Cetirizine drops for oral administration 10 mg/ml bottle, 20 ml (Ozone)

Cetirizine drops orally 10 mg/ml 20 ml (Ozone)

Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing the drug to children under 1 year of age who have the following risk factors for sudden infant death syndrome, such as (but not limited to): - sleep apnea syndrome or sudden infant death syndrome death of infants of a brother or sister; - maternal drug abuse or smoking during pregnancy; - young age of mother (19 years and younger); - smoking abuse by a nanny caring for a child (one pack of cigarettes a day or more); - children who regularly fall asleep face down and are not placed on their back; - premature (gestational age less than 37 weeks) or low birth weight (below the 10th percentile of gestational age) children; - when taking drugs 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 ones. In patients with spinal cord injury, prostatic hyperplasia, or other predisposing factors to urinary retention, caution is required as cetirizine may increase the risk of urinary retention. Caution is recommended when using cetirizine concomitantly with alcohol, although no clinically significant interaction with alcohol was observed at therapeutic doses (at a blood alcohol concentration of 0.5 g/l). Caution should be observed in patients with epilepsy and increased convulsive readiness. Before prescribing allergy tests, a three-day “washing out” period is recommended due to the fact that H1-histamine receptor blockers inhibit the development of skin allergic reactions. Effect of the drug on the ability to drive vehicles and operate machinery: An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when taking the drug at the recommended dose. However, for patients with symptoms of drowsiness while taking the drug, it is advisable to refrain from driving a car, engaging in potentially hazardous activities, or operating machinery that requires increased concentration and speed of psychomotor reactions.

Cetirizine, drops

Dosage regimen

Adults and children over 12 years old

The recommended dose is 10 mg (24 drops) once daily.

Children 6-12 years old

The recommended dose is 5 mg (12 drops) twice daily.

Children 2-5 years old

The recommended dose is 2.5 mg (6 drops) twice daily.

Children from 1 year to 2 years

The recommended dose is 2.5 mg (6 drops) once or twice daily.

Children from 6 months to 1 year

The recommended dose is 2.5 mg (6 drops) once daily.

The maximum duration of treatment in children with seasonal rhinitis should not exceed 4 weeks.

Special patient groups

Elderly

According to available data, with normal renal function, age is not a reason to reduce the dose.

Patients with impaired renal function

There is no data confirming the effectiveness/safety of the drug in patients with impaired renal function. Since cetirizine is mainly excreted through the kidneys (see section “Pharmacokinetic properties”), if it is impossible to use alternative treatment, the dose of the drug should be selected individually, taking into account renal function. The table below helps you choose the right dose. To use this table, it is necessary to determine creatinine clearance (CC) in ml/min. To do this, it is necessary to determine the serum creatinine level and calculate CC using the following formula:

CC = [140 - age (in years)] x weight (kg) (x 0.85 for women)

72 x serum creatinine (mg/dL)

Dose adjustment in patients with impaired renal function:

For children with impaired renal function, the dose should be selected individually, taking into account renal clearance, as well as the age and body weight of the patient.

Patients with impaired liver function

In patients with only liver dysfunction, there is no need for dose adjustment.

Patients with impaired liver and kidney function

Dose adjustment is recommended (see section “Patients with impaired renal function” above).

Mode of application

Drops for oral administration.

The use of the drug does not depend on food intake (see section “Pharmacokinetic properties”).

The solution should either be dripped into a spoon or diluted with water and taken orally. If the solution is diluted with water, then it should be taken into account that the volume of liquid used to dissolve the drug corresponds to the amount of liquid that the patient is able to drink. This is especially important when dosing the drug to children.

Cetirizine-FT drops d/iv approx. 10 mg/ml in bottle 20 ml in pack No. 1

Name

Cetirizine-FT drops daily approx. 10 mgml in bottle 20 ml in pack No. 1

Description

Colorless transparent liquid without sediment, with a weak characteristic odor of acetic acid.

Main active ingredient

Cetirizine

Release form

drops

Dosage

20ml

Pharmacological properties

CETIRIZINE-FT belongs to the blockers of peripheral Hi-receptors, eliminates the effect of histamine released in the body during allergic reactions and has a pronounced antiallergic effect. Has antipruritic and anti-edematous effect.

