Ketotop Pain Relaxer^® (Transdermal patch) Instructions for Use

Marketing Authorization Holder

Handok, Inc. (Republic of Korea)

ATC Code

M02AA10 (Ketoprofen)

Active Substance

Ketoprofen (Rec.INN registered by WHO)

Dosage Form

Ketotop Pain Relaxer®

Patch 30 mg

Dosage Form, Packaging, and Composition

Patch

7 pcs. – bags – paper packs (7 pcs.) – Over-the-Counter

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 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 locations; tendinitis, bursitis; myalgia; neuralgia; radiculitis; injuries of the musculoskeletal system (including sports), muscle and ligament bruises, sprains, ligament and muscle tendon ruptures.

ICD codes

Dosage Regimen

Apply one patch to the affected area. Ensure the skin is clean, dry, and intact.

Use the patch twice daily. The standard application interval is approximately every 12 hours.

Do not exceed three patches within a 24-hour period.

Apply the patch to a different site with each application to minimize skin irritation.

Wash hands thoroughly after handling the patch.

The maximum duration of self-treatment without consulting a physician is 14 days.

Discontinue use and seek medical advice if symptoms persist or worsen.

Avoid applying the patch to broken, damaged, or irritated skin, including areas with rash, eczema, or infection.

Do not use the patch under occlusive dressings or with external heat sources.

Minimize or avoid exposure of the treated area to sunlight and other sources of UV radiation during treatment and for two weeks thereafter.

Adverse Reactions

Allergic reactions very rarely – angioedema, anaphylaxis.

Skin and subcutaneous tissue disorders infrequently – erythema, itching, burning, eczema, mild transient dermatitis; rarely – urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely – isolated case of severe contact dermatitis (against the background of poor hygiene and insolation), isolated 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 cessation 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 on the 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 as occlusive dressings.

Drug Interactions

Since the concentration of ketoprofen in 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.

Concomitant use of other topical agents containing Ketoprofen or other NSAIDs is not recommended.

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 2°C (36°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.