Suprastinex drops for vn. taking 5mg / ml vial. 20ml

Release form, composition and packaging

Drops for oral administration are colorless or almost colorless, without sediment, with a faint smell of acetic acid.

1 ml 1 fl.

levocetirizine dihydrochloride 5 mg 100 mg

glycerol (85%) - 5 g, propylene glycol - 7 g, sodium saccharinate - 0.2 g, sodium acetate trihydrate - 0.12 g, methyl parahydroxybenzoate - 0.027 g, propyl parahydroxybenzoate - 0.003 g, glacial acetic acid - 0.01 g, purified water - up to 20 ml ...

20 ml - dark glass bottles with a dropper (1) - 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

Suction

The 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 using 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 hours +/- 1.9 hours (for drops), 7-10 hours (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 patient groups

In renal failure (CC less than 40 ml / min), clearance is reduced, and T1 / 2 is lengthened (for example, in patients on hemodialysis, total clearance is reduced 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 rashes.

Contraindications for use

- 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 lack of clinical data)

- pregnancy

- period la

Name ENG

SUPRASTINEX

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Levocetirizine

Dosage

5mg / ml x 20ml

Structure

1 ml of drops contains: levocetirizine dihydrochloride 5 mg.

Excipients: glycerol 85%, propylene glycol, sodium saccharinate, sodium acetate trihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glacial acetic acid, purified water.

Indications

Symptomatic treatment:

- Year-round and seasonal allergic rhinitis and conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia).

- Hay fever (hay fever).

- Hives, incl.

chronic idiopathic urticaria.

- Quincke's edema.

- Allergic dermatoses, accompanied by itching and rashes.

Storage conditions and periods

At a temperature not exceeding 25 degrees (do not freeze).

Expiration date: 4 years

after opening - 6 weeks

Contraindications

Severe renal failure (CC less than 10 ml / min).

Children under 6 years of age (for this dosage form).

Pregnancy.

Lactation period.

Lactose intolerance, hereditary lactase deficiency lapp (lactase deficiency in some peoples of the North) or glucose-galactose malabsorption syndrome (due to the content of lactose in tablets).

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

Care should be taken when:

Chronic renal failure.

Elderly patients (glomerular filtration may decrease).

INN / Active ingredient

Levocetirizine

Specifications

Category

Allergy

Scope of the drug

General

Release form

Drops

Manufacturer country

Hungary

Package quantity, pcs

one

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

20 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AE09 Levocetirizine

Dosage form

Drops for oral administration

Expiration date in days

1460

The target audience

Children

Dosage (volume) of the substance in the preparation

5 mg / ml

Package weight, g

fifty

Mode of application

:

The drug should be taken orally with meals or on an empty stomach. The drops should be taken orally immediately after reconstitution. The daily dose is recommended to be taken in 1 dose. The recommended dose for adults and children over 6 years old, elderly patients (subject to normal renal function) is 5 mg - 1 ml drops or 20 drops from a dropper per day. For children aged 2 to 6 years, the drug is prescribed in the form of drops. The daily recommended dose is 2.5 mg in 2 divided doses in equal doses of 1.25 mg (2 times 0.25 ml drops = 2 x 5 drops from a dropper). The duration of admission depends on the disease. The course of treatment for hay fever is on average 1-6 weeks. In chronic diseases (perennial rhinitis, chronic idiopathic urticaria), the course of treatment may be increased. There is clinical experience with the drug for up to 18 months.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture