Ketonal Duo 150mg Modified Release Capsules N30
Condition: New product
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Active ingredients
Ketoprofen
Release form
Capsules
Composition
Active ingredient: Ketoprofen Concentration of active ingredient (mg): 150 mg
Pharmacological effect
Nonsteroidal anti-inflammatory drug (NSAIDs). It has analgesic, anti-inflammatory and antipyretic effects. Due to inhibition of COX-1 and COX-2, and partially lipoxygenase, ketoprofen inhibits the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes. Ketoprofen does not adversely affect the articular cartilage.
Pharmacokinetics
Absorption Capsules Ketonal Duo presented in a new dosage form, which differs from conventional capsules by a special release of the active substance. Capsules contain two types of pellets: white (about 60% of the total) and yellow (coated). Ketoprofen is rapidly released from white pellets and slowly from yellow, which causes a combination of fast and prolonged action. The drug is well absorbed after ingestion. The bioavailability of ketoprofen in the form of conventional capsules and modified release capsules is 90%. Food intake does not affect the overall bioavailability (AUC ) ketoprofena, but reduces the rate of absorption. After ingestion of ketoprofen in a dose of 150 mg in the form of capsules with modified release of Cmax in plasma is 9036.64 ng / ml for 1.76 h. Distribution Ketoprofen binding to plasma proteins (mainly albumin) is 99%. Vd - 0.1-0.2 l / kg. Ketoprofen penetrates well into the synovial fluid, where it reaches 30% plasma concentration. Significant concentrations of ketoprofen in the synovial fluid are stable and persist for up to 30 hours, as a result of which pain syndrome and stiffness of the joints are diminished for a long time. It binds to glucuronic acid and is displayed as a glucuronide. There are no active metabolites of ketoprofen. T1 / 2 - less than 2 hours. Approximately 80% of ketoprofen is excreted in the urine, mainly in the form of ketoprofen glucuronide (more than 90%). About 10% is excreted through the intestines. Pharmacokinetics in special clinical situations in patients with liver failure,Ketoprofen plasma concentration increased by 2 times (probably due to hypoalbuminemia and consequently a high level of unbound active ketoprofen); these patients need to prescribe the drug in the minimum therapeutic dose. In patients with renal insufficiency, ketoprofen clearance is reduced, which requires dose adjustment. In elderly patients, ketoprofen is metabolized and excreted slowly, but this has clinical significance only for patients with reduced kidney function.
Contraindications
• hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other nonsteroidal anti-inflammatory drugs; • complete and incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (including history); • peptic ulcer or duodenal ulcer in the acute stage, ulcerative colitis, Crohn's disease in the acute phase, inflammatory bowel disease in the acute stage; • hemophilia and other bleeding disorders; • children's age (up to 15 years); • severe liver failure; • severe renal failure (creatinine clearance (CC) less than 30 ml / min), progressive kidney disease; • decompensated heart failure; • the postoperative period after coronary artery bypass surgery; • gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); • lactase deficiency, lactose intolerance, glucose-galactose malabsorption; • chronic dyspepsia; • III trimester of pregnancy; • lactation period.
Use during pregnancy and lactation
With prolonged use of NSAIDs, it is necessary to monitor the condition of the blood, as well as the kidney and liver function, especially in elderly patients (over 65). Care should be taken and more often to monitor blood pressure when using ketoprofen to treat patients with arterial hypertension, cardiovascular diseases lead to fluid retention in the body. As with other NSAIDs, ketoprofen can mask signs of infectious diseases. Effects on the ability to drive vehicles and control mechanisms Dan s about the negative impact Ketonal Duo at recommended doses on the ability to drive a car or operate machinery is not.However, patients who notice unusual effects when taking Ketonal Duo should be careful when practicing potentially hazardous activities that require high concentration of attention and quickness of psychomotor reactions.
Dosage and administration
Inside The standard dose of Ketonal DUO for adults and children over 15 years old is 150 mg / day (1 capsule with modified release). Capsules should be taken with or after meals with water or milk (the volume of the liquid should be at least 100 ml). The maximum dose of ketoprofen is 200 mg / day.
Side effects
Ketoprofen can weaken the effect of diuretics and antihypertensive drugs, and enhance the effect of oral hypoglycemic and some anticonvulsant drugs (phenytoin). Combined use with other NSAIDs, salicylates, GCS, ethanol increases the risk of undesirable effects from the gastrointestinal tract. increases the risk of bleeding. At the same time taking NSAIDs with diuretics or ACE inhibitors increases the risk of renal dysfunction. Increases the end tration in plasma cardiac glycosides, calcium channel blockers slow, lithium preparations cyclosporin metotreksata.NPVP may reduce the effectiveness of mifepristone. NSAID administration should begin no earlier than 8-12 days after the abolition of mifepristone.
Overdose
According to the World Health Organization (WHO), undesirable effects are classified according to their development frequency as follows: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); the frequency is unknown (the frequency of occurrence of events cannot be determined on the basis of available data). Disorders of the hematopoietic system and the lymphatic system are rare: hemorrhagic anemia; frequency is unknown: agranulocytosis, thrombocytopenia, impaired bone marrow function. Immune system impairment frequency unknown: anaphylactic reaction (including anaphylactic shock). Nervous system disorders are rare: headache, dizziness, drowsiness; rarely: paresthesias; frequency unknown: seizures, taste disturbance.Mental Disorders: frequency unknown: emotional lability. Disturbances of the senses are rare: blurred vision, tinnitus. Violations of the cardiovascular system, the frequency is unknown: heart failure, increased blood pressure, vasodilation. Respiratory disorders are rare: exacerbation of bronchial asthma; frequency is unknown: bronchospasm (especially in patients with hypersensitivity to NSAIDs), rhinitis. Disorders of the gastrointestinal tract are often: nausea, vomiting, dyspepsia, pain in the abdomen; infrequently: constipation, diarrhea, bloating, gastritis; seldom: peptic ulcer, stomatitis; very rarely: aggravation of ulcerative colitis or Crohn's disease, gastrointestinal bleeding, perforation. Disorders of the liver and biliary tract rarely: hepatitis, increased activity of "liver" transaminases, increasing the concentration of bilirubin. Violations of the skin rare: skin rash, pruritus; frequency is unknown: photosensitivity, alopecia, urticaria, angioedema, erythema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis. Violations of the urinary system frequency is unknown: acute renal failure, interstitial nephritis, nephritic syndrome, nephrotic syndrome, abnormal values of kidney function indicators. Other infrequently: edema; rarely: weight gain; frequency unknown: increased fatigue.
Interaction with other drugs
Precautionary measures
special instructions
Symptoms: nausea, vomiting, abdominal pain, vomiting of blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure. Treatment: overdose shows gastric lavage and the use of activated carbon. Symptomatic therapy is performed. The effects of ketoprofen on the gastrointestinal tract can be reduced with the help of histamine H2-receptor blockers, proton pump inhibitors and prostaglandins.