Ketoprofen, 100 mg, rectal suppositories, 10 pcs.

Ketoprofen 100 mg

Dosage form

Rectal suppositories

Composition per suppository:

Active substance

: ketoprofen – 100 mg.

Excipients

: solid fat (Vitepsol N-15) – 1850 mg, glyceryl caprylocaprate (Migliol 812) – 200 mg.

Description

Suppositories are white or almost white, torpedo-shaped. On a longitudinal section - homogeneous, the presence of an air rod is allowed.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

ATX code

: M01AE0Z.

Pharmacological properties

Pharmacodynamics

Ketoprofen is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. Suppresses the activity of type I and II cyclooxyrenases, which regulate the synthesis of prostaglandins. The analgesic effect is due to both central and peripheral mechanisms. It has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that contribute to tissue destruction during chronic inflammation.

Pharmacokinetics

Absorption. Ketoprofen is easily absorbed from the gastrointestinal tract (GIT) when taken orally. The time to reach maximum concentration (TC max) with rectal administration is 1.4-4 hours. The bioavailability of the drug is 90%. Food intake does not affect the overall bioavailability of ketoprofen, but reduces the rate of absorption.

Distribution. Ketoprofen is 99% bound to plasma proteins, mainly to the albumin fraction. The volume of distribution is 0.1 l/kg. Ketoprofen penetrates into the synovial fluid and reaches a concentration there equal to 30% of the concentration in the blood plasma. Plasma clearance of ketoprofen is approximately 0.08 l/kg/h. Effective concentrations of ketoprofen are determined in the blood even 24 hours after its administration.

Metabolism and excretion. Ketoprofen undergoes intensive metabolism under the action of microsomal liver enzymes, the half-life is less than 2 hours. Ketoprofen binds to glucuronic acid and is excreted from the body in the form of r-lucuronide. There are no active metabolites of ketoprofen. Up to 80% of ketoprofen is excreted by the kidneys within 24 hours, mainly in the form of ketoprofen glucuronide. When using the drug in a dosage of 100 mg or more, excretion by the kidneys may be difficult.

In patients with severe renal impairment, most of the drug is excreted through the intestines. When taking high doses, hepatic clearance also increases. Up to 40% of the drug is excreted through the intestines.

In patients with liver failure, the plasma concentration of ketoprofen is doubled (probably due to hypoalbuminemia and, consequently, a high level of unbound active ketoprofen); such patients must be prescribed the drug in a minimum therapeutic dose.

In patients with renal failure, the clearance of ketoprofen is reduced, but dose adjustment is required only in cases of severe renal failure.

In elderly patients, the metabolism and elimination of ketoprofen is slower, which is of clinical significance only for patients with severe renal impairment.

Indications for use

Inflammatory and degenerative diseases of the musculoskeletal system:

• rheumatoid arthritis;
• seronegative arthritis: ankylosing spondylitis (Bechterew's disease), psoriatic arthritis, reactive arthritis (Reiter's disease);
• osteoarthritis;
• tendinitis;
• bursitis;
• myalgia;
• neuralgia;
• radiculitis.

Pain syndrome:

• headache;
• toothache;
• post-traumatic and postoperative pain syndrome;
• pain syndrome in cancer;
• algodismenorrhea.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

• hypersensitivity to ketoprofen or other components of the drug;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);
• peptic ulcer of the stomach and duodenum in the acute phase;
• ulcerative colitis (exacerbation), Crohn's disease in the acute phase;
• peptic ulcer;
• hemophilia and other bleeding disorders;
• confirmed hyperkalemia;
• severe liver failure;
• active liver disease;
• severe renal failure (creatinine clearance <30 ml/min); progressive kidney disease;
• decompensated heart failure;
• perioperative period after coronary artery bypass surgery;
• chronic dyspepsia;
• gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding);
• inflammatory bowel diseases, including proctitis, diverticulitis;
• children under 15 years of age;
• pregnancy (III trimester) and breastfeeding period.

Carefully

Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, chronic liver failure, chronic renal failure (creatinine clearance 30-60 ml/min), history of ulcerative lesions of the gastrointestinal tract, inflammatory bowel diseases (including ulcerative colitis, Crohn's disease) without exacerbation, the presence of Helicobacter pylori infection, severe somatic diseases, diabetes mellitus, peripheral arterial diseases, dehydration, sepsis, chronic heart failure, coronary heart disease, edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, cerebrovascular diseases, dyslipidemia/hyperlipidemia, long-term use of NSAIDs, concomitant use of oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine , paroxetine, sertraline), old age, pregnancy (I, II trimester). Patients with inflammatory diseases of the rectum should not use ketoprofen in suppository dosage form. If the patient's condition worsens, treatment with the drug should be discontinued. If you have one of the listed diseases, be sure to consult your doctor before taking the drug.

