Ketoprofen Organica, 20 pcs., 100 mg, film-coated tablets
Film-coated tablets
Inside,
during or immediately after a meal, without chewing, with water or milk (the volume of liquid should be at least 100 ml).
Usually the drug is prescribed in 1 tablet. 2 times a day.
Ketoprofen preparations for oral administration can be combined with the use of rectal suppositories, for example, the patient can take 1 tablet. (100 mg) ketoprofen in the morning and administer 1 supp. (100 mg) rectally in the evening. The maximum dose of ketoprofen is 200 mg/day.
It is not recommended to exceed the maximum daily dose of the drug. In order to reduce the risk of developing adverse events from the gastrointestinal tract, patients with risk factors are recommended to simultaneously prescribe proton pump inhibitors.
Capsules
Inside,
during or immediately after meals with plenty of water. Adults and adolescents (15–18 years old) are prescribed 4 caps. of the drug per day, which can be divided into 3 doses (depending on the severity of the pain syndrome), but not more than 2 caps. once. The maximum daily dose should not exceed 200 mg.
Solution for intravenous and intramuscular administration
IV, IM.
To reduce the frequency of adverse reactions, it is recommended to use the minimum effective dose of the drug.
IM administration:
The recommended dose is 100 mg (1 amp.) of ketoprofen 1-2 times a day.
IV infusion:
prescribed only in a hospital setting. The duration of infusion should be from 30 to 60 minutes.
The IV route of administration should be used for no more than 48 hours.
Short IV infusion:
100–200 mg (1–2 amp.) of ketoprofen, diluted in 100 ml of 0.9% sodium chloride solution, is administered over 0.5–1 hour.
Continuous IV infusion:
100–200 mg (1–2 amp.) of ketoprofen, diluted in 500 mg of infusion solution (0.9% sodium chloride solution, lactated Ringer's solution, 5% dextrose solution), is administered over 8 hours; re-administration is possible after 8 hours.
The maximum daily dose (including all dosage forms) should not exceed 200 mg of ketoprofen.
The duration of treatment is determined by the doctor.
Ketoprofen can be used in combination with centrally acting analgesics; it can be mixed with opioids (including morphine) in the same vial.
If necessary, treatment can be supplemented with the use of oral forms (tablets, capsules), rectal suppositories or external dosage forms of ketoprofen.
Special patient groups
Elderly age.
In elderly patients, treatment with Ketoprofen Organica should be started with a low dose of ketoprofen and maintenance treatment should be carried out with the minimum effective dose of the drug.
Kidney failure/dialysis and liver failure.
In patients with renal failure with creatinine Cl less than 20 ml/min and with chronic liver disease (with reduced serum albumin levels), the dose of ketoprofen should be reduced.
Warning
Pharmaceutically incompatible with tramadol solution due to precipitation.
Infusion bottles should be wrapped in black paper or aluminum foil because ketoprofen is sensitive to light.
Ketoprofen organic tablet p/o film 100mg 20 pcs
Pharmacological group:
Non-steroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID). It has anti-inflammatory, analgesic and antipyretic effects. Ketoprofen blocks the action of the enzyme cyclooxygenase 1 and 2 (COX-1 and COX-2) and, partially, lipoxygenase. which leads to suppression of prostaglandin synthesis (including in the central nervous system (CNS), most likely in the hypothalamus). Stabilizes liposomal membranes in vitro and in vivo; at high concentrations in vitro, inhibits the synthesis of bradykinin and leukotrienes.
Ketoprofen does not have a negative effect on the condition of articular cartilage.
Pharmacokinetics:
Absorption
Ketoprofen is easily absorbed from the gastrointestinal tract (GIT), bioavailability is 90%. Bonding with blood plasma proteins is 99%. When 100 mg of ketoprofen is taken orally, the maximum concentration (Cmax) of the drug in the blood plasma (10.4 mcg/ml) is achieved after 1 hour 22 minutes.
