OKI, 80 mg 2 g 12 pcs

OCI has anti-inflammatory, analgesic and antipyretic effects. By inhibiting COX-1 and -2 it inhibits the synthesis of PG. It has anti-bradykinin activity, stabilizes lysosomal membranes and inhibits the release of enzymes from them that contribute to tissue destruction during chronic inflammation. It reduces release of cytokines, inhibits activity of neutrophils.

Limits morning stiffness and swelling of the joints and increases range of motion.

Ketoprofen lysine salt, unlike ketoprofen, is a rapidly soluble molecule with a neutral pH and is almost non-irritating to the gastrointestinal tract.

Pharmacokinetics

Intake. When administered orally, ketoprofen is quickly and completely absorbed from the gastrointestinal tract, its bioavailability is about 80%. Cmax in plasma is noticed after 0.5-2 hours when administered orally; its size depends on the dose taken; after rectal administration Tmax is 45-60 minutes. CSS of ketoprofen is reached 24 hours after the beginning of its regular use.

Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly to albumin. Vd – 0.1-0.2 l/kg. It easily passes through histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into the synovial fluid and connective tissues. Although concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (remains up to 30 h).

Metabolism. Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronidation with formation of glucuronic acid esters.

After the use of 160 mg of ketoprofen lysine salt in the dosage form of topical solution the concentration in plasma of ketoprofen is low – less than 400 ng/ml – and therefore not sufficient for a significant systemic pharmacological effect.

Indications

Sciatica, Painful menstruation (algodysmenorrhea), Arthritis, Joint pain (arthralgia), Neck pain, Myalgia (muscle pain), Neuralgia of the trigeminal nerve, Back pain, Myositis, Gout, Pain, Sore throat, Bursitis, Contusions, Lumbago, Neuralgia, Swelling after injuries and operations, Toothache, Headache, Pain after injuries and operations, Rheumatoid arthritis, Osteochondrosis, Arthrosis, Osteoarthritis

Adults

• rheumatoid arthritis;
• spondyloarthritis;
• osteoarthritis;
• podagra arthritis;
• inflammatory involvement of the periarticular tissues.

Children (over 6 years)

• diseases of the musculoskeletal system;
• otitis;
• curing postoperative pain.

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Active ingredient

Ketoprofen

Composition

Active substance:

ketoprofen lysine salt 80 mg;

Auxiliary substances:

Mannitol – 1700 mg;

Sodium chloride – 132 mg;

Colloidal silicon dioxide – 3 mg;

Ammonium glycerate, 20 mg;

PVP, 20 mg;

sodium saccharin, 15 mg;

Mint flavoring, 30 mg

How to take, the dosage

Ingestion. Adults – dissolve the contents of 1 double sachet (full dose) in half a glass of drinking water and take orally 3 times a day with meals. To get one full dose (80 mg), open the double sachet on the line labeled “full dose”.

In elderly patients, the dose is determined by the physician (2-fold reduction in dosage is desirable).

In children 6-14 years of age: dissolve the contents of 1/2 double sachet (half dose) in half a glass of drinking water and take orally 3 times a day with meals. To get half the dose (40 mg), open the double sachet on the line labeled “half the dose”; for children 14-18 years of age, the doses of the drug are the same as those for adults.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Decreases the effectiveness of uricosuric drugs, increases the effects of anticoagulants, antiaggregants, fibrinolytics, ethanol, the side effects of mineralcorticosteroids, GCS, estrogen. Reduces the effectiveness of hypotensive and diuretics.

Combination with other NSAIDs, GCS, ethanol, corticotropin may lead to ulceration and gastrointestinal bleeding, increased risk of renal dysfunction.

Simultaneous use with oral anticoagulants, heparin, thrombolytics, antiaggregants, cefaperazone, cefamandole and cefotetan increases the risk of bleeding.

Induces hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

The co-administration with sodium valproate causes impairment of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, lithium drugs, methotrexate. Antacids and colestyramine reduce absorption.

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Special Instructions

Special caution is used in patients with liver and kidney diseases, gastrointestinal tract diseases and immediately after major surgical interventions.

In the course of treatment with the drug, systematic monitoring of liver and kidney function is necessary.

The simultaneous administration with anticoagulants increases the risk of bleeding.

Contraindications

• erosive-ulcerative lesions of the gastrointestinal tract in the acute phase
• “aspirin” asthma
• explicit liver and/or kidney function disorders
• high sensitivity to the drug OCI.

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Side effects

Gastrointestinal organs: abdominal pain, diarrhea, duodenitis, gastrointestinal erosive ulcers, gastritis, hematomeisis, esophagitis, stomatitis, melena.

Liver disorders: elevated bilirubin levels, increased liver enzyme activity, hepatitis, liver failure, increased liver size.

Nervous system disorders: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.

Sensory organs: conjunctivitis, visual impairment.

Skin disorders: urticaria, angioedema, erythematous exanthema, pruritus, maculopapular exanthema, increased sweating, erythema multiforme (including Stevens-Johnson syndrome).

Urogenital system disorders: painful urination, cystitis, edema, hematuria, menstrual disorders.

Hematopoietic disorders: leukocytopenia, leukocytosis, lymphangitis, decreased PV, purpura, thrombocytopenia, thrombocytopenic purpura, increased spleen size, vasculitis.

Respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

Cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope, peripheral edema, pallor.

Allergic reactions: anaphylactoid reactions, oral mucous membrane edema, pharyngeal edema, periorbital edema.

Local reactions: burning, itching, heaviness in the anorectal area, exacerbation of hemorrhoids.

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Pregnancy use

In common with other NSAIDs, OCIs should not be used in the third trimester of pregnancy.

The use of the drug in the first and second trimester should be closely monitored by the attending physician.

Breast-feeding should be discontinued when using the drug.

Similarities

Ketonal, OKI, Bystromgel, Febrofid, Flamax forte, Ketoprofen, Flamax, Fastum, Rocketal Rompharm, Pentalgin extra-gel, Ketonal DUO, Ketoprovel, OKI ACT, Brustel