Description
Latin name
AMELOTEX
Release form
Gel for external use is transparent or almost transparent, yellow or yellow with a greenish tint, with a specific odor.
Packaging
50 g – aluminum tubes (1) – packs of cardboard.
Pharmacological action
Amelotex ® gel contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID), which has 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 adversely affect cartilage, 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, including joint pain at rest and during movement. Helps increase range of motion.
Pharmacokinetics
In studies on rabbits, it was found that meloxicam, when applied topically in gel form, 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. No evidence of significant absorption of meloxicam into the systemic circulation has been obtained.
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 excreted mainly in the form of metabolites with urine and feces in approximately equal proportions.
Contraindications
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 of
) impaired skin integrity in adolescents and children over the age of 18 (efficacy and safety not established)
hypersensitivity to meloxicam and other components of the drug (including other NSAIDs).
Caution is advised to use the drug in cases of gastric and duodenal ulcer (in the acute phase), active gastrointestinal bleeding, progressive kidney disease of severe liver failure or active liver disease of confirmed hyperkalemia, inflammatory bowel disease, impaired coagulation of chronic heart failure in elderly patients.
Caution: for severe liver failure or active liver disease
for advanced kidney disease
, use the drug in elderly patients.
Use during pregnancy and lactation
Use of the drug is contraindicated in pregnancy and during breastfeeding.
Composition
meloxicam – 1 g
Excipients: methylpyrrolidone – 15 g, ethanol 95% – 25 g, carbomer – 0.9 g, trometamol – 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.
Dosage and Administration
Externally. Do not use inside.
A strip of gel about 4 cm long (2 g) is applied 2 times / day with a thin layer on clean, dry skin above the lesion and rubbed gently for 2-3 minutes.
The duration of the course of therapy is determined individually, may vary depending on the location of the lesion and the observed therapeutic effect and is no more than 4 weeks.
Side effects
From the skin: hyperemia, papular vesicular eruptions, desquamation, photosensitivity.
Allergic reactions: itching and burning of the skin, erythema multiforme, urticaria, systemic anaphylactic reactions.
In case of adverse reactions, incl. not listed above, the patient should stop using the gel and inform the attending physician.
Drug Interaction
Amelotex ® gel should not be used in conjunction with other external preparations.
It is not recommended to apply the gel at the same time as other NSAIDs.
When used with other dosage forms of meloxicam (tablets, injections), the daily dose should not exceed 15 mg.
Overdose
Due to low systemic absorption, Amelotex ® gel overdosage is unlikely when used externally.
Storage conditions
The drug should be stored out of the reach of childrenth place at a temperature of no higher than 25 ° C. Do not freeze.
Expiration
2 years.
Active substance
Meloxicam
Lek ardic form
dosage form
gel for external use
