Symptomatic treatment of seasonal allergic rhinitis.
Composition:
1 tabl contains 120 mg of fexofenadine hydrochloride (equivalent to 112 mg of fexofenadine).
Action:
Antihistamine, a selective H-receptor antagonist1. Fexofenadine is the pharmacologically active metabolite of terfenadine. It does not have sedative effects or causes significant QT interval changesc in the ECG picture. In a histamine-induced skin reaction model study conducted in humans who received the drug once or twice a day, it was found that the antihistamine action of the drug begins within 1 h, reaches a maximum after 6 h and persists for 24 h. development of tolerance to the drug after 28 days of use. The drug is quickly absorbed from the digestive tract. Maximum plasma concentration occurs after 1-3 h. Plasma protein binding is 60-70%. The drug is metabolized to a minimal extent. T0,5 in the final phase of elimination is 11-15 h after repeated administration. It is excreted primarily from the bile, up to 10% of the dose is excreted in the urine in unchanged form.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Precautions:
Especially cautiously use in elderly patients and patients with impaired renal or hepatic function, as the use data in this group are limited. Patients with a history of cardiovascular disease should be warned that the use of antihistamines may be associated with the occurrence of side effects such as tachycardia and palpitation. There are no data on the safety and efficacy of fexofenadine hydrochloride 120 mg in children under 12 years of age.
Pregnancy and lactation:
There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. It must not be used during pregnancy unless clearly necessary. The drug is excreted in human milk, therefore fexofenadine is not recommended during breast-feeding.
Side effects:
In clinical trials, the following adverse reactions were reported in adults with a similar frequency to that seen in the placebo group: common: pain and dizziness, drowsiness, nausea. Uncommon: fatigue. The frequency of other side effects is unknown (reported after marketing the drug): insomnia, nervousness, sleep disturbances or nightmares / expressive dreams, tachycardia, palpitations, diarrhea, rash, urticaria, pruritus, hypersensitivity reactions with symptoms such as: edema vasomotor, tightness in the chest, shortness of breath, sudden redness of the skin and generalized symptoms of anaphylaxis.
Dosage:
Orally. Adults and children from 12 years: the recommended dose is 120 mg once a day, before meals. No dosage adjustment is necessary for elderly patients or patients with renal or hepatic impairment.
(C)