Use during pregnancy and breastfeeding

The use of ketoprofen in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, the drug can be prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

When taking the drug during breastfeeding, the issue of stopping breastfeeding should be decided.

The use of ketoprofen can affect female fertility, therefore, patients with infertility (including those undergoing examination) are not recommended to use the drug. Inhibition of prostaglandin synthesis may have undesirable effects on pregnancy and/or embryonic development. Data obtained from epidemiological studies with the use of prostaglandin synthesis inhibitors in early pregnancy confirm an increased risk of spontaneous abortion and the formation of heart defects (~ 1-1.5%). The use of ketoprofen in pregnant women during the third trimester of pregnancy is contraindicated due to the possibility of developing weakness of labor in the uterus and/or premature closure of the ductus arteriosus, a possible increase in bleeding time, oligohydramnios and renal failure.

Directions for use and doses

Rectally. Suppositories are inserted deep into the rectum. Patients are prescribed 1 suppository of 100 mg 1-2 times a day. The maximum daily dose of the drug should not exceed 200 mg.

Side effect

Blood and lymphatic system disorders

rarely

: hemorrhagic anemia;

frequency unknown

: agranulocytosis, thrombocytopenia, bone marrow dysfunction.

Immune system disorders

frequency unknown

: anaphylactic reactions (including anaphylactic shock);

Skin disorders

infrequently

: skin rash, skin itching;

frequency unknown

: photosensitivity, alopecia, urticaria, anioneurotic edema, erythema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

Mental disorders

frequency unknown

: emotional lability.

Nervous system disorders

infrequently

: headache, dizziness, drowsiness; rarely: paresthesia;

frequency unknown

: convulsions, disturbance of taste.

Visual disorders

frequency unknown

: blurred vision

Hearing and labyrinth disorders

frequency unknown

: noise in ears.

Heart disorders

frequency unknown

: heart failure

Vascular disorders

frequency unknown

: increased blood pressure, vasodilation.

Respiratory, thoracic and mediastinal disorders

rarely

: exacerbation of bronchial asthma;

frequency unknown

: bronchospasm (especially in patients with hypersensitivity to NSAIDs), rhinitis.

Gastrointestinal disorders

often

: nausea, vomiting, dyspepsia, abdominal pain;

infrequently

: constipation, diarrhea, bloating, gastritis; rarely: peptic ulcer, stomatitis;

very rarely

: exacerbation of ulcerative colitis or Crohn's disease, gastrointestinal bleeding, perforation.

Disorders of the liver and biliary tract

rarely

: hepatitis, increased levels of “liver” transaminases and bilirubin.

Renal and urinary tract disorders

very rarely

: acute renal failure, interstitial nephritis, nephritic syndrome, nephrotic syndrome, abnormal values ​​of renal function indicators.

General and administration site disorders

infrequently

: swelling;

rarely

: weight gain;

frequency unknown

: increased fatigue.

Overdose

Symptoms

: Drowsiness, nausea, vomiting, abdominal pain, bleeding, liver and kidney dysfunction may occur.

Treatment

: symptomatic therapy. In case of accidental ingestion, gastric lavage and/or activated carbon and/or other sorbents.

Interaction with other drugs

Anticoagulants and antiplatelet agents:

It is necessary to use ketoprofen with caution with drugs of these groups due to the risk of bleeding. Patients receiving concomitant treatment with these drugs should be carefully monitored.

Lithium:

Ketoprofen may increase the lithium content in blood plasma. Monitoring serum lithium levels is recommended.

Other NSAIDs, in particular selective COX-2 inhibitors and acetylsalicylic acid: the simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects, especially from the gastrointestinal tract (the development of erosive-ulcerative lesions and perforations).

Methotrexate:

Caution should be exercised when using ketoprofen less than 24 hours before or 24 hours after taking methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase.

Mifepristone:

NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

Pentoxifylline:

There is an increased risk of bleeding. When used together with ketoprofen, more frequent clinical monitoring and monitoring of bleeding time is required.

Diuretic and antihypertensive drugs:

When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers and angiotensin-converting enzyme inhibitors), ketoprofen may reduce their hypotensive effect. In connection with the above, in patients, especially elderly patients, with simultaneous use of ketoprofen and diuretics or antihypertensive drugs, blood pressure should be regularly measured, renal function and hydration levels monitored (due to an increased risk of nephrotoxicity).

