P N010598/02

Trade name drug: Okie

International nonproprietary name:

ketoprofen

Chemical name: Lysine 2-(3-benzoylphenyl)propionate LD

Dosage form:

granules for the preparation of a solution for oral administration.

Compound.
One double sachet contains:
Active ingredient- ketoprofen lysine salt 80 mg;
Auxiliary components: mannitol 1700 mg, sodium chloride 132 mg, colloidal silicon dioxide 3 mg, ammonium glycerate 20 mg, polyvinylpyrrolidone 20 mg, sodium saccharin 15 mg, mint flavor 30 mg.

Description.
The granules are white to pale yellow in color with a characteristic mint odor.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory drug (NSAID).

ATX code:

Pharmacological properties
It has anti-inflammatory, analgesic and antipyretic effects. By inhibiting cyclooxygenase types I and II, it inhibits the synthesis of prostaglandins. It has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that promote tissue destruction during chronic inflammation. Reduces the release of cytokines, inhibits the activity of neutrophils.
Reduces morning stiffness and swelling of the joints, 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.
Suction. When administered orally, ketoprofen is quickly and fairly completely absorbed from gastrointestinal tract, its bioavailability is about 80%. The maximum concentration in plasma when taken orally is observed 0.5-2 hours after oral administration, its value directly depends on dose taken. The equilibrium concentration of ketoprofen is achieved 24 hours after the start of its regular use.
Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. Volume of distribution - 0.1-0.2 kg/l. Easily passes through histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissue. Although the concentrations of ketoprofen in synovial fluid slightly lower than in plasma, they are more stable (last up to 30 hours).
Metabolism. Ketoprofen is primarily metabolized in the liver, where it undergoes glucuronidation to form esters with glucuronic acid.
Excretion. Metabolites are excreted in the urine. The drug does not accumulate.

Indications.
For adults
Symptomatic treatment of inflammatory processes accompanied by fever and painful sensations, including inflammatory and rheumatic diseases of the joints:

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

Children (over 6 years):
Short term symptomatic treatment painful inflammatory processes in diseases of the musculoskeletal system and otitis media.
Relief of postoperative pain.

Contraindications.
Hypersensitivity (including to other NSAIDs), aspirin-induced asthma, peptic ulcer stomach and duodenum (exacerbation), ulcerative colitis(exacerbation), Crohn's disease, diverticulitis, peptic ulcer, hemophilia and other blood clotting disorders, chronic renal failure, childhood(up to 6 years), pregnancy (III trimester), lactation period.
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).

Use during pregnancy and lactation.
Like other NSAIDs, the drug should not be used in the third trimester of pregnancy. The use of the drug in the first and second trimesters should be carefully monitored by the attending physician. Breastfeeding should be discontinued while using the drug.

Directions for use and doses

For adults:
Dissolve the contents of 1 double sachet (full dose) in half a glass drinking water and take orally 3 times a day with meals. To get one full dose(80 mg) open the double sachet along the line labeled “full dose.”
For elderly patients, the dose is determined by the doctor; it is advisable to reduce the dosage by 2 times.
Children (from 6 to 14 years):
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 receive half the dose (40 mg), open the double sachet along the line marked “half dose.”
Children (from 14 to 18 years):
Dosages of the drug correspond to those in adults

Side effects Gastrointestinal tract:
Abdominal pain, diarrhea, duodenitis, erosive and ulcerative lesions gastrointestinal tract, gastritis, hematomesis, esophagitis, stomatitis, melena. Liver:
Increased bilirubin, increased liver enzymes, hepatitis, liver failure, increased liver size.
Nervous system:
Dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.
Sense organs:
Conjunctivitis, visual impairment. Skin:
Hives, angioedema, erythematous exanthema, itching, maculopapular exanthema, increased sweating, multiform exudative erythema(including Stevens-Johnson syndrome).
Genitourinary system:
Painful urination, cystitis, edema, hematuria, disturbance menstrual cycle. Blood-forming 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, pain in chest, syncope, peripheral edema, pallor.
Allergic reactions:
Anaphylactoid reactions, swelling of the oral mucosa, pharyngeal edema, periorbital edema.
On identifying other undesirable effect information not listed in these instructions should be reported to your doctor. If side effects from the intestines are detected, the drug should be taken with food or with milk.

