Certificate of conformity (COC) Ketonal gel 2.5%, 100g

Ketonal gel 2.5%, 100g

$39.00

Active ingredient:	Ketoprofen
Dosage form:	Gel for external use

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Categories: Medication, Other medications, Pain, inflammation

Description
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Composition

Active ingredients:

ketoprofen 25 mg

Auxiliary substances:

(carbomer-20 mg, trollamine (triethanolamine) – 37 mg,

ethanol 96% – 285 mg,

lavender oil (lavender essential oil) – 0.28 mg,

water-632.72 mg) – 1 g

Pharmacological action

of NSAIDs. It has analgesic, anti-inflammatory and decongestant effects. Inhibits COX activity, which leads to inhibition of prostaglandin synthesis. In addition, ketoprofen inhibits lipooxygenase, bradykinin synthesis, stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

Ketoprofen does not have a negative effect on the condition of articular cartilage.

Pharmacokinetics

Ketoprofen is absorbed very slowly and practically does not accumulate in the body. Bioavailability is 5%. Ketoprofen penetrates the subcutaneous tissue, ligaments and muscles, synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in the blood plasma is extremely low. Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine. Ketoprofen is characterized by slow urinary excretion.

Indications

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

rheumatoid arthritis and periarthritis;

— ankylosing spondylitis (Bechterew’s disease);

— psoriatic arthritis;

reactive arthritis (Reiter’s syndrome);

— osteoarthritis of various localization;

— tendonitis, bursitis;

— myalgia;

— ophthalmology;

— sciatica;

— injuries of the musculoskeletal system (including sports), bruises and sprains, sprains, torn ligaments and tendons muscles.

Use during pregnancy and lactation

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

Use in the first and second trimesters is possible in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

The use of Ketonal® during lactation (breastfeeding) is not recommended.

Contraindications

— hypersensitivity to the components of the drug;

— hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, the fenofibrate, blockers of UV rays, the fragrance-free;

— violation of the integrity of the skin (eczema, weeping eczema, open or infected wound);

— specifying a history of asthma attacks caused by NSAIDs and salicylates;

— of photosensitivity reactions in the anamnesis;

— exposure to sunlight, including indirect sunlight and UV radiation in a tanning bed for the entire period of treatment and 2 weeks after cessation of treatment;

III trimester of pregnancy;

— children’s age up to 15 years.

With caution: impaired liver and/or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Side effects

Most often, local reactions occur.

Determination of the frequency of adverse reactions: very common (≥1/10), common (≥1/100 and

Allergic reactions: very rarely – angioedema, anaphylaxis.

From the side of the skin and skin appendages: infrequently – erythema, pruritus, burning sensation, eczema, transient dermatitis of mild severity; rarely – urticaria, rash, photosensitization, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely – an isolated case of severe contact dermatitis (against the background of poor hygiene and sun exposure), an isolated case of severe generalized photodermatitis, toxic epidermal necrolysis.

Respiratory system disorders: very rarely – asthmatic attacks (as a variant of an allergic reaction).

From the urinary system: very rarely – a single case of deterioration of renal function in a patient with chronic renal failure; in isolated cases-interstitial nephritis.

Interaction

Since the concentration of the drug in the blood plasma is extremely low, symptoms of interaction with other drugs (similar symptoms with systemic use) are possible only with frequent and prolonged use.

Concomitant use of other topical and topical forms (ointments, gels) containing ketoprofen or other NSAIDs is not recommended.

Simultaneous use of acetylsalicylic acid reduces the degree of binding of ketoprofen to plasma proteins.

Ketoprofen reduces the elimination of methotrexate and increases its toxicity.

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

Patients taking coumarin-containing anticoagulants are recommended to be treated under the supervision of a doctor.

How to take, course of use and dosage

For external use.

A small amount of gel (approximately 3-5 cm) is applied with light rubbing movements in a thin layer on the skin above the lesion 1-2 times / day.

Please note that 5 cm of gel corresponds to 100 mg of ketoprofen,10 cm-200 mg of ketoprofen. The maximum daily dose when applying the gel is 200 mg.

An occlusive dressing is not recommended.

Ketonal ® gel can be used in combination with other forms of Ketonal (capsules, tablets, rectal suppositories).

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

Overdose

Symptoms: irritation, erythema, pruritus.

Treatment: you should stop using the drug, rinse the skin thoroughly with running water. The patient should consult a doctor.

Special instructions

It is necessary to avoid contact with the gel in the eyes, on the skin around the eyes, mucous membranes.

If you experience any side effects, you should stop using the drug and consult a doctor.

If the patient has forgotten to apply the gel, use it at the time when the next dose should be applied, but do not double it.

Ketonal ® gel for external use can be used in combination with other dosage forms of Ketonal® (capsules, tablets, suppositories). The total daily dose, regardless of the dosage form, should not exceed 200 mg.

If skin reactions occur, including those that develop when combined with octocrylene-containing drugs, treatment should be stopped immediately.

To reduce the risk of photosensitivity, it is recommended to protect the gel-treated skin areas with clothing from UV exposure during the entire treatment period and for another 2 weeks after the gel is discontinued.

Do not apply as occlusive dressings.

You should thoroughly wash your hands after each application of the drug.

Influence on the ability to drive motor vehicles and manage mechanisms

There are no data on the negative effect of Ketonal ® gel on the ability to drive vehicles and other potentially dangerous activities that require concentration of attention and speed of psychomotor reactions.