Soloneks drops vn.pr. 10mg / 20ml ml vial

$5.62

Soloneks drops vn.pr. 10mg / 20ml ml vial

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Description

Composition
Active substance:
Cetirizine dihydrochloride 10.0 mg
Excipients:
Propylene glycol 350.0 mg
Anhydrous Glycerol 250.0 mg
Sodium saccharin 10.0 mg
Sodium acetate trihydrate 10.0 mg
Methyl parahydroxybenzoate 1.35 mg
Propyl parahydroxybenzoate 0.15 mg
Glacial acetic acid to pH 4,0 – 6,0
Water for injection to 1.0 ml
Description:
Transparent colorless or lightly colored liquid with an odor of acetic acid.
Product form:
Drops for oral administration of 10 mg / ml.
20 ml glass vial, with rubber stoppers and dropper cap with tamper-evident and child protecting mechanism or without.
1 bottle together with instructions for use in a stack of cardboard.
Contraindications
– Increased sensitivity to cetirizine, hydroxyzine, or any derivative of piperazine, as well as other components of the preparation.
– End-stage renal failure (creatinine clearance
– Children under the age of 6 months (due to the limited data on the efficacy and safety of the drug).
– Pregnancy.
Precautions – Chronic renal failure (with CC> 10 ml / min required correction mode).
– Elderly patients (with age-related decrease in glomerular filtration rate).
– epilepsy and patients with increased convulsive readiness.
– Patients with predisposing factors for urinary retention (see section “Special Instructions”.).
– Children under the age of 1 year.
– The period of breastfeeding.
– the simultaneous use of alcohol.
Dosage
10 mg / ml
Indications
Use of the drug is indicated in adults and children 6 months of age or older in order to facilitate:
– nasal and ocular symptoms year (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 6 to 12 months is possible only by prescription and under strict medical supervision.
Interaction with other drugs
The simultaneous use of azithromycin, cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine. Pharmacokinetic interactions were observed. According to in vitro testing, cetirizine does not affect protein binding effect of warfarin.
Simultaneous treatment with azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine did not reveal any significant changes in clinical laboratory values, vital signs and ECG. The study while taking theophylline (400 mg daily) and cetirizine (20 mg daily) was observed slight but statistically significant increase in 24-hour AUC (area under the curve) by 19% for cetirizine and 11% for theophylline. In addition, the maximum blood plasma levels increased to 7.7% and 6.4% respectively for cetirizine and theophylline. Simultaneously cetirizine clearance decreased 16% and 10% in the case of theophylline when taken cetirizine patients who have previously received treatment with theophylline. However, pretreatment with cetirizine had no significant effect on the pharmacokinetic parameters of theophylline. After a single dose of cetirizine in a dose of 10 mg effect of alcohol (0,8 ‰) was not significantly amplified; a statistically significant interaction with 5 mg of diazepam was proved in one of 16 psychometric tests. Simultaneous treatment with cetirizine 10 mg daily with glipizide resulted in a slight decrease in glucose parameters. This effect is of no clinical significance. Nevertheless, we recommend separate reception – glipizide morning and evening cetirizine.
If you apply the above or other medications (including over the counter) before using the product, consult your physician.
Overdose
symptoms
In single dose of the drug at a dose of 50 mg may experience the following symptoms: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, fatigue, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.
Treatment
Immediately after dosing – stimulated gastric lavage or emesis.
Recommended administration of activated charcoal, conduct of symptomatic and supportive therapy. No specific antidote. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Cetirizine – active substance of the preparation – is a metabolite of hydroxyzine, refers to a group of competitive antagonists and histamine H1-blocking histamine receptors.
In addition to antihistaminic effect and prevents the development of cetirizine facilitates the allergic reactions in a dose of 10 mg once or twice daily inhibits the late phase of aggregation of eosinophils in the skin and conjunctiva of patients prone to atopy.