Overdose.
Currently, no cases of overdose with Oki have been reported. In case of overdose, carry out treatment prescribed for poisoning with anti-inflammatory non-steroidal drugs.

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, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects mineralcorticosteroids, glucocorticosteroids, estrogens. Reduces the effectiveness of antihypertensive and diuretic drugs.
Combined use with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development gastrointestinal bleeding, to an increased risk of developing renal dysfunction.
Co-administration with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandole 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 disruption of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, lithium preparations, methotrexate. Antacids and cholestyramine reduce absorption.

Special instructions.
During treatment, it is necessary to monitor the peripheral blood picture and functional state 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 symptoms infectious disease. If renal or liver function is impaired, dose reduction and careful monitoring are necessary. The use of ketoprofen by patients suffering from bronchial asthma can lead to an attack of bronchial asthma.
Women planning pregnancy should refrain from taking the drug, because the likelihood of egg implantation may decrease.

Release form
2 g of granulate are packaged in a two-volume bag of (1.0 g in each volume, half the dose) of three-layer material: low-density polyethylene ( inner part), aluminum (intermediate part), paper (outer part). 20 or 12 bags along with instructions for use are placed in a cardboard box.

Best before date.
2 years.
Do not use the drug after the date indicated on the package.

Storage conditions.
At a temperature not higher than 25°C.
Keep out of reach of children

Conditions for dispensing from pharmacies:

according to the recipe.

Manufacturing company
Dompe S.p.A., Via Campo di Pile - 67100 L'Aquila, Italy

Representative office in Russia
JSC "Pharma Riace Limited" 127018, Moscow, 2-Vysheslavtsev lane, 17

Do you need instructions or reviews for OKI? You can find a freely translated abstract and user opinions about the drug below.

Manufacturers: Dompe Farmaceutici S.p.A

Active ingredients

• Ketoprofen

Disease class

• Lesions of the lumbosacral plexus
• Otitis externa, unspecified
• Phlebitis and thrombophlebitis of the superficial vessels of the lower extremities
• Lymphangitis
• Acute pharyngitis, unspecified
• Acute laryngitis
• Acute gingivitis
• Acute pericoronitis
• Periodontal disease
• Stomatitis and related lesions
• Glossitis
• Rheumatoid arthritis, unspecified
• Psoriatic spondylitis (L40.5)
• Ideopathic gout
• Arthritis, unspecified elsewhere
• Arthrosis, unspecified
• Joint pain
• Spinal osteochondrosis, unspecified
• Torticollis
• Ankylosing spondylitis
• Sciatica
• Lower back pain
• Synovitis and tenosynovitis
• Other bursopathies
• Enthesopathy, unspecified
• Myalgia
• Skin damage and subcutaneous tissue unspecified
• Acute pain
• Unspecified pain
• Fresh meniscus tear
• Injury to unspecified muscles and tendons of the trunk
• Dislocation, sprain and overstrain of the capsular-ligamentous apparatus of a joint of an unspecified area of ​​the body
• Unspecified injury
• Surgical practice

Clinical and pharmacological group

• Not specified. See instructions

Pharmacological action

• Anti-inflammatory

Pharmacological group

• NSAIDs - Propionic acid derivatives

Indications for use of the drug OKI

Granules for the preparation of solution for oral administration, rectal suppositories for children, rectal suppositories

For adults

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

Rheumatoid arthritis;

Spondyloarthritis;

Osteoarthritis;

Gouty arthritis;

Inflammatory damage to periarticular tissues.

Children (over 6 years old)

Short-term symptomatic treatment of painful inflammatory processes in conditions such as:

Diseases of the musculoskeletal system;

Relief of postoperative pain.

