Instructions for use PARLAZIN® tab

Instructions for use PARLAZIN® tab

Suction

After taking the drug orally, cetirizine is rapidly absorbed from the gastrointestinal tract.

The equilibrium maximum concentration is approximately 300 ng/ml and is achieved within 1.0 ± 0.5 hours. The equilibrium state is achieved on the third day. In volunteers, pharmacokinetic parameters (Cmax and AUC) and distribution are unimodal.

Food does not affect the completeness of absorption, although the rate of absorption decreases. The degree of bioavailability is similar when cetirizine is used in the form of solution, capsules or tablets.

Distribution

In adults, after taking 10 mg of the drug orally, the apparent volume of distribution is approximately 35 l (0.50 l/kg). 93 ± 0.3% of cetirizine is protein bound. Cetirizine does not affect the binding of warfarin to plasma proteins.

Cetirizine is excreted in small quantities in breast milk.

Biotransformation

Cetirizine does not undergo significant pre-systemic metabolism.

Removal

About 2/3 of the dose is excreted unchanged in the urine. The terminal half-life is approximately 10 hours and cetirizine did not accumulate when administered repeatedly for 10 days at a dose of 10 mg/day.

Linearity/nonlinearity

Cetirizine has linear kinetics in the dose range from 5 to 60 mg.

Special patient groups

Elderly

In 16 elderly volunteer subjects, after a single oral dose of cetirizine 10 mg, the elimination half-life was increased by approximately 50% and clearance was reduced by 40%, compared with younger individuals. The decreased clearance of cetirizine in these elderly volunteers was likely due to worsening renal function.

Children and adolescents under 18 years of age

The half-life of cetirizine was approximately 6 hours in children aged 6 to 12 years and 5 hours in children aged 2 to 6 years. In small children and infants aged 6 to 24 months, the half-life is reduced to 3.1 hours.

Patients with impaired renal function

In patients with mild renal failure (creatinine clearance > 40 ml/min), the pharmacokinetics of the drug were similar to those in healthy volunteers. With moderate renal failure (creatinine clearance 10-40 ml/min), compared with healthy volunteers, the half-life increases three times, and clearance decreases by 70%.

Compared with healthy volunteers, in patients on hemodialysis (CrCl <7 ml/min) after a single dose of cetirizine 10 mg, the half-life increased threefold and clearance decreased by 70%. Cetirizine is poorly removed by hemodialysis (<10%). In case of moderate to severe impairment of renal function, a dose adjustment of cetirizine is necessary (see Dosage Regimen).

Patients with liver dysfunction

In patients with chronic liver dysfunction (hepatocellular, cholestatic or biliary cirrhosis), after oral administration of 10 mg or 20 mg cetirizine, the half-life decreased by 50% and clearance decreased by 40%.

Dose changes are only necessary in patients with concurrent impairment of liver and kidney function.

Parlazin Neo tablets p/o 5 mg No. 7x2

Name

Parlazin Neo tab. p/o 5 mg per bl. in pack No. 7x2

Description

White or almost white, round, moderately biconvex, film-coated tablets, odorless or almost odorless. Engraving: on one side of the tablet there is a stylized letter E, on the other side there is the number 281.

Main active ingredient

Levocetirizine dihydrochloride

Release form

7 or 10 coated tablets in a blister made of a combined “cold” film (polyamide/aluminum foil/PVC)/aluminum foil. 1, 2 or 3 blisters of 10 tablets, 1 or 2 blisters of 7 tablets are placed in a cardboard box with instructions for use for patients.

Dosage

5 mg per bl. in pack No. 7x2

Indications for use

In adults and children over 6 years of age, Parlazin® Neo is used to treat the following diseases: - allergic rhinitis (runny nose), hay fever - allergic conjunctivitis - chronic urticaria (often accompanied by itching) For children aged 2-6 years, Parlazin Neo should be prescribed in droplet form, since in this age group tablets do not provide a safe dosage regimen.

Directions for use and doses

Always take this drug as directed by these instructions or as directed by your doctor. If you are unsure, you should consult your doctor. The duration of treatment is determined by the doctor and depends on the type, duration and dynamics of the patient’s complaints. Dosage regimen Adults, adolescents and children over 6 years of age The daily recommended dose is 1 tablet once a day (1–5 mg). In patients with impaired renal function, reduced doses may be prescribed depending on the severity of renal damage. The dosage regimen must be determined by your doctor. When prescribing the drug to patients with impaired liver function, no dose changes are required. Directions for use The tablets should be swallowed whole, without chewing, and washed down with liquid; they can be taken with or without food. If you have taken too much Parlazin® Neo tablets If you think you have taken an excessive dose of Parlazin® Neo tablets, tell your doctor, who will decide what action is necessary. If you forget to take Parlazin® Neo tablets Do not take a double dose to make up for the missed dose. Just wait until it is time for your next dose and take the regular dose prescribed by your doctor. If you stop taking Parlazin® Neo tablets prematurely Stopping taking Parlazin® Neo tablets earlier than prescribed should not cause harm in the sense that the symptoms of the disease will only gradually return, without becoming more severe than before taking Parlazin® Neo. Do not change the recommended dose. Contact your doctor or pharmacist if you think the effect of the medicine is too weak or strong. If you have any further questions about using this drug, ask your doctor or pharmacist.

Use during pregnancy and lactation

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, tell your doctor. Pregnancy Despite the fact that animal experiments have not revealed the harmful effects of levocetirizine, Parlazin® Neo tablets - like other drugs - are not recommended for use during pregnancy. If you accidentally take Parlazin® Neo tablets during pregnancy, this medicine will not have any adverse effects on the fetus, but you should stop taking the tablets. Breastfeeding During breastfeeding, Parlazin Neo tablets should not be taken, as it is expected that the active substance may pass into breast milk. Before taking any medications, consult your doctor.

Precautionary measures

Talk to your doctor or pharmacist before taking Parlazin® Neo tablets. Be sure to tell your doctor the following information: - if you have a tendency to retain urine (inability to empty your bladder completely), for example due to a spinal cord injury or an enlarged prostate gland; — Parlazin® Neo tablets contain lactose; - if you suffer from other diseases, allergies or use any other medications (for internal or external use), including those sold without a prescription. Children and adolescents under 18 years of age Parlazin® Neo should not be prescribed to infants and children under 2 years of age due to insufficient data on its use. For the safe treatment of children aged 2-6 years, it is recommended to use the drug Parlazin® Neo in the form of drops for oral administration, since the required dose cannot be selected using tablets. The drug Parlazin® Neo tablets contain milk sugar (lactose) as an excipient. The drug Parlazin Neo tablets contain lactose, so if your doctor has told you that you are intolerant to certain sugars, contact him for advice before using this medicine.

Interaction with other drugs

Tell your doctor about any medications you are taking, have recently taken, or plan to take, including those taken without a prescription. Antihistamines can mask skin reactions during allergy skin tests, so Parlazin® Neo should be discontinued at least 3 days before such a test. Taking with food, drinks and alcohol The drug can be taken regardless of meals. Avoid drinking alcohol while taking this drug as concomitant use of levocetirizine and alcohol may have effects on the nervous system in sensitive patients.

Contraindications

- if you are allergic to the active substance, other substances similar in structure, or any of the excipients of the drug listed in the “Composition” section; - if you have severe renal impairment (creatinine clearance

Compound

Active ingredient: 5 mg of levocetirizine dihydrochloride (corresponding to 4.21 mg of levocetirizine) in each coated tablet. Excipients: Core: microcrystalline silica cellulose (composition: microcrystalline cellulose, anhydrous colloidal silicon dioxide), lactose monohydrate (37.9 mg), low-substituted hydroxypropylcellulose (L-HPC-11), magnesium stearate. Shell: Opadry II 33G28523 white (composition: hypromellose 2910, titanium dioxide (E-171), lactose monohydrate (1.05 mg), macrogol 3350, triacetylglycerol).

