for medical use
of DUO Ketonal® medicine
the Trade name
of Ketonal® the DUO
name Ketoprofen Dosage Form
of the Capsule of 150 mg
One capsule contains
active agent – ketoprofen of 150 mg,
excipients: microcrystalline cellulose, lactoses monohydrate, povidone, sodium of a kroskarmelloz, polysorbate 80,
pellet cover: (III) oxide yellow (E172), silicon dioxide colloidal anhydrous,
structure of a cover of the capsule eudragit RS/RL30D, triethyl citrate, polysorbate 80, talc, iron: gelatin, indigo carmine (E 132), titan dioxide (E 171).
Solid gelatin capsules with the transparent body and a lid of blue color. Contents of capsules – pellets of white and yellow color.
Non-steroidal anti-inflammatory drugs.
Derivatives of propionic acid. Ketoprofen
the ATX M01AE03 Code
Pharmacokinetics of the DUO Ketonal® Capsule properties represent the new dosage form differing from standard in various release of active agent. Capsules contain two types of pellets: standard (white) and coated (yellow). Ketoprofen is quickly released from white pellets (60% of total) and slowly from yellow pellets (40% of total) that allows to combine the fast and prolonged action. The effect begins to be shown in 20 minutes after reception.
The DUO Ketonal® capsules of 150 mg are well soaked up and the bioavailability of ketoprofen at oral administration is 90%. Meal does not affect the general bioavailability, but reduces absorption speed.
Ketoprofen for 99% is connected with proteins of blood plasma, mainly with albumin fraction. The volume of distribution is 0.1-0.2 l/kg. Ketoprofen gets into synovial fluid and reaches the concentration equal of 50% plasma there (1.5 mkg/ml).
After oral administration of ketoprofen of 150 mg of capsules with the modified release the maximum plasma concentration is reached within 1.76 hours.
Elimination half-life of ketoprofen makes 2 hours (of white pellets). However thanks to the modified release of active agent from the yellow pellets covered with a special kishechnorastvorimy cover duration of effect of Ketonal® DUO reaches 18-20 hours that allows to take the drug once in day.
Ketoprofen is exposed to metabolism in a liver. About 60-75% of ketoprofen
are allocated with urine, mainly in the form of a conjugate with glucuronic acid. Less than 10% are removed in not changed view with a stake.
Ketoprofen – the nonsteroid antirheumatic means possessing anesthetic and anti-inflammatory action.
The mechanism of action Ketonala is connected with inhibition of biosynthesis of prostaglandins and leukotrienes due to suppression of activity of enzyme of cyclooxygenase (TsOG-1 and TsOG-2) which catalyzes synthesis of prostaglandins from arachidonic acid. Ketoprofen stabilizes membranes of lysosomes and has antibradikininovy activity.
– a pseudorheumatism
– seronegative spondylarthrites (an ankylosing spondylarthritis, psoriasis arthritis, reactive arthritis)
– gout, a pseudogout
– extraarticular rheumatism (a tendinitis, a bursitis, a capsulitis of a shoulder joint)
the Pain syndrome:
– pain in metastases in a bone at patients with oncological diseases.
It is necessary to swallow of a route of administration and doses of the DUO Capsule Ketonal®, washing down with a full glass of water, it is possible to wash down with milk also.
The standard dose makes one DUO capsule Ketonala® (150 mg) once a day. The maximum daily dose makes 200 mg.
For reduction of risk of development of side effects from digestive tract it is recommended to take the antiacid drugs (the medicines reducing secretion of gastric juice).
