Ketonal cream 5%, 50g

Composition

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of 1 g of cream for external use contains:

Active ingredient:

ketoprofen – 50 mg;

Auxiliary substances:

methyl parahydroxybenzoate,

propyl parahydroxybenzoate,

propylene glycol,

isopropyl myristate,

petroleum jelly (white),

elfacos ST9,

propylene glycol glyceryl oleate,

magnesium sulfate,

water.

Pharmacological action

PHARMACOTHERAPY GROUP:  Nonsteroidal Anti-inflammatory drug (NSAID)

ATX Code: MO 2 AE 03

PHARMACOLOGICAL PROPERTIES

Ketoprofen is a non – steroidal anti-inflammatory drug, the main properties of which are analgesic, anti-inflammatory and decongestant effects.

It penetrates well into the subcutaneous tissue, ligaments and muscles, into the synovial fluid and reaches therapeutic concentrations there. The concentration of the drug in the plasma is extremely low. Ketoprofen does not have a negative effect on the condition of articular cartilage.

Indications

Symptomatic therapy:

— rheumatoid arthritis and periarthritis;

— ankylosing spondylitis (Bechterew’s disease);

— psoriatic arthritis;

reactive arthritis (Reiter syndrome);

— osteoarthritis of various localization;

— tendinitis, bursitis;

— myalgia;

— neuralgia

— sciatica;

— injuries of the musculoskeletal system (including sports), bruises and sprains, sprains, ruptures of 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.

Ketonal should not be used during lactation (breastfeeding).

Contraindications

hypersensitivity to the components of the drug;

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

reaction of photosensitivity in history;

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 up to age 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 <1/10), infrequent (≥1/1000 and<1/100), rare (≥1/10 000 and <1/1000), very rare (

Allergic reactions: very rarely – angioedema, anaphylaxis.

From the skin and skin appendages: infrequently – erythema, itching, burning, 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.

From the respiratory system: very rarely – asthmatic attacks (as a variant of an allergic reaction).

From the urinary system: very rarely – deterioration of renal function in patients with chronic renal failure.

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 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

A small amount of cream (3-5 cm) is applied in a thin layer on the skin above the lesion 2-3 times a day, lightly rubbing.

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

Overdose

Symptoms: irritation, erythema, pruritus.

Treatment: the drug should be discontinued. Conduct symptomatic therapy.

Special instructions

When using Ketonal, avoid contact with the drug on the mucous membranes and in the eyes.

If side effects occur, the drug should be discontinued.

During therapy, direct sunlight and ultraviolet radiation should be avoided.

The cream can be used in combination with other forms of the drug Ketonal (capsules, tablets, candles). The total dose, regardless of the dosage, should not exceed 300 mg.

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

Influence on the ability to drive motor vehicles and manage mechanisms:  no data available.

Form of production

White or almost white homogeneous cream.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Ketoprofen

Dosage form

cream