PARLAZIN
Active material: Cetirizine
When ATH: R06AE07
CCF: Gistaminovыh blocker H1-receptors. Allergy medication
ICD-10 codes (testimony): H10.1, J30.1, J30.3, L20.8, L23, L24, L28.0, L29, L30.0, L50, T78.3
When CSF: 13.01.01.02
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)
Pharmaceutical form, composition and packaging
◊ Pills, coated light orange, lenticular, oblong, chamfered, with Valium on one party and chasing “E 511” on the other side, without smell; of presentations: shell outer ring light orange, core tablet White or almost white.
| 1 tab. | |
| cetirizine digidrohlorid | 10 mg |
Excipients: Colloidal anhydrous silica, magnesium stearate, lactose monohydrate, microcrystalline cellulose.
The composition of the shell: hydroxypropyl, Titanium dioxide, macrogol 400, ariavit “Sunset” yellow.
5 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
◊ Drops for intake colorless or nearly colorless, sweet, no precipitation or mechanical inclusions, with a faint odor of acetic acid.
| 1 ml | |
| cetirizine digidrohlorid | 10 mg |
Excipients: glycerol, propylene glycol, sodium acetate, metilparagidroksiʙenzoat, propilparagidroksibenzoat, sodium saccharin, glacial acetic acid, Purified water.
20 ml – dropper bottle of dark glass (1) – packs cardboard.
Pharmacological action
Selective histamine H1-receptors from the group of piperazine derivatives. It is the main metabolite of hydroxyzine carboxylate. Compared with Hydroxyzine is less lipophilic, worse CNS penetration and causes less sedation. As compared with other antihistamines cetirizine is more polar (less lipophilic) groups, attached to the side chain ethylamine, which reduces its entry into the CNS, It improves the selectivity towards the histamine H1-Receptor, and reduces the side effects, associated with anticholinergic activity.
The drug inhibits the migration of eosinophils and eosinophil chemotaxis inhibiting factor. Significantly reduce the accumulation of eosinophils in the skin, and resolving cutaneous reaction to histamine, estimated the size of the blister and hyperemia. Besides, and other drug inhibits cell inflammatory infiltrate (incl. Neutrophils).
Parlazin® prevents and facilitates the allergic reactions, It has antipruritic and protivoekssudativnoe action. Decreases capillary permeability, prevents the development of edema, relieves smooth muscle spasm. Preparation action begins 20 minutes after administration, maximal effect develops after 1 no, duration – 24 no.
Pharmacokinetics
Absorption
After oral administration, the drug is absorbed quickly and completely. Simultaneous food intake has little effect.
Distribution
Plasma protein binding is 93%. In Кажущийсяd cetirizine – 0.5-0.8 l / kg, which is considerably less, than other electoral histamine H1-receptors.
It penetrates through the BBB in small quantities and almost no interaction with the central histamine H1-receptors. Provided with breast milk.
Metabolism
Not subjected to intensive metabolism in the liver. Discovered one inactive metabolite, formed by oxidative O-dealkylation of the side chain (detected in plasma, Kale).
Deduction
T1/2 is 7.4-9 no. In applying the drug in a dose 10 about mg 60% Cetirizine is excreted in the urine unchanged within 24 no, 10% is displayed in the subsequent 4 day; 10% – excreted in the feces within 5 days. O-alkylated metabolite excreted in the feces, It is also the excretion of gall.
Pharmacokinetics in special clinical situations
In children, the final T1/2 is 6.2 no (on 33% less, than in adults). Children under the age of 4 T years1/2 – 4.9 no. In the elderly and in patients with chronic liver disease T1/2 increases by 50%. T1/2 may increase and renal failure. In renal insufficiency, mild or moderate T1/2 is 19-21 no. Renal clearance with normal renal function is 40 ml / min, in renal failure mild – 7 ml / min, in renal failure of moderate severity – 1.5 ml / min. Although the clinical significance of these factors is not installed, such patients should be correct dosage.
With hemodialysis does not change the pharmacokinetics of cetirizine.
Testimony
- Seasonal and perennial allergic rhinitis and conjunctivitis;
- Hay fever (hay fever);
- Itchy allergic dermatitis;
- Urticaria (incl. chronic idiopathic);
- Angioedema.
Dosage regimen
Adults and adolescents over 12 years appoint 10 mg (1 tab. or 20 drops) 1 time / day, preferably overnight.