Distribution
Ketoprofen is 99% bound to blood proteins, mainly to the albumin fraction. The volume of distribution is 0.1 l/kg. Ketoprofen penetrates into the synovial fluid and reaches a concentration there equal to 30% of the concentration in the blood plasma. Plasma clearance of ketoprofen is approximately 0.08 l/kg/h.
Metabolism and excretion
Ketoprofen undergoes intensive metabolism under the influence of microsomal liver enzymes, the half-life (T1/2) is less than 2 hours. Ketoprofen binds to glucuronic acid and is excreted from the body in the form of glucuronide. Ketoprofen has no active metabolites. Up to 80% of ketoprofen is excreted by the kidneys within 24 hours, mainly in the form of ketoprofen glucuronide. When using the drug in a dose of 100 mg or more, excretion by the kidneys may be difficult.
In patients with liver failure, the plasma concentration of ketoprofen is doubled (probably due to hypoalbuminemia and, consequently, a high level of unbound active ketoprofen): such patients should be prescribed the drug in the minimum therapeutic dose.
In patients with renal failure, the clearance of ketoprofen is reduced, but dose adjustment is required only in cases of severe renal failure. In severe renal failure, most of the drug is excreted through the intestines. When taking high doses, hepatic clearance also increases. Up to 40% of the drug is excreted through the intestines.
In elderly patients, the metabolism and elimination of ketoprofen is slower. which is of clinical significance only for patients with severe renal impairment.
Ketoprofen
Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID), a derivative of methylacetic acid. It is used mainly for the treatment of inflammatory and degenerative diseases of the musculoskeletal system, diseases of the joints and spine. It has analgesic, anti-inflammatory and antipyretic effects. It is used as a symptomatic remedy, i.e. in order to eliminate the negative manifestations of the disease, but not its causes. One of the main objectives of the drug is pain relief. Pain is the main reason for seeking medical help. First of all, this applies to elderly patients, whose general condition is affected by the presence of multiple concomitant pathologies. And given the trend towards an aging population, the relevance of effective pain management will only increase in the future. The elimination of mild and moderate pain has traditionally relied on the use of NSAIDs. If the pain does not subside, or, on the contrary, intensifies, they resort to the help of heavy analgesic “artillery” in the form of more serious drugs, including narcotics. NSAIDs are the first choice drugs for pain relief in rheumatic diseases. The “classic” side effect of this group of drugs - a negative effect on the mucous membrane of the gastrointestinal tract - can be neutralized by careful monitoring of the dose taken and duration of treatment, as well as the adequacy of concomitant therapeutic measures.
The mechanism of action of ketoprofen is due to the suppression of the activity of the enzyme cyclooxygenase, which is involved in the metabolism of the prostaglandin “substrate” - arachidonic acid. Prostaglandins are known to be mediators of pain and inflammation. The pronounced analgesic effect of the drug is due to a dual mechanism of action: through inhibition of prostaglandin synthesis in the periphery (peripheral component) and in the central nervous system (central component).
In addition, the drug affects the biological activity of various neurotropic substances involved in the secretion of pain mediators in the spinal cord. In addition to this, ketoprofen is endowed with antibradykinin activity, normalizes the state of lysosome membranes, and significantly suppresses the activity of neutrophils in patients suffering from rheumatoid arthritis. Inhibits the ability of platelets to aggregate. When taken orally, ketoprofen is well absorbed from the digestive tract. The maximum concentration of the active substance in the blood plasma is observed after 1-5 hours (for the tablet form), after 20-30 minutes (for the injection form with intramuscular administration), after 5 minutes (for the injection form with intravenous administration). Ketoprofen is available in three dosage forms: in addition to the already mentioned tablets and solution for injection, it is a gel for external use. The dosage regimen of the drug is established individually depending on the nature of the disease. For the tablet form, the initial daily dose is 300 mg 2-3 times a day. For the treatment of acute pain syndrome or exacerbation of chronic pain, preference is given to an injectable dosage form, which is administered as a single intramuscular injection in an amount of 100 mg. Ketoprofen in the form of an injection solution should not be used for more than 2-3 days. Then the patient is transferred to the tablet form of the drug. The maximum daily dose of injectable ketoprofen is 200 mg. Ketoprofen gel is applied to the surface of the skin in the area of the inflammatory focus 2 times a day. Pharmacotherapy with ketoprofen provides for a number of restrictions on taking other medications. Thus, the drug is incompatible with injectable tramadol. Ketoprofen increases the side effects of gluco- and mineralocorticosteroids, female sex hormones, and reduces the effectiveness of antihypertensive and diuretic drugs.
