The instruction for medical use
of Ketonal® medicine
the Trade name
the International unlicensed
name Ketoprofen Dosage Forms 5% Cream Structure One Gram of cream contains
active agent – ketoprofen of 50 mg,
excipients: methylparahydroxybenzoate (E 218), propilparagidroksibenzoat (E 216), propylene glycol, isopropyl myristate, vaseline white, polyethyleneglycol/dodecyl copolymer (Elfacos ST 9), glitserolsorbitan stearate ester (Arlacel 481 V), magnesium sulfate heptahydrate, water purified.
Homogeneous cream from white till almost white color.
Non-steroidal anti-inflammatory drugs for topical administration. Ketoprofen.
The ATX M02AA10 code
Pharmacokinetics In comparison with properties oral forms (tablet capsules), bioavailability of ketoprofen in the form of cream makes 5% therefore action has local character and has no system effects.
Effect of the drug Ketonal cream begins to be shown 2-3 hours later after putting cream on skin. Time of achievement of peak plasma concentration is 5-6 hours. Duration of effect reaches 3-4 hours.
Ketoprofen for 99% contacts proteins of blood plasma.
Active ingredient is present at synovial fluid in therapeutic concentration, its concentration in blood is insignificant is small. After drawing from 70 mg to 80 mg of ketoprofen in the form of cream on the surface of a knee joint three times a day the maximum concentration in 6 hours reaches 0.0182 mkg/ml +0.118 in blood plasma. 12 hours later after putting cream on area of a joint – concentration of ketoprofen in synovial fluid reaches 1.31 mkg/g +0.89, in fatty tissue reaches 4.7 mkg/g +3.87, in the articulate capsule reaches 2.35 mkg/g +2.41.
Drug is exposed to metabolism in a liver where it conjugates with glucuronic acid and in this look about 75% of ketoprofen are removed with urine.
Metabolism of ketoprofen is not changed at elderly people, in a heavy renal failure or cirrhosis.
Ketoprofen is one of enzyme inhibitors cyclooxygenase. It also suppresses action of a lipoxygenase and bradykinin. Stabilizing membranes of liposomes, ketoprofen prevents release of the enzymes involved in inflammatory processes. Ketoprofen has similar pharmakodinamichesky properties, and influences other non-steroidal anti-inflammatory drugs. It has anesthetic and anti-inflammatory effect.
The drug Ketonal cream possesses local anesthetic and anti-inflammatory (including antiedematous) action.
– acute and chronic inflammatory diseases of the musculoskeletal system
– a musculoskeletal system injury (pains and inflammation of joints in rheumatic diseases, sprains, ruptures of ligaments and sinews of muscles, a tendinitis, a bruise of muscles and ligaments)
– a posttraumatic pain syndrome
the Route of administration and doses
the Drug Ketonal cream is intended for external use, for drawing on skin.
Adults and teenagers are aged more senior than 15 years: the drug Ketonal cream is applied a thin layer to skin over the center of defeat and carefully rubbed 2 – 3 times a day.
The dosage has to be picked up according to the area of an affected area: 2.5 cm of cream (2 g) correspond to 100 mg of ketoprofen.
The drug Ketonal cream can be used in a combination with other dosage forms of the drug Ketonal (capsules, tablets, suppositories). The total daily dose of ketoprofen at the same time should not exceed 200 mg. Duration of a course of treatment should not exceed 14 days.
Imposing of an occlusive bandage is not required.
Right after use of cream it is necessary to wash out hands carefully.
It is necessary to avoid contact with eyes and other mucous membranes.
Special recommendations about a dosage for patients of advanced age are absent.
– reactions of hypersensitivity (itching, reddening and tranzitorny inflammation of skin of easy degree, contact dermatitis)
it is rare
– urticaria, rash, reaction of photosensitivity, violent a rash, a purpura, an exudative mnogoformny erythema, lichenoid dermatitis, skin necrosis,
Stephens-Johnson Ochen’s syndrome seldom
– a Quincke’s disease and anaphylactic reactions
– heavy inflammatory reaction of skin (contact dermatitis)
– heavy contact long photoallergic reaction with distribution on all body surface, hypersensitivity of skin by sunlight if skin to which cream is applied was subjected to influence of sunshine or UF of radiation (in a sunbed)
– a skin dieback
– an epidermal necrolysis
– renal failures at the patient with chronic kidney disease
– intestitsialny nephrite
– asthmatic attacks as option of allergic reaction.
