Amelotex gel for external use 1%, 30g

Composition

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of 100 g of gel contains:

Active ingredient:

meloxicam (in terms of 100% substance) – 1.0 g;

excipients: methylpyrrolidone, ethanol 95%, carbomer, trometamol, orange blossom oil, lavender oil, purified water.

Pharmacological action

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug for external use.

ATX code: M 02 AA

Pharmacological properties

Pharmacodynamics

AMELOTEX ® gel contains meloxicam — a nonsteroidal anti-inflammatory drug (NSAID) that has an analgesic, anti-inflammatory effect. The anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the inflammatory region. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.

Meloxicam is a “chondroneutral” drug, does not have a negative effect on cartilage tissue, does not affect the synthesis of proteoglycan by chondrocytes of articular cartilage.

When applied topically, the drug reduces or eliminates pain in the area of applying the gel, including joint pain at rest and when moving. Helps to increase the volume of movement.

Pharmacokinetics

In studies on rabbits, it was found that meloxicam when applied on the skin in the form of a gel is characterized by prolonged transdermal absorption, prolonged circulation in the blood and gradual elimination, significantly differing in kinetic characteristics from the intramuscular method of drug use. There are no data indicating significant absorption of meloxicam into the systemic circulation.

In the systemic circulation, meloxicam binds strongly to plasma proteins, mainly albumin (99%). It undergoes biotransformation in the liver with the formation of inactive metabolites. It is mainly excreted in the form of metabolites in the urine and feces in approximately equal proportions.

Indications

Symptomatic treatment of osteoarthritis accompanied by pain syndrome.

Post-traumatic pain syndrome (traumatic bruises, dislocations, damage to ligaments, muscles and tendons, muscle tears without violating the integrity of the skin).

It is used for symptomatic therapy, reducing pain and inflammation; it does not affect the progression of the disease.

Use during pregnancy and lactation

The use of the drug is contraindicated during pregnancy and lactation.

Contraindications

With caution:  

peptic ulcer of the stomach and duodenum 12 (in the acute phase), active gastrointestinal bleeding; progressive kidney disease, severe liver failure or active liver disease, confirmed hyperkalemia, inflammatory bowel diseases, advanced age, blood clotting disorders, chronic heart failure.

Side effects

For drugs that are NSAIDs for external use, the following side effects are described.

From the skin: hyperemia, papular-vesicular rashes, peeling, photosensitization.

Allergic reactions: itching and burning of the skin, erythema multiforme, urticaria, systemic anaphylactic reactions.

If you experience side effects, including those not mentioned above, you should stop using the gel, and also inform your doctor.

Interaction

AMELOTEX ® gel should not be used together with other drugs for external use.

It is not recommended to use the gel simultaneously with other NSAIDs. When combined with other medicinal forms of meloxicam (tablets, injections), the daily dose should not exceed 15 mg.

How to take, course of use and dosage

Externally. Do not use inside!

A strip of gel about 4 cm long (2 g) is applied 2 times a day in 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, may vary depending on the site of the lesion and the noted therapeutic effect, and is no more than 4 weeks.

Overdose

Due to the low systemic absorption during the application of Amelotex® gel, overdose with external use is unlikely.

Description

Transparent or almost transparent gel of yellow or yellow with a greenish tinge of color with a specific smell.

Special instructions

It is necessary to monitor the doctor when prescribing Amelotex ® gel to elderly patients with impaired renal function, liver, chronic heart failure, patients with bleeding of the stomach and duodenum 12, ulcers in the acute stage or severe blood coagulation disorders.

Amelotex ® gel is recommended to be applied only to undamaged areas of the skin, avoiding contact with open wounds. Avoid contact with the gel in the eyes and mucous membranes.

To reduce the risk of adverse reactions, it is necessary to use the minimum effective dose with the shortest duration of treatment. If the patient’s condition does not improve, he should definitely consult a doctor.

Do not use in patients with a history of hypersensitivity to NSAIDs. If hypersensitivity reactions develop, treatment should be discontinued.

Photosensitivity reactions may occur during treatment. To reduce the risk of photosensitization, patients should avoid UV radiation and tanning beds.

Influence on the performance of potentially dangerous activities that require special attention and speed of psychomotor reactions.

Amelotex ® gel has no effect on driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Transparent or almost transparent gel of yellow or yellow with a greenish tinge of color with a specific smell.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Meloxicam

Dosage form

gel for external use

Description

For adults as directed by your doctor

Indications

Osteoarthritis, Periarthritis, Arthritis, Osteoarthritis, Lumbago, Sciatica, Osteochondrosis, Rheumatoid Arthritis, Sciatica