Artrozilen gel d / nar. approx. 5% tube 50g

Release form, composition and packaging

Gel for external use 5% transparent, light yellow in color, with a characteristic odor.

100 g

ketoprofen lysine (ketoprofen lysine salt) 5 g,

-which corresponds to the content of ketoprofen 3.125 g

carbomer - 1 g, trolamine - 1.9 g, polysorbate 80 - 0.8 g, ethanol 95% - 5 g, methyl parahydroxybenzoate - 0.1 g, lavender-nerolium flavoring - 0.2 g, purified water - 86 ml.

30 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

NSAID, a derivative of propionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever.

The pronounced analgesic effect of ketoprofen is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system, as well as the effect on the biological activity of other neurotropic substances that play a key role in the release of pain mediators in the spinal cord). brain).

In addition, ketoprofen has anti-bradykinin activity, stabilizes lysosomal membranes, and causes a significant inhibition of neutrophil activity in patients with rheumatoid arthritis.

Suppresses platelet aggregation.

Pharmacokinetics

When taken orally and rectally, ketoprofen is well absorbed from the gastrointestinal tract.

Cmax in plasma when taken orally is achieved after 1-5 hours (depending on the dosage form), with rectal administration - after 45-60 minutes, intramuscular administration - after 20-30 minutes, intravenous administration - after 5 minutes.

Plasma protein binding is 99%.

Due to pronounced lipophilicity, it quickly penetrates the BBB.

Css in blood plasma and cerebrospinal fluid persists from 2 to 18 hours. Ketoprofen penetrates well into the synovial fluid, where its concentration exceeds that in plasma 4 hours after administration.

Metabolized by binding to glucuronic acid and to a lesser extent by hydroxylation.

It is excreted mainly by the kidneys and to a much lesser extent through the intestines.

T1 / 2 of ketoprofen from plasma after oral administration is 1.5-2 hours, after rectal administration - about 2 hours, after intramuscular administration - 1.27 hours, after intravenous administration - 2 hours.

Indications for use

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout)

symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (periarthritis, arthrosynovitis, tendinitis, tendosynovitis, bursitis, lumbago), pain in the spine, neuralgia, myalgia.

Uncomplicated injuries, in particular sports injuries, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain.

As part of a combination therapy for inflammatory diseases of veins, lymphatic vessels, lymph nodes (phlebitis, periphlebitis, lymphangitis, superficial lymphadenitis).

Contraindications for use

For oral administration: erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, aspirin triad", severe liver and / or kidney dysfunction

III trimester of pregnancy

age up to 15 years (for retard tablets)

hypersensitivity to ketoprofen and salicylates.

For rectal use: a history of proctitis and rectal bleeding.

For external use: weeping dermatoses, eczema, infected abrasions, wounds.

Dosage regimen

Set individually, taking into account the severity of the disease.

For oral administration for adults, the initial daily dose is 300 mg in 2-3 divided doses.

For maintenance treatment, the dose depends on the dosage form used.

For the treatment of acute conditions or relief of exacerbation of chronic

Name ENG

ARTROSILEN

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

5% x 50g

Structure

ketoprofen lysine (ketoprofen lysine salt) 5 g ,.

- which corresponds to the content of ketoprofen 3.125 g, carbomer - 1 g, trolamine - 1.9 g, polysorbate 80 - 0.8 g, ethanol 95% - 5 g, methyl parahydroxybenzoate - 0.1 g, lavender-nerolium flavoring - 0.2 g, purified water - 86 ml.

Indications

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout)

symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (periarthritis, arthrosynovitis, tendinitis, tendosynovitis, bursitis, lumbago), pain in the spine, neuralgia, myalgia.

Uncomplicated injuries, in particular sports injuries, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain.

As part of a combination therapy for inflammatory diseases of veins, lymphatic vessels, lymph nodes (phlebitis, periphlebitis, lymphangitis, superficial lymphadenitis).

Contraindications

For oral administration: erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, "aspirin triad", severe liver and / or kidney dysfunction

III trimester of pregnancy

age up to 15 years (for retard tablets)

hypersensitivity to ketoprofen and salicylates.

For rectal use: a history of proctitis and rectal bleeding.

For external use: weeping dermatoses, eczema, infected abrasions, wounds.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

ketoprofen lysine

Specifications

Category

Bruises, sprains

Scope of the drug

General

Release form

Gel

Manufacturer country

Italy

Package quantity, pcs

one

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

Dompe Farmaceutici SPA

The amount of the dosage form in the primary package

50 g

Primary packaging type

Aluminum tube

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Gel for external use

Expiration date in days

1095

Drug action

Analgesic

,

Anti-inflammatory

,

Antipyretic

Dosage (volume) of the substance in the preparation

5 g

Package weight, g

fifty

Mode of application

:

A single dose of the gel is 3-5 g (the volume of a large cherry), aerosol - 1-2 g (the volume of a walnut). < br> Depending on the size of the damaged area, the drug should be applied 2-3 times a day or according to the doctor's instructions, carefully rubbing until completely absorbed. < br> With iontophoresis, the drug is applied to the negative pole.

The duration of treatment without consulting a doctor should not exceed 10 days.

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