Side effect

Like all medicines, Parlazin® Neo tablets can cause side effects, although not all patients get them. Fatigue, drowsiness, dry mouth, headache, and weakness have been reported. In some cases, allergic reactions were observed (swelling of the lips, tongue, eyelids, itching, inflammatory skin rash), photosensitivity of the skin, skin cracks, swelling, sinus thrombosis, jugular vein thrombosis, paresthesia (changes in skin sensitivity, for example, a feeling of tingling or ants crawling on skin), hypotrichosis (hair loss), gastrointestinal disorders, abdominal pain, palpitations, rapid pulse, angina, cramps, eye inflammation, blurred vision, blurred vision, muscle pain, aggression or restlessness, insomnia, thoughts of suicide, hallucinations, depression, increased runny nose, respiratory failure, liver inflammation, liver dysfunction (changes in laboratory test results), increased appetite, vomiting, dizziness, trembling, loss of consciousness, impaired taste, weight gain, sudden urge to urinate, urinary retention - inability to completely empty the bladder, ineffectiveness of the drug, dry mucous membranes. If you experience any of the side effects listed above, contact your healthcare provider, who will assess the severity of your symptoms and decide what action is necessary. Reporting side effects If you notice any of these side effects or if you experience any effects not listed in this leaflet, please contact your doctor or pharmacist. By reporting side effects, you will be providing additional information about the safety of this drug.

Storage conditions

Store at a temperature not exceeding 30°C, out of the reach of children!

Parlazin film-coated tablets 10 mg No. 30

pharmachologic effect

Parlazin has an antiallergic effect. Cetirizine is a selective blocker of H1-histamine receptors.

Indications

Seasonal and year-round allergic rhinitis and conjunctivitis, itchy allergic dermatoses, hay fever (hay fever), urticaria (including chronic idiopathic), Quincke's edema.

Contraindications

Hypersensitivity to cetirizine or other components of Parlazine, pregnancy, lactation, children under 1 year of age.

special instructions

Parlazin is prescribed with caution for moderate to severe chronic renal failure, as well as for elderly patients (dosage regimen adjustment is required.

Compound

1 tab. contains cetirizine dihydrochloride 10 mg.

Directions for use and doses

Adults and adolescents over 12 years of age are prescribed 10 mg (1 tablet or 20 drops) 1 time/day, preferably at night. Children aged 6-12 years are prescribed 5 mg (1/2 tablet or 10 drops) 2 times a day. (morning and evening) or 10 mg (1 tablet or 20 drops) 1 time/day. (In the evening). Children aged 2-6 years are prescribed 5 mg (10 drops) 1 time/day. You can also divide this dose into 2 doses of 2.5 mg (5 drops in the morning and evening). For children aged 1-2 years, Parlazin is prescribed 2.5 mg (5 drops) 2 times a day. Elderly patients and patients with renal failure are recommended to reduce the daily dose to 5 mg. Parlazin tablets are taken orally with plenty of water (200 ml). Parlazin drops are dissolved in water before taking.

Side effects

Parlazin is usually well tolerated. The following side effects may occur extremely rarely: drowsiness (depending on the dose), feeling tired, headache, migraine, dizziness, dry mouth, nausea and other gastrointestinal symptoms, anxiety (increased motor activity). The intensity of side effects can be reduced. , dividing the daily dose into 2 doses. Hypersensitivity reactions (vascular edema, rash) occur extremely rarely (≤2%).

Drug interactions

No clinically significant interaction of cetirizine with glipizide, diazepam, cimetidine, azithromycin, pseudoephedrine, ketoconazole, or erythromycin has been established. With simultaneous use of cetirizine with theophylline (400 mg/day), there is a decrease in the total clearance of cetirizine by 16%. The pharmacokinetics of theophylline does not change.

