Ketonal caps. 50mg 25 pc


Ketonal caps. 50mg 25 pc



Active substance:
1 capsule contains: ketoprofen – 50.0 mg ;.
Lactose – 186.1 mg; Magnesium stearate – 2.4 mg; Colloidal silicon dioxide – 1.5 mg; capsule shell – titanium dioxide – 0.94 mg; patent blue dye – 0.17 mg; gelatin and 47 mg.
Capsules: Capsules № 3 opaque white and blue cap body. Contents of capsules: floury or pressed powder white with a yellowish tinge.
Product form:
Capsules of 50 mg.
Primary Packaging: 25 capsules in a bottle of dark glass, cover with a sealed polymer safety ring.
Secondary Packaging: 1 bottle was placed in a cardboard box, together with instructions for medical use.
Hypersensitivity to ketoprofen or other ingredients, and also salicylates or other NSAIDs; complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history); gastric ulcer or duodenal ulcer in the acute stage; inflammatory bowel disease in the acute stage; ulcerative colitis; Crohn’s disease; hemophilia and other bleeding disorders; children’s age (15 years); severe hepatic impairment; severe renal failure (creatinine clearance (CC) of less than 30 ml / min); decompensated heart failure; postoperative period after coronary artery bypass surgery; gastrointestinal, and other cerebrovascular bleeding (bleeding or suspected); chronic dyspepsia; III trimester of pregnancy, during breast-feeding; lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Peptic ulcer history, a history of asthma, symptomatic cardiovascular disease, cerebrovascular disease and peripheral arterial disease, dyslipidemia, progressive liver disease, hyperbilirubinemia, alcoholic cirrhosis, hepatic failure, renal failure (creatinine clearance of 30-60 ml / min) chronic heart failure, arterial hypertension, blood disorders, dehydration, diabetes, medical history of the development of ulcerative lesions of the gastrointestinal tract ( GIT), the presence of Helicobacter pylori infection, advanced age, smoking, concomitant anticoagulation therapy (e.g. warfarin), antiplatelet agents (for example, acetylsalicylic acid), glucocorticosteroids for ingestion (e.g., prednisone), selective serotonin reuptake inhibitors (e.g., citalopram, sertraline), prolonged use of the IVC.
50 mg
Symptomatic treatment of painful and inflammatory processes of various origins, including: inflammatory and degenerative diseases, musculoskeletal system: rheumatoid arthritis; seronegative arthritis, ankylosing spondylitis – ankylosing spondylitis, psoriatic arthritis, reactive arthritis (Reiter’s syndrome); gout, pseudogout; osteoarthritis; tendinitis, bursitis, myalgia, neuralgia, sciatica; pain, including mild, moderate and pronounced: headache; toothache; post-traumatic and postoperative pain; pain in cancer syndrome; algomenorrhea; symptomatic therapy of pain in inflammatory diseases of the pelvic organs in women.
Interaction with other drugs
Ketoprofen may weaken the effect of diuretics and antihypertensives and potentiate hypoglycemic agents for oral and some anticonvulsants (phenytoin).
The combined use with other NSAIDs, salicylates, corticosteroids, ethanol increases the risk of adverse effects from the gastrointestinal tract. The simultaneous use of anticoagulants (heparin, warfarin), thrombolytics, antiplatelet agents (ticlopidine, clopidogrel), pentoxifylline increases the risk of bleeding.
The simultaneous use of potassium salts, potassium-sparing diuretics, ACE inhibitors, NSAIDs, low molecular weight heparin, cyclosporin, tacrolimus and trimethoprim increases the risk of hyperkalemia.
Increasing the concentration in the blood plasma of cardiac glycosides, blockers “slow” calcium channels, lithium drugs, cyclosporine, methotrexate and digoxin.
Increases the toxicity of methotrexate and cyclosporine nephrotoxicity.
The simultaneous use of probenecid significantly reduces the clearance of ketoprofen in plasma.
A combined reception with corticosteroids and other NSAIDs (including selective inhibitors TSOG2) increases the likelihood of side effects (in particular from the gastrointestinal tract).
NSAIDs can reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after withdrawal of mifepristone.
As with the other NSAIDs, ketoprofen overdose may experience nausea, vomiting, abdominal pain, vomiting of blood, melena, disturbance of consciousness, respiratory depression, convulsions, impaired kidney function and kidney failure.
In overdose shown gastric lavage, and the use of activated carbon.
Treatment – symptomatic; ketoprofen effect on the gastrointestinal tract can be reduced by means of reducing the secretion of gastric glands (e.g., proton pump inhibitors) and prostaglandins.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ketoprofen has anti-inflammatory, analgesic and antipyretic action. Ketoprofen blocks the action of the enzyme cyclooxygenase 1 and 2 (and TSOG1 TSOG2) and partially lipoxygenase, leading to the suppression of prostaglandin synthesis (including in the central nervous system (CNS), most likely in the hypothalamus).
Stabilizes in vitro and in vivo liposomal membrane at high concentrations in vitro ketoprofen inhibits the synthesis of leukotrienes and bradykinin.
Ketoprofen has no negative impact on the status of the articular cartilage.