Ketoprofen Organics
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The incidence of side effects is determined according to the following scale: very often - >10%, often - >1% and 0.1% and 0.01% and
From the digestive system: often - NSAID gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), infrequently - stomatitis, impaired liver function; rarely - erosive and ulcerative lesions; very rarely - bleeding and perforation of the gastrointestinal tract, changes in taste.
From the nervous system: often - headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, rarely - confusion or loss of consciousness, forgetfulness, memory impairment, migraine, peripheral neuropathy.
From the senses: rarely - noise or ringing in the ears, blurred vision, conjunctivitis, dry mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, dizziness, vertigo.
From the cardiovascular system: infrequently - edema, increased blood pressure, rarely - tachycardia.
From the respiratory system: infrequently - hemoptysis, shortness of breath, pharyngitis, rhinitis, bronchospasm, laryngeal edema (signs of an anaphylactic reaction); rarely - asthma attacks.
From the hematopoietic organs: rarely - agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. High doses of the drug can inhibit platelet aggregation, thereby prolonging bleeding time, and cause epistaxis and bruising.
From the urinary system: infrequently - edematous syndrome, rarely - cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, very rarely - hematuria.
From the immune system: rarely - reactivity of the respiratory system, including bronchial asthma, its exacerbation, bronchospasm or shortness of breath (especially in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs); very rarely - angioedema and anaphylaxis.
Allergic reactions: often - skin rash (including erythematous urticaria), skin itching, infrequently - rhinitis, rarely exfoliative dermatitis.
Other: infrequently - increased sweating, rarely - nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding.
Cases of overdose have not been described. A specific antidote is unknown. If necessary, carry out symptomatic treatment.
Buy Ketoprofen film-coated tablets 100 mg No. 20 in pharmacies
Instructions for use Ketoprofen
Buy Ketoprofen TB 100 mg Dosage forms tablets 100 mg Manufacturers Organika JSC (Russia) Group Anti-inflammatory drugs - propionic acid International nonproprietary name Ketoprofen Synonyms Arketal Rompharm, Artrosilene, Artrum, Bystrumgel, Bystrumkaps, Valusal, Ketonal, Ketonal Duo, Ketoprofen, Keto profen Organics, Ketoprofen -Verte, Ketoprofen-Vramed, Oki, Fastum, Febrofid, Flamax, Flamax forte, Flexen
Description
Ketoprofen
Latin name Ketoprofen
Release form Modified release tablets
Composition 1 tablet contains ketoprofen - 150 mg
Pack of 20 pcs.
Pharmacological action Ketoprofen is a non-steroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects associated with suppression of the activity of cyclooxygenases 1 and 2, which regulate the synthesis of prostaglandins and bradykinin; stabilizes lysosomal membranes. Does not have a negative effect on the condition of articular cartilage.
Indications Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, ankylosing spondylitis, gouty arthritis, osteoarthritis. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease. Pain syndrome: myalgia, ossalgia, neuralgia, tendinitis, arthralgia, bursitis, radiculitis, adnexitis, otitis, headache and toothache, with cancer; post-traumatic and postoperative pain syndrome, accompanied by inflammation, algodismenorrhea.