Indications for use

For adults and children 6 years of age and older: treatment of seasonal and year-round allergic rhinitis (the duration of treatment in children with seasonal allergic rhinitis is a maximum of 4 weeks); treatment of allergic conjunctivitis; treatment of chronic idiopathic urticaria. For children from 2 to 6 years old: treatment of seasonal allergic rhinitis. For children from 6 months to 2 years: treatment of year-round allergic rhinitis; treatment of chronic idiopathic urticaria.

Directions for use and doses

CETIRIZINE-FT is prescribed orally, regardless of food intake. The drug can be taken undiluted or diluted in a glass of water. It is preferable to take the drug in the evening, because At this time of day the symptoms are more pronounced. Seasonal allergic rhinitis Adults and adolescents over 12 years of age: The recommended dose of the drug is 10 mg of cetirizine dihydrochloride (24 drops) once a day. Children aged 6 to 12 years: The recommended dose is 10 mg cetirizine dihydrochloride (24 drops) once daily for a maximum of 4 weeks. The dose can be divided into two doses (12 drops in the morning and evening). Children aged 2 to 6 years: the recommended daily dose is 5 mg of cetirizine dihydrochloride (12 drops) in two doses (6 drops in the morning and evening). The duration of treatment is no more than 4 weeks. Allergic conjunctivitis Adults and adolescents over 12 years of age: the recommended dose of the drug is 10 mg of cetirizine dihydrochloride (24 drops) once a day. Children aged 6 to 12 years: 10 mg cetirizine dihydrochloride (24 drops) once daily for a maximum of 4 weeks. The dose can be divided into two doses (12 drops in the morning and evening). Perennial allergic rhinitis, chronic idiopathic urticaria Adults and adolescents over 12 years of age: the recommended dose of the drug is 10 mg of cetirizine dihydrochloride (24 drops) once a day. Children aged 6 to 12 years: The recommended dose is 10 mg cetirizine dihydrochloride (24 drops) once daily. The daily dose can be divided into two doses (12 drops in the morning and evening). For children aged 6 months to 2 years, the drug is prescribed only on the recommendation of a doctor. Special patient groups Elderly: If renal function is normal, there is no need to reduce the dose of CETIRIZINE-FT. If renal function is impaired in elderly patients, the dose must be adjusted. Patients with impaired renal function: since cetirizine is eliminated primarily through the kidneys, the dose of the drug should be adjusted individually depending on the value of creatinine clearance (CC). CC for men can be calculated using the formula based on serum creatinine values: CC (ml/min) =

140 – age (years)

? body weight (kg)/ 72 ? creatinine concentration (mg/dl) For women, CC is calculated by multiplying the resulting value by a factor of 0.85. In patients with only impaired liver function, there is no need to adjust the dose. Patients with impaired liver and kidney function require individual dose selection (see table above). If mild side effects occur in adults and adolescents over 12 years of age, it is recommended to take 12 drops of CETIRIZINE-FT morning and evening. The duration of treatment is determined by the doctor individually depending on the course of the disease. The maximum duration of treatment for seasonal allergic rhinitis in children from 2 to 12 years old and allergic conjunctivitis in children from 6 to 12 years old is 4 weeks. If you forget to take CETIRIZINE-FT, do not take a double dose to make up for the missed dose. Skip the missed dose and continue taking the drug as usual.

Use during pregnancy and lactation

Pregnancy It is not recommended to use CETIRIZINE-FT in the first trimester of pregnancy. The decision to prescribe the drug in the second and third trimester is made only by the doctor after a careful assessment of the ratio of the expected benefit to the mother and the risk to the fetus. If possible, a safer drug should be used. Lactation Cetirizine passes into breast milk, therefore it is recommended to interrupt breastfeeding during the period of treatment with CETIRIZINE-FT.

Precautionary measures

In patients with impaired renal function, the dose of CETIRIZINE-FT should be selected individually (see section “Dosage and Administration”). In elderly patients, due to a possible decrease in renal function, the dose of the drug should be adjusted. In patients with epilepsy and a tendency to seizures, the use of CETIRIZINE-FT should be used with caution. During treatment with the drug, you should avoid drinking alcohol and taking medications that depress the central nervous system. Caution should be exercised when prescribing to patients with problems with urination (benign prostatic hyperplasia, spinal cord damage, etc.), because Cetirizine may increase the risk of urinary retention. Methyl parahydroxybenzoate and propyl parahydroxybenzoate included in CETIRIZINE-FT can cause allergic reactions. Use in children Due to the lack of relevant studies, the use of cetirizine in children under 6 months is not recommended. Effect on the ability to drive vehicles and other complex mechanisms In some cases, cetirizine may cause drowsiness. Therefore, after taking CETIRIZINE-FT, you should not drive vehicles or perform other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Interaction with other drugs