– turgidity of hands, feet, ankle joints, persons, lips, a mouth or a throat that can cause the complicated swallowing or breath
– painful feelings, allergic skin reactions
– the skin diseases which are characterized by various forms of reddening of integuments, skin exfoliation, blisters, burning sensations, wounds, inflammations and ulcers which can extend to mucous membranes of a mouth eyes and genitals
– cases of more serious reactions, such as eczema with blisters or small blisters which can extend and be generalized (on all body)
– the localized tumor of a hypodermic basis (Quincke’s disease), an acute anaphylaxis, reactions of hypersensitivity
of the Contraindication
– individual hypersensitivity to ketoprofen and/or other components of cream
– individual hypersensitivity to acetylsalicylic acid or other NPVS (instructions in the anamnesis on the bronchial asthma, a small tortoiseshell or rhinitis connected with intake of acetylsalicylic acid), thiapro-foehn acid, fenofibrat, UF-blockers or on perfumery
– eczema, the becoming wet dermatitis, an open or contaminated wound in the place of expected drawing (cream should not be applied to the injured skin)
– the third trimester of pregnancy and the period of a lactation
– reaction of photosensitivity in the anamnesis
– influence of sunshine (even diffused light), including ultra-violet light from a sunbed, during treatment and within 2 weeks after its termination
– children’s age up to 15 years
Interaction with other medicines at topical administration of the drug Ketonal cream is improbable.
It was reported about serious interactions after use of a high dose of a methotrexate with NPVS, including ketoprofen, at introduction in the system way. Like other NPVS, ketoprofen reduces the level of removal of a methotrexate, strengthening, thus, toxic influence of this drug. The accompanying administration of salicylates is not recommended.
It is recommended to control a condition of the patients receiving treatment coumarin – the containing drugs.
It is necessary to avoid drug Ketonal hit cream on the damaged surface of skin, open wounds, in eyes, zones around eyes, on mucous membranes, an anus, a zone of genitalias.
At emergence of irritation on skin, it is necessary to stop temporarily therapy, at the expressed irritation, it is not recommended to continue therapy.
At development of any skin reactions including connected with the accompanying use of the products containing oktokrilen the treatment should be stopped immediately.
Though systemic side effects of ketoprofen for external use have to be low, the drug Ketonal cream has to be used with care at patients with a renal, heart or liver failure, at patients in the anamnesis from a round ulcer or inflammatory bowel disease, cerebrovascular bleeding or hemorrhagic diathesis.
The patients, asthma associated with chronic rhinitis, chronic sinusitis and/or polipozy a nose are subject to the increased risk of developing of an allergy to acetylsalicylic acid and/or NPVS.
During treatment and within 2 weeks after the termination of treatment it is necessary to avoid direct sunlight, visit of a sunbed and Ural federal district.
the Drug Ketonal cream can be appointed at the first or second trimester of pregnancy only if exceeding advantage of the expected therapeutic effect over risk for mother and/or a fruit is expected.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose does not influence
If you used a high dose of Ketonal, than it is necessary, wash away skin carefully under flowing water and consult with the doctor or the druggist.
At external use the overdose by ketoprofen is improbable. At accidental ingestion of the drug Ketonal cream systemic side effects which expressiveness depends on amount of the swallowed cream can develop. In this case it is necessary to carry out the symptomatic and supporting treatment.
The form of release and packing
On 30 g of cream place in tubas aluminum with internal varnish coating, a protective membrane and the twisting plastic cover.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
Not to use a period of storage of 5 years expiry date.
According to the prescription
of Producer/Upakovshchik Salyutas Pharm GmbH, Germany
Lange Göhren 3, 39171 Osterweddingen, Germany
the Owner of the registration certificate
Lek Pharmasyyutikals of d, Slovenia
Verovskova, 57, 1526 Ljubljana, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
responsible for post-registration observation of safety of medicine
Representative office of JSC Sandoz Pharmasyyutikals d. d. in
Republic of Kazakhstan Republic of Kazakhstan, 050051, Almaty, Luganskogo St., 96, Business center “Keruyen”, ph. +7 (727) 2581048 Fax: +7 (727) 2581047,
8 800 080 0066 – free number of dialing across Kazakhstan