Universal reference book for medicines
Product name: OKI

Active substance: ketoprofen

Type: NSAIDs

Manufacturer: DOMPE (Italy) manufactured by ISTITUTO de ANGELI (Italy)
Composition, form of production and packaging
Suppositories rectal
from white to light yellow color, torpedo-shaped.

1 supp.

ketoprofen lysine salt 160 mg

Excipients: semi-synthetic glycerides - 1640 mg.

5 pieces.
- Strips (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

NSAIDs.
Has anti-inflammatory, analgesic and antipyretic effect. Inhibiting COX-1 and COX-2, inhibits the synthesis of prostaglandins. It has anti-bradykinin activity, stabilizes lysosomal membranes, and delays the release of enzymes that promote tissue destruction in chronic inflammation. Reduces the secretion of cytokines, inhibits the activity of neutrophils.
Reduces the morning stiffness and swelling of the joints, increases the volume of movements.

Ketoprofen lysine salt, in contrast to ketoprofen, is a quick-dissolving compound with a neutral pH and, as a result, almost does not irritate the gastrointestinal tract.

PHARMACOKINETICS

Suction

After rectal administration, it is rapidly absorbed.
Time to reach C max after rectal administration 45-60 min.
The concentration in the plasma depends linearly on the dose taken.

Distribution

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

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

Excretion

Metabolites are excreted mainly with urine (up to 76% within 24 hours).
The drug does not cumulate.
INDICATIONS

Symptomatic treatment of inflammatory processes, accompanied by an increase in body temperature and pain, in t.ch.
inflammatory and rheumatic diseases of joints:
- rheumatoid arthritis;

- Spondyloarthritis;

- osteoarthrosis;

- gouty arthritis;

- Inflammation of the periarticular tissues.

DOSING MODE

Apply rectally to 1 suppository 2-3 times / day.
The maximum daily dose is 480 mg.
Elderly patients should not use more than 2 suppositories / day.

SIDE EFFECT

On the part of the hematopoiesis system: leukocytopenia, leukocytosis, lymphangitis, reduction of prothrombin time, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

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

From the side of the organ of vision: conjunctivitis, impaired vision.

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

On the part of the respiratory system: bronchospasm, dyspnoea, sensation of spasm of the larynx, laryngospasm, laryngeal edema, rhinitis.

On the part of the digestive system: abdominal pain, diarrhea, stomatitis, esophagitis, gastritis, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, hematemesis, melena, increased bilirubin levels, hepatic enzyme activity, hepatitis, hepatic insufficiency, liver enlargement.

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

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

Allergic reactions: urticaria, angioedema, exudative erythema multiforme (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, violation of the menstrual cycle, peripheral edema, pallor.

CONTRAINDICATIONS

- "aspirin" asthma;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- ulcerative colitis in the phase of exacerbation;

- Crohn's disease;

- diverticulitis;

- peptic ulcer;

- Violations of blood clotting (including hemophilia);

- chronic renal failure;

- children and adolescence under 18;

- III trimester of pregnancy;

- lactation period;

- Hypersensitivity to ketoprofen or other NSAIDs.

With caution should prescribe the drug for anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis, hyperbilirubinemia, liver failure, diabetes, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia) , a deficiency of globose-6-phosphate dehydrogenase, stomatitis, in the first and second trimesters of pregnancy, as well as in elderly patients.

PREGNANCY AND LACTATION

The use of the drug in the third trimester of pregnancy is contraindicated.
In the first and second trimesters of pregnancy, use the drug with caution and under the supervision of a doctor.
If you need to use the drug during lactation, breastfeeding should be discontinued.

Women planning pregnancy, should refrain from the use of the drug, tk.
on the background of its administration, the probability of implantation of the ovule may decrease.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in chronic renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for alcoholic cirrhosis of the liver, hyperbilirubinemia, liver failure.

APPLICATION FOR CHILDREN

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

APPLICATION IN ELDERLY PATIENTS

Caution should be used in elderly patients.

SPECIAL INSTRUCTIONS

During treatment with Oka, periodic 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 test.

Reception of ketoprofen can mask signs of an infectious disease.

If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary.

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

Impact on the ability to drive vehicles and manage mechanisms

During the period of drug use, it is necessary to refrain from potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

At present, cases of Oka overdose have not been reported.

DRUG INTERACTION

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

Against the background of simultaneous application with the Oka drug, the effectiveness of uricosuric drugs decreases, the effect of anticoagulants, antiplatelet agents, fibrinolytic agents, ethanol, side effects of mineral corticoids, glucocorticoids, estrogens increases;
decreases the effectiveness of antihypertensive drugs and diuretics.
The simultaneous use of Oka with other NSAIDs, GCS, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, an increased risk of kidney dysfunction.

Simultaneous application of Oka with oral anticoagulants, heparin, thrombolytic agents, antiaggregants, cefoperazone, cefamandol and cefotetan increases the risk of bleeding.

Oak preparation with simultaneous application increases hypoglycemic action of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

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

Ketoprofen with simultaneous application increases the concentration in the plasma of verapamil and nifedipine, lithium, methotrexate.

Antacids and colestyramine reduce the absorption of ketoprofen.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C.
Shelf life - 5 years.
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