Zodak allergy medicine drops for oral administration 10mg/ml 20ml
A country
Germany
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Cetirizine
Compound
The active ingredient is cetirizine.
pharmachologic effect
Antihistamine, antiallergic. Selectively blocks peripheral histamine H1 receptors, weakens the effect of histamine on blood vessels, reduces hyperemia and swelling. Effectively inhibits the development of skin reactions (blister and hyperemia) to the introduction of histamine, specific allergens, cooling (in patients with cold urticaria). The effect appears within 1-2 hours after administration, the duration of blockade of H1 receptors reaches more than 24 hours, in newborns and children under 2 years old - about 12 hours. It alleviates the symptoms of allergic rhinitis (sneezing, runny nose, nasal congestion, itching, lacrimation). Dose-dependently weakens histamine-induced bronchoconstriction in mild bronchial asthma. Inhibits the development of the histamine-mediated early phase of the allergic reaction. Food intake does not affect the completeness of absorption. It is minimally metabolized in the liver to form an inactive metabolite and is excreted unchanged primarily by the kidneys. Passes into breast milk.
Indications for use
Seasonal and year-round allergic rhinitis, hay fever, allergic conjunctivitis, chronic idiopathic urticaria, itching, angioedema; complex therapy of atopic dermatitis, chronic eczema, bronchial asthma.
Mode of application
Adults and children over 12 years old - 20 drops 1 time per day, at night. Children aged 6-12 years - 10 drops in the morning and evening or 20 drops in the evening. Children aged 2-6 years - 10 drops in the evening or 5 drops morning and evening. Children aged 1-2 years, 5 drops morning and evening.
Interaction
Theophylline slightly reduces clearance. Compatible with azithromycin, pseudoepinephrine, ketoconazole, erythromycin, diazepam and cimetidine.
Side effect
From the nervous system and sensory organs: drowsiness, fatigue, agitation, headache, dizziness, anxiety, nervousness, emotional lability, impaired concentration and thinking, insomnia, depression, euphoria, confusion, amnesia, depersonalization, ataxia, impaired motor coordination , tremor, hyperkinesis, calf muscle cramps, paresthesia, dysphonia, myelitis, paralysis, ptosis, impaired accommodation and vision, eye pain, glaucoma, xerophthalmia, conjunctivitis, hemorrhage in the eye, ototoxicity, tinnitus, deafness, impaired sense of smell. From the gastrointestinal tract: dry mouth, change or absence of taste perception, increased appetite, anorexia, stomatitis (including ulcerative), discoloration and swelling of the tongue, increased salivation, increased caries, thirst, vomiting, dyspepsia, gastritis, pain in abdomen, flatulence, diarrhea, constipation, hemorrhoids, melena, rectal bleeding, liver dysfunction. From the cardiovascular system: migraine, extremely rarely - palpitations, hypertension, heart failure. From the respiratory system: rhinitis, nosebleeds, nasal polyp , pharyngitis, cough, sinusitis, bronchitis, increased bronchial secretion, bronchospasm, dyspnea, upper respiratory tract infection, pneumonia, hyperventilation. From the genitourinary system: urinary retention, edema, polyuria, dysuria, hematuria, urinary tract infection, cystitis, decreased libido , dysmenorrhea, intermenstrual bleeding, menorrhagia, vaginitis. From the musculoskeletal system: arthralgia, arthritis, arthrosis, myalgia, back pain, muscle weakness. From the skin: dry skin, rash, blistering rashes, itching, acne, furunculosis , dermatitis, eczema, hyperkeratosis, erythema, increased sweating, alopecia, angioedema, hypertrichosis, photosensitivity, seborrhea. Others: malaise, fever, chills, hot flashes, dehydration, diabetes mellitus, lymphadenopathy, breast pain, weight gain, skin allergic reactions, incl. hives.
Contraindications
Hypersensitivity, including to hydroxyzine, pregnancy, breastfeeding, children under 2 years of age (up to 6 years with impaired renal or liver function). Restrictions on use: Impaired renal and liver function, old age.
