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

Excipients: propylene glycol 10.0 g, ethanol 95% (ethanol 95%) 15.0 g, carbomer (carbomer 940) 1.3 g, trolamine (triethanolamine) 5.2 g, benzalkonium chloride (50% solution) 0.1 g in terms of 100%, purified water up to 100 g.

Description:

Colorless or slightly yellowish shade 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:

Non-steroidal anti-inflammatory agent, a derivative of propionic acid. Has a local anti-inflammatory, antiexudative and analgesic effect. The mechanism of action is associated with the suppression of the activity of cyclooxygenase 1 and 2, which regulates the synthesis of prostaglandins. In the form of a gel has a local anti-inflammatory effect against the affected joints, tendons, ligaments, muscles. With articular syndrome, weakening of pain in the joints at rest and movement, reduction of morning stiffness and swelling of the joints. Does not render catabolic effect on articular cartilage.

Pharmacokinetics:

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

Indications:

- Acute and chronic inflammatory diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, inflammatory lesions 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).

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

Contraindications:

- Hypersensitivity to ketoprofen or other components of the drug;

- hypersensitivity to other non-steroidal anti-inflammatory drugs;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history);

- violation of integrity, skin, wetting dermatoses, eczema, infected abrasions, wounds - at the site of the intended application;

- pregnancy (III trimester);

- the period of breastfeeding;

- children's age (up to 6 years).

Carefully:

Hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract, severe violations of the liver and / or kidney function, chronic heart failure, bronchial asthma, elderly age, children ages 6 to 12 years, Pregnancy I and II trimester.

Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. In the first and second trimesters of pregnancy, the use of the drug is possible after consultation with the doctor only if the potential benefit to the mother exceeds, the potential risk to the fetus.

If you need to use the drug during lactation, breastfeeding, you should stop breastfeeding.

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 and painful areas 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 you can impose a dry bandage. Can be used in phonophoresis.

The duration of treatment is no more than 14 days without consulting a doctor.

Side effects:Local Reactions: skin hyperemia, exanthema, photodermatitis, purpura.

With prolonged use on extensive surfaces, it is possible to develop systemic side effects: urticaria, generalized skin rash, swelling, photosensitivity, stomatitis.

Overdose:

No data available.

Interaction:

Despite the insignificant degree of absorption of ketoprofen through the skin, with frequent and long-term use there may appear symptoms of interaction with other drugs (same as in systemic application).

When co-administered with other NSAIDs, GCS, ethanol, corticotropin, ulceration and the development of gastrointestinal bleeding may occur.

When combined, increases the toxicity of methotrexate.

Special instructions:

The gel should be applied only to intact skin.

Avoid contact with eyes.

Do not use the drug for an occlusive dressing.

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

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 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:

In a dry place 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:LP-001401

Date of registration:28.12.2011

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: & nbsp28.12.2011

Illustrated instructions

Instructions

Ketoprofen (Ketoprofen)