Amelotex gel for external use 1%, 50 g

Symptomatic therapy of osteoarthritis, accompanied by pain.
It is used for symptomatic therapy, pain and inflammation reduction; does not affect the progression of the disease.

Outwardly. Do not use internally!
A strip of gel about 4 cm long (2 g) is applied 2 times a 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, may vary depending on the site of the lesion and the observed therapeutic effect and is no more than 4 weeks.

100 g of gel contain: the
active substance meloxicam (in terms of 100% substance) - 1.0 g;
excipients: methylpyrrolidone - 15.0 g, ethanol 95% - 25.0 g, carbomer - 0.9 g, trometamol - 2.0 g to 3.0 g (up to pH 7.5-8.9 g), orange blossom oil - 0.015 g, lavender oil - 0.01 g, purified water - up to 100.0 g

• 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 a history),

• violation of the integrity of the skin in the places of intended application;

• children's age (up to 18 years old) (efficacy and safety have not been established);

• pregnancy.

With care : 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, old age, coagulation disorders, chronic heart failure.

Pharmacological properties

Pharmacodynamics
AmelotexЃ gel contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory effects. 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 is involved in the regulation of blood flow in the kidneys.
Meloxicam is a 'chondroneutral' drug, does not have a negative effect on the cartilage tissue, does not affect the synthesis of proteoglycan by the chondrocytes of the articular cartilage.
When applied topically, the drug reduces or eliminates pain in the area of ??application of the gel, including joint pain at rest and during movement. Promotes increased range of motion.

Pharmacokinetics
In 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 intramuscular route of administration of the drug. 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 biotransformation 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.

Application during pregnancy and during breastfeeding

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

Side effect

For drugs that are NSAIDs for external use, the following side effects are described.
From the side of the skin: hyperemia, papular-vesicular rash, peeling, photosensitivity.
Allergic reactions: itching and burning of the skin, erythema multiforme, urticaria, systemic anaphylactic reactions.
In case of adverse reactions, including those not mentioned above, you should stop using the gel, and also inform your doctor.

Overdose

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

Interaction with other medicinal products

AmelotexЃ 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:

Doctor's supervision is necessary when prescribing AmelotexЃ gel to elderly patients with impaired renal and liver function, chronic heart failure, patients with bleeding of the stomach and duodenum, ulcers in the acute stage or severe blood coagulation disorders.
AmelotexЃ gel is recommended to be applied only to intact skin areas, avoiding contact with open wounds. Avoid getting 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 the course 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 photosensitization, patients should avoid UV exposure and visit a tanning bed.

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

AmelotexЃ gel does not affect the management of transport and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.