Ketoactin (Gel) Instructions for Use

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

ATC Code

M02AA10 (Ketoprofen)

Active Substance

Ketoprofen (Rec.INN registered by WHO)

Dosage Form

Ketoactin

Gel for external use 2.5%: 30 g, 40 g, 50 g or 100 g tubes

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, transparent, colorless or with a yellowish tint, with the smell of ethanol; opalescence is allowed.

Excipients: ethanol 95% – 15 g, propylene glycol – 10 g, trolamine – 3.2 g, carbomer – 1 g, benzalkonium chloride – 0.1 g, purified water – up to 100 g.

30 g – aluminum tubes (1) with caps – cardboard packs.
40 g – aluminum tubes (1) with caps – cardboard packs.
50 g – aluminum tubes (1) with caps – cardboard packs.
100 g – aluminum tubes (1) with caps – cardboard packs.
30 g – tubes made of combined material (1) with caps – cardboard packs.
40 g – tubes made of combined material (1) with caps – cardboard packs.
50 g – tubes made of combined material (1) with caps – cardboard packs.
100 g – tubes made of combined material (1) with caps – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; non-steroidal anti-inflammatory drugs for external use

Pharmacological Action

NSAID. It has analgesic, anti-inflammatory and anti-edematous effects. It inhibits the activity of COX, which leads to the suppression of prostaglandin synthesis. In addition, Ketoprofen inhibits lipoxygenase, bradykinin synthesis, stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

Ketoprofen does not have a negative effect on the condition of the articular cartilage.

Pharmacokinetics

Ketoprofen is absorbed very slowly and practically does not accumulate in the body. Bioavailability is 5%. Ketoprofen penetrates into the subcutaneous tissue, ligaments and muscles, synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in the blood plasma is extremely low. Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine. Ketoprofen is characterized by slow excretion in the urine.

Indications

Symptomatic therapy of painful and inflammatory processes of various origins, including: rheumatoid arthritis and periarthritis; ankylosing spondylitis (Bekhterev’s disease); psoriatic arthritis; reactive arthritis (Reiter’s syndrome); osteoarthritis of various localizations; tendinitis, bursitis; myalgia; neuralgia; radiculitis; injuries of the musculoskeletal system (including sports), muscle and ligament bruises, sprains, ruptures of ligaments and muscle tendons.

ICD codes

Dosage Regimen

Apply a sufficient amount of gel to cover the affected area. Use 2 to 3 times daily.

Administer a strip of gel 3 to 5 cm long for smaller areas; use a strip of 5 to 10 cm for larger body surfaces.

Gently rub the gel into the skin until fully absorbed.

Wash hands thoroughly with soap and water after each application.

The duration of treatment should not exceed 14 days without consulting a physician.

Discontinue use if no improvement is observed within this period and seek medical advice.

Avoid contact with eyes, mucous membranes, and broken or infected skin.

Do not apply under occlusive dressings.

Minimize or avoid exposure of treated skin areas to sunlight and UV radiation during treatment and for two weeks thereafter.

When used concomitantly with oral ketoprofen, ensure the total daily dose from all formulations does not exceed 200 mg.

Adverse Reactions

Allergic reactions very rarely – angioedema, anaphylaxis.

Skin and subcutaneous tissue disorders infrequently – erythema, itching, burning, eczema, transient mild dermatitis; rarely – urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely – a single case of severe contact dermatitis (against the background of poor hygiene and insolation), a single case of severe generalized photodermatitis, toxic epidermal necrolysis.

Respiratory system disorders very rarely – asthmatic attacks (as a variant of an allergic reaction).

Urinary system disorders very rarely – deterioration of renal function in patients with chronic renal failure.

Contraindications

Hypersensitivity to ketoprofen; hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, to fenofibrate, UV blockers, fragrances; violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound); history of bronchial asthma attacks caused by taking NSAIDs and salicylates; history of photosensitivity reactions; exposure to sunlight, including indirect sunlight and UV radiation in a solarium throughout the entire treatment period and for another 2 weeks after the end of treatment; III trimester of pregnancy; children under 15 years of age.

With caution

Impaired liver and/or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Use in Pregnancy and Lactation

Use is contraindicated in the III trimester of pregnancy. Use in the I and II trimesters is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Use during lactation (breastfeeding) is not recommended.

Use in Hepatic Impairment

Should be used with caution in case of impaired liver function.

Use in Renal Impairment

Should be used with caution in case of impaired renal function.

Pediatric Use

Contraindication: children under 15 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

It is necessary to avoid getting this product into the eyes, on the skin around the eyes, and mucous membranes.

Ketoprofen can be used externally in combination with oral administration. The total daily dose, regardless of the dosage form, should not exceed 200 mg.

To reduce the risk of developing photosensitivity, it is recommended to protect the skin areas treated with ketoprofen with clothing from exposure to UV radiation throughout the entire treatment period and for another 2 weeks after stopping the use of the gel.

Do not use in the form of occlusive dressings.

Drug Interactions

Since the concentration of ketoprofen in the blood plasma is extremely low, manifestations of interaction symptoms with other drugs (similar symptoms with systemic use) are possible only with frequent and long-term use.

It is not recommended to use other topical agents containing Ketoprofen or other NSAIDs simultaneously.

Concomitant administration of acetylsalicylic acid reduces the degree of binding of ketoprofen to plasma proteins.

Ketoprofen reduces the excretion of methotrexate and contributes to an increase in its toxicity.

Patients taking coumarin-containing anticoagulants are recommended to undergo treatment under medical supervision.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.