Solution for local application

Symptomatic treatment inflammatory diseases ENT organs and oral cavity:

Laryngitis;

Pharyngitis;

Tonsillitis;

Stomatitis;

Gingivitis;

Glossitis;

Paradontopathy;

Chronic periodontal disease;

Dental manipulations (as an analgesic).

Release form of the drug OKI

Granules for solution for oral administration 80 mg; double bag (bag) 2 g cardboard box (box) 20;

Granules for solution for oral administration 80 mg; double bag (bag) 2 g cardboard box (box) 12.

Granules for preparing a solution for oral administration 1 pack. two-volume
ketoprofen lysine salt 80 mg
excipients: 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
in two-volume bags made of three-layer material, 2 g each (half the dose - 1 g - in each volume); V cardboard box 12 or 20 sachets.

Pharmacodynamics

It 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 delays the release of enzymes from them that contribute to tissue destruction during chronic inflammation. Reduces the release of cytokines, inhibits the activity of neutrophils.

Reduces morning stiffness and swelling of joints, 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

Suction. When administered orally, ketoprofen is quickly and fairly completely absorbed from the gastrointestinal tract, its bioavailability is about 80%. Cmax in plasma when taken orally is observed after 0.5–2 hours, its value directly depends on the dose taken; after rectal use, Tmax is 45–60 minutes. CSS of ketoprofen is achieved 24 hours after the start of its regular use.

Distribution. Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. Vd - 0.1–0.2 l/kg. Easily passes through histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into synovial fluid and connective tissue. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (lasts 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 use, the plasma concentration of ketoprofen is low - less than 400 ng/ml - and, therefore, insufficient for a pronounced systemic pharmacological effect.

Use of the drug OKI during pregnancy

For granules, rectal suppositories and solution for topical use. Like other NSAIDs, OCI should not be used in the third trimester of pregnancy. The use of the drug in the first and second trimesters should be carefully monitored by the attending physician. Breastfeeding should be discontinued while using the drug.

Contraindications for use

Common to all forms

Hypersensitivity (including to other NSAIDs);

Aspirin asthma.

General for granules, rectal suppositories for children, rectal suppositories:

Gastric ulcer and duodenum(exacerbation)

Ulcerative colitis (exacerbation);

Crohn's disease;

Diverticulitis;

Peptic ulcer;

Children's age up to 6 years (for granules and rectal suppositories for children), for rectal suppositories - up to 18 years;

Pregnancy (III trimester);

Lactation period.

With caution:

Bronchial asthma;

Hyperbilirubinemia;

Liver failure;

Diabetes mellitus;

Dehydration;

Chronic heart failure;

Arterial hypertension;

Blood diseases (including leukopenia);

Glucose-6-phosphate dehydrogenase deficiency;

Stomatitis.

For granules and rectal suppositories additionally

With caution:

Alcoholism;

Tobacco smoking;

Alcoholic cirrhosis of the liver;

Old age;

Pregnancy (I, II trimesters).

For topical solution

With caution:

Peptic ulcer of the stomach and duodenum (exacerbation);

Ulcerative colitis (exacerbation);

Crohn's disease;

Diverticulitis;

Peptic ulcer;

Hemophilia and other bleeding disorders;

Chronic renal failure;

Children's age (up to 6 years);

Pregnancy (III trimester);

Lactation period.

Side effects

Common for granules, rectal suppositories for children and rectal suppositories

From the gastrointestinal 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.

From the outside nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.

From the senses: conjunctivitis, visual impairment.

From the outside skin: urticaria, angioedema, erythematous exanthema, itching, maculopapular exanthema, increased sweating, erythema multiforme exudative (including Stevens-Johnson syndrome).

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

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

From the outside respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

From the outside cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope, peripheral edema, pallor.

Allergic reactions: anaphylactoid reactions, swelling of the oral mucosa, pharyngeal edema, periorbital edema.

