Ketoprofen - instructions for use, doses, side effects, contraindications

Has a local anti-inflammatory, antiexudative and analgesic effect. Inhibiting cyclooxygenase I and II type, inhibits the synthesis of prostaglandins. Has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes that contribute to tissue destruction in chronic inflammation.

Ketoprofen, penetrating through the skin, reaches the focus of inflammation, thus providing the opportunity for local treatment of lesions (joints, tendons, ligaments and muscles) accompanied by pain syndrome.

With articular syndrome, weakening of pain in the joints in mowing and motion, a decrease in morning stiffness and swelling of the joints.

Pharmacokinetics:

With external application penetrates into the focus of inflammation through the skin, the absorption of ketoprofen from the focus of inflammation into the systemic blood flow is extremely slow (bioavailability of the gel is about 5%). After application in a dose of 50-150 mg of ketoprofen, the concentration in the blood plasma after 5-8 hours is 0.08-0.15 μg / ml. Practically does not cumulate in the body. It is excreted primarily through the kidneys in the form of glucuronide.

Indications:

- Acute and chronic inflammatory diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory defeat of ligaments and tendons, bursitis, sciatica, lumbago);

- muscular pain of rheumatic and non-rheumatic origin;

- Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Individual hypersensitivity to ketoprofen or other components of the drug, acetylsalicylic acid or other NSAIDs (history of bronchospasm, urticaria or rhinitis caused by acetylsalicylic acid), tiaprofenic acid and fenofibrate;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis);

- increased sensitivity of the skin to the effects of solar radiation (photosensitization) in the anamnesis;

- skin allergy in a history of sunscreen or perfume;

- exposure of the sun to the treated areas, including the solarium, during the course of the drug and 2 weeks after;

- wet dermatoses, eczema, infected abrasions, wounds (at the site of application of the gel);

- Children under 12 years of age (efficacy and safety not studied);

- Pregnancy (III trimester) and the period of breastfeeding.

Carefully:

Hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidneys,chronic heart failure, bronchial asthma, advanced age, pregnancy (I and II trimester).

Pregnancy and lactation:

The use of the drug during breast-feeding is not recommended.

Dosing and Administration:

For external use.

A strip of gel 5-10 cm long is applied a thin layer on the affected area or skin over the focus of inflammation 2 times a day and lightly rubbed.

The amount of gel applied depends on the size of the treated area.

It is possible to use ketoprofen in combination with physiotherapy (phonophoresis and ionophoresis).

Dosage in children aged 12 years corresponds to that in adults and depends on the site of application and the doctor's recommendations.

Side effects:

Possible side effects are given in the descending frequency of occurrence: very often (> 10%), often (> 1%, <10%), infrequently (> 0.1%, <1%), rarely (> 0.01%, <0.1%), very rarely (<0.01 %).

From the skin: infrequently - erythema, itching, eczema; rarely - photosensitivity, bullous dermatitis, urticaria; very rarely - contact dermatitis, angioedema.

From the gastrointestinal tract: very rarely - peptic ulcer, bleeding, diarrhea.

From the immune system: very rarely - anaphylactic reactions, hypersensitivity reactions.

From the urinary system: very rarely - aggravation of the course of renal failure.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.

In case of accidental ingestion of large amounts of the drug (more than 20 g), systemic undesirable reactions characteristic of NSAIDs may occur. It is necessary to wash the stomach, taking activated charcoal. Treatment is symptomatic.

Interaction:With external application of ketoprofen in the form of a gel, it is possible to increase the effect of drugs that cause photosensitization. Other interactions are not established, however, it is recommended that patients who take anticoagulants of the coumarin series regularly monitor the international normalized relationship (INR).

Special instructions:

Do not apply to damaged (including open wounds) and inflamed skin!

Avoid contact with eyes (danger of irritation of the conjunctiva).

It is recommended to wash hands thoroughly after applying the drug.

Do not use in the form of hermetic bandages. Do not use in conjunction with hermetic clothing.

Long-term use of topical agents can lead to increased sensitivity or local irritation.

To avoid any manifestations of hypersensitivity or photosensitivity, direct sunlight should be avoided (including a visit to the solarium) during the treatment period and within two weeks after application of the drug and it is recommended to cover the treated areas with clothing. Patients with severe renal, cardiac or liver failure should be careful with ketoprofen.

It should stop using the drug in case of any skin reaction, including reactions while applying to the skin of sunscreen or other cosmetics containing an organic sunscreen octocrylene.

When using the drug in large amounts, it is possible, in very rare cases, the development of systemic side effects (hypersensitiveawn, bronchialstma, disorders of the gastrointestinal tract, aggravation of the course of renal failure).

The risk of systemic side effects increases depending on the amount of gel applied,the area of the treated area of the skin, the state of the skin, the duration of treatment.

Avoid sunlight or UV rays, including a solarium, on the treated areas during the treatment period and within two weeks after treatment.

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

The drug does not affect the ability to drive and other mechanical means.

Form release / dosage:Gel for external use 2.5%.

Packaging:

For 30, 50 or 100 g in tubes are aluminum.

Each tube, together with the instruction for use, is placed in a cardboard package (bundle).

Storage conditions:

In a protected spotlight 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:LP-002891

Date of registration:03.03.2015

Expiration Date:03.03.2020

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp05.01.2018

Illustrated instructions

Instructions

Ketoprofen (Ketoprofen)