Ketoprofen is readily absorbed from the gastrointestinal tract, bioavailability – 90%. Communication with plasma proteins – 99%. The ingestion of 100 mg of ketoprofen maximum concentration (Cmax) in blood plasma drug (10.4 mg / ml) was reached after 1 hour 22 minutes.
Ketoprofen is 99% bound to plasma proteins, mainly albumin fraction. The volume of distribution of 0.1 l / kg. Ketoprofen penetrates into the synovial fluid and it reaches a concentration equal to 30% of the plasma concentration. The plasma clearance of ketoprofen is approximately 0.08 l / kg / hr.
Metabolism and excretion
Ketoprofen undergoes extensive metabolism by the action of liver microsomal enzyme half-life (T1 / 2) is less than 2 hours. Ketoprofen binds to glucuronic acid and excreted as glucuronide. No active metabolites of ketoprofen. To 80% ketoprofen excreted by the kidneys within 24 hours, mostly in the form of ketoprofen glucuronide. In applying the drug in doses of 100 mg or more renal excretion may be difficult.
In patients with severe renal insufficiency, most of the drug is released through the intestines. When receiving high doses of hepatic clearance also increases. Through the intestine is output to 40% of the formulation.
Patients with liver failure plasma concentration of ketoprofen doubled (possibly due to hypoalbuminemia, and therefore a high level of unbound ketoprofen active); Such patients should be administered the drug in the minimum therapeutic dose.
In patients with renal insufficiency, the clearance of ketoprofen reduced, however dose adjustment is required only in case of severe renal insufficiency.
Elderly patients metabolism and excretion of ketoprofen are slower, which has clinical significance only for patients with severe renal insufficiency.
Pregnancy and breast-feeding
Inhibition of prostaglandin synthesis may have an undesirable influence on the pregnancy and / or fetal development. The data obtained in epidemiological studies in the application of a prostaglandin synthesis inhibitor in early pregnancy, confirm an increased risk of spontaneous abortion and the formation of heart disease (~ 1-1.5%).
Use the drug to pregnant women in I and II trimesters of pregnancy is possible only when the benefits to the mother justifies the potential risk to the fetus.
Contraindicated the use of ketoprofen in pregnant women during the III trimester of pregnancy due to the possibility of uterine weakness generic activities and / or premature closure of the ductus arteriosus, a possible increase in bleeding time, water scarcity, and renal failure.
To date, no data on the allocation of ketoprofen into breast milk, so if you need to use ketoprofen nursing mother should decide the issue of termination of breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (> 1/100,
special instructions
Not to be combined with the reception of ketoprofen taking other NSAIDs and / or TSOG2 inhibitors.
With prolonged use of NSAIDs is necessary to periodically evaluate the clinical analysis of blood, control kidney and liver function, especially in elderly patients (65 years), to analyze the fecal occult blood.
Care should be taken more frequently monitor blood pressure during application of ketoprofen to treat patients suffering from hypertension, cardiovascular disease, which result in fluid retention.
In the event of violations of the organs of vision, treatment should be immediately discontinued.
Like other NSAIDs, ketoprofen may mask the symptoms of infectious and inflammatory diseases. In the event of evidence of infection or degradation being against application of the drug to immediately seek medical attention.
With a history of contraindications of the gastrointestinal tract (bleeding, perforation, ulcers), conducting long-term therapy and the use of high doses of ketoprofen patient should be under close medical supervision.
Due to the importance of prostaglandins in maintaining renal blood flow should be particularly careful when using ketoprofen patients with cardiac or renal insufficiency as well as in the treatment of elderly patients taking diuretics, and patients who, for whatever reason, the decrease in the volume of circulating observed blood. Use of the drug should be discontinued prior to major surgery.
Use of ketoprofen can affect female fertility, so patients with infertility (including passing examination) is not recommended to apply the preparation.
Information about the negative impact of the drug at the recommended doses Ketonal® on the ability to drive a car or operate machinery is not. However, patients who during treatment with the drug occur drowsiness, dizziness or other discomfort on the part of the nervous system, including visual disturbances, should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Ketonal® Capsules should be swallowed whole during or after eating, drinking water or milk (fluid volume must be not less than 100 ml). Usually the drug is administered 1-2 capsules 2-3 times per day.
Ketonal® Preparations for oral administration may be combined with the use of rectal suppositories; for example, the patient can take 1 capsule Ketonal® (50 mg) in the morning and in the middle of the day and enter 1 suppository (100 mg) rectally evening.
The maximum dose of ketoprofen is 200 mg / day.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

Sandoz RX

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