Ketoprofen (Gel) Instructions for Use
ATC Code
M02AA10 (Ketoprofen)
Active Substance
Ketoprofen (Rec.INN registered by WHO)
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, the synthesis of bradykinin, 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 locations; 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
| ICD-10 code | Indication |
| M02.3 | Reiter's disease |
| M05 | Seropositive rheumatoid arthritis |
| M07 | Psoriatic and enteropathic arthropathies |
| M15 | Polyosteoarthritis |
| M19.9 | Unspecified arthrosis |
| M42 | Spinal osteochondrosis |
| M45 | Ankylosing spondylitis |
| M47 | Spondylosis |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M65 | Synovitis and tenosynovitis |
| M70 | Soft tissue disorders related to use, overuse, and pressure |
| M71 | Other bursopathies |
| M75.0 | Adhesive capsulitis of shoulder |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| T14.0 | Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect) |
| T14.3 | Dislocation, sprain and strain of joint and ligament of unspecified body region |
| ICD-11 code | Indication |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| EH92 | Dermatoses provoked by friction or mechanical impact |
| EH92.1 | Blister due to friction |
| FA05 | Polyosteoarthritis |
| FA0Z | Osteoarthritis, unspecified |
| FA11.2 | Arthropathy following genitourinary system infection |
| FA20.0 | Seropositive rheumatoid arthritis |
| FA21.Z | Psoriatic arthritis, unspecified |
| FA85.Z | Defects of vertebral end-plates, unspecified |
| FA8Z | Degenerative disease of spine, unspecified |
| FA92.0Z | Ankylosing spondylitis, unspecified |
| FB40.Z | Tenosynovitis, unspecified |
| FB50.1 | Bursitis associated with use, overuse or pressure |
| FB50.Z | Bursitis, unspecified |
| FB53.0 | Adhesive capsulitis of shoulder |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.2 | Myalgia |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
| ND56.0 | Superficial injury of unspecified body region |
| ND56.3 | Dislocation, sprain or strain of unspecified body region |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Apply a sufficient amount of gel to cover the affected area two to three times daily.
Use the fingertip unit for accurate dosing: a strip of gel from the distal skin crease to the tip of the adult index finger is approximately 500 mg, sufficient for an area of 400-800 cm².
Gently massage the gel into the skin until fully absorbed.
Wash hands thoroughly with soap and water after each application, unless the hands are the treated area.
The maximum daily application area should not exceed 1000 cm² for a 2.5% gel.
The maximum single dose is 1 gram of gel (approximately two fingertip units).
The maximum daily dose is 3 grams of gel (approximately six fingertip units).
Do not exceed a treatment duration of 14 days for self-medication without consulting a physician.
For longer-term use, medical supervision is required to assess the need for continued therapy.
Discontinue use and consult a doctor if symptoms persist or worsen after 7 days of treatment.
Avoid applying the gel to broken skin, open wounds, or mucous membranes.
Do not apply under occlusive dressings or bandages.
After application, protect the treated area from sunlight and UV radiation (e.g., solarium) for the duration of treatment and for two weeks thereafter.
Adverse Reactions
Allergic reactions very rarely – angioedema, anaphylaxis.
Skin and subcutaneous tissue disorders uncommon – 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 – 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
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 an occlusive dressing.
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 simultaneously other topical products containing Ketoprofen or other NSAIDs.
Concomitant use of acetylsalicylic acid reduces the degree of binding of ketoprofen to blood 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Gel for external use 2.5%: tubes 30 g or 50 g
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
 |
Ketoprofen-Vertex | Gel for external use 2.5%: tubes 30 g or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use homogeneous, colorless or with a light yellow tint, transparent, with a characteristic odor; the presence of opalescence and air bubbles is allowed.
| 1 g | |
| Ketoprofen | 25 mg |
Excipients: propylene glycol – 100 mg, ethanol 95% (ethyl alcohol 95%) – 150 mg, carbomer – 10 mg, trolamine (triethanolamine) – 32 mg, benzalkonium chloride (50% solution) – 1 mg calculated as 100%, purified water – up to 1 g.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5%: tubes 30 g or 50 g
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Ketoprofen-Vertex | Gel for external use 5%: tubes 30 g or 50 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a light yellow tint, transparent, with the smell of ethanol; the presence of opalescence and air bubbles is allowed.
| 100 g | |
| Ketoprofen | 5 g |
Excipients: propylene glycol, ethanol 95% (ethyl alcohol 95%), carbomer, trolamine (triethanolamine), benzalkonium chloride (50% solution), purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Gel for external use 2.5%: 30 g, 50 g or 100 g tube
Gel for external use 5%: tube 30 g, 50 g, or 100 g
Marketing Authorization Holder
Stmfarm LLC (Russia)
Manufactured By
Avexima Siberia LLC (Russia)
Dosage Forms
|
Ketoprofen Avexima | Gel for external use 2.5%: 30 g, 50 g or 100 g tube |
| Gel for external use 5%: tube 30 g, 50 g, or 100 g |
Dosage Form, Packaging, and Composition
Gel for external use homogeneous, colorless or with a yellowish tint. The presence of opalescence is allowed.
| 1 g | |
| Ketoprofen | 25 mg |
Excipients: carbomer, trolamine (triethanolamine), ethanol 96%, lavender oil (lavender essential oil), purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
Gel for external use homogeneous, colorless or with a yellowish tint. The presence of opalescence is allowed.
| 1 g | |
| Ketoprofen | 50 mg |
Excipients: carbomer, trolamine (triethanolamine), ethanol 96%, lavender oil (lavender essential oil), purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
Gel for external use 2.5%: tubes 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, or 60 g
Marketing Authorization Holder
Danson-BG (Bulgaria)
Manufactured By
Vetprom, AD (Bulgaria)
Dosage Form
|
Ketoprofen DS | Gel for external use 2.5%: tubes 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, or 60 g |
Dosage Form, Packaging, and Composition
Gel for external use transparent or slightly opalescent, homogeneous, colorless or with a yellowish tint.
| 100 g | |
| Ketoprofen | 2.5 g |
Excipients: carbomer 940, trolamine, ethanol 96%, methylparahydroxybenzoate, water.
