Ketonal duo instructions for use of capsule 150. Ketonal duo - description of the drug, instructions for use, reviews. Directions for use and dosage

Compound

active substance: ketoprofen;

1 capsule contains ketoprofen 150 mg

Excipients:

capsule contents: microcrystalline cellulose, lactose, povidone, croscarmellose sodium, polysorbate 80, methacrylate copolymer (type B), methacrylate copolymer (type A), triethyl citrate, talc, iron oxide yellow (E172), colloidal silicon dioxide

capsule shell: gelatin, titanium dioxide (E 171), indigo (E 132).

Dosage form

Modified-release capsules, hard.

Basic physical and chemical properties: capsules with a transparent body and a blue cap containing white and yellow pellets.

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Pharmacological group

Non-steroidal anti-inflammatory drugs. Ketoprofen. ATX code M01A E03.

Pharmacological properties

Pharmacological.

Ketoprofen is an NSAID that has analgesic, anti-inflammatory and antipyretic effects.

During inflammation, ketoprofen inhibits the synthesis of prostaglandins and leukotrienes, inhibiting the activity of cyclooxygenase and partially lipoxygenase, also inhibits the synthesis of bradykinin and stabilizes lysosomal membranes.

It has a central and peripheral analgesic effect and eliminates the symptoms of inflammatory and degenerative diseases of the musculoskeletal system.

In women, ketoprofen reduces the symptoms of primary dysmenorrhea due to inhibition of prostaglandin synthesis.

Pharmacokinetics.

Absorption. Ketonal ® Duo capsules - new dosage form, which differs from conventional capsules in the way the active substance is released. The capsules contain two types of pellets: standard (white) and coated ( yellow color). Ketoprofen is released quickly from white pellets (60% of the total amount) and slowly from yellow pellets (40% of the total amount), which leads to immediate and prolonged action of the drug.

After taking Ketonal capsules ® Duo ketoprofen is quickly absorbed in the digestive tract. The bioavailability of ketoprofen is 90%.

Food intake does not affect the overall bioavailability of ketoprofen, but reduces the rate of absorption. Fatty foods increase the time to reach maximum concentration, but do not reduce the bioavailability and maximum concentration of ketoprofen in blood plasma. Simultaneous use of drugs that reduce the acidity of gastric juice does not affect the rate and volume of absorption of ketoprofen. The maximum plasma concentration - 9036.64 ng / ml - is achieved within 1.76 hours.

Distribution. The degree of binding to blood proteins is 99%. Distribution volume - 0.1 l / kg. Ketoprofen penetrates into the synovial fluid and reaches a concentration there that is 30% of the plasma concentration. Although the concentration of ketoprofen in synovial fluid slightly lower than in blood plasma, it is stable (lasts up to 30 hours), therefore pain syndrome and joint stiffness is reduced for a long time.

Metabolism and excretion. Ketoprofen is extensively metabolized in the liver using microsomal enzymes. It is excreted from the body in the form of a conjugate with glucuronic acid. About 80% of the administered dose of ketoprofen is excreted in the urine, usually (more than 90%), in the form of glucuronide, about 10% in feces. There are no active metabolites of ketoprofen. The clearance of ketoprofen is approximately 0.08 l/kg/h.

In patients with renal failure, the elimination of ketoprofen is slow, the half-life increases by 1:00. In patients with liver failure, ketoprofen may accumulate in tissues. In older patients, the metabolism and excretion of ketoprofen slow down, but this is of clinical significance only in cases of impaired renal function.

Indications

Joint diseases: rheumatoid arthritis serologically spondyloarthritis (ankylosing spondylitis, psoriatic arthritis, reactive arthritis); gout, pseudogout; osteoarthritis; extra-articular rheumatism (tendinitis, bursitis, capsulitis of the shoulder joint).

Pain syndrome: lumbago, post-traumatic pain, postoperative pain, pain due to tumor metastases in the bones, algodismenorrhea.

