Ketoprofen (Gel, cream)

Active material: Ketoprofen
When ATH: M02AA10
CCF: NSAIDs for outdoor use
ICD-10 codes (testimony): M02, M02.3, M05, M07, M10, M15, M45, M54.1, M65, M70, M71, M79.1, M79.2, R52.0, T14.0, T14.3
At KFU: 05.01.02
Manufacturer: LEK d.d. (Slovenia)

Pharmaceutical form, composition and packaging

◊ Gel for external use 2.5% uniform, colorless, clear.

Excipients: karʙomer, trolamin (triethanolamine), ethanol 96%, Lavender essential oil, water.

50 g – aluminum tuba (1) – packs cardboard.

◊ Cream for external application 5% white or nearly white, uniform.

Excipients: metilgidroksiʙenzoat, propyl, propylene glycol, isopropylmyristate, white petrolatum, elfakos ST9, Propylene glycol glyceryl oleate, magnesium sulfate, water.

30 g – aluminum tuba (1) – packs cardboard.
50 g – aluminum tuba (1) – packs cardboard.

Pharmacological action

NSAIDs, propionic acid. It has analgesic, anti-inflammatory and antipyretic effect. The mechanism of action is associated with inhibition of prostaglandin synthesis at the level of cyclooxygenase. Besides, Ketoprofen inhibits lipoxygenase, It has antibradikininovoy activity, stabilizes the lysosomal membrane, It prevents the release of enzymes, involved in the inflammatory process.

Ketoprofen has no negative impact on the status of articular cartilage.

Pharmacokinetics

Absorption

When topically applied ketoprofen vsyvaetsya slowly and hardly accumulates in the body. Bioavailability is 5%. Ketoprofen is well into the subcutaneous tissue, ligaments and muscles, synovial fluid and there reaches therapeutic levels. The concentration of drug in the blood plasma is very low.

Metabolism and excretion

Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine. Ketoprofen is characterized by slow excretion in the urine.

Pharmacokinetics in special clinical situations

Metabolism of ketoprofen not depend on the age, the presence of severe renal failure or liver cirrhosis.

Testimony

Symptomatic treatment of painful and inflammatory processes of various origins, including:

- Rheumatoid arthritis and periarthritis;

- Ankylosing spondylitis (ankylosing spondylitis);

- Psoriatic arthritis;

- Reactive arthritis (Reiter's syndrome);

- Osteoarthritis of different localization;

- Tendonitis, ʙursita;

- Mialgii;

- Neuralgia;

- Radikulita;

- Injuries of the musculoskeletal system (incl. Sports), bruises and sprains, sprains ankle, tears of ligaments and tendons muscles.

Dosage regimen

A small amount of gel (3-5 cm) put a thin layer on the skin over the lesion 1-2 times / day, gently rubbing the skin. The dose depends on the area affected: 5 cm gel match 100 mg ketoprofen, 10 cm gel match 200 mg ketoprofen.

A small amount of cream (3-5 cm) put a thin layer on the skin over the lesion 2-3 times / day, gently rubbing.

Ketoprofen^® in the form of a gel may be used in combination with other medicinal forms Ketonala^® (capsules, tablets, suppozitorii). The total maximum daily dose, irrespective of dosage forms, should not exceed 200 mg.

Ketoprofen^® in cream form can be used in combination with other forms Ketonala^® (capsules, tablets, suppozitorii). The total dose regardless of dosage form not exceed 300 mg.

The duration of the treatment without consulting your doctor – no more 14 days.

The use of occlusive dressings are not recommended.

Side effect

Dermatological reactions: in 3% cases – эritema, itch, bland transient dermatitis; rarely - photosensitivity. Described 1 cases of severe contact dermatitis due to poor hygiene and exposure to the sun and 1 cases of severe generalized dermatitis.

The respiratory system: rarely – asthmatic attacks (alternatively the allergic reaction).

From the urinary system: described 1 in case of deterioration of kidney function in patients with chronic renal failure after applying Ketonala^® in the form of a gel; in a few cases – interstitial nephritis.

Contraindications

- Indicate a history of bronchospasm, urticaria and rhinitis, caused by NSAIDs and salicylates.

- Violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound);

- III trimester of pregnancy;

- Children up to age 12 years;

- Hypersensitivity to ketoprofen or other ingredients, aspirin or other NSAIDs;

FROM caution It should appoint a drug in violation of the liver and / or kidney, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, asthma, chronic heart failure.

Pregnancy and lactation

The drug is contraindicated for use in the III trimester of pregnancy.

Application of I and II may in cases trimesters, when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Ketoprofen^® should not be used during lactation (breast-feeding).

Cautions

When using Ketonala^® Avoid contact with the drug on the mucous membranes, the eyes and the skin around the eyes.

When side effects, stop using the product.

The total daily dose regardless of dosage form not exceed 200 mg.

During therapy, and for 2 weeks after discontinuation of therapy should avoid direct sunlight and UV radiation.

After applying the cream or gel should be thoroughly wash your hands.

If irritation of the skin should temporarily discontinue therapy. When expressed irritation continue therapy is not recommended.

If the patient has forgotten to put the cream, it should use it while, when you need to apply another dose, but doubling it.

Effects on ability to drive vehicles and management mechanisms

No data.

Overdose

Symptoms Overdose Ketonala^® in dosage forms for external application is not registered. There may be skin reactions – irritation, эritema, itch.

Recommended cancel product, the application of the gel should be thoroughly wash skin with running water. If necessary spend symptomatic therapy.

Drug Interactions

Since the concentration of drug in plasma is extremely low, symptoms of interaction with other drugs (Similar symptoms when administered systemically) only possible with frequent and prolonged use.

Not recommended simultaneous application of other topical forms (ointment, Gels), containing ketoprofen or other NSAIDs.

Simultaneous treatment with acetylsalicylic acid reduces the binding of ketoprofen plasma proteins.

Ketoprofen reduces excretion of methotrexate and increases its toxicity.

Interactions with other drugs and the effect on their elimination are not significant.

In appointing Ketonala^® patients, receiving coumarin, recommended medical supervision.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life cream – 5 years, gel – 3 year.