Clinical efficacy and safety
Studies in healthy volunteers have shown that cetirizine at doses of 5 or 10 mg significantly inhibit the reaction in the form of rash and redness on administration to the skin in high concentrations of histamine, but not a correlation with efficiency. In a 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant asthma mild and moderate flow shown that taking cetirizine 10 mg once daily reduces the symptoms of rhinitis and no effect on lung function.
The results of this study confirm the safety of cetirizine in patients with allergies and asthma mild and moderate flow.
In a placebo-controlled study demonstrated that cetirizine receiving 60 mg daily for 7 days did not cause clinically significant lengthening of the interval QT.
Admission cetirizine at the recommended dose showed improvement in the quality of life of patients with perennial and seasonal allergic rhinitis.
Children
The 35-day study in patients aged 5-12 years, no evidence of immunity to the antihistamine effect of cetirizine. Normal skin reaction to histamine was restored within three days after discontinuation of the drug when it is used repeatedly.
The 7-day placebo-controlled trial of the drug in dosage form, syrup involving 42 patients aged 6 to 11 months demonstrated the safety of the drug. Cetirizine was administered at a dose of 0.25 mg / kg twice a day, which corresponded to about 4.5 mg per day (dose range was from 3.4 to 6.2 mg per day).
Use in children 6 to 12 months is possible only by prescription and under strict medical supervision.
Pharmacokinetics:
Pharmacokinetic parameters cetirizine when used in doses from 5 to 60 mg vary linearly.
Suction
The maximum concentration (Cmax) in plasma achieved after 1 ± 0,5 hours and is 300 ng / ml.
Various pharmacokinetic parameters such as maximum plasma concentration and area under the curve “concentration-time” have a homogeneous character.
Food intake does not affect the absorption of cetirizine completeness, though its speed is reduced.
The bioavailability of various dosage forms of cetirizine (solution, capsule, tablet) is comparable.
Distribution
Cetirizine 93 ± 0,3% bound to plasma proteins. The volume of distribution (Vd) is 0.5 l / kg. Cetirizine does not affect the binding of warfarin with proteins.
Metabolism
Cetirizine does not undergo extensive primary metabolism.
breeding
The half-life (T1 / 2) is about 10 hours.
Before the drug in a daily dose of 10 mg of cetirizine accumulation were observed for 10 days.
Approximately 2/3 of the dose of the drug is excreted in the urine unchanged.
Elderly patients
At 16 elderly patients with single dose of the drug at a dose of 10 mg
T1 / 2 was 50% higher and clearance – 40% lower compared to individuals not elderly.
Decrease in clearance of cetirizine in elderly patients, probably due to the decrease in renal function in these patients.
Patients with renal insufficiency
Patients with mild renal impairment (creatinine clearance (CC)> 40 ml / min), the pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.
In patients with renal insufficiency of moderate severity in patients on hemodialysis (creatinine clearance
For patients with renal failure secondary to severe corresponding change in the dosing regime required (see. The section “Method of administration and dose”).
Cetirizine poorly removed from the body during hemodialysis.
Patients with hepatic insufficiency
In patients with chronic diseases of the liver (hepatocellular, holesta- cally and biliary cirrhosis) under single dose of the drug in a dose of 10 mg or 20 T1 / 2 is increased by about 50%, and the clearance is reduced by 40% as compared with healthy subjects. No dose adjustment is necessary only in case of a patient with hepatic insufficiency, there is also a concomitant renal insufficiency.
Children
T1 / 2 in children 6 to 12 years of 6 hours from 2 to 6 years – 5 hours from 6 months to 2 years – is reduced to 3.1 hours.
Pregnancy and breast-feeding
Pregnancy
In the analysis of prospective data from more than 700 pregnancy outcomes revealed no cases of the formation of malformations, fetal and neonatal toxicity with a clear cause-and-effect relationship.
Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including those in the postnatal period), during pregnancy and postnatal development.