Cardiac glycosides:

The simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.

Cyclosporine:

Increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine, especially in elderly patients.

Glucocorticosteroids:

Increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Quinolone antibiotics:

In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase. Cyclosporine:

Increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine, especially in elderly patients.

Anticoagulants and thrombolytic drugs:

NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.

Probenecid:

Co-administration of ketoprofen and probenecid may significantly reduce the plasma clearance of ketoprofen.

Selective serotonin reuptake inhibitors.

Concomitant use of ketoprofen with selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Zidovudine:

Concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ketoprofen.

special instructions

During treatment with the drug Ketoprofen, it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys, especially in patients over 65 years of age, and it is also necessary to conduct a stool test for occult blood. If renal or liver function is impaired, dose reduction and careful monitoring are necessary. Caution should be exercised when prescribing the drug to patients with a history of peptic ulcers of the gastrointestinal tract.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

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

With the simultaneous use of ketoprofen and warfarin, as well as coumarin anticoagulants or lithium salts, patients should be under strict medical supervision.

Taking the drug Ketoprofen can mask the signs of an infectious disease.

If visual impairment develops, consultation with an ophthalmologist is necessary.

It is necessary to be careful and monitor blood pressure more often when using ketoprofen to treat patients suffering from arterial hypertension and cardiovascular diseases that lead to fluid retention in the body. If there is a history of contraindications from the gastrointestinal tract (bleeding, perforation, peptic ulcer), long-term therapy and the use of high dosages of ketoprofen, the patient should be under close medical supervision. Clinical studies of NSAIDs (COX-2 selective and non-selective) have shown an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. Increased risk was more often observed with higher doses.

The effect of the drug on the ability to drive vehicles and machinery

During treatment with ketoprofen, a decrease in the speed of mental and motor reactions is possible. In addition, while using the drug, drowsiness, dizziness or other unpleasant sensations from the nervous system, including blurred vision, may occur, so it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Rectal suppositories, 100 mg.

1, 2, 3, 4, 5, 6, 7, 8, 9, 10 suppositories in a blister pack made of a two-layer film or a film made of PVC/PE polymer materials or a white combined PVC/PE film or a polyvinyl chloride film.

1, 2, 3, 4, 5, 6, 7, 8, 9, 10 blister packs together with instructions for medical use of the drug are placed in a cardboard pack.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Best before date

5 years.

Do not use after the expiration date stated on the packaging.

Vacation conditions

Dispensed by prescription.

Ketoprofen 100 mg, 10 rectal suppositories

Registration Certificate Holder

TULA PHARMACEUTICAL FACTORY (Russia)

Dosage form

Medicine - Ketoprofen

Description

Rectal suppositories

white or almost white, torpedo-shaped; on a longitudinal section - homogeneous, the presence of an air rod is allowed.

1 sup.

ketoprofen 100 mg

Excipients

: solid fat (Vitepsol N-15) - 1850 mg, glyceryl caprylocaprate (miglyol 812) - 200 mg.

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Indications

Symptomatic treatment of pain syndrome, incl. in inflammatory processes of various origins: rheumatoid arthritis; seronegative arthritis: ankylosing spondylitis (Bechterew's disease), psoriatic arthritis, reactive arthritis (Reiter's syndrome); gout, pseudogout; degenerative diseases of the musculoskeletal system, incl. osteoarthritis; mild, moderate and severe pain syndrome with headaches, migraines, tenditis, bursitis, myalgia, neuralgia, radiculitis; post-traumatic and postoperative pain syndrome, incl. accompanied by inflammation and fever; pain syndrome in cancer; algodismenorrhea.

Contraindications for use

Hypersensitivity to ketoprofen, as well as salicylates or other NSAIDs; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history); peptic ulcer of the stomach or duodenum in the acute phase; ulcerative colitis, Crohn's disease; hemophilia and other bleeding disorders; severe liver failure; severe renal failure (creatinine clearance less than 30 ml/min), confirmed hyperkalemia, progressive kidney disease; decompensated heart failure; postoperative period after coronary artery bypass surgery; gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); chronic dyspepsia; III trimester of pregnancy; breastfeeding period; children under 15 years of age; for rectal use - inflammatory diseases of the rectum and/or bleeding from the rectum.