30 g – laminate tubes (1) – cardboard packs.
35 g – laminate tubes (1) – cardboard packs.
40 g – laminate tubes (1) – cardboard packs.
45 g – laminate tubes (1) – cardboard packs.
50 g – laminate tubes (1) – cardboard packs.
55 g – laminate tubes (1) – cardboard packs.
60 g – laminate tubes (1) – cardboard packs.
Gel for external use 25 mg/g: tubes 15 g, 25 g, 30 g, 50 g, 75 g, 100 g, 120 g, or 150 g.
Gel for external use 50 mg/g: tubes 15 g, 25 g, 30 g, 50 g, 75 g, 100 g, 120 g, or 150 g.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Forms
|
Ketoprofen Renewal | Gel for external use 25 mg/g: tubes 15 g, 25 g, 30 g, 50 g, 75 g, 100 g, 120 g, or 150 g. |
| Gel for external use 50 mg/g: tubes 15 g, 25 g, 30 g, 50 g, 75 g, 100 g, 120 g, or 150 g. |
Dosage Form, Packaging, and Composition
Gel for external use homogeneous, colorless or with a light yellow tint, transparent with a characteristic odor; the presence of opalescence and air bubbles is allowed.
| 1 g | |
| Ketoprofen | 25 mg |
Excipients: ethanol (ethyl alcohol) 95%, propylene glycol, trolamine (triethanolamine), carbomer, benzalkonium chloride, purified water.
15 g – tube (1) – cardboard packs.
25 g – tube (1) – cardboard packs.
30 g – tube (1) – cardboard packs.
50 g – tube (1) – cardboard packs.
75 g – tube (1) – cardboard packs.
100 g – tube (1) – cardboard packs.
120 g – tube (1) – cardboard packs.
150 g – tube (1) – cardboard packs.
Gel for external use homogeneous, colorless or with a light yellow tint, transparent with a characteristic odor; the presence of opalescence and air bubbles is allowed.
| 1 g | |
| Ketoprofen | 50 mg |
Excipients: ethanol (ethyl alcohol) 95%, propylene glycol, trolamine (triethanolamine), carbomer, benzalkonium chloride, purified water.
15 g – tube (1) – cardboard packs.
25 g – tube (1) – cardboard packs.
30 g – tube (1) – cardboard packs.
50 g – tube (1) – cardboard packs.
75 g – tube (1) – cardboard packs.
100 g – tube (1) – cardboard packs.
120 g – tube (1) – cardboard packs.
150 g – tube (1) – cardboard packs.
Gel for external use 2.5%: tubes 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g
Marketing Authorization Holder
Vetprom, AD (Bulgaria)
Dosage Form
|
Ketoprofen VP | Gel for external use 2.5%: tubes 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g |
Dosage Form, Packaging, and Composition
Gel for external use transparent or slightly opalescent, homogeneous, colorless or with a yellowish tint.
| 100 g | |
| Ketoprofen | 2.5 g |
Excipients: carbomer 940 – 2 g, ethanol 96% – 32 g, trolamine – 4 g, methylparahydroxybenzoate – 0.1 g, purified water – up to 100 g (59.4 g).
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
90 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
Gel for external use 2.5%: tube 40 g
Marketing Authorization Holder
Sopharma, JSC (Bulgaria)
Dosage Form
|
Ketoprofen Vramed | Gel for external use 2.5%: tube 40 g |
Dosage Form, Packaging, and Composition
Gel for external use 2.5% colorless, transparent or slightly opalescent, with a smell of essential oils and ethyl alcohol.
| 1 g | |
| Ketoprofen | 25 mg |
Excipients: ethanol 96%, carbomer 940, propylene glycol, diethanolamine, benzalkonium chloride, orange flower oil (synthetic), lavender oil, disodium edetate, macrogol 400, purified water.
40 g – aluminum tubes (1) – cardboard packs.
Gel for external use 5%: tubes 30 g, 50 g, or 100 g
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Ketoprofen-ACOS | Gel for external use 5%: tubes 30 g, 50 g, or 100 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a yellowish tint, homogeneous; the presence of opalescence is allowed.
| 100 g | |
| Ketoprofen | 5 g |
Excipients: carbomer (carbopol), ethanol 96% (rectified ethyl alcohol), trolamine (triethanolamine), lavender oil, purified water.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
Gel for external use 2.5%: 30 g, 50 g, or 60 g tubes
Marketing Authorization Holder
Teva Pharmaceutical Industries, Ltd. (Israel)
Manufactured By
Laboratoires Chemineau (France)
Dosage Form
|
Ketoprofen-Teva | Gel for external use 2.5%: 30 g, 50 g, or 60 g tubes |
Dosage Form, Packaging, and Composition
Gel for external use homogeneous transparent, with a smell of lavender and alcohol.
| 100 g | |
| Ketoprofen | 2.5 g |
Excipients: carbomer 980 – 2 g, ethanol 96% – 28.5 g, lavender flavor – 0.028 g, triethanolamine – 3.7 g (to pH – 6.5), purified water – up to 100 g.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
![Ketoprofen [Gel] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ketoprofen [Gel] 2")