With simultaneous use of cetirizine with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, theophylline, diazepam, gypizide, no clinically significant pharmacodynamic and pharmacokinetic interactions were observed. When used together with ketoconazole, macrolides, theophylline and pseudoephedrine, no changes were detected on the ECG. When using the drug in therapeutic doses, there is no evidence of a significant increase in the effect of alcohol. According to in vitro studies, cetirizine does not alter the binding of warfarin to blood proteins. With simultaneous course treatment with ritonavir (600 mg 2 times a day), the duration of action of cetirizine at a dose of 10 mg/day increases by 40%, the effect of ritonavir decreases by 11%. When combining cetirizine at a dose of 20 mg/day with theophylline 400 mg/day, an increase in the AUC24 value of cetirizine by 19% and theophylline by 11% was detected; Cmax of cetirizine increased by 7.7%, theophylline by 6.4%. If theophylline was first prescribed and then cetirizine was added, the clearance of cetirizine decreased by 16%, and the clearance of theophylline by 10%. However, in individuals initially treated with cetirizine, the addition of theophylline did not lead to changes in the pharmacokinetics of the latter. After a single dose of 10 mg of cetirizine, the effect of alcohol is not significantly enhanced (0.8%). When coadministered with diazepam 5 mg, a clinically significant interaction was observed in only one of 16 psychometric tests. Concomitant use of 10 mg cetirizine with glipizide may slightly reduce blood glucose levels. When taking cetirizine daily with glipizide, it is recommended to take glipizide in the morning and cetirizine in the evening. The degree of absorption of cetirizine is not reduced when taken together with food, although the rate of absorption decreases by 1 hour. Before performing skin allergy tests, it is recommended to discontinue cetirizine at least three days before.

Contraindications

hypersensitivity to cetirizine, hydroxyzine or any piperazine derivative, as well as to any of the auxiliary components of the drug; end-stage renal disease (ESRD)

Compound

Active substance: cetirizine dihydrochloride 10 mg/ml Excipients: propylene glycol, glycerin, sodium acetate trihydrate, sodium saccharin, methyl parahydroxybenzoate, glacial acetic acid, propyl parahydroxybenzoate, purified water.

Overdose

Symptoms of CETIRIZINE-FT overdose are usually related to its effects on the central nervous system and anticholinergic activity. Taking cetirizine at a dose 5 times the recommended daily dose is accompanied by symptoms such as confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, itching, anxiety, sedation, drowsiness, stupor, tachycardia, tremor and urinary retention. Treatment. Within an hour after an overdose, it is necessary to rinse the stomach and give activated charcoal. If necessary, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis in case of cetirizine overdose is not effective.

Side effect

Clinical studies have shown that, at recommended dosages, cetirizine causes minor CNS adverse reactions, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system was noted. Although cetirizine is a selective peripheral H1 receptor antagonist and has little or no anticholinergic activity, difficulty urinating, disturbances in accommodation, and dry mouth have been reported in isolated cases. There have been cases of liver dysfunction with increased levels of liver enzymes accompanied by increased levels of bilirubin. These changes generally disappear when treatment with cetirizine dihydrochloride is stopped. Adverse reactions are indicated by body system and frequency of occurrence, as: very often (? 1/10); often (from ? 1/100 to

Storage conditions

Store in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children!

Cetirizine instructions

The regimen for taking an antihistamine directly depends on its release form and the age of the patient. The daily dosage may vary in cases of decreased renal function or renal failure.

Let's consider general recommendations for use:

• Adults are recommended to take one tablet (10 mg) once a day or half a tablet (5 mg) twice a day.
• Children over 6 years of age can take the drug in the same way.

Take the tablets with a sufficient volume of water, at least 200 ml.

The duration of treatment, as well as the dosage, depends on the individual characteristics of the patient and the nature of the allergy. In cases with seasonal exacerbations, the treatment period reaches 6 weeks of continuous use of the drug based on cetirizine [2].