Adequate and well-controlled clinical studies on safety of the drug during pregnancy has not been so Soloneks should not be used during pregnancy.
Breast-feeding
Do not apply the drug during breast-feeding, as Cetirizine is excreted in breast milk.
fertility
Available data on the effect on human fertility is limited, but a negative effect on fertility has not been revealed.
Conditions of supply of pharmacies
Without recipe.
side effects
Results from clinical studies have demonstrated that the use of cetirizine at recommended doses leads to the development of minor adverse effects on the central nervous system (CNS), including drowsiness, fatigue, dizziness and headache. In some cases it was registered paradoxical CNS stimulation.
Despite the fact that cetirizine is a selective blocker of peripheral H1-receptors and almost no anticholinergic action, it was reported a few cases of micturition difficulty, accommodation disturbances and dry mouth.
Reported violations of the liver accompanied the increase in liver enzymes and bilirubin. Most adverse events were resolved after discontinuation of cetirizine.
The list of undesirable side reactions
There are data obtained during the double-blind controlled clinical studies aimed at comparing cetirizine and placebo or other antihistamines used at the recommended doses (10 mg once daily for cetirizine) in more than 3200 patients on the basis of which it is possible to carry out a reliable analysis safety data.
According to the results of the combined analysis of placebo-controlled studies in the application of cetirizine 10 mg were identified following undesirable reaction with a frequency of 1.0% or higher:
General disorders and disturbances at the injection site
fatigue:
Cetirizine 10 mg (n = 3260) – 1.63%
Placebo (n = 3061) – 0.95%
Disorders of the nervous system
Dizziness:
Cetirizine 10 mg (n = 3260) – 1.10%
Placebo (n = 3061) – 0.98%
Headache:
Cetirizine 10 mg (n = 3260) – 7.42%
Placebo (n = 3061) – 8.07%
Disorders of the gastrointestinal tract
Abdominal pain:
Cetirizine 10 mg (n = 3260) – 0.98%
Placebo (n = 3061) – 1.08%
Dry mouth:
Cetirizine 10 mg (n = 3260) – 2.09%
Placebo (n = 3061) – 0.82%
Nausea:
Cetirizine 10 mg (n = 3260) – 1.07%
Placebo (n = 3061) – 1.14%
mental disorders
Drowsiness:
Cetirizine 10 mg (n = 3260) – 9.63%
Placebo (n = 3061) – 5.00%
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Pharyngitis:
Cetirizine 10 mg (n = 3260) – 1.29%
Placebo (n = 3061) – 1.34%
Although the incidence of sleepiness cetirizine group was higher than that in the placebo group, in most cases this undesirable phenomenon was mild or moderate in severity. When an objective assessment, undertaken in other studies,
it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers has no effect on their daily activities.
Children
In placebo-controlled trials in children aged 6 months to 12 years, the following adverse reactions with a frequency of 1% were identified above:
Disorders of the gastrointestinal tract
Diarrhea:
Cetirizine (n = 1656) – 1.0%
Placebo (n = 1294) – 0.6%
mental disorders
Drowsiness:
Cetirizine (n = 1656) – 1.8%
Placebo (n = 1294) – 1.4%
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Rhinitis:
Cetirizine (n = 1656) – 1.4%
Placebo (n = 1294) – 1.1%
General disorders and disturbances at the injection site
fatigue:
Cetirizine (n = 1656) – 1.0%
Placebo (n = 1294) – 0.3%
Previous post-registration application
In addition to adverse events identified during clinical trials and described above, within the post-registration of the drug following adverse reactions were observed.
Adverse events are shown below in classes MedDRA body system and the incidence of post-registration based on data of the drug.