Carefully

History of peptic ulcer, presence of Helicobacter pylori infection; history of bronchial asthma; clinically significant cardiovascular, cerebrovascular and peripheral arterial diseases; dyslipidemia; moderate liver failure, hyperbilirubinemia, alcoholic cirrhosis of the liver; chronic renal failure (creatinine clearance 30-60 ml/min); chronic heart failure (II-IV FC according to NYHA classification); arterial hypertension; blood diseases; dehydration; diabetes; smoking; elderly age; long-term use of NSAIDs, simultaneous use of anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), oral corticosteroids (including prednisolone), selective serotonin reuptake inhibitors (including fluoxetine, paroxetine, citalopram, sertraline).

pharmachologic effect

NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects. Ketoprofen blocks the action of the enzyme COX-1 and COX-2 and, partially, lipoxygenase, which leads to suppression of prostaglandin synthesis (including in the central nervous system, most likely in the hypothalamus).

Stabilizes liposomal membranes in vitro and in vivo; at high concentrations in vitro, inhibits the synthesis of bradykinin and leukotrienes. Ketoprofen does not have a negative effect on the condition of articular cartilage.

Drug interactions

The combined use of ketoprofen with other NSAIDs (including selective COX-2 inhibitors and salicylates in high doses) is not recommended due to the increased risk of gastrointestinal bleeding and ulceration of the gastrointestinal mucosa.

Simultaneous use with anticoagulants (heparin, warfarin), antiplatelet agents (ticlopidine, clopidogrel) increases the risk of bleeding. If the use of such a combination is unavoidable, the patient's condition should be carefully monitored.

When used simultaneously with lithium preparations, it is possible to increase the concentration of lithium in the blood plasma up to toxic values. The concentration of lithium in the blood plasma should be carefully monitored and the dose of lithium preparations should be promptly adjusted during and after the use of NSAIDs.

Ketoprofen increases the hematological toxicity of methotrexate, especially when used in high doses (more than 15 mg/week). The time interval between stopping or starting therapy with ketoprofen and taking methotrexate should be at least 12 hours.

During therapy with ketoprofen, patients taking diuretics, especially if dehydration develops, have a higher risk of developing renal failure due to a decrease in renal blood flow caused by inhibition of prostaglandin synthesis. Before starting to use ketoprofen in such patients, rehydration measures should be carried out. After starting treatment, it is necessary to monitor kidney function.

The combined use of ketoprofen with ACE inhibitors and angiotensin II receptor antagonists (ARA II) in patients with impaired renal function (with dehydration, in elderly patients) can lead to worsening impaired renal function, including the development of acute renal failure.

During the first weeks of simultaneous use of ketoprofen and methotrexate at a dose not exceeding 15 mg/week, blood tests should be monitored weekly. In elderly patients or if there are any signs of renal impairment, the study should be performed more frequently.

Ketoprofen may weaken the hypotensive effect of antihypertensive drugs (beta-blockers, ACE inhibitors, diuretics).

Concomitant use of ketoprofen with selective serotonin reuptake inhibitors (SSRIs) increases the risk of gastrointestinal bleeding.

Concomitant use with thrombolytics increases the risk of bleeding.

The simultaneous use of ketoprofen with potassium salts, potassium-sparing diuretics, ACE inhibitors, ARB II, NSAIDs, low molecular weight heparins, cyclosporine, tacrolimus and trimethoprim increases the risk of developing hyperkalemia.

When used simultaneously with cyclosporine and tacrolimus, there may be a risk of additive nephrotoxicity, especially in elderly patients.

The simultaneous use of several antiplatelet drugs (tirofiban, eptifibatide, abciximab, iloprost) increases the risk of bleeding.

Ketoprofen increases the plasma concentration of cardiac glycosides, slow calcium channel blockers, cyclosporine, methotrexate and digoxin.

The combined use of ketoprofen with corticosteroids and ethanol increases the risk of developing adverse events from the gastrointestinal tract.

Ketoprofen may enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin).

Concomitant use with probenecid significantly reduces the plasma clearance of ketoprofen.

NSAIDs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.

Ketoprofen is pharmaceutically incompatible with tramadol solution due to precipitation.

Dosage regimen

Used orally, rectally, parenterally.

When taken orally, the dose and frequency of use are set individually depending on the indications and the dosage form used.

Rectally - 100 mg 1-2 times/day.

IV or IM single dose - 100-200 mg. The frequency of administration depends on the indications and clinical symptoms.

Parenteral administration of ketoprofen can be combined with the use of other dosage forms of ketoprofen (tablets, capsules, rectal suppositories). The maximum dose of ketoprofen is 200 mg/day.