Cetirizine FT

Pharmacodynamics Cetirizine is a piperazine derivative and is a carboxylated metabolite of hydroxyzine. Cetirizine has selective antagonism of peripheral H1 receptors and has a pronounced antiallergic effect. Has antipruritic and antiexudative effect. It has almost no effect on other types of receptors, does not have anticholinergic and antiserotonergic effects. Cetirizine affects the “early” histamine-dependent stage of the allergic reaction, and also limits the release of inflammatory mediators at the “late” stage of the allergic reaction, and has an anti-inflammatory effect. It reduces the migration of eosinoyls, neutrophils and basophils, stabilizes the membranes of mast cells. Reduces capillary permeability, prevents the development of tissue edema, and eliminates spasm of smooth muscles. Eliminates skin reaction to the introduction of histamine, specific allergens, cooling, reduces histamine-induced bronchial obstruction in mild bronchial asthma. Cetirizine is less lipophilic compared to hydroxyzine, practically does not penetrate the blood-brain barrier and does not act on H1 receptors in the central nervous system. In therapeutic doses it does not have a sedative effect. After taking 10 mg of cetirizine, the effect develops within 20 minutes in 50% of patients, after 60 minutes in 95% of patients and lasts more than 24 hours. With repeated doses, addiction to the drug does not develop. After discontinuation of treatment, the effect persists for three days.

Pharmacokinetics Absorption: After oral administration, cetirizine is rapidly and completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached within 1.0±0.5 hours and is approximately 300 ng/ml. When taken simultaneously with food, the completeness of absorption does not change, but its rate decreases. The equilibrium state is achieved on the third day. In volunteers, pharmacokinetic parameters such as Cmax and AUC are unimodal. The degree of bioavailability is similar when cetirizine is used in the form of a solution, tablets or capsules. In the dose range from 5 to 60 mg, the pharmacokinetics are linear.

Distribution: In adults, after taking 10 mg of the drug orally and in children after taking 5 mg of the drug, the volume of distribution is approximately 35 l (0.5 l/kg) and 17 l, respectively. The binding of cetirizine to plasma proteins is 93±0.3%. Cetirizine does not alter the binding of warfarin to blood proteins. When taking 10 mg/day for 10 days, no accumulation of the drug was observed.

Metabolism: Cetirizine does not undergo first-pass metabolism. In small quantities, it is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other H1-histamine receptor blockers, which metabolize with the participation of the cytochrome P 450 system).

Excretion: About 2/3 of the administered dose of cetirizine is excreted unchanged from the body in the urine. The half-life in adults is about 10 hours, in children 6-12 years old - about 6 hours, in children aged 2-6 years - 5 hours, from 6 months to 2 years - 3.1 hours. After taking 10 mg of the drug in adults, total clearance increases to 0.6 ml/min/kg. in children after taking 5 mg - up to 0.93 ml/min/kg. After discontinuation of cetirizine, its blood level quickly decreases to undetectable low values.

In elderly patients and patients with chronic liver dysfunction, after a single dose of cetirizine at a dose of 10 mg, T1/2 increases by approximately 50%, and clearance decreases by 40% compared to middle-aged patients. In patients with mild renal impairment (creatinine clearance > 40 ml/min), the pharmacokinetic parameters of cetirizine are similar to those in healthy volunteers. In patients with moderate renal failure and in patients. patients on hemodialysis (creatinine clearance < 7 ml/min), a single dose of 10 mg of the drug led to a threefold prolongation of T1/2 and a decrease in clearance by 70%, which requires dose adjustment. Cetirizine is not removed from the body by hemodialysis.

Cetirizine

Description of selected adverse reactions:

Cases of pruritus, including intense itching and/or urticaria, have been reported following discontinuation of cetirizine.

If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms observed after apparent drug overdose have affected the central nervous system or have been associated with a possible anticholinergic effect. Symptoms that occurred after taking at least five times the recommended daily dose included the following: confusion, diarrhea, fatigue, headache, malaise, mydriasis, itching, restlessness, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.

Treatment:

There is no specific antidote.

In case of overdose, symptomatic or supportive treatment is recommended. Gastric lavage and/or activated charcoal may be effective if the overdose has occurred recently. Cetirizine is partially eliminated by dialysis.

Interaction with other drugs

Concomitant use with azithromycin, cimetidine, erythromycin, ketaconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine.

No pharmacokinetic interactions were observed. in vitro test

, cetirizine does not affect the protein binding effect of warfarin. Concomitant use of azithromycin, erythromycin, ketoconazole, theophylline and pseudoephedrine did not reveal significant changes in clinical laboratory parameters, vital signs and ECG.

In a study of co-administration of theophylline (400 mg per day) and cetirizine (20 mg per day), a small but statistically significant increase in 24-hour AUC (area under the curve) was found by 19% for cetirizine and 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.