The incidence of adverse events was determined as follows: very often (> 1/10), often (> 1/100
special instructions
In view of the potential inhibitory effect on the central nervous system Caution should be exercised when administering the drug to children under the age of 1 year, subject to the following risk factors for sudden infant death syndrome, such as (but not limited to this list):
– sleep apnea and sudden infant death syndrome in infants have a brother or sister;
– abuse of drugs or mothers smoking during pregnancy;
– A young maternal age (19 years and younger);
– abuse of smoking babysitting, caring for a child (one pack of cigarettes per day or more);
– Children regularly falling asleep face down and are not laid on his back;
– preterm (gestational age less than 37 weeks) or born underweight (below the 10th percentile for gestational age) children;
– with a joint reception drugs that have a depressant effect on the central nervous system.
The preparation includes excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions, including delayed type.
Patients with spinal cord injury, prostate hyperplasia, and in the presence of other predisposing factors to urinary retention required compliance caution as cetirizine may increase the risk of urinary retention.
It is recommended to be careful when using cetirizine with alcohol.
Caution should be exercised in patients with epilepsy and increased convulsive readiness.
Before assigning allergy three samples recommended “washout” period because the H1-histamine receptor blockers inhibit the development of cutaneous allergic reactions.
After discontinuation of cetirizine may appear itching and / or rash, even if these symptoms were absent at the beginning of treatment. In some cases, symptoms can be intense and require the reintroduction of cetirizine. The symptoms disappeared when resuming reception of cetirizine.
The effect on the ability of control of vehicles and mechanisms
When an objective assessment of the ability to drive vehicles and management mechanisms do not reliably reveal any adverse effects while taking the drug at the recommended dose. However, patients with symptoms of sleepiness in patients receiving the drug it is advisable to refrain from driving, classes of potentially hazardous activities or control mechanisms that require high concentration and speed of psychomotor reactions.
Storage conditions
Store at a temperature not higher than 25 degrees.
Keep out of the reach of children.
After opening the bottle – 6 months.
Dosing and Administration
Inside, drip in a spoon or dissolve in water.
The amount of water for dissolving the drug should correspond to the amount of fluid that the patient (especially children) unable to swallow.
The solution should be taken immediately after preparation.
Adults
10 mg (20 drops) 1 time per day.
Elderly patients
There is no need to reduce the dosage in elderly patients if the renal function is not impaired.
Patients with renal insufficiency
Since Cetirizine is excreted mainly by the kidneys (see. Subsection “Pharmacokinetics”), the impossibility of alternative treatment in patients with renal insufficiency drug dosing regimen should be adjusted depending on renal function (CC value).
QC for males can be calculated from the serum creatinine concentration in blood plasma, by the following formula:
CC (ml / min) = [140 – age (years)] x body weight (kg) / 72 x KKsyvorot (mg / dl)
QC for women can be calculated by multiplying the obtained value by a factor of 0.85.
Dosage in adult patients with renal insufficiency:
Normal> 80 CC (ml / min) – 10 mg 1 time per day
Light 50-79 QC (ml / min) – 10 mg 1 time per day
Average 30-49 QC (ml / min) – 5 mg 1 time per day
Heavy 10-29 QC (ml / min) – 5 mg every other day
End-stage – patients on dialysis
Patients with impaired liver function
In patients with impaired liver function only correct dosing regimen is required.
In patients with impaired liver function and, and renal function is recommended dosage correction.
Children
Use in children 6 to 12 months is possible only by prescription and under strict medical supervision.
Children aged 6 to 12 months – 2.5 mg (5 drops), 1 daily
Children aged 1 to 6 years – 2.5 mg (5 drops), 2 times a day
Children aged 6 to 12 years – 5 mg (10 drops), 2 times a day
Children older than 12 years – 10 mg (20 drops) per day 1
Sometimes an initial dose of 5 mg (10 drops) may be sufficient if it is possible to achieve satisfactory control of symptoms.
Children with renal insufficiency dose corrected for QC and body weight.
If after treatment there is no improvement or symptoms are aggravated, or there are new symptoms, you should consult with your doctor.
Use according to the drug only indications that the application and in those doses which are specified in the instruction.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Grotex Ltd.

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