Overdose
Symptoms: drowsiness, possible anxiety, urinary retention, tremor, tachycardia, itching, rash. Treatment: gastric lavage, administration of activated charcoal; supportive and symptomatic therapy. Hemodialysis is ineffective.
special instructions
The concomitant use of CNS depressants and alcohol consumption is not recommended. Use with caution while working for vehicle drivers and people whose profession involves increased concentration.
Zodak drops for oral administration 10 mg/ml 20 ml dropper bottle 1 pc. in Moscow
Pharmacological action: Pharmacodynamics
Cetirizine is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1 histamine receptors.
In addition to the antihistamine effect, cetirizine prevents the development and alleviates the course of allergic reactions: at a dose of 10 mg 1 or 2 times a day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients with allergic reactions.
Clinical efficacy and safety
Studies in healthy volunteers have shown that cetirizine, when taken in doses of 5 or 10 mg, significantly inhibits the rash and redness response to high concentrations of histamine in the skin, but the correlation with effectiveness has not been established. A 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild to moderate bronchial asthma showed that cetirizine 10 mg once daily reduced symptoms of rhinitis and did not affect pulmonary function.
The results of this study confirm the safety of cetirizine in patients suffering from allergies and mild to moderate bronchial asthma.
A placebo-controlled study showed that taking cetirizine at a dose of 60 mg/day for 7 days did not cause a clinically significant prolongation of the QT interval. Taking cetirizine at the recommended dose has shown an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis.
Children.
In a 35-day study in patients 5–12 years of age, there was no evidence of resistance to the antihistamine effect of cetirizine. The normal skin reaction to histamine was restored within 3 days after discontinuation of the drug with repeated use.
A 7-day placebo-controlled study of cetirizine syrup in 42 patients aged 6 to 11 months demonstrated the safety of its use. Cetirizine was prescribed at a dose of 0.25 mg/kg twice daily, which corresponds to approximately 4.5 mg per day (dose range was 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.
Pharmacokinetics
The pharmacokinetic parameters of cetirizine when taken in doses from 5 to 60 mg change linearly.
Suction
Tmax in blood plasma is (1±0.5) hours, and Cmax is 300 ng/ml.
Pharmacokinetic parameters such as plasma Cmax and AUC are uniform. Food intake does not affect the complete absorption of cetirizine, although its rate decreases. The bioavailability of different dosage forms of cetirizine is comparable.
Distribution
Cetirizine is (93±0.3)% bound to blood plasma proteins. Vd is 0.5 l/kg. Cetirizine does not affect the protein binding of warfarin.
Metabolism
Cetirizine does not undergo extensive first-pass metabolism.
Removal
T1/2 is approximately 10 hours.
When taking cetirizine at a daily dose of 10 mg for 10 days, no accumulation was observed.
Approximately 2/3 of the dose taken is excreted unchanged in the urine.
Special patient groups
Elderly.
In 16 elderly people, with a single dose of cetirizine at a dose of 10 mg, T1/2 was 50% higher, and clearance was 40% lower compared to non-elderly people.
The decreased clearance of cetirizine in elderly patients is likely due to decreased renal function in this category of patients.
Kidney failure.
In patients with mild renal failure (Cl creatinine >40 ml/min), pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.
In patients with moderate renal failure and patients on hemodialysis (Cl creatinine <7 ml/min), when taking cetirizine orally at a dose of 10 mg, T1/2 is extended by 3 times, and total clearance is reduced by 70% relative to healthy volunteers with normal nocturnal function.
For patients with moderate or severe renal insufficiency, an appropriate change in the dosage regimen is required (see "Dosage and Administration").
Cetirizine is poorly removed from the body during hemodialysis.
Liver failure.
In patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis), with a single dose of cetirizine at a dose of 10 or 20 mg, T1/2 increases by approximately 50%, and clearance decreases by 40% compared to healthy subjects. Dose adjustment is only necessary if the patient with hepatic insufficiency also has concomitant renal insufficiency.
