Deloris

Each film-coated tablet contains Desloratadine 5 mg.

PHARMACOLOGY: Desloratadine is a long acting tricyclic histamine antagonist with selective H₁-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H₁-receptor. Desloratadine inhibited histamine release from human mast cells in vitro.

Allergic Rhinitis: DELORIS Tablet are indicated for the relief of the nasal and non-nasal symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis) in patients 12 years of age and older.
Urticaria: DELORIS Tablet are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with urticaria 12 years of age and older.

In adults and children 12 years of age and over: 5 mg once daily.
In patients with liver or renal impairment: a starting dose of one 5 mg tablet every other day is recommended.
Intermittent allergic rhinitis (presence of symptoms for less then 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 could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods.

At doses of 10 mg and 20 mg/day somnolence was reported.

Contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine.

Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of desloratadine was assessed using loratadine studies.
Information for Patients: Desloratadine should be used with caution in patients with medical record or having historical family in seizures. Children are susceptible to seizures, during Desloratadine treatment. Physician must stopped treatment immediately if patients has a seizure during treatment with Desloratadine. Patients should be instructed to use Desloratadine as directed. As there are no food effects on bioavailability, patients can be instructed that Desloratadine may be taken without regard to meals. Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with Desloratadine.
Use in Pregnancy: Pregnancy Category C: No adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.
Use in Lactation: Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.
Use in Children: The safety and effectiveness of Desloratadine in pediatric patients under 12 years of age have not been established.
Use in the Elderly: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Pregnancy Category C: No adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.
Nursing Mothers: Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.

Allergic Rhinitis: There were no serious adverse events in patients receiving desloratadine.
Chronic Idiopathic Urticaria: The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, and rarely hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, somnolence, seizures, hepatitis and elevated liver enzymes including bilirubin.

Store below 30°C, away from excessive moisture.

Antihistamines & Antiallergics

R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.

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