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Parlazin® (Tablets, Drops) Instructions for Use

ATC Code

R06AE07 (Cetirizine)

Active Substance

Cetirizine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H1-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H1-histamine receptor blocker

Pharmacological Action

A third-generation histamine H1-receptor blocker. It affects the “early” stage of the allergic reaction and reduces eosinophil migration; it limits the release of mediators at the “late” stage of the allergic reaction.

It has practically no anticholinergic or antiserotonin action. In therapeutic doses, it does not cause a sedative effect.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract. Cmax after oral administration is reached within 1 hour. The bioavailability of cetirizine when taken as tablets and syrup is the same. Food does not affect the completeness of absorption (AUC), but prolongs the time to reach Cmax by 1 hour and reduces the value of Cmax by 23%.

When taken at a dose of 10 mg once a day for 10 days, Css in plasma is 310 ng/ml and is noted 0.5-1.5 hours after administration. Plasma protein binding is 93% and does not change with cetirizine concentrations in the range of 25-1000 ng/ml.

The pharmacokinetic parameters of cetirizine change linearly when prescribed in a dose of 5-60 mg. Vd is 0.5 l/kg. It is metabolized in the liver in small amounts by O-dealkylation to form a pharmacologically inactive metabolite (unlike other H1-histamine receptor antagonists, which are metabolized in the liver by the cytochrome system). It does not accumulate.

Two-thirds of the dose is excreted unchanged by the kidneys and about 10% in the feces. Systemic clearance is 53 ml/min. T1/2 in adults is 7-10 hours, in children aged 6 to 12 years – 6 hours, from 2 to 6 years – 5 hours, from 6 months to 2 years – 3.1 hours.

In elderly patients, T1/2 increases by 50%, and systemic clearance decreases by 40% (decreased renal function). In patients with impaired renal function (CrCl<40 ml/min), the clearance of the drug decreases and T1/2 is prolonged (for example, in patients on hemodialysis, total clearance decreases by 70% and is 0.3 ml/min/kg, and T1/2 is prolonged 3 times), which requires an appropriate change in the dosage regimen.

It is practically not removed during hemodialysis. In patients with chronic liver diseases (hepatocellular, cholestatic or biliary cirrhosis), an increase in T1/2 by 50% and a decrease in total clearance by 40% are noted (dose adjustment is required only with a concomitant decrease in glomerular filtration rate). It penetrates into breast milk.

Indications

Hay fever; allergic rhinitis, conjunctivitis, dermatitis; urticaria, angioedema.

ICD codes

ICD-10 code Indication
H10.1 Acute atopic (allergic) conjunctivitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L23 Allergic contact dermatitis
L24 Irritant contact dermatitis
L28.0 Lichen simplex chronicus (circumscribed neurodermatitis)
L50 Urticaria
T78.3 Angioneurotic edema (Quincke's edema)
ICD-11 code Indication
9A06.70 Atopic eczema of the eyelids
9A60.01 Acute atopic conjunctivitis
9A60.02 Allergic conjunctivitis
9A60.0Y Other specified papillary conjunctivitis
9A60.0Z Papillary conjunctivitis, unspecified
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA83.00 Lichen simplex of vulva
EA83.01 Lichen simplex of male genital organs
EA83.02 Lichen simplex of perianal area
EA83.0Z Lichen simplex of unspecified location
EA85.20 Atopic hand eczema
EB04 Idiopathic angioedema
EK00.Z Allergic contact dermatitis, unspecified
EK02.Z Irritant contact dermatitis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the tablets orally with a glass of water. Administer the drops orally, undiluted or mixed with a small amount of food or infant formula immediately before use.

For adults and children over 12 years, the standard dose is 10 mg once daily. Alternatively, administer 5 mg twice daily.

For children aged 6 to 12 years, administer 10 mg once daily or 5 mg twice daily.

For children aged 2 to 6 years, administer 5 mg once daily or 2.5 mg twice daily.

For children aged 1 to 2 years, administer 5 drops (2.5 mg) twice daily.

For infants aged 6 to 12 months, administer 5 drops (2.5 mg) once daily.

For patients with moderate renal impairment (creatinine clearance 30-49 ml/min), administer 5 mg once daily.

For patients with severe renal impairment (creatinine clearance 10-29 ml/min), administer 5 mg every other day.

For patients with end-stage renal disease (creatinine clearance less than 10 ml/min) and those on hemodialysis, the use of cetirizine is contraindicated.

For elderly patients with normal renal function, no dose adjustment is required. For elderly patients with age-related renal impairment, adjust the dose according to creatinine clearance.

For patients with hepatic impairment and normal renal function, no dose adjustment is required. For patients with concomitant hepatic and renal impairment, adjust the dose according to renal function.

Adverse Reactions

Possible dry mouth, drowsiness, headache, fatigue.

Rarely skin manifestations of allergic reactions, angioedema.

In isolated cases dyspepsia, agitation.

Contraindications

Renal failure, pregnancy, lactation period, hypersensitivity to cetirizine.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation.

Use in Renal Impairment

Contraindicated in renal failure.

Cetirizine should be prescribed with caution to patients with chronic renal failure (moderate and severe – dose adjustment is required).

Pediatric Use

Cetirizine should be prescribed with caution to children (experience of use in children under 1 year is insufficient).

Geriatric Use

Cetirizine should be prescribed with caution to elderly patients (a decrease in glomerular filtration is possible).

For elderly patients with normal renal function, no dose adjustment is required.

Special Precautions

Cetirizine should be prescribed with caution to patients with chronic renal failure (moderate and severe – dose adjustment is required), and to elderly patients (a decrease in glomerular filtration is possible).

For elderly patients with normal renal function, no dose adjustment is required.

Use in pediatrics

Cetirizine should be prescribed with caution to children (experience of use in children under 1 year of age is insufficient).

Effect on the ability to drive vehicles and machinery

When the dose exceeds 10 mg/day, the ability for rapid reactions may deteriorate. During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

No pharmacokinetic interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam and glipizide was found.

Concomitant administration with theophylline (400 mg/day) led to a 16% decrease in the total clearance of cetirizine (the kinetics of theophylline did not change).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Dosage Form

Bottle OTC Icon Parlazin® Film-coated tablets, 10 mg: 5, 7, 10, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light orange in color, biconvex, oblong, with a bevel, with a score on one side and an engraving “E 511” on the other side, odorless; on the break: the outer ring of the shell is light orange, the tablet core is white or almost white.

1 tab.
Cetirizine dihydrochloride 10 mg

Excipients: colloidal anhydrous silicon dioxide, magnesium stearate, lactose monohydrate, microcrystalline cellulose.

Shell composition opadry Y-1-7000, sunset yellow (C.I.15985) (sunset yellow dye).

5 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Dosage Form

Bottle OTC Icon Parlazin® Drops for oral administration 10 mg/1 ml: dropper bottle 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Drops for oral administration colorless or almost colorless, without sediment, with a weak characteristic odor of acetic acid.

1 ml
Cetirizine dihydrochloride 10 mg

Excipients: glycerol – 250 mg, propylene glycol – 350 mg, sodium saccharin – 10 mg, sodium acetate trihydrate – 10 mg, methylparahydroxybenzoate – 1.35 mg, propylparahydroxybenzoate – 0.15 mg, glacial acetic acid – 0.5 mg, purified water – up to 1 ml.

20 ml – brown glass bottles (1) with a PE dropper and a PP cap with an internal PE layer, with first-opening control, as well as with child-resistant closure – cardboard packs.

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