Any other undesirable effect not listed in this instruction should be reported to your doctor. If side effects from the intestines are detected, the drug in the form of granules should be used with meals or with milk.

For rectal suppositories for children and rectal suppositories additionally

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

For topical solution. Allergic reactions. If the drug is swallowed, systemic side effects may develop.

Directions for use and doses

Rectally, orally, locally.

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 obtain one full dose (80 mg), open the double sachet along the line labeled “full dose.”

For elderly patients, the dose is determined by the doctor (it is advisable to reduce the dosage by 2 times).

Children 6–14 years old: dissolve the contents of 1/2 of a two-volume sachet (half the 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 the double sachet along the line marked “half dose”; for children 14–18 years of age, dosages of the drug correspond to those for adults

Rectally. Children 6–12 years old (body weight more than 30 kg) - 1 suppository OKI 60 mg 1–2 times a day; over 12 years old - up to 3 times a day. Daily dose- no more than 5 mg/kg. Do not use for more than 5 days without consulting a doctor.

The dosages used to treat children are insufficiently effective in treating adults.

Adults - 1 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.

Locally. 2 rinses per day, 10 ml of OKI solution (5 injections) per dose. A solution of 5 injections should be diluted in the glass supplied with the package, half filled drinking water. When you press the dispenser-injector located at the top of the bottle, the patient receives 1 injection - 2 ml of OKI solution. Accidental ingestion of rinse solution will not cause serious consequences, because single dose for rinsing contains 160 mg of ketoprofen lysine salt, which corresponds to the dose intended for oral administration. Adolescents over 12 years of age should use no more than 3 sprays per cup.

Overdose

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

Treatment: in case of overdose, carry out treatment prescribed for NSAID poisoning.

Interaction with other drugs

For granules, rectal suppositories for children, rectal suppositories. 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, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of mineralcorticosteroids, corticosteroids, estrogens. Reduces the effectiveness of antihypertensive and diuretic drugs.

Combined use with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction.

Co-administration with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandole 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 disruption of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, lithium preparations, methotrexate. Antacids and cholestyramine reduce absorption.

For topical solution. No interactions were detected.

Special instructions when taking the drug OKI

During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Taking ketoprofen can mask the signs of an infectious disease.

If renal or liver function is impaired, dose reduction and careful monitoring are necessary. The use of ketoprofen by patients suffering from bronchial asthma can lead to an attack of bronchial asthma.

Women planning pregnancy should refrain from taking the drug, because the likelihood of egg implantation may decrease.

Influence on the ability to drive vehicles and operate machinery. During the period of use of the drug, you should refrain from potentially dangerous species activities associated with the need for concentration and rapid psychomotor reactions.

Solution for topical use. Long-term use external drugs can lead to sensitization. In this case, you should stop using the drug and select adequate treatment methods.

Instructions for preparing the solution. Bring the sprayer to the functional position, turning the “spout” towards the inscription “open”, inject into the attached plastic cup by pressing the sprayer all the way (injections are repeated until the dose prescribed by the doctor is reached), dissolve the injected dose in 100 ml of drinking water (half a plastic cup ).

Storage conditions

List B.: At a temperature not exceeding 25 °C.

Best before date

ATX classification:

M Musculoskeletal system

M01 Anti-inflammatory and antirheumatic drugs

M01A Non-steroidal anti-inflammatory drugs

M01AE Propionic acid derivatives

Source of information portal: www.eurolab.ua

The instructions for use classify the drug “OKI” as an NSAID. It is intended for local and internal use. The main component is ketoprofen, which has antipyretic, analgesic, and anti-inflammatory effects. The medication inhibits the production and reduces the activity of bradykinins, strengthens the cytolemmas of lysosomes and slows down the release of tissue-destructive enzymes from them. Antibacterial action the medication “OKI” (the instructions for use confirms this) does not have. In case of swelling, it also reduces the severity of morning stiffness syndrome and increases joint mobility.