Overdose

Symptoms: often - feeling tired, drowsiness. Children experience restlessness and irritability, followed by drowsiness. When taking a single dose of 50 mg, urinary retention and constipation may occur. Treatment: it is necessary to induce vomiting, rinse the stomach. If necessary, provide supportive and symptomatic treatment. There is no specific antidote. Hemodialysis is not effective.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Active substance

Cetirizine

Parlazin drops for internal use 10mg/ml 20ml

Compound

Active substance: cetirizine dihydrochloride 10 mg.
Excipients: glycerol - 250 mg, propylene glycol - 350 mg, sodium saccharinate - 10 mg, sodium acetate trihydrate - 10 mg, methyl parahydroxybenzoate - 1.35 mg, propyl parahydroxybenzoate - 0.15 mg, glacial acetic acid - 0.5 mg, purified water - up to 1 ml.

Pharmacokinetics

Suction

After oral administration, cetirizine is rapidly absorbed, Cmax in blood plasma is reached within 30-60 minutes. Concomitant food intake does not affect the degree of absorption, however, food causes a delay in reaching Cmax in plasma by 1.7 hours and reduces Cmax by 23%.

Distribution

No accumulation was detected after oral administration. When taken orally in doses of 5 to 60 mg, cetirizine has linear pharmacokinetics (zero-order kinetics). Plasma protein binding is 93% and is independent of concentration in the range from 25 to 1000 ng/ml; this range includes therapeutic plasma concentration values.

As the main metabolite of hydroxyzine, cetirizine is more hydrophilic than the parent substance and therefore has a very low ability to penetrate the BBB. Cetirizine passes into breast milk.

Metabolism

Only a small part of cetirizine is metabolized by conversion to a practically inactive O-dealkylated metabolite in the liver.

Removal

Within 24 hours, 60% of the oral dose is excreted as unchanged substance through the kidneys, and another 10% is excreted over the next 4 days. Approximately 10% is excreted through the intestines, partly in the form of metabolites. T1/2 from blood plasma is 8-12 hours in adults.

Pharmacokinetics in special groups of patients

T1/2 is approximately 6 hours in children aged 6 to 12 years and approximately 5 hours in children aged 1 to 6 years.

Due to the higher incidence of decreased renal function in elderly patients, the clearance of cetirizine may be reduced in them.

With repeated administration, the pharmacokinetics of cetirizine does not change significantly in mild renal failure compared to healthy volunteers. However, in patients with moderate renal failure, T1/2 of cetirizine increases threefold, and clearance decreases by 70% compared to patients with normal renal function. In patients receiving hemodialysis treatment, a threefold increase in T1/2 and a 70% decrease in clearance is possible even after a single dose of 10 mg of cetirizine.

Compared with the same parameters of healthy volunteers, in patients with chronic liver failure there was an approximately 50% increase in T1/2 and a 40% decrease in clearance.

Indications for use

• Seasonal and year-round allergic rhinitis and conjunctivitis;
• itchy allergic dermatoses;
• hay fever (hay fever);
• urticaria (including chronic idiopathic urticaria);
• angioedema angioedema.

Contraindications

• Renal failure (creatinine clearance less than 10 ml/min);
• pregnancy;
• lactation period (breastfeeding);
• children under 1 year of age;
• hypersensitivity to cetirizine or other components of the drug.

The drug should be used with caution in moderate to severe chronic renal failure (dosage regimen adjustment is required), as well as in elderly patients (dosage regimen adjustment is required).

Directions for use and doses

The drug is taken orally. Drops are dissolved in a small amount of water before use.

• Adults and children over 12 years of age: 10 mg (20 drops) 1 time/day, preferably at night.
• Children aged 1-2 years: 2.5 mg (5 drops) 2 times a day.
• Children aged 2-6 years: 5 mg (10 drops) once. You can also divide this dose into two doses of 2.5 mg (5 drops in the morning and evening).
• Children aged 6-12 years: 5 mg (10 drops) 2 times a day in the morning and evening; or 10 mg (20 drops) in the evening.

It may be necessary to reduce the dose in elderly patients.

