OKI, rectal suppositories 160mg, 10pcs

Composition

of ketoprofen lysine salt 160 mgsupport substances: semisynthetic glycerides-1640 mg

Pharmacological action

Pharmacotherapeutic group. Nonsteroidal anti-inflammatory drug (NSAID).

ATX code: M 01 AE 03

Pharmacological properties It has anti-inflammatory, analgesic and antipyretic effects. Inhibiting cyclooxygenase type I and II, it inhibits prostaglandin synthesis. It has anti-radikinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that contribute to tissue destruction in chronic inflammation. Reduces the release of cytokines, inhibits the activity of neutrophils. Reduces morning stiffness and swelling of the joints, increases the amount of movement. Ketoprofen lysine salt, unlike ketoprofen, is a fast-soluble molecule with a neutral pH and almost does not irritate the gastrointestinal tract.

Pharmacokinetics. Suction. Ketoprofen lysine salt is rapidly absorbed: the time to reach the maximum concentration (Tsax) after rectal use is 45-60 minutes. The value of the plasma concentration depends linearly on the dose taken. Distribution. Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly albumin. The volume of distribution is 0.1-0.2 l / kg. It easily passes through histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissues. Although the concentrations of ketoprofen in synovial fluid are slightly lower than in plasma, they are more stable (persist for up to 30 hours). Metabolism. Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronidation to form esters with glucuronic acid. Output. Metabolites are mainly excreted in the urine (up to 76% after 24 hours). The drug does not accumulate.

Indications

Symptomatic treatment of inflammatory processes accompanied by fever and pain, including inflammatory and rheumatic diseases of the joints:

• rheumatoid arthritis
• spondyloarthritis
• osteoarthritis
• gouty arthritis
• inflammatory damage to the periarticular tissues

Contraindications

Hypersensitivity (including to other NSAIDs), “aspirin” asthma, peptic ulcer of the stomach and duodenum (exacerbation), ulcerative colitis (exacerbation), Crohn’s disease, diverticulitis, peptic ulcer, hemophilia, etc. blood clotting disorders, CRF, childhood (up to 18 years), pregnancy (III trimester), lactation.

With caution – anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, liver failure, diabetes mellitus, dehydration, sepsis, CHF, edema, arterial hypertension, blood diseases (including leukopenia), glucose-6-phosphate dehydrogenase deficiency, stomatitis, old age, pregnancy (I, II trimester). If the patient’s condition worsens, discontinue treatment with the drug.

Side effects

Gastrointestinal tract: abdominal pain, diarrhea, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, gastritis, hematomesis, esophagitis, stomatitis, melena. Liver: increased bilirubin, increased “liver” enzymes, hepatitis, liver failure, increased liver size. The nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise. Sensory organs: conjunctivitis, visual impairment. Skin conditions: urticaria, angioedema, erythematous exanthema, pruritus, maculopapular exanthema, increased sweating, erythema multiforme (including Stevens-Johnson syndrome). Genitourinary system: painful urination, cystitis, edema, hematuria, menstrual disorders. Hematopoietic organs: leukocytopenia, leukocytosis, lymphangitis, decreased prothrombin time, purpura, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis. Respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis. Cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncopal states, peripheral edema, pallor. Allergic reactions: anaphylactoid reactions, edema of the oral mucosa, pharyngeal edema, periorbital edema. Local reactions: burning, itching, heaviness in the anorectal area, exacerbation of hemorrhoids.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of mineralcorticosteroids, glucocorticosteroids, estrogens. Reduces the effectiveness of antihypertensive and diuretic drugs. Co-use with other NSAIDs, glucocorticosteroids, ethanol, and corticotropin may lead to ulceration and gastrointestinal bleeding, as well as an increased risk of developing impaired renal function. Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandol and cefotetan increases the risk of bleeding. Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary). Co-use with sodium valproate causes a violation of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, lithium preparations, and methotrexate. Antacids and colestyramine reduce absorption. Use during pregnancy and lactation. As with other NSAIDs, OCI should not be used in the third trimester of pregnancy. The use of the drug in the first and second trimester should be carefully monitored by the attending physician. Breast-feeding should be discontinued when using the drug.

How to take, course of use and dosage

One suppository 2-3 times a day. The maximum daily dose is 480 mg. In elderly patients, it is necessary to use no more than 2 suppositories per day.

Overdose

Currently, no cases of overdose with OKI have been reported.

Special instructions

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Taking ketoprofen may mask the signs of an infectious disease. In case of impaired renal and hepatic function, dose reduction and careful monitoring are necessary. The use of ketoprofen in patients suffering from bronchial asthma can lead to an attack of bronchial asthma. Women planning pregnancy should refrain from taking the drug, as the likelihood of egg implantation may decrease.

Influence on the ability to drive vehicles and manage mechanisms. During the period of using the drug, you should refrain from potentially dangerous activities related to the need for concentration of attention and rapid psychomotor reactions.

Form of production

5 suppositories in a strip of A1-foil. 2 strips in a cardboard box with instructions for use.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 5 years. Do not use the product after the date indicated on the package.

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

rectal suppositories

Description

Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Gout, Arthritis, Osteoarthritis, Osteoarthritis, Rheumatoid Arthritis, Osteochondrosis