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

Symptomatic treatment of osteoarthritis accompanied by pain.

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

Used for symptomatic therapy, reducing pain and inflammation; does not affect the progression of the disease.

Pharmacological effect

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

ATX code: M02AA

Pharmacological properties

Pharmacodynamics

AMELOTEX® gel contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID), which has an analgesic and 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 area of ​​inflammation. 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 takes part in the regulation of blood flow in the kidneys.

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

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

Pharmacokinetics

Studies on rabbits have shown that meloxicam, when applied cutaneously in gel form, is characterized by prolonged transdermal absorption, prolonged circulation in the blood and gradual elimination, significantly different in kinetic characteristics from the intramuscular route of administration of the drug. There is no data indicating significant absorption of meloxicam into the systemic circulation.

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

Special instructions

Physician supervision is required when prescribing Amelotex® gel to elderly patients with impaired renal function, liver function, 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 areas of the skin, avoiding contact with open wounds. Avoid getting the gel into 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.
Should not be used in patients with a history of hypersensitivity to NSAIDs. If hypersensitivity reactions develop, treatment should be discontinued.

During the treatment period, photosensitivity reactions may develop. To reduce the risk of developing photosensitivity, patients should avoid UV irradiation and visiting a solarium.

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

Amelotex® gel does not affect driving or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Meloxicam

Composition

100 g of gel contain:

active ingredient:

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

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

Contraindications

Hypersensitivity to meloxicam and other components of the drug (including other NSAIDs);
complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history), violation of the integrity of the skin at the sites of intended application;
children’s age (up to 18 years) (efficacy and safety have not been established); pregnancy and breastfeeding period.

With caution:

peptic ulcer of the stomach and duodenum (in the acute phase), active gastrointestinal bleeding; advanced renal disease, severe liver failure or active liver disease, documented hyperkalemia, inflammatory bowel disease, advanced age, bleeding 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, photosensitivity.

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

If adverse reactions occur, including those not listed 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 used in combination with other dosage forms of meloxicam (tablets, injections), the daily dose should not exceed 15 mg.

Overdose

Due to the low systemic absorption upon application of AMELOTEX® gel, overdose for external use is unlikely.

Storage conditions

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

Shelf life

3 years.

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

Manufacturer

Ozon, Russia