Contraindications Hypersensitivity to ketoprofen and other components of the drug, as well as to other non-steroidal anti-inflammatory drugs. Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history). Peptic ulcer of the stomach and/or duodenum (acute stage), ulcerative colitis (exacerbation stage), Crohn's disease; hemophilia and other blood clotting disorders; confirmed hyperkalemia; diverticulitis, peptic ulcer, active gastrointestinal bleeding, inflammatory bowel disease; decompensated heart failure, period after coronary artery bypass surgery; severe liver failure or active liver disease; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney diseases; children's age (up to 15 years); pregnancy (III trimester), breastfeeding period.
Use during pregnancy and breastfeeding In the third trimester of pregnancy, the use of ketoprofen is contraindicated. In the first and second trimesters of pregnancy, the drug can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. During lactation, when taking the drug, it is necessary to decide whether to stop breastfeeding.
Directions for use and dosage: Orally, during or after meals, 1 tablet (150 mg) 1 time per day. The tablets should be swallowed whole, without chewing, with a large amount (at least 100 ml) of water or milk. The minimum effective dose should be used for the shortest possible short course.
Side effects From the digestive system: often - dyspepsia (nausea, diarrhea or constipation, flatulence, vomiting, heartburn, loss of appetite), NSAID gastropathy, abdominal pain, stomatitis, impaired liver function; rarely - perforation of the gastrointestinal tract, exacerbation of Crohn's disease, melena, gingival, gastrointestinal, hemorrhoidal bleeding. From the central nervous system: often - headache, dizziness, insomnia, drowsiness, fatigue, agitation, nervousness, depression, asthenia; rarely - confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy; very rarely - hallucinations, disorientation and speech disorder. From the senses: rarely - noise or ringing in the ears, blurred vision, changes in taste, conjunctivitis, hearing loss, dry mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, vertigo. From the cardiovascular system: rarely - tachycardia, arterial hypertension, peripheral edema. From the hematopoietic organs: ketoprofen reduces platelet aggregation, transient increase in the level of liver enzymes, rarely - agranulocytosis, anemia, thrombocytopenia, purpura, hemolytic anemia, leukopenia. From the urinary system: rarely - impaired renal function, cystitis, urethritis, interstitial nephritis, nephrotic syndrome, hematuria (more often develops in people taking NSAIDs and diuretics for a long time). Allergic reactions: often - skin reactions (itching, urticaria); rarely - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions, exfoliative dermatitis. Other: increased sweating, rarely - hemoptysis, nosebleeds, menometrorrhagia, muscle twitching, thirst, photosensitivity.
Special instructions Ketoprofen can be washed down with milk or taken with antacids to reduce the frequency of gastrointestinal disorders; Antacids and milk do not affect the absorption of the drug. During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary, especially in elderly patients. If renal or liver function is impaired, dose reduction and careful monitoring are necessary. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Taking the drug may mask signs of an infectious disease. The drug should not be used simultaneously with other NSAIDs. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Drug interactions Ketoprofen may weaken the effect of diuretics and antihypertensive drugs and enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin). Combined use with other NSAIDs, glucocorticosteroids, salicylates, ethanol, corticotropin increases the risk of developing adverse events from the gastrointestinal tract. Co-administration with anticoagulants, thrombolytics, antiplatelet agents, as well as cefaperazone, cefamandole, cefotetan and moxalactam increases the risk of bleeding. When taking non-steroidal anti-inflammatory drugs simultaneously with diuretics and ACE inhibitors, the risk of renal dysfunction increases. Increases plasma concentrations of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate. Nonsteroidal anti-inflammatory drugs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone. Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Co-administration with sodium valproate causes disruption of platelet aggregation. Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary). Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
Overdose In case of overdose with ketoprofen, as with other non-steroidal anti-inflammatory drugs, nausea, vomiting, vomiting with blood, abdominal pain, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure may occur. There is no specific antidote. Treatment is symptomatic. The effects of ketoprofen on the gastrointestinal tract can be weakened with the help of H2 receptor antagonists, proton pump inhibitors and prostaglandins. Gastric lavage and the use of activated carbon are indicated.
Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 °C.
Shelf life: 5 years.