Indications for use

Locally, the medicine is used to treat inflammatory diseases of the oral cavity, larynx, and pharynx, including gingivitis, periodontopathy, tonsillitis, periodontal disease, glossitis, and laryngitis. Applicable as analgesic when performing dental procedures. For symptomatic therapy inflammatory pathologies respiratory tract, rheumatic and inflammatory pathologies of the joints, accompanied by pain and increased temperature, the drug "OKI" instructions for use recommends using rectally. The drug is used for spondyloarthritis, rheumatoid and osteoarthritis. The drug is also prescribed to relieve postoperative pain.

Release form and composition

For local use, the medicine is produced in the form of a clear greenish solution with a minty odor. The solution is sold in 150 ml plastic bottles complete with a dosing cup and a dispenser necessary for injection. One milliliter contains 0.016 grams of ketoprofen. The solution also contains auxiliary components: ethanol, sodium hydrogen phosphate, mint flavor, sodium saccharin, glycerol, purified water, methyl parahydroxybenzoate, menthol. “OKI” powder intended for preparing the solution is also produced. The instructions indicate the effectiveness of this drug. One sachet of powder contains 0.8 grams of ketoprofen. For systemic use, it is produced in the form of torpedo-shaped light yellow or white rectal suppositories medicine "OKI". Instructions for use indicate that one suppository includes 0.16 grams of ketoprofen and 1.64 grams of semi-synthetic glycerides. Suppositories intended for children contain the active ingredient - ketoprofen - in an amount of 0.06 grams.

Method of use

In the form of a solution, the medicine is used for rinsing. To carry out one procedure, you need to use 10 milliliters of OKI solution. The instructions recommend rinsing twice a day. Children 6-12 years old require 4 ml of product per procedure, after 12 years old - 6 ml. In the form of suppositories, adults and children over 14 years of age are recommended to use the drug twice or thrice a day. Children 6-12 years old are recommended to use one children's suppository 1-2 times a day, and after 12 years - 3 times.

Oki (ketoprofen) is an NSAID whose precursor is methylacetic acid. It has analgesic, anti-inflammatory and antipyretic effects. The pharmacological activity of the drug is a consequence of its ability to inhibit the activity of the enzyme cyclooxygenase, which takes part in the metabolic reactions of the precursor of pain and inflammation mediators arachidonic acid. Prostaglandins, in turn, are peculiar instigators of a “biochemical revolution” in the body in the form of pain, elevated temperature and inflammation. The analgesic effect of the drug develops according to two physiological patterns: peripheral (supported by inhibition of the formation of the prostaglandins already mentioned above) and central (associated with the suppression of the synthesis of prostaglandins in the central nervous system and the effect on biological activity other substances that can interact with neurons and are involved in the release of algogenic neurotransmitters in spinal cord). In addition to this, the drug suppresses the activity of bradykinin, stabilizes the state of lysosome membranes, and inactivates neutrophil granulocytes in individuals with infectious nonspecific polyarthritis. Prevents platelets from sticking to each other. When taken orally and in suppositories, it is well absorbed from the gastrointestinal tract. Peak concentration in the blood is observed at 2-5 hours ( oral form) and 45-60 minutes (suppositories) from the moment of administration. Almost all of the incoming amount of the drug interacts with plasma proteins. Undergoes metabolic transformations in the liver. Elimination from the body occurs mainly through urine and, to a lesser extent, through feces. Half-life is 1.5-2 hours. Used for infectious nonspecific polyarthritis, deforming arthrosis, ankylosing spondylitis, inflammation of periarticular tissues large joints(joint capsule, its ligaments, surrounding tendons and muscles), synovial membrane of joints, inflammation and degeneration of tendon tissue, inflammation joint capsule, spinal pain, muscle pain, sports and household injuries (dislocations, bruises, sprains), as part of combined pharmacotherapy for inflammation of the vessels of the venous and lymphatic beds (inflammation venous walls tissues surrounding the vein, lymphatic vessels and superficial lymph nodes).

