Zodac film-coated pills 10mg N10
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Cetirizine
Release form
Pills
Composition
1 tablet contains: Active substances: cetirizine dihydrochloride - 10 mg.; Excipients: lactose monohydrate - 73.4 mg, corn starch - 33 mg, povidone 30 - 2.4 mg, magnesium stearate - 1.2 mg; Shell composition: hypromellose 2910/5 - 3.45 mg, macrogol 6000 - 0.35 mg, talc - 0.35 mg, titanium dioxide - 0.80 mg, simethicone SE4 emulsion - 0.05 mg.
Pharmacological effect
Histamine H1 receptor blocker. Cetirizine is a competitive antagonist of histamine, practically does not have anticholinergic and antiserotonin action. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions. It has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in the late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as cooling (with cold urticaria). In therapeutic doses, almost no sedative effect. Against the background course intake, tolerance does not develop.; The effect of the drug begins after 20 minutes (in 50% of patients), after 1 hour (in 95% of patients) and lasts for 24 hours.
Pharmacokinetics
After oral administration, cetirizine is rapidly and well absorbed from the gastrointestinal tract. Cmax is determined in about 30-60 minutes. Food intake does not have a significant effect on the amount of absorption, however, in this case, the absorption rate slightly decreases.; Distribution; Binding to plasma proteins is approximately 93%. The value of Vd is low (0.5 l / kg), the drug does not penetrate into the cell. The drug does not penetrate through the BBB. It is excreted in breast milk.; Metabolism; Cetirizine is poorly metabolized in the liver to form an inactive metabolite. When used at a dose of 10 mg for 10 days, there is no accumulation of the drug.; Excretion; After a single dose of a single dose, the T1 / 2 value is about 10 hours. 70% of the dose is excreted by the kidneys mostly unchanged. The magnitude of systemic clearance is about 54 ml / min; Pharmacokinetics in special clinical situations; In children inage from 2 to 12 years T1 / 2 decreases to 5-6 hours; against the background of chronic diseases and in elderly patients there is an increase in T1 / 2 by 50% and a decrease in clearance by 40%; In case of impaired renal function (CC below) 11-31 ml / min) and in patients on hemodialysis (CC less than 7 ml / min), T1 / 2 increases by 3 times, clearance decreases by 70%. Hemodialysis is ineffective.
Indications
- seasonal and perennial allergic rhinitis and conjunctivitis; - pruritic allergic dermatosis; - pollinosis (hay fever); - urticaria (including chronic idiopathic); - Quincke swelling.
Contraindications
- terminal stage of renal failure (CC <10 ml / min) (for taking pills); - hereditary intolerance to galactose, lactase deficiency or glucose-galactose malabsorption syndrome (for taking pills); - children's age up to 6 years (for taking pills); - children's age up to 1 year (for receiving drops); - pregnancy; - lactation period (breastfeeding); - Hypersensitivity to the components of the drug. With caution: chronic renal failure of moderate severity (correction of the dosing regimen is required), old age (reduction of glomerular filtration is possible). When taking pills: chronic liver disease (hepatocellular, cholestatic or biliary cirrhosis) (dose adjustment is required only with a concomitant decrease in glomerular filtration rate).
Use during pregnancy and lactation
Contraindicated use during pregnancy and lactation (breastfeeding).
