinically relevant interactions with desloratadine was observed in clinical trials.
• There was no effect of food or grapefruit juice on the disposition of desloratadine.
• Desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.

Adverse Effects

In clinical trials in a range of indications including allergic rhinitis and idiopathic Uticria, at the recommended dose of 5mg daily, undesirable effects with desloratadine was reported in 3% of patients in excess of those treated with placebo. The most frequent adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).

Very rare cases of hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures, elevations of liver enzymes, hepatitis, and increased bilirubin have been reported during the marketing of desloratadine.

Precautions

• Efficacy and safety of desloratadine in children under 12 years of age have not been established.
• Effects On Ability To Drive And Use Machines: No effects on the ability to drive and use machines have been observed.

Usage During Pregnancy And Lactation

• No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended
  clinical dose.
• No teratogenic or mutagenic effects were observed in animal trials with desloratadine. Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of desloratadine during pregnancy has not been established. Desloratadine is not to be used during pregnancy unless the potential benefits outweigh the risks.
• Desloratadine is excreted into breast milk, therefore the use of desloratadine is not recommended in breast-feeding women.

Overdosage Information

• In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.
• Based on a multiple dose clinical trial in adults and adolescents, in which up to 45mg of desloratadine was administered (9 times the clinical dose), no clinically relevant effects were observed.
• Desloratadine is not eliminated by hemodialysis; it is not known if it is eliminated by peritoneal dialysis

إيريوس أقراص [٥ ملجم ديسلُورَاتادين] مضاد للحساسية ممتد المفعول

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