If renal function is impaired, the dose should be adjusted individually according to renal function. The table below will help in selecting the dose. To use this table, you should estimate the patient's CC in ml/min. After determining the serum creatinine concentration (mg%), the CC value (ml/min) can be estimated using the following formula:

CC = [140 - age (years)] × body weight (kg)/72 - serum creatinine (mg%)

For women, the resulting value should be multiplied by 0.85

Dose selection depending on QC

Storage conditions

At a temperature not exceeding 25°C, in a place protected from light. Keep out of the reach of children.

Best before date

4 years. Do not use the drug after the expiration date indicated on the package.

Store an open bottle for no more than 4 weeks.

special instructions

If hypersensitivity reactions occur, the drug should be stopped immediately.

Due to the reduced rate of elimination of cetirizine, it may accumulate in the body of patients with impaired renal function; the frequency and severity of anticholinergic side effects or effects on the central nervous system may increase, even when taking the usual adult dose. Therefore, in such cases it is recommended to reduce the dose.

Elderly patients are particularly sensitive to the anticholinergic effects of antihistamines (eg, dry mouth, urinary retention). If these side effects are observed for a long time, or if their intensity increases, the drug should be discontinued. Although cetirizine rarely causes anticholinergic side effects or severe CNS side effects, it can accumulate (age-related decline in renal function is more likely in older patients) and cause anticholinergic side effects or CNS side effects even when administered at the usual adult dose.

The drops contain the excipient methyl parahydroxybenzoate, which can cause late allergic reactions.

Taking Parlazin® should be stopped at least 3 days before performing an allergic skin test to avoid false negative results.

Description

Antiallergic agent - H1-histamine receptor blocker.

Use in children

The drug is contraindicated for use in children under 1 year of age.

Pharmacodynamics

Cetirizine is a carboxylated metabolite of hydroxyzine and belongs to the class of piperazine derivatives antihistamines. The action of cetirizine and its antiallergic effects are based on the selective blockade of peripheral histamine H1 receptors. Through this mechanism, cetirizine suppresses early allergic reactions mediated by histamine, reduces the migration of inflammatory cells and the release of mediators associated with late allergic reactions. Cetirizine has only minor anticholinergic and antiserotonergic effects.

Side effects

Usually the drug is well tolerated. In very rare cases, the following side effects may occur.

From the hematopoietic organs: thrombocytopenia.

From the nervous system: drowsiness, dizziness, headache, aggression, agitation, confusion, depression, hallucinations, insomnia, tic, convulsions, dyskinesia, dystonia, parasthesia, fainting, tremor.

From the organ of vision: disturbance of accommodation, disturbance of visual perception, nystagmus.

From the cardiovascular system: tachycardia.

From the respiratory system: rhinitis, pharyngitis.

From the digestive system: dryness of the oral mucosa, nausea, abdominal pain, diarrhea, impaired liver function (increased activity of liver transaminases, alkaline phosphatase, GGT, bilirubin concentration).

From the urinary system: urinary disorder, urinary incontinence.

From the skin and subcutaneous tissue: itching, rash, urticaria, angioedema.

Allergic reactions: hypersensitivity, up to the development of anaphylactic shock.

Other: weight gain, fatigue, asthenia, malaise, edema.

Use during pregnancy and breastfeeding

There are no data from clinical studies of the use of the drug during pregnancy, and therefore Parlazin® is contraindicated during pregnancy.

Cetirizine is excreted in breast milk, so the drug is contraindicated during breastfeeding. If it is necessary to use the drug during lactation, it is necessary to decide on stopping breastfeeding.

Interaction

No interaction was detected when used together with diazepam, cimetidine, azithromycin, erythromycin, ketoconazole, pseudoephedrine.

Combined use with theophylline (400 mg/day) leads to a decrease in the overall clearance of cetirizine (theophylline kinetics does not change).

The combined use of cetirizine and macrolide antibiotics or cetirizine with ketoconazole did not cause clinically significant ECG changes.

Ethanol: As with any other antihistamine, alcoholic beverages should be avoided during treatment.

Overdose

Symptoms (when taking a single dose of 50 mg): dryness of the oral mucosa, drowsiness, stupor, urinary retention, constipation, anxiety, increased irritability

Treatment: gastric lavage, taking activated charcoal, symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.