Side effect

From the hematopoietic system: rarely - hemorrhagic anemia, hemolytic anemia, leukopenia; frequency unknown - agranulocytosis, thrombocytopenia, bone marrow dysfunction.

From the immune system: frequency unknown - anaphylactic reactions (including anaphylactic shock).

From the nervous system: often - insomnia, depression, asthenia; infrequently - headache, dizziness, drowsiness; rarely - paresthesia, confusion or loss of consciousness, peripheral polyneuropathy; frequency unknown - convulsions, taste disturbances, emotional lability.

From the senses: rarely - blurred vision, tinnitus, conjunctivitis, dry mucous membrane of the eye, pain in the eyes, hearing loss; frequency unknown - optic neuritis.

From the cardiovascular system: infrequently - tachycardia; frequency unknown - heart failure, increased blood pressure, vasodilation.

From the respiratory system: rarely - exacerbation of bronchial asthma, nosebleeds, laryngeal edema; frequency unknown - bronchospasm (especially in patients with hypersensitivity to NSAIDs), rhinitis.

From the digestive system: often - nausea, vomiting, dyspepsia, abdominal pain, NSAID gastropathy; uncommon - constipation, diarrhea, bloating, gastritis; rarely - peptic ulcer, stomatitis; very rarely - exacerbation of ulcerative colitis or Crohn's disease, gingival, gastrointestinal, hemorrhoidal bleeding, melena, perforation of the gastrointestinal tract; frequency unknown - gastrointestinal discomfort, stomach pain.

From the liver and biliary tract: rarely - hepatitis, increased activity of liver enzymes in the blood, increased concentration of bilirubin in the blood.

From the urinary system: rarely - cystitis, urethritis, hematuria; very rarely - acute renal failure, interstitial nephritis, nephrotic syndrome, abnormal values ​​of renal function indicators.

From the skin and subcutaneous tissues: infrequently - skin rash, itching; frequency unknown - photosensitivity, alopecia, urticaria, exacerbation of chronic urticaria, angioedema, erythema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, purpura.

Other: infrequently - peripheral edema, fatigue; rarely - hemoptysis, menometrorrhagia, shortness of breath, thirst, muscle twitching.

Local reactions: with rectal use - burning sensation, loose stools, irritation of the rectal mucosa.

special instructions

With long-term use of NSAIDs, it is necessary to periodically evaluate a clinical blood test, as well as monitor kidney and liver function, especially in elderly patients (over 65 years), and conduct a stool test for occult blood. It is necessary to be careful and monitor blood pressure more often when using ketoprofen to treat patients suffering from arterial hypertension and cardiovascular diseases that lead to fluid retention in the body.

If visual disturbances occur, treatment should be stopped immediately.

Like other NSAIDs, ketoprofen can mask the symptoms of infectious and inflammatory diseases. If signs of infection or deterioration in health while using the drug are detected, the patient should immediately consult a doctor.

If there is a history of contraindications from the gastrointestinal tract (bleeding, perforation, peptic ulcer), in the case of long-term therapy and the use of ketoprofen in high doses, the patient should be under close medical supervision.

Because of the important role of prostaglandins in maintaining renal blood flow, particular caution should be exercised when using ketoprofen in patients with cardiac or renal failure, as well as in the treatment of elderly patients taking diuretics and patients who have a decrease in blood volume for any reason (eg , after surgery).

Impact on the ability to drive vehicles and machinery

During treatment, drowsiness, dizziness or other unpleasant sensations from the nervous system, including blurred vision, may occur. When using ketoprofen, patients should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Use is contraindicated in the third trimester of pregnancy. Use in the first and second trimesters of pregnancy is possible only when the expected benefit of therapy for the mother outweighs the risk to the fetus. In this case, ketoprofen should be used in the minimum effective dose for the shortest possible course.

Use is contraindicated during breastfeeding.

The use of ketoprofen can affect female fertility, so use is not recommended for patients with infertility (including those undergoing examination).

Use for renal impairment

Restrictions for impaired renal function - With caution.

Use is contraindicated in severe renal failure (creatinine clearance less than 30 ml/min), confirmed hyperkalemia, and progressive kidney disease.

It should be used with caution in chronic renal failure (creatinine clearance 30-60 ml/min).

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

Use is contraindicated in cases of severe liver failure.

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

Use in elderly patients

Restrictions for elderly patients - Use with caution. Use with caution in elderly patients.

Use in children

Restrictions for children - With caution. Contraindicated in children and adolescents under 15 years of age.

Terms of sale

The drug is available with a prescription.