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

Excipients: propylene glycol 10.0 g, ethanol 95% (ethyl alcohol 95%) 15.0 g, carbomer (carbomer 940) 1.0 g, trolamine (triethanolamine) 3.2 g, benzalkonium chloride (50% solution) 0.1 g in terms of 100%, water purified to 100.0 g.

Description:

Colorless transparent gel with the smell of ethanol.

Opalescence and air bubbles are allowed.

Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:Has a local anti-inflammatory, antiexudative and analgesic effect. In the form of a gel provides a local therapeutic effect on the affected joints, tendons, ligaments, muscles. With articular syndrome, weakening of pain in joints at rest and during movement, reduction of morning stiffness and swelling of the joints.

Has no catabolic effect on articular cartilage.

Pharmacokinetics:

With topical application in the form of gel ketoprofen absorbed extremely slowly and almost does not cumulate in the body.Bioavailability of ketoprofen is about 5%. After application in a dose of 50-150 mg concentration in the plasma after 5-8 hours - 0.08-0.15 μg / ml

Indications:Acute and chronic inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, ankylosing spondylitis, arthrosis, osteochondrosis); back injury-motor apparatus (including sports), sprains of ligaments, ruptures of ligaments and tendons of muscles, tendonitis, contusion of muscles and ligaments, edema, phlebitis, lymphangitis, inflammatory processes of the skin.

Contraindications:

- Hypersensitivity to the components of the drug, acetylsalicylic acid or other NSAIDs;

- 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);

- pregnancy (III trimester);

- lactation period;

- Children's age (up to 6 years);

- violation of the integrity of the skin, wet dermatoses, eczema, infected abrasions, wounds in the place of intended application.

Carefully:

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe disorders of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, children under 12 years, pregnancy I and II trimester.

Pregnancy and lactation:

The drug should not be used in the III trimester of pregnancy. Use in I and II trimesters is possible only after consultation with a doctor.

Experiences with the use of ketoprofen preparations during lactation are not available.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12 apply a small amount of gel (3-5 cm) 2-3 times a day with a thin layer, followed by a long and careful rubbing into the inflamed or painful parts of the body.

Children from 6 to 12 years old Apply no more than 1-2 cm of the gel not more than 2 times a day.

After rubbing the gel, a dry bandage can be applied.

Can be used in phonophoresis.

Duration of treatment - 12-14 days or more (after consulting a doctor).

Side effects:

Local Reactions: allergic dermatitis, skin eczema / hyperemia, photodermatitis, bullous dermatitis, skin exanthema, purpura.

Systemic reactions: urticaria, generalized skin rash, swelling, photosensitivity, stomatitis.

Overdose:

No data available.

Interaction:Despite the small degree of absorption of ketoprofen through the skin during topical application, it is possible that the drug can interact with other NSAIDs or with methotrexate in the caseapplication of the latter in high doses.

Special instructions:

Do not apply gel to open wounds and inflamed skin. Avoid contact with the eye gel.

Do not use the drug for an occlusive dressing.

After applying the gel, you should immediately wash your hands.

In order to avoid manifestations of hypersensitivity and photosensitivity, it is recommended to avoid exposure to the skin of direct sunlight during the course of treatment.

When skin rash occurs, local drug use should be discarded.

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

The drug does not affect the ability to drive vehicles and work with potentially dangerous mechanisms.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

For 30 g or 50 g in aluminum tubes.

Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001968

Date of registration:09.08.2011

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia

Information update date: & nbsp14.03.2012

Illustrated instructions

Instructions

Ketoprofen (Ketoprofen)