Airtal, cream 1.5%, 60g

Composition

>

of 1 g of cream contains:

Active ingredient:

aceclofenac 100% micronized 0.015 g.

Auxiliary substances:

emulsion wax 0.1 g,

liquid paraffin 0.04 g,

methyl parahydroxybenzoate 0.002 g,

propyl parahydroxybenzoate 0.0005 g,

water 0.8425 g.

Tuba 60 g

Pharmacological action

Pharmacodynamics

Aceclofenac is a nonsteroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. The drug suppresses the development of edema and erythema regardless of the etiology of inflammation. Aceclofenac inhibits the formation of prostaglandins and leukotrienes by reversibly suppressing cyclooxygenase types 1 and 2.

The established clinical efficacy of the drug is complemented by good tolerability. The use of Airtal cream is advisable in patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.

Pharmacokinetics

Suction

After application, aceclofenac is absorbed from the application area, quickly reaching saturation. It accumulates in the absorption zone, which contributes to an increase in anti-inflammatory activity, and gradually enters the systemic bloodstream in small amounts, and therefore the risk of side effects, including on the gastrointestinal tract, is minimized.

Distribution

Aceclofenac is distributed throughout the body.

Elimination

Aceclofenac is metabolized in the liver and is slowly excreted by the kidneys and through the intestines, partially unchanged.

Indications

• Treatment of local pain due to traumatic injuries and inflammatory diseases of the musculoskeletal system, including sports injuries;
• the drug can be used to reduce inflammation of tendons, ligaments, muscles and joints in cases of sprains, overexertion or bruises, as well as for the treatment of lumbago, torticollis and periarthritis.

Use during pregnancy and lactation

Pregnancy

Airtal ® cream is contraindicated during pregnancy. There is no information on the use of Airtal cream during pregnancy.

Breast-feeding period

It is not known whether aceclofenac passes into breast milk. Airtal cream should not be used during breast-feeding.

Contraindications

• Hypersensitivity to the components of the drug (aceclofenac) or any of the excipients;
• past intolerance to NSAIDs, including diclofenac;
• past attacks of bronchial asthma, urticarial rash or acute rhinitis while taking acetylsalicylic acid (ASA) or other NSAIDs;
• presence of infection caused by varicella-zoster virus.
• pregnancy.
• children under 18 years of age.
• violation of the integrity of the skin in the intended place of application.

With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), severe liver and kidney function disorders, CHF; bronchial asthma, urticaria or acute rhinitis caused by taking ASA or other NSAIDs; blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), old age, lactation.

Side effects

Adverse events reported in clinical trials and post-marketing follow-up are listed below; adverse events are grouped according to the classes of organ systems according to the Medical Dictionary for Regulatory Affairs (MedDRA) and frequency of occurrence:

• very common (≥ 1/10);
• common (≥ 1/100 to < 1/10);
• uncommon (≥1/1000 to < 1/100);
• rare (≥1/10000 to < 1/1000);
• very rare (

General disorders and disorders at the injection site: infrequently-photosensitivity reaction, erythema, pruritus; rarely-skin irritation; very rarely-bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

There are very rare reports of severe skin reactions, sometimes leading to death, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of NSAIDs.

Interaction

Despite the lack of data on possible interactions of aceclofenac with other drugs, caution should be exercised when prescribing it to patients taking other medications, especially those that include lithium, digoxin. Caution should also be exercised when concomitant therapy with anticoagulants, diuretics or painkillers.

How to take, course of use and dosage

Airtal cream is intended for external use only and should not be applied under occlusal dressings. Airtal® should be applied with light massaging movements to the affected area three times a day. The dose used depends on the size of the affected area: 1.5-2 g of Airtal cream (approximately corresponds to a strip of cream 5-7 cm long).

Use in children

There is no experience of using Airtal cream in children, so Airtal cream is contraindicated for use in children.

Elderly patients

Correction of the dosage regimen in the elderly is not required.

Overdose

Symptoms: Cases of aceclofenac overdose are unknown. The exact symptoms of aceclofenac overdose are unknown. If used improperly or accidentally swallowed, hypotension, renal failure, convulsions, irritation of the gastrointestinal mucosa, and respiratory depression may develop.

Treatment: symptomatic and supportive therapy is provided. Absorption of the drug should be prevented as soon as possible by gastric lavage and use of activated charcoal.

Forced diuresis or hemoperfusion is ineffective due to the high degree of binding of aceclofenac to plasma proteins and its intensive metabolism.

Special instructions

• If irritation develops at the site of application of Airtal® cream, its use should be discontinued and appropriate treatment should be carried out.
• After applying Airtal® cream, you should wash your hands, except when the hands are the place where the cream is applied.
• Airtal cream should not be applied to the eyes or mouth.
• Airtal cream should not be used for the treatment of open wounds, mucous membranes, as well as irritation (eczematous) of the skin or in cases where there is any other pathological process on the skin at the site of application of the cream. The cream should only be applied to undamaged skin.
• There are no data on the use of Airtal cream in children.
• To prevent photosensitivity reactions, protect the area where the cream is applied from exposure to sunlight.
• Hypersensitivity and skin reactions. Just like other NSAIDs, Airtal cream may cause allergic reactions at the beginning of use, including anaphylactic/anaphylactoid reactions. Serious skin reactions, including fatal ones, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in rare cases associated with NSAID use. Patients are at the highest risk of such reactions at the beginning of the course of treatment, skin reactions in most cases occur during the first month of treatment. If skin rash, mucosal lesions, or other hypersensitivity symptoms occur, treatment with Airtal ® cream should be discontinued.
• In rare cases, varicella-zoster virus can cause serious complications in the form of skin and soft tissue infection. Currently, it is impossible to completely exclude the negative effect of NSAIDs on the course of these infections. In this regard, it is not recommended to use aceclofenac for infection caused by the varicella-zoster virus.
• 1 g of Airtal cream contains 0.002 g of methyl parahydrocybenzoate and 0.0005 g of propyl parahydrocybenzoate, which can cause allergic reactions (including delayed ones). Airtal cream also contains cetyl stearyl alcohol. It can cause local skin reactions (for example, contact dermatitis).

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Airtal ® cream does not affect the ability to drive vehicles and work with mechanisms.

Form of production

Cream for external use.

Storage conditions

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

Shelf

life is 2 years.

Active ingredient

Aceclofenac

Dosage form

cream

Purpose

For athletes, For adults as prescribed by a doctor

Indications

Bruises, Periarthritis, Swelling after injuries and operations, Lumbago, Rheumatoid Arthritis, Osteoarthritis, Sciatica, Sciatica, Osteoarthritis and arthritis