Suprastinex tab. p / o captivity. 5mg # 7

Release form, composition and packaging

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Film-coated tablets of white or almost white color, round, biconvex

engraved with E" on one side and "281" on the other, with little or no odor.

1 tab.

levocetirizine dihydrochloride 5 mg,

which corresponds to the content of levocetirizine 4.21 mg

silicon microcrystalline cellulose (Prosolv® HD90) - 40.4 mg (microcrystalline cellulose (98%), colloidal anhydrous silicon dioxide (2%)), lactose monohydrate - 37.9 mg, low-substituted hyprolose (L-HPC11) - 10 mg, magnesium stearate - 1.7 mg.

Shell composition: opadry II 33G28523 white - 5 mg (hypromellose 2910 (40%), titanium dioxide (25%), lactose monohydrate (21%) - 1.05 mg, macrogol 3350 (8%), triacetin (6%)).

7 pcs.

- blisters (1) - cardboard packs.

7 pcs.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (3) - cardboard packs.

pharmachologic effect

Levocetirizine - the R-enantiomer of cetirizine, which belongs to the group of competitive histamine antagonists, blocks histamine H1 receptors.

It has an effect on the histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators.

It prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect.

Virtually no anticholinergic and antiserotonergic action.

In therapeutic doses, it practically does not have a sedative effect.

The action of the drug Suprastinex drops begins 12 minutes after taking a single dose in 50% of patients, after 1 hour - in 95% and lasts for 24 hours.

Pharmacokinetics

Absorption Pharmacokinetic parameters of levocetirizine vary linearly and practically do not differ from the pharmacokinetics of cytirizine. After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, but reduces its rate. In adults, after a single dose of the drug in a therapeutic dose (5 mg), Cmax in blood plasma is reached after 0.9 h and is 207 ng / ml (for tablets) and 270 ng / ml (for drops), after repeated administration at a dose of 5 mg - 308 ng / ml. Bioavailability reaches 100%. Distribution Levocetirizine is 90% bound to blood plasma proteins. Vd is 0.4 l / kg. Css is reached after 2 days. Metabolism Less than 14% of the drug is metabolized in the liver by N- and O-dealkylation (in contrast to other antagonists of histamine H1 receptors,which are metabolized in the liver by the CYP system). Due to the low metabolism and metabolic potential, the interaction of levocetirizine with other drugs seems unlikely. Withdrawal In adults, T1 / 2 is 7.9 h ± 1.9 h (for drops), 7-10 h (for tablets), the total clearance is 0.63 ml / min / kg. About 85.4% of the taken dose of the drug is excreted by the kidneys unchanged by glomerular filtration and tubular secretion about 12.9% - through the intestines. Pharmacokinetics in special groups of patients In renal failure (CC less than 40 ml / min), clearance decreases, and T1 / 2 is lengthened (for example, in patients on hemodialysis, total clearance decreases by 80%), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.In young children, T1 / 2 is shortened.

Indications for use

Symptomatic treatment: - Year-round (persistent) and seasonal (intermittent) allergic rhinitis and conjunctivitis (itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia)

- hay fever (hay fever)

- urticaria, incl.

chronic idiopathic urticaria (for tablets)

- Quincke's edema (for tablets)

- allergic dermatoses, accompanied by itching and you

Name ENG

SUPRASTINEX

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Levocetirizine

Dosage

5mg

Structure

1 film-coated tablet contains: levocetirizine dihydrochloride 5 mg, which corresponds to the content of levocetirizine 4.21 mg.

Excipients: microcrystalline silicon cellulose (microcrystalline cellulose, anhydrous colloidal silicon dioxide), lactose monohydrate (37.9 mg), low-substituted hyprolose (L-HPC11), magnesium stearate.

Shell composition: opadry II 33G28523 white (hypromellose 2910, titanium dioxide, lactose monohydrate (1.05 mg), macrogol 3350, triacetin)

Indications

Symptomatic treatment:

perennial (persistent) and seasonal (intermittent) allergic rhinitis and conjunctivitis (itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia)

hay fever (hay fever)

urticaria, incl.

chronic idiopathic urticaria (for tablets)

Quincke's edema (for tablets)

allergic dermatoses, accompanied by itching and rashes.

INN / Active ingredient

Levocetirizine

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 5 years

Contraindications

end stage renal failure (CC less than 10 ml / min)

children under 6 years of age (for tablets)

children under 2 years of age (for oral drops - due to the lack of clinical data)

pregnancy

lactation period

lactose intolerance, hereditary lactase deficiency or glucose-galactose malabsorption syndrome (for tablets)

hypersensitivity to the active substance (including piperazine derivatives) or any auxiliary component of the drug.

Caution should be used in chronic renal failure (dosage regimen must be adjusted), in elderly patients (glomerular filtration may be reduced), in patients with spinal cord injury, prostatic hyperplasia, and in the presence of other predisposing factors to urinary retention (levocetirizine may increase the risk of urinary retention), while consumed with alcohol.

Specifications

Category

Allergy

Scope of the drug

General

Release form

Tablet

Manufacturer country

Hungary

Package quantity, pcs

7

Minimum age from

2 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Shelf life after opening

Store an open bottle no more than 6 weeks.

Volume, ml.

20 ml

Brand name

Egis

The amount of the dosage form in the primary package

7 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AE09 Levocetirizine

Dosage form

Film-coated tablets

The target audience

Children

Expiration date in days

1460

Dosage (volume) of the substance in the preparation

Levocetirizine 4.21 mg

Package weight, g

ten

Mode of application

:

The drug should be taken with food or on an empty stomach with a small amount of water, do not chew the tablets.

The daily dose is recommended to be taken in 1 dose.

Recommended dose for adults and children over 6 years old, elderly patients: (subject to normal renal function) - 5 mg (1 tablet) / day.

The duration of admission depends on the disease.

The course of treatment for hay fever is on average 1-6 weeks.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture "