Solonex oral drops 10mg/ml, 20ml

Composition

>1 ml of the drug contains: Active ingredient: Cetirizine Dihydrochloride 10.0 MGM Auxiliary substances: Propylene glycol 350.0 mgGlycerol anhydrous 250.0 mg Sodium saccharinate 10.0 mg Sodium acetate trihydrate 10.0 mg methylparahydroxybenzoate 1.35 mg Propylparahydroxybenzoate 0.15 mg Glacial acetic acid up to pH 4.0 – 6.0 Water for injection up to 1.0 ml

Pharmacological action

Cetirizine – the Active ingredient of the drug – is a metabolite of hydroxyzine, belongs to the group of competitive antagonists histamine and blocks H1-histamine receptors. In addition to the antihistamine effect, cetirizine prevents the development and eases the course of allergic reactions: at a dose of 10 mg once or twice a day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients subject to atopy. Clinical efficacy and safety Studies in healthy volunteers have shown that cetirizine at doses of 5 or 10 mg significantly inhibits the rash and redness response to high concentrations of histamine injected into the skin, but no correlation with efficacy has been established. In a 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild and moderate bronchial asthma, cetirizine 10 mg once daily was shown to reduce the symptoms of rhinitis and not affect lung function. The results of this study confirm the safety of using cetirizine in patients suffering from allergies and mild to moderate bronchial asthma. A placebo-controlled study showed that taking cetirizine 60 mg daily for 7 days did not cause clinically significant prolongation of the QT interval. Taking cetirizine at the recommended dose showed an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis. Children In a 35-day study involving patients aged 5-12 years, there were no signs of immunity to the antihistamine effect of cetirizine. Normal skin response to histamine was restored within three days after discontinuation of the drug with repeated use. In a 7-day placebo-controlled study of the drug in the dosage form of syrup with the participation of 42 patients aged 6 to 11 months, the safety of the drug was demonstrated. Cetirizine was administered at a dose of 0.25 mg / kg twice daily, which approximately corresponded to 4.5 mg per day (the dose range was from 3.4 to 6.2 mg per day). Use in children from 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.

Indications

The use of the drug is indicated in adults and children from 6 months and older for relief: – nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia; – symptoms of chronic idiopathic urticaria. Use in children from 6 to 12 months is possible only when prescribed by a doctor and under strict medical supervision.

Recommendations for use

Inside, drop in a spoon or dissolve in water. The amount of water to dissolve the drug should correspond to the amount of liquid that the patient (especially a child) is able to swallow. The solution should be taken immediately after preparation. Adults 10 mg (20 drops) 1 time a day. Elderly patients There will be an increased need to reduce the dosage in elderly patients if renal function is not impaired. Patients with renal insufficiency Since cetirizine is mainly eliminated from the body by the kidneys, if alternative treatment is not possible for patients with renal insufficiency, the dosage regimen of the drug should be adjusted depending on renal function (creatinine clearance). CC for men can be calculated based on the concentration of serum creatinine in blood plasma, using the following formula: CC (ml / min) = [140 – age (years)] × body weight (kg) /72 × KXYVER (mg / dl)CC for women can be calculated by multiplying the obtained value by a factor of 0.85. Patients with impaired hepatic functionin patients with impaired liver function alone, no dosage adjustment is required. Dosage adjustment is recommended in patients with impaired hepatic and renal function. DetyPrimenenie in children from 6 to 12 months can only be prescribed by a doctor and under strict medical supervision. Children from 6 to 12 months 2.5 mg (5 drops) 1 time a day Children from 1 year to 6 years 2.5 mg (5 drops) 2 times a day Children from 6 to 12 years 5 mg (10 drops) 2 times a day Children over 12 years of age 10 mg (20 drops) once daily, sometimes an initial dose of 5 mg (10 drops) may be sufficient if it allows for satisfactory control of symptoms. In children with renal insufficiency, the dose is adjusted for creatinine clearance and body weight. If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Contraindications

-Hypersensitivity to cetirizine, hydroxyzine or any piperazine derivatives, as well as to other components of the drug. – End-stage renal failure (CC – Children under 6 months of age (due to limited data on the effectiveness and safety of the drug). – Pregnancy. With caution – Chronic renal failure (with creatinine clearance > 10 ml / min, dosage adjustment is required). – Elderly patients (with age-related decrease in glomerular filtration rate). – Epilepsy and patients with increased convulsive readiness. – Patients with predisposing factors to urinary retention (see section “Special instructions”). – Children under 1 year of age. – The period of breastfeeding. – When used concomitantly with alcohol