For children 6-12 years appoint 5 mg (1/2 tab. or 10 drops) 2 times / day (in the morning and in the evening) or 10 mg (1 tab. or 20 drops) 1 time / day (in the evening).
For children 2-6 years appoint 5 mg (10 drops) 1 time / day. It is also possible to divide the dose to 2 receiving at 2.5 mg (by 5 drops in the morning and evening).
For children 1-2 years appoint 2.5 mg (5 drops) 2 times / day.
Elderly patients and patients with renal insufficiency It is recommended to reduce the daily dose of 5 mg.
The tablets are taken orally, drinking plenty of water (200 ml). Drops pre-dissolved in water.
Side effect
CNS: rarely - somnolence (dose dependent), feeling tired, headache, migraine, dizziness, anxiety (increase in motor activity).
From the digestive system: dry mouth, nausea.
The intensity of the above symptoms can be reduced, dividing the daily dose in the 2 admission.
Allergic reactions: rarely (≤2%) – angioedema, rash.
Contraindications
- Pregnancy;
- Lactation (breast-feeding);
- Children up to age 1 year;
- Children up to age 6 years (Pill);
- Hypersensitivity to cetirizine or other ingredients.
C caution use in patients with chronic renal failure, moderate to severe (requires correction mode), as well as in elderly patients (requires correction mode).
Pregnancy and lactation
The drug is contraindicated in pregnancy. IN experimental studies found, Cetirizine is not teratogenic. However, these well-controlled studies in humans are absent.
Cetirizine is excreted in breast milk, the risk of the alleged adverse effects in breast-fed babies is greater than the possible benefit to the mother, and therefore take Parlazin® lactation is contraindicated.
Cautions
With the development of hypersensitivity reactions treatment with Parlazin® discontinue.
In patients with renal insufficiency due to the slowdown Withdrawal possible cumulation of cetirizine. In appointing Parlazina® these patients at recommended doses for adults may experience side effects, associated with anticholinergic action and effect on the CNS. Therefore, when using the drug in patients with impaired renal function dose reduction is recommended.
Elderly patients increases the risk of anticholinergic effects of the drug (dry mouth, urinary retention). With increasing symptoms such treatment Parlazinom® discontinue. Pronounced anticholinergic or depressive effect on the central nervous system in the appointment Parlazina® at standard doses, usually, It does not occur. Nonetheless, increases the risk of accumulation of cetirizine (due to a progressive decrease in renal function in elderly patients).
It should be taken into account, that Parlazin® in the form of tablets containing lactose. Therefore, patients with lactose intolerance should be informed about this.
Treatment Parlazinom® should be discontinued 3 days before the prick test, in order to prevent distortion of the reaction.
It should refrain from drinking alcoholic beverages during treatment Parlazinom®.
Use in Pediatrics
Children under 1 year Parlazin® is not indicated in any pharmaceutical form, tk. in this age group, the safety and efficacy has not been established.
For the treatment of children aged 1 Year to 6 years should apply Parlazin® in the form of drops for oral.
Parlazin® in the form of tablets can be used in children 6 and older.
Effects on ability to drive vehicles and management mechanisms
The first reception Parlazina® should pay attention to the possibility of side effects (drowsiness). Patients are advised to refrain from driving or operating mechanical devices to the disappearance of side effects. In the future, if necessary, driving a car or operating, requiring greater attention, Patients should not exceed the daily dose 10 mg.
Overdose
Symptoms: often – feeling tired, drowsiness. Children marked anxiety and irritability, followed by drowsiness. When receiving a single dose of 50 mg may experience urinary retention, constipation.
Treatment: necessary to induce vomiting, wash out the stomach. If necessary, a supportive and symptomatic treatment. No specific antidote. Hemodialysis is not effective.
Drug Interactions
Not found clinically significant interactions of cetirizine with glipizide, diazepamom, cimetidine, Azithromycin, Pseudoephedrine, ketoconazole, Erythromycin.
With simultaneous use of cetirizine with theophylline (400 mg / day) there is a decrease in the total clearance of cetirizine 16%. Pharmacokinetics theophylline is not changed.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug is in the form of tablets should be stored out of reach of children at or above 25 ° C. Shelf life - 2 year.
The drug is in the form of drops should be kept in the dark, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 4 year. Open the vial should be stored no more than 4 weeks.