The dose of the drug (initial, shock, maintenance) is set individually depending on clinical picture And individual characteristics patient. Possible side effects: epigastric pain, vomiting, involuntary eruption of stomach contents through the mouth, constipation or diarrhea, loss of appetite, stomach pain, liver dysfunction, headaches, partial loss of balance, tinnitus, sleep disorder accompanied by a constant or periodic desire to sleep during times not intended for sleep, renal dysfunction, bronchospasm. The drug is not used for ulcers and erosions of the stomach and duodenum in the acute phase, aspirin intolerance, severe violations liver and kidney function, pregnancy, individual intolerance active component and any salicylates (oral form - granules), inflammation of the rectum and bleeding from the intestine, incl. preceding treatment (for suppositories), weeping dermatitis, eczematous skin lesions, bacterially contaminated wounds in the treatment area (for topical solution). Persons suffering from liver or kidney disease digestive tract, with signs of dyspepsia while taking the drug should be under regular medical supervision with monitoring of basic functional indicators liver and kidneys. It is not recommended to use the drug with other NSAIDs: this increases the risk of damage to the mucous membrane of the digestive tract. At sharing OKI with antihypertensive drugs the effect of taking the latter decreases.

Pharmacology

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

Reduces morning stiffness and swelling of joints, increases range of motion.

Ketoprofen lysine salt, unlike ketoprofen, is a rapidly soluble compound with a neutral pH and therefore almost does not irritate the gastrointestinal tract.

Pharmacokinetics

Suction

After rectal application it is quickly absorbed. The time to reach Cmax after rectal application is 45-60 minutes.

The plasma concentration depends linearly on the dose taken.

Distribution

Up to 99% of ketoprofen is bound to plasma proteins, mainly albumin. V d - 0.1-0.2 l/kg. Easily penetrates histohematic barriers and is distributed in tissues and organs. Ketoprofen penetrates well into the synovial fluid and connective tissue. Although the concentration of ketoprofen in synovial fluid is slightly lower than in plasma, it is more stable (lasts up to 30 hours).

Metabolism

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

Removal

Metabolites are excreted mainly in the urine (up to 76% within 24 hours). The drug does not accumulate.

Release form

Rectal suppositories are white to light yellow in color, torpedo-shaped.

Excipients: semi-synthetic glycerides - 1640 mg.

5 pcs. - strips (2) - cardboard packs.

Dosage

Apply rectally 1 suppository 2-3 times/day. The maximum daily dose is 480 mg.

Elderly patients should use no more than 2 supp./day.

Overdose

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

Interaction

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

During simultaneous use with the drug Oki, the effectiveness of uricosuric drugs decreases, the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, and the side effects of mineralcorticoids, glucocorticoids, and estrogens are enhanced; the effectiveness of antihypertensive drugs and diuretics decreases.

The simultaneous use of the drug Oki with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction.

Concomitant use of Oka with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

The drug Oki, when used simultaneously, enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dosage recalculation is necessary).

The combined use of Oka with sodium valproate causes a violation of platelet aggregation.

Ketoprofen, when used simultaneously, increases the plasma concentration of verapamil and nifedipine, lithium, and methotrexate.

Antacids and cholestyramine reduce the absorption of ketoprofen.

Side effects

From the hematopoietic system: leukocytopenia, leukocytosis, lymphangitis, decreased prothrombin time, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

From the central nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability.

From the organ of vision: conjunctivitis, visual impairment.

From the cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope.

From the respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

From the outside digestive system: abdominal pain, diarrhea, stomatitis, esophagitis, gastritis, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, hematemesis, melena, increased bilirubin levels, increased activity of liver enzymes, hepatitis, liver failure, increased liver size.

From the urinary system: painful urination, cystitis, edema, hematuria.

From the skin and subcutaneous tissues: erythematous exanthema, itching, maculopapular rash, increased sweating.

Allergic reactions: urticaria, angioedema, erythema multiforme exudative (including Stevens-Johnson syndrome), anaphylactoid reactions (edema of the oral mucosa, pharyngeal edema, periorbital edema).