Dosage and administration
Before using the drug Zodac; you must consult with your doctor to avoid complications.; The drug is taken orally, regardless of the meal.; Tablets; Adults and children over the age of 12 years are prescribed, as a rule, in a dose of 10 mg (1 tab.) 1 time / day; Children between the ages of 6 and 12, Zodac; usually administered 10 mg (1 tab.) 1 time / day or 5 mg (1/2 tab.) 2 times / day, morning and evening. In patients with renal insufficiency, the dose should be reduced depending on CC: with CC 30-49 ml / min - 5 mg 1 time / day; at 10-29 ml / min - 5 mg every other day. When administering the drug to elderly patients with renal insufficiency, the dose should be adjusted depending on the QC value.; QC for men can be calculated based on the concentration of serum creatinine, according to the following formula: QC (ml / min) = [140 - age (years)] × body weight (kg) / 72 × X serum.(mg / dL); QC for women can be calculated by multiplying the obtained value by a factor of 0.85.; Patients with impaired liver function do not need to adjust the dosage regimen; In the event that the time of the next drug intake is approaching, the next dose should be taken according to the schedule, without increasing the total dose; Zodac; can be taken regardless of the time of ingestion.; Coated pills should be swallowed whole with a small amount of water.; Drops; Before taking the drops should be dissolved in water. Adults and children over 12 years old: 10 mg of cetirizine ( 20 drops) 1 time / day, daily, preferably in the evening.; Children aged 6 to 12 years: 10 mg cetirizine (20 drops) 1 time / day or 5 mg cetirizine (10 drops) 2 times / day, in the morning and in the evening.; Children aged 2 to 6 years: 5 mg of cetirizine (10 drops) 1 time / day or 2.5 mg of cetirizine (5 drops) 2 times a / day, morning and evening.; Children aged 1 to 2 years: 2.5 mg (5 drops) 2 times / day; In patients with renal insufficiency, the recommended dose should be reduced by 2 times.; In patients with impaired function liver, it is necessary to slightly reduce the dose of cetirizine - up to 5 mg (10 drops) per day.; In elderly patients, patients with normal renal function do not need dose adjustment.; Instructions for opening the vial with a safety cap; opening by children. The bottle opens by pressing the cap down and then unscrewing it counterclockwise. After use, the bottle cap must be screwed on again.
Side effects
The drug is usually well tolerated. Adverse reactions are rare and transient. Determination of the frequency of adverse reactions: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10 000, <1 / 1000), very rarely (<1/10 000), the frequency is unknown (according to the available data it is impossible to determine the frequency of occurrence of the side effect); From the hematopoietic system: very rarely - thrombocytopenia.; From the immune system: rarely - reactions hypersensitivity; very rarely - anaphylactic shock. From the nervous system: often - headache, drowsiness, fatigue, dizziness; infrequently - paresthesias; seldom - spasms, disturbances of motive function; very rarely - taste perversions, dyskinesia, dystonia, syncope, tremor, tic; frequency unknown - memory impairment, incl.amnesia. Mental disturbances: infrequently - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; frequency is unknown - suicidal ideas. On the part of the organ of vision: very rarely - accommodation disturbances, blurred vision, nystagmus; On the part of the organ of hearing and balance: the frequency is unknown - vertigo.; On the part of the digestive system: often - dry mouth, nausea; infrequently - diarrhea, pain in the abdomen. From the side of the cardiovascular system: rarely - tachycardia.; From the respiratory system: often - rhinitis, pharyngitis; From the side of metabolism: rarely - an increase in body weight.; From the urinary system: very rarely - dysuria, enuresis; frequency unknown - urinary retention. From the laboratory indicators: rarely - changes in liver function tests (increased activity of hepatic transaminases, alkaline phosphatase, GGT and bilirubin concentration); very rarely - thrombocytopenia. From the skin and subcutaneous tissues: infrequently - rash, itching; very rarely - persistent erythema.; Allergic reactions: rarely - urticaria; very rarely - angioedema. General reactions: infrequently - asthenia, malaise; rarely, peripheral edema; frequency unknown - increased appetite.
Overdose
Symptoms: confusion, dizziness, drowsiness, lethargy, stupor, weakness, anxiety, irritability, sedation, fatigue, headache, mydriasis, itching, tachycardia, tremor, urinary retention, dry mouth, diarrhea, constipation (most often when taking 50 mg of cetirizine per day), malaise.; Treatment: gastric lavage, the appointment of activated charcoal, conducting symptomatic therapy. The specific antidote is not known. Hemodialysis is ineffective.
Interaction with other drugs
No clinically significant interaction of cetirizine with other drugs has been established. Joint administration with theophylline (400 mg / day) leads to a decrease in the overall clearance of cetirizine (theophylline kinetics do not change); At recommended doses, it does not enhance the effect of ethanol more than 0.8 g / l), however, it is recommended to refrain from taking ethanol during drug treatment.
special instructions
Patients with impaired renal function,liver and elderly patients need to consult with a doctor before taking the drug.; Simultaneous use of drugs that depress the central nervous system, alcohol is not recommended; to drive vehicles and control mechanisms; During the treatment period, patients should refrain from engaging in potentially hazardous activities that require increased concentration mania and psychomotor speed reactions.