INSTRUCTIONS FOR MEDICAL USE
Trade name of the drug: Allegra
Active substance (INN): Cetirizine hydrochloride
Contents per 5 ml of syrup:
Active ingredient: cetirizine hydrochloride – 5 mg
Excipients: sucrose, propylene glycol, sodium benzoate, sodium edetate (trilon B), “Sunset Yellow” dye E110, essence of orange, citric acid, purified water.
Description: syrup-like liquid of orange color, sweet taste and characteristic odor.
Pharmacotherapeutic group: Anti-allergic agents.
ATX code: R06AE07
Antiallergic drug, blocker of histamine H1-receptors. Cetirizine belongs to competitive histamine antagonists. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions. It has an antipruritic and antiexudative effect. It affects the early stage of allergic reactions and also reduces the migration of inflammatory cells; it inhibits the release of mediators involved in late allergic reactions. Reduces capillary permeability, prevents the development of tissue edema, relieves smooth muscle spasm. It eliminates the skin reaction to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria).
It practically has no anticholinergic and antiserotonin action.
In therapeutic doses does not cause a sedative effect. Tolerance does not develop during a course of treatment.
The action of the drug starts within 20 minutes (50% of patients) or within 1 hour (95% of patients) and lasts for 24 hours.
After oral administration, cetirizine is quickly and well absorbed from the gastro-intestinal tract. The maximum level of concentration (Cmax) in plasma is determined after about 30-60 minutes. Food intake has no significant effect on the absorption value, but in this case the absorption rate is slightly reduced.
Distribution: Cetirizine binds to plasma proteins by approximately 93%. Volume of distribution (Vd low 0.5 l/kg) The drug does not penetrate the cell. It does not penetrate through the blood-brain barrier.
The drug is weakly metabolized in the liver to form inactive metabolite. There is no accumulation of the drug in 10-day use at a dose of 10 mg.
About 70% is excreted by the kidneys mainly unchanged. Systemic clearance is about 54 ml/min.
After a single dose, the half-life (T ½ ) is about 10 hours. In children aged 2 to 12 years, T ½ is reduced to 5-6 hours. In patients with impaired renal function, creatinine clearance (CK below 11-31 ml/min) and in patients on hemodialysis (CK less than 7 ml/min) T ½ increases 3-fold, clearance decreases by 70%. Against the background of chronic diseases and in elderly patients there is an increase in T ½ by 50% and a decrease in clearance by 40%. Hemodialysis is ineffective.
Indications for use
- Seasonal and year-round allergic rhinitis, and conjunctivitis;
- pruritic allergic dermatoses;
- Pollinosis (hay fever);
- Urticaria (including chronic idiopathic);
- Quincke’s edema.
Methods of administration and dosage.
The drug is prescribed orally, regardless of food intake.
It is recommended to adults and children above 12 years old to take 10 ml of syrup 1-2 times per day, preferably in the evening.
Children aged 6 to 12 years old should take 10 ml of the syrup once a day or 5 ml twice a day, morning and evening.
Children from 2 to 6 years of age should take 5 ml of syrup once a day or 2.5 ml twice a day, morning and evening.
For patients with moderate or severe renal failure, the drug dosage should be reduced by half.
For patients with liver dysfunction the dose should be adjusted individually, reducing it to 5 ml/day or less, with special caution in concomitant renal failure.
Dose adjustment is not required for elderly patients with normal renal function.
Digestive system: dry mouth, dyspepsia.
CNS disorders: headache, drowsiness, fatigue, dizziness, agitation, migraine.
Allergic reactions: skin rash, angioedema, urticaria, itching.
The drug is usually well tolerated. Side effects are rare and transient.
Hypersensitivity to the components of the drug, severe kidney disease, the elderly, children under 2 years of age, pregnancy and lactation.
No clinically significant interactions of cetirizine with other drugs have been established. Concomitant use with theophylline (400 mg/day) leads to decreased total clearance of the drug (theophylline kinetics does not change).
Simultaneous use of agents depressing the central nervous system and alcohol consumption is not recommended.
It must be taken into account that if patients with diabetes mellitus take the drug, 10 ml of syrup contains 3 g sorbitol, which corresponds to 0.25 units.
During the treatment, it is necessary to refrain from potentially hazardous activities that require high concentration and quick psychomotor reactions.
Keep the drug out of reach of children and do not use it after expiration date.
Symptoms: drowsiness, restlessness, lethargy, weakness, fatigue (more often when taking cetirizine at a dose of 50 mg/day), headache, irritability, urinary retention, tremor, tachycardia, itching, rash are possible.
Treatment: gastric lavage, administration of activated charcoal; symptomatic therapy. No specific antidote was found. Hemodialysis is ineffective.
Form of production
Syrup in 50, 60 and 100 ml bottles.
Store in a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children!
3 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released without a prescription.