Zodak drops for oral administration of 10 mg / ml-20 ml vial cap.

$5.05

Zodak drops for oral administration of 10 mg / ml-20 ml vial cap.

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Description

Composition
Active substance:
1 ml of solution contains: 10 mg of cetirizine dihydrochloride.
Excipients:
Methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharin dihydrate, sodium acetate trihydrate, glacial acetic acid, purified water.
Description:
The clear, colorless to light yellow solution.
Product form:
Drops for oral administration of 10 mg / ml. 20 ml vial of dark glass, rubber stoppers and provided with a dropper cap with tamper children. Each vial together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to cetirizine, hydroxyzine or a piperazine derivative, as well as other components of the formulation; end-stage renal failure (creatinine clearance
Carefully
Chronic renal failure (creatinine clearance> 10 ml / min, the required correction mode); elderly patients (age under reducing glomerular filtration rate); epilepsy and patients with increased convulsive readiness; patients with predisposing factors to urinary retention (spinal cord lesions, prostatic hyperplasia); children under 1 year; during breastfeeding.
Dosage
10 mg / ml
Indications
Shown in adults and children 6 months and older to relieve: nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, runny nose, watery eyes, redness of the conjunctiva; symptoms of chronic idiopathic urticaria.
Interaction with other drugs
Any cetirizine drug interactions with other drugs was observed. Based on the results of studies of drug interactions cetirizine in particular studies of the interaction with pseudoephedrine or theophylline at a dose of 400 mg per day, clinically significant interactions has been established. The simultaneous use of cetirizine with alcohol and other drugs, CNS depressants, can further reduce the concentration and speed of reaction, although cetirizine does not potentiate the effect of alcohol (when its concentration in blood of 0.5 g / l).
Overdose
The clinical picture is observed with an overdose of cetirizine, it was due to its effect on the central nervous system.
Symptoms: after a single dose of cetirizine in a dose of 50 mg was observed following clinical picture: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, anxiety, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention, .
Treatment: Immediately after administration of the drug is necessary to gastric lavage or induce vomiting. 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 is a metabolite of hydroxyzine, refers to a group of competitive antagonists of histamine and histamine receptors N1- blocks. In addition to antihistaminic effect and prevents the development of cetirizine facilitates the allergic reactions in a dose of 10 mg of 1 or 2 times a day to inhibit late phase 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 1 time a day reduces rhinitis symptoms 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: a 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 study, cetirizine syrup in the formulation 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, 2 times 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: 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.
Excretion: 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: in 16 elderly patients with single dose of the drug at a dose of 10 mg of T1 / 2 was 50% higher and clearance was less than 40% as compared with no patients older. Decrease in clearance of cetirizine in elderly patients is likely due to a decrease in renal function in these patients.
Patients with renal impairment: Patients with mild renal insufficiency (kreatiniia 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
Patients with liver failure: patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis) under single dose of the drug at 10 or 20 mg of 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 between 6 and 12 years of age is 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: 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 the safety of the drug during pregnancy was conducted, and the drug Zodak® not be used in pregnancy.
Breastfeeding: Cetirizine is excreted in breast milk at a concentration of from 25% to 90% of the plasma concentration of the drug versus time after administration. During the period of breastfeeding used after consulting a doctor, if the intended benefits to the mother outweighs the potential risk to the child.
Fertility: The 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
The data obtained in clinical trials
Overview: the results of 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 N1- peripheral 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 dihydrochloride
Enumeration of undesirable side reactions with 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 1 time per day for cetirizine) in more than 3200 patients, based on which can be made reliable analysis of 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: fatigue, dizziness, headache, abdominal pain, dry mouth, nausea, drowsiness, pharyngitis
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 revealed the following adverse reactions with a frequency of 1% or higher: diarrhea, drowsiness, rhinitis, fatigue
Applying post-marketing experience: besides 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 organ system development and frequency, on the basis of data on post drug application.
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 CNS should be careful in appointing a drug Zodak® 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 syndrome infant death from a brother or sister; mother abuse drugs or smoking during pregnancy; young maternal age (19 years and younger); tobacco abuse nurse, 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; premature infants (gestational age less than 37 weeks) or born with insufficient body weight (below the 10th percentile for gestational age) children; when co-administered drugs that have a depressant effect on the central nervous system. The preparation includes excipients metilparabenzol propilparabenzol and which may cause allergic reactions, including delayed type 12. Patients with spinal cord injury, prostate hyperplasia, and in the presence of other predisposing factors to urinary retention, requires compliance caution as cetirizine may increase the risk of urinary retention. Caution is recommended with the use of cetirizine with alcohol, although in therapeutic doses not clinically significant interaction with alcohol (at a blood alcohol concentration of 0.5 g / l). Caution should be exercised in patients with epilepsy and increased convulsive readiness. Before assigning allergy three samples recommended “washout” period because the blockers H1-histamine receptor inhibits the development of cutaneous allergic reactions.
Impact on the ability of car driving and operate machinery
When an objective assessment of the ability to transport management and operation mechanisms not reliably reveal any adverse effects when using the drug Zodak® at recommended doses. However, patients with symptoms of sleepiness in patients receiving the drug during treatment 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
It does not require any special storage conditions.
Keep out of the reach of children!.
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. Sometimes an initial dose of 5 mg (10 drops) may be sufficient if it is possible to achieve satisfactory control of symptoms.
Elderly patients: elderly patients with normal renal function, there is no need for dose reduction
Patients with impaired renal function: when administering the drug to patients with impaired kidney function in the case when the alternative treatment can not be administered, the dose should be adjusted depending on the magnitude QC because cetirizine is excreted mainly by the kidneys.
QC indicator for men can be calculated from serum creatinine concentration in the blood plasma according to 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. Adult patients with impaired renal function dosing is carried out as follows:
CC (ml / min) over 80 dose of 10 mg / day
CC (ml / min) 50-79, 10 mg / day
CC (ml / min) 30-49, 5 mg / day
CC (ml / min) than 30-dose of 5 mg every other day
CC (ml / min) than 10-medication contraindicated
Patients with abnormal liver function: patients with impaired liver function correction mode is not required. Patients with impaired and liver function and kidney function, recommended dosing correction (see. Above).
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 time per day. Children aged 1 to 6 years 2.5 mg (5 drops), 2 times per day. Children aged 6 to 12 years 5 mg (10 drops), 2 times per day. Children older than 12 years, 10 mg (20 drops), 1 per day. 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.
Instructions for opening the bottle: bottle cap closed with a safety device to prevent the opening of its children. The vial was opened under strong pressure lid down, followed by unscrewing it anticlockwise. After use, the vial cap is necessary to re-tighten firmly.
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

Zodak

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