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

Other: general malaise, menstrual irregularities, peripheral edema, pallor.

Indications

Symptomatic treatment of inflammatory processes accompanied by increased body temperature and pain, incl. inflammatory and rheumatic diseases of the joints:

• rheumatoid arthritis;
• spondyloarthritis;
• osteoarthritis;
• gouty arthritis;
• inflammatory damage to periarticular tissues.

Contraindications

• "aspirin" asthma;
• peptic ulcer of the stomach and duodenum in the acute phase;
• ulcerative colitis in the acute phase;
• Crohn's disease;
• diverticulitis;
• peptic ulcer;
• blood clotting disorders (including hemophilia);
• chronic renal failure;
• children's and adolescence up to 18 years old;
• III trimester of pregnancy;
• lactation period;
• hypersensitivity to ketoprofen or other NSAIDs.

The drug should be prescribed with caution in case of anemia, bronchial asthma, alcoholism, smoking, alcoholic cirrhosis liver, hyperbilirubinemia, liver failure, diabetes mellitus, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia), glycoso-6-phosphate dehydrogenase deficiency, stomatitis, in the first and second trimesters of pregnancy, as well as in elderly patients.

Features of application

Use during pregnancy and breastfeeding

The use of the drug in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, the drug should be used with caution and under the supervision of a physician.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Women planning pregnancy should refrain from using the drug, because taking it may reduce the likelihood of egg implantation.

Use for liver dysfunction

The drug should be prescribed with caution for alcoholic cirrhosis of the liver, hyperbilirubinemia, and liver failure.

Use for renal impairment

Contraindicated in chronic renal failure.

Use in children

The drug is contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

Caution should be used in elderly patients.

Special instructions

During treatment with Oki, it is necessary to periodically monitor the peripheral blood picture 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 can mask the signs of an infectious disease.

If renal or liver function is impaired, dose reduction and careful monitoring are necessary.

The use of the drug for bronchial asthma can provoke an attack of suffocation.

Impact on the ability to drive vehicles and operate machinery

During the period of use of the drug, you should refrain from potentially hazardous activities that require increased concentration attention and speed of psychomotor reactions.

OKI is a non-steroidal anti-inflammatory drug that is often used in the treatment of diseases musculoskeletal system. The drug is also available in granule format for the preparation of a solution intended for topical use. The drug in this dosage form can be used in dental practice. The composition is often used in the treatment of lesions of the oral cavity.

Dosage form

The drug OCI is produced by pharmacological companies in several dosage forms:

• solution for oral use (granules for preparing a solution);
• rectal suppositories;
• solution intended for topical use.

Description and composition

The granules contain the following components:

• lysine salt – active substance;
• sodium chloride;
• mannitol;
• ammonium glycerate;
• saccharin nitrate;
• colloidal silicon dioxide;
• mint flavor.

Composition of suppositories:

• lysine salt – active ingredient(60 and 160 mg);
• semi-synthetic glycerides.

Solution for external use:

• lysine salt;
• ethanol;
• glycerol;
• mint flavor;
• hydroxybenzoate;
• sodium saccharin;
• methanol;
• sodium hydrogen phosphate;
• purified water.

Pharmacological group

OCI drugs significantly inhibit the process of prostaglandin synthesis due to the existing ability to inhibit COX and COX 2; the drugs have antipyretic, anti-inflammatory and analgesic effects. The drugs have antibrakinin activity, inhibit the process of release of lysosomal membrane enzymes and stabilize such indicators. This efficiency ensures tissue destruction during chronic inflammatory processes. The drug reduces the production of cytokines and stops the process of neutrophil production. The drugs do not have antibacterial activity.

Indications for use

The drug OKI in the form of a solution prepared from granules and rectal suppositories is used for rheumatic and inflammatory lesions joints. The list of indications for use of the product includes:

• gouty arthritis;
• rheumatoid arthritis;
• intra-articular lesions;
• inflammatory processes involving periarticular tissues;
• osteoarthritis;
• spodoloarthritis.

