Expiration date: 01/2026

The composition and form of issue: 

Gel for external use 2, 5% 1 g

active substance:

Ketoprofen 25 mg

excipients: carbomer trolamine (triethanolamine) ethanol 96% lavender oil (lavender essential oil) water 

in the aluminium tubes 50 grams, in a cardboard bundle 1 tuba.

Cream for external use 5% 1 g

active substance:

Ketoprofen 50 mg

excipients: methyl parahydroxybenzoate parahydroxybenzoate propylene glycol methyl ethyl ketone petroleum jelly (white) alpacas ST9 propylene glycol glyceryl oleate magnesium sulfate water 

in tubes of 30 or 50 grams in a cardboard bundle 1 tuba.

Description of dosage form:

Gel: homogeneous, colorless, transparent.

Cream: white or almost white, uniform.

Characteristic:

Ketoprofen is a NSAID.

Pharmacokinetics:

Ketoprofen is absorbed very slowly and practically does not cumulate in the body when applied locally in the form of gel. Bioavailability of gel-about 5%. It penetrates into subcutaneous tissue, ligaments and muscles, synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in plasma is extremely low. Ketoprofen is metabolized in the liver to form conjugates, which are excreted primarily in the urine. Metabolism of Ketoprofen is not dependent on age, presence of severe renal failure or cirrhosis of the liver. Excretion of Ketoprofen with urine is carried out slowly.

Description of the pharmacological action:

Ketoprofen inhibits COX, inhibits the activity of lipoxygenase and bradykinin. Stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process. The main properties of Ketoprofen are analgesic, anti-inflammatory and anti-edema effect. Ketoprofen has no negative effect on the condition of articular cartilage.

Indications:

Symptomatic therapy of painful and inflammatory processes of different origin, including:

• rheumatoid arthritis and periarthritis
  
• ankylosing spondylitis (Bekhterev's disease), psoriatic arthritis, reactive arthritis (Reuters syndrome)
  
• osteoarthritis of different localization
  
• tendinitis, bursitis, myalgia, neuralgia, radiculitis
  
• injuries of the musculoskeletal system (including sports), bruising of muscles and ligaments, sprains, rupture of ligaments and tendons of muscles.
  

Contraindications:

Total for the cream and gel were Ketonal

• hypersensitivity to Ketoprofen or other components of the drug, as well as salicylates or other NSAIDs
  
• indication of a history of bronchial asthma attacks after NSAIDs and salicylates
  
• pregnancy (III trimester)
  
• children's age (up to 12 years)
  
• violation of the integrity of skin (eczema, weeping dermatitis, open or infected wound).
  

For Ketonal cream additionally

With caution:

• impaired liver and/or kidney function
  
• erosive-ulcerative lesions of the gastrointestinal tract
  
• blood disease
  
• bronchial asthma
  
• chronic heart failure.
  

In the presence of the above conditions before applying Ketonal cream should consult with your doctor.

Application during pregnancy and breast-feeding:

Have Ketonal gel and cream is contraindicated in the third trimester of pregnancy.

Ketonal gel and cream can be used in the I and II trimesters of pregnancy after consultation with a doctor, if the expected benefit to the mother exceeds the possible risk to the fetus. The application of gel and cream has Ketonal during breastfeeding is not recommended.

Side effect:

Total for the cream and gel were Ketonal

Often there are local symptoms of skin irritation (3% of patients) in the form of erythema, itching and transient dermatitis of mild severity. One case of severe contact dermatitis on the background of poor hygiene and insolation, as well as one case of severe generalized photodermatitis are described. Photosensitization.

Respiratory system: very rarely — asthma attacks as a variant of an allergic reaction.

For Ketonal gel additionally

Urinary system: describes one case of deterioration of renal function in a patient with chronic renal failure after the drug was Ketonal gel. In rare cases, interstitial nephritis is found.

Drug interaction:

Total for the cream and gel were Ketonal

Not recommended the simultaneous use of other topical forms (ointments, gels) containing Ketoprofen or other NSAIDs.

The simultaneous intake of acetylsalicylic acid reduces the degree of binding of Ketoprofen to plasma proteins.

Ketoprofen, like other NSAIDs, may reduce the excretion of methotrexate and increase its toxicity.

Interaction with other drugs and the impact on their elimination are not significant.

For Ketonal gel additionally

Since the concentration of the drug in plasma is extremely low, symptoms of interaction with other drugs (similar to symptoms in systemic use) are possible only with frequent and prolonged use.

Patients taking coumarin-containing antifouling drugs are recommended to be treated under the supervision of a doctor.

Method of application and doses:

Outwardly.

Gel. A small amount of gel (3-5 see) mark thin layer on the skin inflamed or painful area of the body 1-2 times a day and gently rubbed in.

The dosage should be adjusted in accordance with the size of the affected area: 5 cm was Ketonal gel correspond to the 100 mg of Ketoprofen, 10 cm — 200 mg of Ketoprofen.

If necessary, have Ketonal gel can be combined with other dosage forms were Ketonala.

The maximum dose of Ketoprofen is 200 mg / day.

Occlusive dressing is not recommended.

Do not use without medical advice for more than 14 days.

Cream. A small amount of cream (about 3-5 cm) light rubbing movements apply a thin layer to the skin of an inflamed or painful area of the body 2-3 times a day. The duration of treatment without medical advice should not exceed 14 days.

Overdose:

Symptoms: irritation, erythema and itching.

Treatment: in case of overdose, the skin should be thoroughly washed under running water, stop using gel and Ketonal cream and consult your doctor.

Special instruction:

Have Ketonal gel should not be applied to damaged skin (eczema, weeping dermatitis, open or infected wound).

Have Ketonal gel and cream can be used in combination with other medicinal forms have Ketonala (capsules, tablets, candles). The total daily dose, regardless of dosage form, should not exceed 200 mg.

It is necessary to avoid getting gel and Ketonal cream on mucous membranes, in the eyes and on the skin around the eyes.

If there are any side effects, it is necessary to stop using the drug and consult a doctor.

If the patient forgot to apply the cream, you should apply it at a time when the next dose should be applied, but do not double it.

If skin irritation occurs, therapy should be temporarily discontinued. With severe irritation, it is not recommended to continue therapy.

During therapy and within 2 weeks after its termination direct sunlight and UV irradiation should be avoided.

Influence on the ability to drive vehicles and work with mechanisms.Data on the impact of the drug was Ketonal the effect on physical activity no.