Contraindications

Hypersensitivity to ketoprofen or to the excipient. Hypersensitivity to drugs with a similar therapeutic effect (non-steroidal anti-inflammatory drugs (NSAIDs), for example, acetylsalicylic acid), including a history of bronchial asthma and rhinitis caused by acetylsalicylic acid. Severe heart failure. Treatment of PERIOPERATIVE pain during coronary artery bypass surgery. Active phase or relapse peptic ulcer stomach and/or duodenum or ulceration/perforation (two or more separate cases). History of gastrointestinal bleeding or perforation associated with previous NSAID treatment. Hemorrhagic diathesis. Severe liver or kidney dysfunction.

Interaction with other drugs and other types of interactions

The simultaneous use of ketoprofen with other NSAIDs and salicylates, including selective COX-2 inhibitors, should be avoided. Increased risk of gastrointestinal bleeding/ulceration.

Anticoagulants (heparin, warfarin), drugs that suppress platelet aggregation (ticlopidine, clopidogrel) when used with ketoprofen increase the risk of gastrointestinal bleeding.

When used simultaneously with lithium preparations, the excretion of lithium is reduced, and the concentration in the blood plasma increases to toxic levels.

After using ketoprofen together with methotrexate (doses above 15 mg/week), severe, sometimes with fatal, toxicity. Toxicity is due to increased and prolonged plasma concentrations of methotrexate.

Concomitant use with ketoprofen requires safety precautions

Diuretics may increase the risk of NSAID nephrotoxicity. Patients receiving diuretics should be rehydrated before ketoprofen is administered and renal function should be closely monitored during treatment.

ACE inhibitors and angiotensin II antagonists when used with ketoprofen in patients with impaired renal function (dehydrated patients, elderly patients) increase the risk of nephrotoxicity with the possibility of developing acute renal failure.

Concomitant use with corticosteroids increases the risk of gastrointestinal ulceration or bleeding.

When ketoprofen is used concomitantly with methotrexate (doses below 15 mg/week), blood counts should be monitored weekly.

When ketoprofen is used simultaneously with pentoxifylline, the risk of bleeding increases. It is necessary to monitor the condition of the blood coagulation system.

Concomitant use with ketoprofen requires caution

Ketoprofen may reduce the effects of antihypertensive drugs (beta blockers, ACE inhibitors) and diuretics due to inhibition of prostaglandin synthesis.

The use of ketoprofen together with thrombolytics and selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Co-administration of probenecid may lead to a significant decrease in the clearance of ketoprofen from blood plasma.

Ketoprofen binds to blood proteins when used simultaneously with other drugs that bind to proteins, for example, anticoagulants, sulfonamides, hydantoin; dose adjustment may be required to prevent an increase in the level of these drugs due to competition for binding to plasma proteins.

Potassium salts, potassium-sparing diuretics, ACE inhibitors, non-steroidal anti-inflammatory drugs, heparin (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim can cause hyperkalemia.

Ketoprofen enhances the effects of oral antidiabetic and anticonvulsants (phenytoin).

The simultaneous use of NSAIDs and cardiac glycosides can cause exacerbation of heart failure, reduce the glomerular filtration rate and increase the level of glycosides in the blood plasma.

Concomitant use with cyclosporine and tacrolimus increases the risk of nephrotoxicity, especially in elderly patients.

When used simultaneously with NSAIDs, the effect of mifepristone may be reduced. Nonsteroidal anti-inflammatory drugs should be taken 8-12 days after using mifepristone.

Features of application

Special precautions.

Undesirable effects (especially from the digestive tract and of cardio-vascular system) can be prevented by taking the minimum effective dose for a short duration of use.

The drug should be prescribed with caution to patients who are using concomitant medications that may increase the risk of bleeding or ulceration, such as oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors, antithrombotic drugs (acetylsalicylic acid).

The simultaneous use of ketoprofen with other NSAIDs, including selective COX-2 inhibitors, should be avoided.

Ketoprofen should be prescribed with caution to patients with a history of gastrointestinal diseases. Bleeding and perforation may develop suddenly without prior symptoms.

