Symptomatic treatment of allergic rhinitis and conjunctivitis (seasonal and perennial) and urticaria.
Composition:
1 tabl contains 20 mg of bilastine.
Action:
An antihistamine for general use. Bilastine does not have sedative properties. It is a long-acting selective antagonist of peripheral H-receptors1that does not show affinity for muscarinic receptors. In clinical trials, bilastine taken as a single dose for 14-28 days effectively alleviated symptoms such as sneezing, runny nose, feeling of itching or nasal congestion, conjunctiva pruritus, tearing and redness of the eyes, and symptoms associated with urticaria - intensity of pruritus, number and bubble size and discomfort caused by urticaria. Bilastine effectively controlled the symptoms for 24 hours. It is quickly absorbed, it reaches Cmax after about 1.3 hours. No accumulation of bilastine in the body was observed. The mean value of bioavailability of bilastine after an oral dose is 61%. researchin vitro andin vivo showed that bilastine is a substrate of P-glycoprotein and organic anion transporting polypeptides, but does not inhibit transport proteins in the general circulation. It binds to plasma proteins in 84-90%. Almost 95% of the administered dose is excreted in the urine (28.3%) and faeces (66.5%) in the unchanged form - which confirms that bilastine is not significantly metabolised in the human body. T0,5 is 14.5 hours.
Contraindications:
Hypersensitivity to bilastine or to any of the excipients.
Precautions:
The efficacy and safety of bilastine in children under 12 years have not been established. In patients with moderate or severe renal impairment, bilastine should be avoided concomitantly with P-glycoprotein inhibitors (eg ketoconazole, Erythromycin, cyclosporin, ritonavir, diltiazem).
Pregnancy and lactation:
It is recommended to avoid taking the drug during pregnancy. The decision to continue or stop breastfeeding and to continue or stop drug therapy should be made after careful consideration of the benefit for the child and the benefits for the mother.
Side effects:
The number of adverse events experienced by patients with allergic rhinoconjunctivitis or chronic idiopathic urticaria receiving 20 mg bilastine in clinical trials was comparable to the number of adverse events experienced by patients treated with placebo (12.7% versus 12, 8%). The most commonly reported adverse reactions for patients receiving bilastine 20 mg during Phase II and III clinical trials were headache, drowsiness, dizziness and fatigue. The same side effects were similar in patients taking placebo. Side effects at least possibly related to bilastine and reported by more than 0.1% of patients taking the drug at 20 mg are listed below. Common: drowsiness, headache. Uncommon: facial herpes; increased appetite; anxiety, insomnia; tinnitus, dizziness of peripheral origin; right limb block, sinus arrhythmia, QT prolongation in ECG, other ECG abnormalities; dizziness of central origin; dyspnoea; feeling of discomfort in the nose, feeling dry in the nose; epigastric pain, abdominal pain, nausea, abdominal discomfort, diarrhea, dry mouth, indigestion, gastritis; itching; fatigue, thirst, worsening of symptoms, increased body temperature, weakness; increased activity of γ-glutamyltransferase, ALT, AST, creatinine, triglycerides in the blood, weight gain.
Dosage:
Orally. Adults and children over 12 years of age: 20 mg once daily, 1 hour before or 2 h after a meal or consumption of fruit juice. The duration of treatment of rhinitis should be limited to the period of exposure to allergens. The duration of urticaria treatment depends on the type, duration and course of the discomfort. No dosage adjustment is required in elderly patients with impaired renal or hepatic function.
(C)