Children.
T1/2 in children from 6 to 12 years is 6 hours, from 2 to 6 years - 5 hours, from 6 months to 2 years - reduced to 3.1 hours.
Zodak drops for oral administration 10 mg/ml 20 ml dropper bottle 1 pc. in Stavropol
Pharmacological action: Pharmacodynamics
Cetirizine is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1 histamine receptors.
In addition to the antihistamine effect, cetirizine prevents the development and alleviates the course of allergic reactions: at a dose of 10 mg 1 or 2 times a day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients with allergic reactions.
Clinical efficacy and safety
Studies in healthy volunteers have shown that cetirizine, when taken in doses of 5 or 10 mg, significantly inhibits the rash and redness response to high concentrations of histamine in the skin, but the correlation with effectiveness has not been established. A 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild to moderate bronchial asthma showed that cetirizine 10 mg once daily reduced symptoms of rhinitis and did not affect pulmonary function.
The results of this study confirm the safety of cetirizine in patients suffering from allergies and mild to moderate bronchial asthma.
A placebo-controlled study showed that taking cetirizine at a dose of 60 mg/day for 7 days did not cause a clinically significant prolongation of the QT interval. Taking cetirizine at the recommended dose has shown an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis.
Children.
In a 35-day study in patients 5–12 years of age, there was no evidence of resistance to the antihistamine effect of cetirizine. The normal skin reaction to histamine was restored within 3 days after discontinuation of the drug with repeated use.
A 7-day placebo-controlled study of cetirizine syrup in 42 patients aged 6 to 11 months demonstrated the safety of its use. Cetirizine was prescribed at a dose of 0.25 mg/kg twice daily, which corresponds to approximately 4.5 mg per day (dose range was 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.
Pharmacokinetics
The pharmacokinetic parameters of cetirizine when taken in doses from 5 to 60 mg change linearly.
Suction
Tmax in blood plasma is (1±0.5) hours, and Cmax is 300 ng/ml.
Pharmacokinetic parameters such as plasma Cmax and AUC are uniform. Food intake does not affect the complete absorption of cetirizine, although its rate decreases. The bioavailability of different dosage forms of cetirizine is comparable.
Distribution
Cetirizine is (93±0.3)% bound to blood plasma proteins. Vd is 0.5 l/kg. Cetirizine does not affect the protein binding of warfarin.
Metabolism
Cetirizine does not undergo extensive first-pass metabolism.
Removal
T1/2 is approximately 10 hours.
When taking cetirizine at a daily dose of 10 mg for 10 days, no accumulation was observed.
Approximately 2/3 of the dose taken is excreted unchanged in the urine.
Special patient groups
Elderly.
In 16 elderly people, with a single dose of cetirizine at a dose of 10 mg, T1/2 was 50% higher, and clearance was 40% lower compared to non-elderly people.
The decreased clearance of cetirizine in elderly patients is likely due to decreased renal function in this category of patients.
Kidney failure.
In patients with mild renal failure (Cl creatinine >40 ml/min), pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function.
In patients with moderate renal failure and patients on hemodialysis (Cl creatinine <7 ml/min), when taking cetirizine orally at a dose of 10 mg, T1/2 is extended by 3 times, and total clearance is reduced by 70% relative to healthy volunteers with normal nocturnal function.
For patients with moderate or severe renal insufficiency, an appropriate change in the dosage regimen is required (see "Dosage and Administration").
Cetirizine is poorly removed from the body during hemodialysis.
Liver failure.
In patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis), with a single dose of cetirizine at a dose of 10 or 20 mg, T1/2 increases by approximately 50%, and clearance decreases by 40% compared to healthy subjects. Dose adjustment is only necessary if the patient with hepatic insufficiency also has concomitant renal insufficiency.
Children.
T1/2 in children from 6 to 12 years is 6 hours, from 2 to 6 years - 5 hours, from 6 months to 2 years - reduced to 3.1 hours.