List of indications for use of the product in solution form:

• glossitis;
• aphthous;
• periodontal disease

for adults

The drug can be used by patients provided there are no contraindications for use. In compliance with the rules of increased caution, the drug is prescribed to patients who have severe disturbances in the functioning of the liver and kidneys.

for children

Children over 6 years of age are allowed to take the drug for a short time if available. next indications for use:

• relief of postoperative pain;
• pathologies of the motor system;
• inflammation of the middle ear.

The drug in the form of rectal suppositories can be used subject to the rules of increased caution in 1 and . The use of a solution indicated for oral use is prohibited at all stages of gestation. The use of the solution for topical use is not prohibited. During lactation, there are restrictions on the use of the drug, regardless of the form of release. Before using the composition, you should consult a qualified physician.

Contraindications

Scroll general contraindications for use medicines all forms of release can be presented in the following form:

• aspirin asthma;
• increased sensitivity of the patient's body to any non-steroidal anti-inflammatory drugs.

The list of general contraindications for the use of rectal suppositories can be presented as follows:

• Crohn's disease;
• renal failure;
• ulcerative colitis in the acute phase;
• stomach and duodenal ulcers;
• peptic ulcer;
• childhood;
• pregnancy period and breastfeeding.

Applications and dosages

Dosages are determined privately by a specialist after assessing the patient’s condition. The instructions include only approximate standards, which should not become a guide to the use of the composition.

for adults

Maximum dosage for patients old age is 1 suppository 2-3 times a day. Maximum daily dosage is no more than 480 mg. For elderly people, it is recommended to use no more than 2 suppositories per day.

for children

Children under 14 years of age are recommended to take oral granules in the following form. Half the contents of 1 sachet should be dissolved in 100 ml of water and taken 3 times a day, 20-30 minutes before meals. To receive half the dose of the product, the package should be torn along a special line.

When using the product in suppositories, follow the following recommendations: children from 6 to 12 years old - 60 mg of the drug no more than 2 times a day, children over 12 years old - 60 mg of the drug 3 times a day. The daily dose should be no more than 5 mg/kg body weight.

The drug should not be used for more than 5 days, unless the doctor recommends otherwise.

for pregnant women and during lactation

The medicine can be used during pregnancy and breastfeeding after consultation with your doctor. The dosage of the drug is determined individually after assessing the timing of pregnancy. The product can only be used if the expected benefit to the mother significantly outweighs the risks to the raft.

Side effects

Scroll adverse reactions quite extensive:

• duodenitis;
• abdominal pain;
• increased bilirubin levels;
• increased activity of liver enzymes;
• esophagitis;
• gastritis;
• hepatitis;
• liver failure;
• dizziness;
• tremor;
• vertigo;
• anxiety;
• mood swings;
• irritability;
• hallucinations;
• visual impairment;
• malaise;
• Quincke's edema;
• manifestation;
• bronchospasm;
• collapse;
• hypotension;
• tachycardia;
• swelling of tissues and mucous membranes.

Interaction with other drugs

Data about drug interactions currently missing.

Special instructions

The regimen for using OCI should be discussed with your doctor individually.

Overdose

Symptoms of overdose are reduced to the active manifestation of adverse reactions. Therapeutic manipulations in this case, they come down to gastric lavage. If the patient’s condition is assessed as serious, you should seek emergency medical help.

Storage conditions

The drug is sold to the public through a network of pharmacies without a prescription. The product should be stored at a temperature of no more than 25 degrees, out of the reach of children. Maximum duration Storage – 5 years from the date of production.

Analogues

The drug OKI has several structural analogues.

The drug is also a direct analogue of the drug OKI. This product is available in the form of a solution intended for infusion. The product is dispensed from a network of pharmacies with a prescription. The drug is not used in pediatric practice.

Price

The cost of Oka is on average 337 rubles. Prices range from 227 to 586 rubles.