# 20 Amelotex gel d / external. apply. 1% tube 30g

Release form, composition and packaging

Gel for external use is transparent or almost transparent, yellow or yellow with a greenish tinge, with a specific odor.

100 g

meloxicam (in terms of 100% substance) 1 g

methylpyrrolidone - 15 g, ethanol 95% - 25 g, carbomer - 0.9 g, trometamol - from 2 g to 3 g (up to pH 7.5-8.9), orange blossom oil - 0.015 g, lavender oil - 0.01 g, purified water - up to 100 g

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

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

pharmachologic effect

Has analgesic, anti-inflammatory effect.

The anti-inflammatory effect is associated with inhibition of the enzymatic activity of COX-2, which is involved in the biosynthesis of prostaglandins in the area of ​​inflammation.

To a lesser extent, meloxicam acts on COX-1, which is involved in the synthesis of prostaglandin, which protects the gastrointestinal mucosa and takes part in the regulation of blood flow in the kidneys.

Meloxicam is a chondroneutral drug that does not adversely affect cartilage tissue, does not affect proteoglycan synthesis by articular cartilage chondrocytes.

When applied topically, the drug reduces or eliminates pain in the area of ​​application of the gel, incl.

joint pain at rest and on movement.

Promotes increased range of motion.

Pharmacokinetics

In experimental studies on rabbits, it was found that when applied to the skin in the form of a gel, meloxicam is characterized by prolonged transdermal absorption, prolonged circulation in the blood and gradual elimination, significantly differing in kinetic characteristics from the i / m route of drug administration.

There is no evidence of significant absorption of meloxicam into the systemic circulation.

In the systemic circulation, meloxicam strongly binds to blood plasma proteins, mainly albumin (99%).

Undergoes metabolism in the liver with the formation of inactive metabolites.

It is excreted mainly in the form of metabolites in the urine and feces in approximately equal proportions.

Indications for use

- symptomatic therapy of osteoarthritis, accompanied by pain.

It is used for symptomatic therapy, reducing pain and inflammation

does not affect the progression of the disease.

Contraindications for use

- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history)

- violation of the integrity of the skin in the places of the intended application

- children and adolescents up to 18 years of age (efficacy and safety have not been established)

- pregnancy

- hypersensitivity to meloxicam and other components of the drug (including other NSAIDs).

The drug should be used with caution in case of gastric ulcer and duodenal ulcer (in the acute phase)

active gastrointestinal bleeding

progressive kidney disease

severe liver failure or active liver disease

confirmed hyperkalemia

inflammatory bowel disease

violation of coagulation

chronic heart failure

in elderly patients.

Dosage regimen

Outwardly.

Do not use internally.

A strip of gel about 4 cm long (2 g) is applied 2 times / day with a thin layer on clean, dry skin over the lesion and rubbed lightly for 2-3 minutes.

The duration of the course of therapy is determined individually, it can vary depending on the site of the lesion and the observed therapeutic effect and is no more than 4 weeks.

Overdose

Due to the low systemic absorption when applying Amelotex gel, an overdose with external use is unlikely.

Side effect

For drugs from the NSAID group for external use, the following side effects are described.

On the part of the skin: hyperemia, papular-vesicular rash, peeling, photosensitivity.

Allergic

Name ENG

AMELOTEX

Clinical and pharmacological group

NSAIDs for external use

ATX code

Non-steroidal anti-inflammatory drugs for external use

Dosage

1 g

Structure

meloxicam - 1 g.

Excipients: methylpyrrolidone - 15 g, ethanol 95% - 25 g, carbomer - 0.9 g, trometamol - from 2 g to 3 g (up to pH 7.5-8.9), orange blossom oil - 0.015 g, lavender oil - 0.01 g, water peeled - up to 100 g.

Indications

Symptomatic therapy of osteoarthritis, accompanied by pain.

It is used for symptomatic therapy, reducing pain and inflammation

does not affect the progression of the disease

Contraindications

Hypersensitivity to meloxicam and other components of the drug (including other NSAIDs)

complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history), violation of the integrity of the skin in the places of intended application

children's age (up to 18 years) (effectiveness and safety have not been established)

pregnancy.,

With care

peptic ulcer and 12 duodenal ulcer (in the acute phase), active gastrointestinal bleeding

progressive kidney disease, severe liver failure or active liver disease, confirmed hyperkalemia, inflammatory bowel disease, old age, coagulation disorders, chronic heart failure.

Storage conditions and periods

The drug should be stored out of reach of children at a temperature not exceeding 25C.

Do not freeze.

Shelf life is 2 years.

INN / Active ingredient

meloxicam

Specifications

Category

Bruises, sprains

Scope of the drug

Musculoskeletal system

Release form

Gel

Manufacturer country

Russia

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Sotex

The amount of the dosage form in the primary package

30 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Dosage form

Gel for external use

Dosage (volume) of the substance in the preparation

meloxicam (in terms of 100% substance) 1 g

Drug action

Pain reliever

,

Anti-inflammatory

Expiration date in days

24

Package weight, g

45

Mode of application

:

Outwardly.

Do not use inside. < br> < br> A strip of gel about 4 cm long (2 g) is applied 2 times / day with a thin layer on clean, dry skin over the lesion and rubbed lightly for 2-3 minutes. < br> < br> The duration of the course of therapy is determined individually, it can vary depending on the site of the lesion and the observed therapeutic effect and is no more than 4 weeks.

Pharmaco-therapeutic group

:

Non-steroidal anti-inflammatory drug for external use

Anatomical and therapeutic characteristics

:

M02AA Topical non-steroidal anti-inflammatory drugs

Information on technical characteristics, delivery set, country of manufacture