Duration of a course of treatment decides by the attending physician
– the dispeptic phenomena, a loss of appetite, nausea, vomiting, a meteorism, abdominal pains, a constipation
– diarrhea, gastritis
– a headache, dizziness, drowsiness
– skin rash
– hemorrhagic anemia, a leukopenia
– a depression, insomnia, nervousness, paresthesia
– deterioration in sight
– stomatitis, ulcer of stomach and duodenum
– hepatitis, increase in level of transaminases and bilirubin
– increase in body weight
– an acute anaphylaxis
– a bronchospasm, an attack of bronchial asthma
– exacerbation of colitis and Crohn’s disease, gastrointestinal bleedings
– an abnormal liver function
– an acute renal failure, tubulointerstitsialny nephrite
– a hypernatremia, a hyperpotassemia
– an agranulocytosis, thrombocytopenia
– heart failure
– arterial hypertension
– a photosensitization, a Quincke’s edema, bullous rash, including Stephens-Johnson’s syndrome, a toxic epidermal necrolysis
of the Contraindication
– individual hypersensitivity to ketoprofen or any auxiliary component of drug
– patients on history of rhinitis, the bronchospasm, asthma, allergic rash or allergic reactions caused by intake of ketoprofen or similar active ingredients, such as other non-steroidal anti-inflammatory drugs or salicylates (for example, such as acetylsalicylic acid)
– heavy heart failure
– for treatment of postoperative pain in case of surgical aortocoronary shunting
– to patients on a round ulcer in an active form, or any history of gastrointestinal bleeding, formation of ulcers or a perforation
– bleedings (gastrointestinal, cerebrovascular or other active bleedings)
– tendency to bleedings
– the significant disturbances of functions of a liver or kidneys
– disturbances from blood (leukopenia, thrombocytopenia, disturbances of hemocoagulation)
– pregnancy and the period of a lactation
– children’s age up to 18 years
the Concomitant use of the antiacid or other medicines reducing acidity of gastric juice does not influence the speed and volume of absorption of drug.
Кетонал®ДУО reduces effect of diuretics and antihypertensives, and (Phenytoinum) increases effect of oral hypoglycemic drugs and some antiepileptic drugs.
Potassium drugs, kaliysberegayushchy diuretics, APF inhibitors, heparins (low molecular weight or undivided on fraction), cyclosporine, takrolimus and Trimethoprimum at simultaneous use with non-steroidal anti-inflammatory drugs can promote emergence of a hyperpotassemia.
Due to the increased risk of bleedings the patients accepting Ketonal®DUO with anticoagulants or corticosteroids need continuous monitoring.
Кетонал® DUO reduces removal and by that increases toxicity of cardiac glycosides, lithium, cyclosporine and a methotrexate.
Кетонал® DUO can reduce efficiency of mifepristone.
Reception of NPVS needs to be begun not earlier than in 8-12 days after mifepristone cancellation.
Кетонал® DUO should not be appointed together with other non-steroidal anti-inflammatory drugs and salicylates.
Non-steroidal anti-inflammatory drugs, including Ketonal®DUO, possess aggressive action on a mucous membrane of digestive tract and prolonged, uncontrolled use of these drugs can lead ment of stomach ulcer.
With extra care patients should appoint drug with a gastrointestinal disease in the anamnesis. Bleeding and perforation can suddenly develop without the previous symptoms. The special attention is also required by use of drug for patients with disturbance of a hemostasis, hemophilia, an angiohemophilia, heavy thrombocytopenia, a renal or liver failure and also at the patients accepting anticoagulants (coumarin and derivatives of heparin, generally low-molecular heparins).
With care people of advanced age should appoint drug.
Кетонал®ДУО the patients having the hypertension and heart diseases which are followed by a liquid delay in an organism should appoint with care. Monitoring of arterial blood pressure, especially at patients with cardiovascular diseases is recommended.
Long courses of therapy by non-steroidal anti-inflammatory drugs, including Ketonal®DUO, demand monitoring of hematologic indicators, indicators of function of a liver and kidneys, in particular from elderly patients.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
in case of developing of dizziness, a spatial disorientation, drowsiness, out-of-focus sight or spasms should not conduct transport or to operate potentially dangerous mechanisms.
Symptoms: nausea, vomiting, abdominal pain, vomiting blood, black kcal, consciousness disturbance, respiratory depression, spasms, disturbance of renal and hepatic function.
Treatment: specific antidote does not exist. Gastric lavage and use of activated carbon is shown. Treatment has to be symptomatic, impact of ketoprofen on digestive tract can be weakened by means of H2 blockers, inhibitors of a proton pomp and prostaglandins.
The form of release and packing
On 10 capsules place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in original packing at a temperature not above 25 °C.
To store out of children’s reach!
not to apply a period of storage after the expiration date specified on packing.
According to the prescription
the Producer/packer Lek Pharmasyyutikals of of, Slovenia
Verovshkova 57, Ljubljana
the Owner of the registration certificate
Lek Pharmasyyutikals of of, Slovenia
Verovshkova 57, Ljubljana
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of JSC Sandoz Pharmasyyutikals d. d. in Republic of Kazakhstan Almaty, Luganskogo St. 96,
the Phone number – 258 10 48, fax: +7 727 258 10 47