Ketonal - instructions for use, dose, side effects, contraindications

Ketoprofen is one of the most effective inhibitors of cyclooxygenases. It also inhibits the activity of lipoxygenase and bradykinin. It stabilizes the lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

The main properties of ketoprofen are analgesic, anti-inflammatory and anti-edematous action.

Ketoprofen does not adversely affect the condition of the articular cartilage.

Pharmacokinetics:

Ketoprofen, when applied topically in the form of a gel, is absorbed extremely slowly and practically does not accumulate in the body. Bioavailability of the gel is about 5%.It penetrates into the synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in the plasma is extremely low.

Ketoprofen is metabolized in the liver with the formation of conjugates, which are excreted mainly in the urine. Metabolism of ketoprofen does not depend on age, the presence of severe renal failure or cirrhosis of the liver.

Excretion of ketoprofen with urine is slow.

Indications:

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

- rheumatoid arthritis and periarthritis;

- ankylosing spondylitis (Bechterew's disease), psoriatic arthritis, reactive arthritis (Reiter's syndrome);

osteoarthrosis of different localization;

- tendonitis, bursitis, myalgia, neuralgia, sciatica;

- injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments,

sprains, ligament tears and muscle tendons.

Contraindications:

- Hypersensitivity to ketoprofen or other components of the drug, and

also to salicylates, tiaprofenic acid, or other non-steroidal

anti-inflammatory drugs, fenofibrate, blockers of UV rays, fragrances;

- an indication in an anamnesis for seizures of bronchial asthma after the application of NSAIDs and salicylates;

- III trimester of pregnancy;

- Children's age (up to 15 years);

- violation of the integrity of the skin (eczema, dandruff, open or infected wound);

- photosensitivity reaction in the anamnesis;

- exposure to sunlight, incl. indirect sunlight and ultraviolet irradiation in the solarium throughout the treatment period and 2 more weeks after discontinuation of treatment with the drug.

Carefully:

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

Pregnancy and lactation:

Ketonal® gel is contraindicated in the third trimester of pregnancy.

Ketonal® gel can be used in the first and second trimesters of pregnancy after consultation with the doctor if the expected benefit to the mother exceeds the possible risk to the fetus.

The use of Ketonal® gel during breastfeeding is not recommended.

Dosing and Administration:

For external use.

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

Dosage should be selected according to the area of the affected area: 5 cm Ketonal® gel corresponds to 100 mg of ketoprofen, 10 cm to 200 mg of ketoprofen.

If necessary Ketonal® gel can be combined with other Ketonala dosage forms (capsules, tablets, rectal suppositories).

The maximum dose of ketoprofen is 200 mg / day.

An occlusive dressing is not recommended.

Do not use without consulting a doctor for more than 14 days.

Side effects:

The most frequent manifestations associated with the use of a gel containing ketoprofen, are local manifestations.

Classification of adverse reactions by the frequency of their detection: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (<1/10000).

Allergic reactions: very rare - angioedema, anaphylaxis.

From the skin and skin appendages: infrequently - erythema, itching, burning, eczema, transient dermatitis of a lethal severity; rare - hives, rashes, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely - a single case of severe contact dermatitis (against a background of poor hygiene and insolation),single case of severe generalized photodermatitis, toxic epidermal necrolysis.

From the respiratory system: rarely - asthmatic attacks as a variant of an allergic reaction.

From the side of the urinary system: rarely - a single case of impaired renal function in a patient with chronic renal failure after using Ketonal® gel, interstitial nephritis occurs in single cases.

Overdose:

Symptoms of overdose are irritation, erythema and pruritus.

In case of an overdose, the skin should be thoroughly rinsed under running water, stop using Ketonal® gel and consult a doctor.

Interaction:

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

It is not recommended simultaneous use of other topical forms (ointments, gels) containing ketoprofen or other NSAIDs.

Simultaneous reception of acetylsalicylic acid reduces the degree of binding of ketoprofen to plasma proteins.

Krtoprofen, like other NSAIDs, can reduce the excretion of methotrexate and increase its toxicity.

Interaction with other drugs and the effect on their excretion are not significant.

Patients taking kumarin containing anticoagulants are recommended to undergo medical treatment under the supervision of a doctor.

Special instructions:

You should avoid getting the gel in the eyes, on the skin around the eyes, mucous membranes.

If any side effects occur, discontinue use and consult a doctor.

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

Gel for external use Ketonal ® can be used in combination with other medicinal forms of Ketonal ® (capsules, tablets, candles). The total daily dose, regardless of the dosage form, should not exceed 200 mg.

When skin reactions appear, including those that develop when combined with octocrylene-containing drugs, treatment should be discontinued immediately.

To reduce the risk of photosensitivity, it is recommended to protect gel-treated skin areasclothing from exposure to UFO throughout the treatment period and another 2 weeks after discontinuation of use. Do not use in the form of occlusive dressings.

Wash hands thoroughly after each application.

Effect on the ability to drive transp. cf. and fur:

Data onb negative influence of Ketonal ® gel on the ability to drive vehicles and engage in other potentially dangerous activities that require concentration of attention and speed of psychomotor reactions are not present.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

50 g or 100 g in an aluminum tube sealed with a membrane on the neck of the lip, sealed with a screwed plastic cap, equipped with a cone-shaped device for puncturing the membrane.

One tube together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-010502/08

Date of registration:24.12.2008

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SANDOZ, d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp22.05.2015

Illustrated instructions

Instructions

Ketonal® (Ketonal®)