OKI, sachets 80 mg 2 g, 12 pcs.

Composition

Active ingredient:

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 flavor-30 mg

Pharmacological action

OKI has anti-inflammatory, analgesic and antipyretic effects. By inhibiting COX-1 and -2, it inhibits PG 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 rapidly soluble molecule with a neutral pH and almost does not irritate

the gastrointestinal tract.

Suction. Administered orally, ketoprofen is rapidly and fairly fully absorbed from the gastrointestinal tract, its bioavailability is about 80%. Cmax in plasma when taken orally is noted in 0.5-2 hours, its value directly depends on the dose taken; after rectal administration, Tmax is 45-60 minutes. CSS of ketoprofen is reached 24 hours after the start of its regular intake.

Distribution. Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly 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 synovial fluid and connective tissues. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (persists up to 30 hours).

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

After using 160 mg of ketoprofen lysine salt in dosage form solution for topical application, the plasma concentration of ketoprofen is low-less than 400 ng / ml-and, therefore, insufficient for a pronounced systemic pharmacological effect.

Indications

Adults

• : rheumatoid arthritis;
• spondyloarthritis;
• osteoarthritis;
• gouty arthritis;
• inflammatory lesion of periarticular tissues.

Children (over 6 years old)

• diseases of the musculoskeletal system;
• otitis media;
• relief of postoperative pain.

Use during pregnancy and lactation

As with other NSAIDs, AKI 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.

Contraindications

• erosive and ulcerative lesions of the gastrointestinal tract in the acute phase
• of “aspirin” asthma
• severe liver and/or kidney function disorders
• hypersensitivity to the drug OKI.

Side effects

From the side of the digestive tract: abdominal pain, diarrhea, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, gastritis, hematomesis, esophagitis, stomatitis, melena.

From the liver: increased bilirubin levels, liver enzyme activity, hepatitis, liver failure, increased liver size.

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

From the side of the senses: conjunctivitis, visual impairment.

From the side of the skin: urticaria, angioedema, erythematous exanthema, pruritus, maculopapular exanthema, increased sweating, erythema multiforme (including Stevens-Johnson syndrome).

From the genitourinary system: painful urination, cystitis, edema, hematuria, menstrual disorders.

From the side of hematopoietic organs: leukocytopenia, leukocytosis, lymphangitis, decreased blood pressure PV, purpura, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

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

From the cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope, 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, corticosteroids, estrogens. Reduces the effectiveness of antihypertensive and diuretic drugs.

Concomitant use with other NSAIDs, corticosteroids, ethanol, and corticotropin can lead to ulceration and gastrointestinal bleeding, and increase the risk of developing impaired renal function.

Concomitant administration 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-administration 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.

How to take, course of administration and dosage

Inside. Adults-dissolve the contents of 1 two-volume sachet (full dose) in half a glass of drinking water and take orally 3 times a day with meals. To receive one full dose (80 mg), open a double sachet along the line labeled “full dose”.

For elderly patients, the dose is determined by the doctor (preferably reducing the dosage by 2 times).

Children 6-14 years old: dissolve the contents of 1/2 two-volume sachet (half dose) in half a glass of drinking water and take orally 3 times a day with meals. To receive half the dose (40 mg), open a double sachet along the line marked “half dose”; for children aged 14-18 years, the dosage of the drug corresponds to that of adults.

Special instructions

With extreme caution, the drug OKI is prescribed to patients with liver and kidney diseases, diseases of the gastrointestinal tract and immediately after serious surgical interventions.

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

Concomitant administration with anticoagulants increases the risk of bleeding.

Form of production

Granules for the preparation of an oral solution

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

5 years

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral administration

Description

For adults as prescribed by a doctor, Children over 6 years of age, Children as prescribed by a doctor, For adults

Indications

Trigeminal neuralgia, Bursitis, Rheumatoid Arthritis, Bruises, Myositis, Arthritis, Osteoarthritis, Sciatica, Lumbago, Gout, Swelling after injuries and operations, Osteoarthritis, Osteochondrosis

Weight

Weight: 51 g.