Side effects

Data obtained in clinical trials Reviewthe results of clinical trials have shown that the use of cetirizine at the recommended doses leads to the development of minor undesirable effects on the central nervous system (CNS), including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system was recorded. Despite the fact that cetirizine is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effect, isolated cases of difficulty urinating, accommodation disorders and dry mouth have been reported. Hepatic dysfunction associated with elevated liver enzymes and bilirubin levels has been reported. In most cases, adverse events resolved after discontinuation of cetirizine. List of undesirable side effects There are data obtained from double-blind controlled clinical trials comparing cetirizine and placebo or other antihistamines used at the recommended doses (10 mg once daily for cetirizine) in more than 3,200 patients, on the basis of which a reliable analysis of safety data can be carried out.

Interaction

Concomitant use with azithromycin, cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine. No pharmacokinetic interactions were observed. According to 11 in vitro studies, cetirizine does not affect the binding effect of warfarin protein. Concomitant use of azithromycin, erythromycin, ketoconazole, theophylline, and pseudoephedrine showed no significant changes in clinical laboratory parameters, vital signs, or ECG. In a study with simultaneous use of theophylline (400 mg daily) and cetirizine (20 mg daily), a slight but statistically significant increase in 24-hour AUC (area under the curve) was found by 19% for cetirizine and by 11% for theophylline. In addition, maximum plasma levels increased to 7.7% and 6.4%, respectively, for cetirizine and theophylline. At the same time, the clearance of cetirizine decreased by 16%, and also by 10% in the case of theophylline, when cetirizine was taken by patients who had previously received treatment with theophylline. However, pretreatment with cetirizine did not significantly affect the pharmacokinetic parameters of theophylline. After a single 10 mg dose of cetirizine, the effect of alcohol (0.8%) was not significantly enhanced; a statistically significant interaction with 5 mg of diazepam was proven in one of 16 psychometric tests. Concomitant use of 10 mg of cetirizine per day with glipizide resulted in a slight decrease in glucose levels. This effect is not clinically relevant. However, a separate dose is recommended-glipizide in the morning and cetirizine in the evening. If you are using the above or other medications (including over-the-counter medications), please consult your doctor before using the drug.

Overdose

Symptoms With a single dose of 50 mg, the following symptoms may occur: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, restlessness, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention. Treatment immediately after taking the drug – gastric lavage or stimulation of vomiting. It is recommended to take activated charcoal, conduct symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Special instructions

Due to the potential depressing effects on the central nervous system, caution should be exercised when prescribing the drug to children under the age of 1 year in the presence of the following risk factors for sudden children death syndrome, such as (but not limited to): – sleep apnea syndrome or sudden children death syndrome of children in a sibling; – mother’s abuse of drugs or smoking during pregnancy;- young age of the mother (19 years and younger);- abuse of smoking by a babysitter caring for a child (one pack of cigarettes per day or more);- children who regularly fall asleep face down and are not placed on their backs; – premature (gestational age less than 37 weeks) or born with an insufficient 12 body weight (below the 10th percentile of gestational age) children;- when taking medications together that have a depressing effect on the central nervous system. The drug contains excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions, including delayed type. Caution should be exercised in patients with spinal cord injury, prostatic hyperplasia, or other predisposing factors to urinary retention, as cetirizine may increase the risk of urinary retention. Caution is recommended when using cetirizine concomitantly with alcohol. Caution should be exercised in patients with epilepsy and increased convulsive readiness. A three-day “wash-off” period is recommended before the appointment of allergological tests, since H1-histamine receptor blockers inhibit the development of allergic skin reactions. After discontinuation of cetirizine, pruritus and/or urticaria may occur, even if these symptoms were absent at the beginning of treatment. In some cases, the symptoms may be intense and require resumption of cetirizine. Symptoms disappear when cetirizine is resumed.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 3 years. After opening the bottle – 6 months. Do not use after the expiration date!

Active ingredient

Cetirizine

Dosage form

oral drops