ALRINAST (Desloratadine 5 mg)

ALRINAST (Desloratadine 5 mg)

ALRINAST (Desloratadine 5 mg)

Pharmacotherapeutic group: Antihistamines-H1 antagonist ATC code: R06A X27.

Desloratadine is a non-sedating, long-acting, potent, selective peripheral H1-receptor antagonist. Desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system after oral administration.

Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells, as well as inhibition of the expression of the adhesion molecule P- selectin on endothelial cells. The clinical importance of these observations remains to be confirmed.

Therapeutic indications

ALRINAST is indicated for the relief of symptoms related with allergic rhinitis such as sneezing, runny nose and itching, congestion / stuffiness but also in the eyes itching, tearing and redness, in the palate itching and coughing.

ALRINAST is also indicated for the elimination of symptoms such as ridges and redness of the skin, relief of itching associated with urticaria.

Posology and method of administration

Adults and adolescents (12 years of age and over): The recommended dose is one tablet once a day.

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Intermittent allergic rhinitis with presence of symptoms for 4 days per week or for less than 4 weeks should be managed in accordance with the evaluation of patient’s disease history and the treatment should be suspended in the event of removal and recurrence of symptoms.

In persistent allergic rhinitis with presence of symptoms for 4 days or more per week and for more than 4 weeks, continuous treatment should be recommended in the event of the emergence of the patient’s allergies.

Paediatric population: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age.

The safety and efficacy of desloratadine film-coated tablets in children below the age of 12 years have not been established. No data are available.

Method of administration:

Oral use. The dose can be taken with or without food.

Hepatic impairment: There is no data on the use in patients with hepatic insufficiency.

Renal impairment: ALRINAST should be used cautiously in patients with severe renal insufficiency.

Geriatric population: There are no specific studies targeting the geriatric population.

Contraindications

Hypersensitivity to the active substance, to any of the excipients or to loratadine.

Special warnings and precautions for use

In the case of severe renal insufficiency, ALRINAST should be used with caution.

Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.

This medicinal product contains 2.8 mg lactose monohydrate at each dose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered.

In a clinical pharmacology trial, desloratadine taken concomitantly with alcohol, did not potentiate the performance impairing effects of alcohol. However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

Pregnancy and lactation

Pregnancy category: C

Women with childbearing potential / Birth control (contraception)

There is no data on effects on fertility in woman with childbearing potential.

Pregnancy: There is limited (less than 300 pregnancy outcomes) or no data on the use of desloratadine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

The potential risk for humans is unknown. ALRINAST should not be used during pregnancy unless it is necessary.

Lactation: Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ALRINAST therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Reproductivity / fertility

There are no data available on male and female fertility.

Effects on ability to drive and use machines

Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials. Patients should be informed that most people do not experience drowsiness. Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.

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Overdose and Treatment

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 which up to 45 mg of desloratadine was administered (9 times the clinical dose), no clinically relevant effects were observed. Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.

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