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

atExcipients: carbomer 980 - 1.5 g, ethanol (ethyl alcohol rectified from food raw materials 96%) - 24.0 g, lavender oil - 0.097 g macrogol (polyethylene 400) - 10.0 g of diethanolamine to pH 5,0-7,5 g, purified water - up to 100.0 g.

Description:

Colorless, transparent or almost transparent gel, homogeneous in consistence with a fragrant smell. Air bubbles are allowed.

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

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Nonsteroidal anti-inflammatory drug has a local anti-inflammatory, analgesic and antipyretic actions associated with the suppression of activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) regulating the synthesis of prostaglandins (Pg). When the articular syndrome causes a weakening of arthralgia at rest and during movement, reducing the "morning stiffness" and swelling of the joints.

Pharmacokinetics:

With topical application in the form of a gel, it penetrates into the focus of inflammation through the skin and is absorbed from the inflammation focus extremely slowly, practically not cumulating in the body. Bioavailability of the gel is about 5%. After application in a dose of 50-150 mg concentration in the blood plasma after 5-8 hours is 0.08-0.15 μg / ml.

Indications:

- Diseases of the musculoskeletal system (articular syndrome: with exacerbation of gout, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory lesions of ligaments, tendons, lumbago, bursitis, sciatica, psoriatic arthritis);

- muscular pain of rheumatic and non-rheumatic origin;

- injuries of the musculoskeletal system (including sports), post-traumatic inflammation of soft tissues.

The drug is intended for symptomatic therapy, the progression of the disease is not affected.

Contraindications:

- Individual hypersensitivity to ketoprofen or other components of the drug;

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

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

- pregnancy III trimester;

- lactation period;

- children's age - up to 12 years.

Carefully:

Erosive-ulcerative lesions of the gastrointestinal tract, pronounced violations of kidney and liver function, hepatic porphyria; chronic heart failure, bronchial asthma, pregnancy I and II trimester.

Pregnancy and lactation:

Due to the fact that adequate and controlled studies of the safety of the use of the drug in pregnant women have not been carried out and since the adverse effect of agents inhibiting the synthesis of PG on the fetal cardiovascular system (premature closure of the arterial duct) is known; ketoprofen should be used with caution in the I and II trimester of pregnancy. The use of the drug in the third trimester of pregnancy is contraindicated.

Like other substances that are excreted in breast milk, it is not recommended to use ketoprofen during lactation.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12 a small amount of gel (3-5 cm) is applied 2-3 times a day with a thin layer on the injured area or skin over the focus of inflammation and lightly rub.

The duration of the course of treatment without consulting a doctor should not exceed 14 days.

Side effects:

Allergic reactions: skin hyperemia, photosensitivity, skin exanthema, purpura.

With prolonged use on extensive surfaces, it is possible to develop systemic side effects, such as: violations of the gastrointestinal tract: bleeding, diarrhea, peptic ulcer.

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

Overdose:

Low systemic absorption of the active component of the drug with external application makes an overdose almost impossible. In case of accidental ingestion of a large amount of gel (more than 20 g), systemic undesirable reactions characteristic of non-steroidal anti-inflammatory drugs (NSAIDs) may occur. It is necessary to wash the stomach, taking activated charcoal.

Interaction:

Pharmaceutically incompatible with tramadol solution.

Joint reception with other non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoid agents (GCS), ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding.

Simultaneous administration with indirect and direct anticoagulants, thrombolytic agents, antiplatelet agents, cefoperazone, cefamandole, cefotetan and latamoxef increases the risk of bleeding.

Reduces the effect of antihypertensive drugs (LS) and diuretics (inhibition of prostaglandin synthesis (Pg)).

Increases hypoglycemic action of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Co-administration with valproic acid causes disruption of platelet aggregation.

Increases the concentration in the plasma of verapamil and nifedipine.

Special instructions:

Avoid getting the drug on the mucous membrane of the eyes (danger of irritation of the conjunctiva);

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

Do not use in the form of occlusive dressings. Do not use in combination with airtight 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 using the drug).

Patients with severe renal failure should be careful when using the drug Ketoprofen gel.

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

A drug Ketoprofen gel does not affect the ability to drive vehicles and work requiring increased concentration of attention.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

For 30, 50 g in tubes of aluminum.

Each tube together with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use at the end of the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002206

Date of registration:28.08.2013

Expiration Date:28.08.2018

The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Manufacturer: & nbsp

BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Representation: & nbspBORISOVSKIY FACTORY OF MEDPREPARATES, OJSCBORISOVSKIY FACTORY OF MEDPREPARATES, OJSC

Information update date: & nbsp05.01.2018

Illustrated instructions

Instructions

Ketoprofen (Ketoprofen)