Ketonal, cream 5% 50 g

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

ATX code: MO2AE03

PHARMACOLOGICAL PROPERTIES

Ketoprofen is a non-steroidal anti-inflammatory drug whose main properties are analgesic, anti-inflammatory and anti-edema action.

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 plasma is extremely low. Ketoprofen has no negative effect on the articular cartilage.

Indications

Symptomatic therapy:

– rheumatoid arthritis and periarthritis;

– ankylosing spondylitis (ankylosing spondylitis);

– psoriatic arthritis;

– reactive arthritis (Reiter’s syndrome);

— osteoarthritis of various localizations;

– tendinitis, bursitis;

– myalgia;

– neuralgia;

– radiculitis;

– injuries to the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

Pharmacological effect

PHARMACOTHERAPEUTIC GROUP: Non-steroidal anti-inflammatory drug (NSAID)

ATX code: MO2AE03

PHARMACOLOGICAL PROPERTIES

Ketoprofen is a non-steroidal anti-inflammatory drug, the main properties of which are analgesic, anti-inflammatory and anti-edema 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 plasma is extremely low. Ketoprofen does not have a negative effect on the condition of articular cartilage.

Special instructions

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

If side effects occur, you should stop using the drug.

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, suppositories). The total dose, regardless of the dosage, should not exceed 300 mg.

If the patient forgets to apply the cream, he should use it at the time when the next dose is due, but not double it.

Effect on the ability to drive vehicles and operate machinery: no data.

Active ingredient

Ketoprofen

Composition

1 g of cream for external use contains:

Active substance:

ketoprofen – 50 mg;

Excipients:

methyl parahydroxybenzoate,

propyl parahydroxybenzoate,

propylene glycol,

isopropyl myristate,

Vaseline (white),

elfakos ST9,

propylene glycol glyceryl oleate,

magnesium sulfate,

water.

Pregnancy

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 outweighs the potential risk for 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, fenofibrate, UV blockers, fragrances; violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound);

indications in the anamnesis of attacks of bronchial asthma caused by taking NSAIDs and salicylates;

history of photosensitivity reactions;

exposure to sunlight, incl. indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment;

III trimester of pregnancy;

children under 15 years of age.

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

Local reactions occur most often. Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10,000 and <1/1000), very rarely (<10,000).

Allergic reactions: very rarely – angioedema, anaphylaxis.

From the skin and skin appendages: infrequently – erythema, itching, burning, eczema, mild transient dermatitis; rarely – urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome; very rarely – a single case of severe contact dermatitis (due to poor hygiene and insolation), a single 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.

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

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

Ketoprofen reduces the excretion of methotrexate and increases its toxicity.

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

Patients taking coumarin-containing anticoagulant drugs are advised to undergo treatment under medical supervision.

Overdose

Symptoms: irritation, erythema, itching.

Treatment: the drug must be discontinued. Symptomatic therapy is carried out.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Manufacturer

Salutas Pharma GmbH, Germany