Amelotex gel for external use 1% 30 g (meloxicam)

Latin name

AMELOTEX

Release form

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

Packaging

1 tube with instructions for use in a pack of cardboard.

Pharmacological action

Pharmacotherapeutic group: Glucocorticostroid for topical use

ATC code S01BAO1

Pharmacological action

Pharmacodynamics

Synthetic fluorinated glucocorticosteroid. with 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

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) violation of the integrity of the skin in places of the alleged application of children's age (up to 18 years) (effectiveness and safety have not been established) pregnancy.

Precautions: 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.

Use during pregnancy and lactation

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

Composition of

100 g of gel contain:

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

Dosage and administration

Externally. Do not use inside!

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 gently for 2-3 minutes. The duration of the course of therapy is determined individually, it can vary depending on the location of the lesion and the observed therapeutic effect and is no more than 4 weeks.

Side effects

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

From 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 listed above, you should stop using the gel, and also inform your doctor.

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

Overdose

Due to the low systemic absorption of Amelotex® gel application, overdose is not likely when used externally.

Storage conditions

Store at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.

Expiration

2 years. Do not use after the expiry date stated on the packaging.

Prescription terms from

pharmacies Over-the-counter

dosage form

dosage form

gel for for external use



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