Ketonal tab n / 100mg film about 20 pc

Description

Composition
Active substance:
1 tablet contains: Ketoprofen – 100,000 mg ;.
Excipients:
Magnesium stearate – 1,600 mg; colloidal silicon dioxide – 1,200 mg; Povidone – 5,000 mg; corn starch – 44,200 mg; talc – 8,000 mg; lactose – 60,000 mg; composition of the film coating: Hypromellose (4.622 mg), macrogol 400 (0.940 mg), indigo carmine E132 (0.153 mg), titanium dioxide (1.054 mg), talc (0.281 mg), carnauba wax (0.050 mg).
Description:
Pale blue, round, biconvex tablets, film-coated.
Product form:
Tablets, film-coated, 100 mg.
Primary packaging
20 tablets, film-coated, placed in a dark glass bottle, a sealed plastic cap with safety ring.
Or 10 tablets, film-coated, in Al. / Al. or PVC / Al. blister.
secondary packaging
1 bottle together with instructions for use in a cardboard box.
Or 1, 2, 3, 4 or 5 blisters together with instructions for use in a cardboard box.
Contraindications
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 ASA or other NSAIDs (including history); rhinitis or urticaria history caused by the intake of aspirin or other NSAIDs; gastric ulcer or duodenal ulcer in the acute stage, ulcerative colitis; Crohn’s disease; hemophilia and other bleeding disorders; children’s age (15 years); severe hepatic failure; 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); progressive renal disease, diverticulitis, active liver disease, inflammatory bowel disease, confirmed hyperkalemia; lactose intolerance, lactase deficiency, a syndrome of glucose-galactose malabsorption; chronic dyspepsia; III trimester of pregnancy; during breastfeeding.
Carefully
Bronchial asthma is a history of symptomatic cardiovascular disease, cerebrovascular disease and peripheral vascular disease, dyslipidemia, progressive liver disease, liver failure, hyperbilirubinemia, alcoholic cirrhosis, renal failure (creatinine clearance of 30-60 ml / min), chronic heart failure, arterial hypertension, blood disorders, dehydration, diabetes, medical history data about the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pilory infection severe somatic disease, 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) long NSAIDs; elderly patients taking diuretics; Patients with a decrease in circulating blood volume.
Dosage
100 mg
Indications
Symptomatic treatment of painful and inflammatory processes of various origins, including: inflammatory and degenerative diseases of the 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.
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.
Interactions 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.
Overdose
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).
Pharmacodynamics:
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.
Pharmacokinetics:
Absorption
Ketoprofen is readily absorbed from the gastrointestinal tract (GIT), 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.
Distribution
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 during breast-feeding, 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 with hypertension, cardiovascular diseases, 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 in patients with cardiac or renal insufficiency as well as in the treatment of elderly patients taking diuretics, and patients who, for whatever reason, a 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 the reach of children.
Dosing and Administration
Inside.
Ketonal® tablets, film-coated, 100 mg 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 prescribed 1 tablet 2 times per day.
Formulations for oral Ketonal® can be combined with the use of rectal suppositories, e.g., a patient may take one tablet (100 mg) in the morning and enter Ketonal® 1 suppository (100 mg) in the evening rectally. The maximum dose of ketoprofen is 200 mg / day.
Do not exceed the maximum recommended daily dose.
To reduce the risk of adverse effects from the gastrointestinal tract (GIT), patients with risk factors to simultaneously assign reception proton pump inhibitors.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist