120 mg tablets: relief of symptoms of seasonal allergic rhinitis. Table. 180 mg: relief of symptoms of chronic idiopathic urticaria.
Composition:
One tablet contains 120 mg or 180 mg of fexofenadine hydrochloride equivalent to 112 mg or 168 mg of fexofenadine.
Action:
Antihistamine, a selective H-receptor antagonist1, deprived of a sedative effect. Fexofenadine is the pharmacologically active metabolite of terfenadine. There were no changes in the QT intervalc. Rapidly absorbed after oral administration. Maximum plasma concentration occurs after 1-3 h. Plasma protein binding is 60-70%. The drug is not subject to intensive metabolism. 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 any of the excipients.
Precautions:
Caution should be exercised in elderly patients and patients with impaired renal or hepatic function. Patients with current or past cardiovascular disease should be warned that the use of antihistamines is associated with the occurrence of tachycardia and palpitation. There are no data on safety and efficacy in children under 12 years of age.
Pregnancy and lactation:
Fexofenadine should not be used during pregnancy unless clearly necessary. The drug is excreted in human milk, therefore fexofenadine is not recommended in women who are breastfeeding.
Side effects:
Common: pain and dizziness, drowsiness. Uncommon: fatigue. In addition, with an unknown frequency: hypersensitivity reactions with symptoms such as angioneurotic edema, tightness in the chest, dyspnea, redness and generalized anaphylaxis; insomnia, sleep disorders, nervousness, nightmares; tachycardia, palpitations; diarrhea; rash, urticaria, pruritus.
Dosage:
Orally. Adults and children from 12 years. Allergic rhinitis: 120 mg once a day before meals. Chronic idiopathic urticaria: 180 mg once a day before meals.
(C)
