Amelotex, gel 1% 50 g

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug for external use.

ATX code: M02AA

Pharmacological properties

Pharmacodynamics

Amelotex^® The gel contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory effects. Its 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 area of inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucosa of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.

Meloxicam is a “chondroneutral” drug and has no adverse effect on cartilage tissue and does not affect the synthesis of proteoglycan by chondrocytes of articular cartilage.

When applied topically, the product reduces or eliminates pain in the area where the gel is applied, including joint pain at rest and on movement. Helps increase range of motion.

Pharmacokinetics

In studies on rabbits it was established that meloxicam when applied topically in the form of gel is characterized by prolonged transdermal absorption, prolonged circulation in blood and gradual elimination, differing significantly in kinetic characteristics from intramuscular administration of the drug. There is no evidence of significant absorption of meloxicam into the systemic bloodstream.

In the systemic bloodstream meloxicam is firmly bound to plasma proteins, mainly to albumin (99%). It undergoes biotransformation in the liver to form inactive metabolites. It is excreted mainly as metabolites in urine and feces in approximately equal proportions.

Indications

Periarthritis, Radiculitis, Arthrosis, Arthritis, Lumbago, Pain, Sciatica, Osteochondrosis, Rheumatoid arthritis, OsteoarthritisSymptomatic therapy for osteoarthritis accompanied by pain syndrome.

Post-traumatic pain syndrome (traumatic bruises, sprains, injuries of ligaments, muscles and tendons, muscle tears without violation of the integrity of the skin).

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

Active ingredient

Meloxicam

Composition

100 g of the gel contain:

the active substance:

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

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

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How to take, the dosage

Externally. Do not use internally!

A strip of gel about 4 cm long (2 g) is applied 2 times a day in a thin layer to clean dry skin over the lesion and rubbed in gently for 2-3 minutes. The duration of the course of therapy is determined individually and may vary depending on the lesion and the therapeutic effect noted, and is no more than 4 weeks.

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 dosage forms of meloxicam (tablets, injections) the daily dose should not exceed 15 mg.

Special Instructions

A physician should be supervised when prescribing Amelotex® Gel to elderly patients with impaired renal function, liver, chronic heart failure, patients with bleeding of the stomach and duodenum, acute ulcers or severe blood coagulation disorders.

Amelotex® Gel is recommended to be applied only to intact skin areas avoiding contact with open wounds. Avoid getting the gel into the eyes and mucous membranes.

To reduce the risk of adverse reactions, the lowest effective dose with the shortest duration of treatment should be used. If the patient’s condition does not improve, the patient should definitely consult a physician.
Patients with a history of hypersensitivity to NSAIDs should not use. In case of hypersensitivity reactions the treatment should be discontinued.

During treatment, photosensitivity reactions may develop. Patients should avoid UV exposure and visiting a solarium to reduce the risk of photosensitivity.

Influence on performance of potentially hazardous activities requiring particular attention and quick psychomotor reactions

Amelotex® Gel has no effect on driving and engaging in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

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Synopsis

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

Contraindications

Precaution:

Gastric and 12 duodenal ulcer (acute phase), active gastrointestinal bleeding; advanced renal disease, severe liver failure or active liver disease, confirmed hyperkalemia, inflammatory bowel disease, advanced age, clotting disorders, chronic heart failure.

Side effects

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

Skin side effects: hyperemia, papular vesicular rashes, peeling, photosensitization.

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

If you have any adverse reactions, including those not mentioned above, you should discontinue use of the gel and tell your physician.

Overdose

Because of the low systemic absorption by application of AMELOTEX® Gel, an overdose by external application is unlikely.

Similarities

Movalis, Meloxicam, Amelotex, Movasin, Arthrosan, Meloxicam-Teva, Meloxicam DS, Meloxicam Stada, Petcam Tabs, Meloxidil, Elox-SOLofar