The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses of NSAIDs in patients with a history of ulcers, especially complications such as hemorrhage or perforation, and in the elderly. These patients should begin treatment with the lowest dose.

In such patients, combination therapy with protective drugs (eg, misoprostol or proton pump inhibitors) should be used.

Patients who have previously experienced gastrointestinal adverse reactions, especially elderly patients, should report any unusual abdominal symptoms (in particular gastrointestinal bleeding), especially at the beginning of treatment.

If bleeding or ulceration occurs in patients treated with ketoprofen, therapy should be discontinued.

In rare cases, skin reactions have been reported with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Most high risk Such reactions exist at the beginning of therapy (in most cases, such reactions occur in the first months of treatment). Ketoprofen should be discontinued at the first manifestations of a skin rash, damage to the mucous membranes, or other signs of hypersensitivity.

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially in high doses and long-term use) may be associated with an increased risk of arterial thrombotic complications (eg, myocardial infarction or stroke). There is insufficient data to exclude such a risk for ketoprofen.

Precautionary measures.

NSAIDs should be prescribed with caution to patients with a history of ulcerative colitis or Crohn's disease, as their condition may worsen.

At the beginning of treatment, renal function should be monitored in patients with heart failure, chronic renal failure, cirrhosis, nephrosis, as well as in patients taking diuretics, especially in elderly patients. In such patients, the administration of ketoprofen may lead to a decrease in renal blood flow through suppression of prostaglandin synthesis.

Careful monitoring is necessary for patients with arterial hypertension and/or a history of mild to moderate chronic heart failure, as fluid retention and edema have been reported with NSAID therapy.

Ketoprofen, like other NSAIDs that have analgesic, anti-inflammatory and antipyretic properties, can mask the signs and symptoms of an infectious disease.

In patients with abnormal liver function tests or a history of liver disease, transaminase levels should be periodically monitored, particularly during long-term therapy.

Isolated cases of jaundice and hepatitis associated with treatment with ketoprofen have been reported.

The use of ketoprofen may have a negative effect on reproductive function women, so it should not be taken by women planning pregnancy. Women who are unable to become pregnant or are undergoing investigations for infertility should stop taking ketoprofen.

In patients bronchial asthma in combination with chronic rhinitis, sinusitis and/or nasal polyposis, most often occur allergic reactions after taking acetylsalicylic acid and/or NSAIDs. Application of such medicines may cause bronchial asthma.

As with other NSAIDs, ketoprofen should be prescribed with caution to patients with uncontrolled arterial hypertension, chronic heart failure, progressive coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, as well as patients with risk factors (for example, hypertension , hyperlipidemia, diabetes mellitus, patients who smoke) if long-term therapy is planned.

When using ketoprofen, patients with hypersensitivity to sunlight or a history of phototoxic reactions should also be carefully monitored.

Treatment with ketoprofen should be discontinued if visual disturbances such as blurred vision are observed.

The drug contains lactose, so it should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Suppression of prostaglandin synthesis may negatively affect the course of pregnancy and/or the development of the embryo/fetus. The risk of miscarriages and the development of heart defects and gastroschisis increases when using prostaglandin synthesis inhibitors on early stages pregnancy. The risk increases with increasing doses of such drugs and duration of therapy.

The safety of using ketoprofen during pregnancy has not been determined, so the use of the drug is possible in the first and second trimesters of pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus. In these cases, the dose of ketoprofen should be low and the duration of treatment short.

In the third trimester of pregnancy, NSAIDs can cause cardiopulmonary toxicity in the fetus (with premature closure of the ductus arteriosus and the development of pulmonary hypertension), renal dysfunction, which can progress to renal failure with oligohydroamniosis.

The use of NSAIDs immediately before childbirth may cause prolongation of bleeding time, inhibition of uterine contractility and an increase in the duration of labor.

There are no data on the excretion of ketoprofen into breast milk.

The use of ketoprofen in the third trimester of pregnancy and during breastfeeding is contraindicated.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Until the individual reaction to the drug is determined (may be dizziness, drowsiness, convulsions), it is recommended to refrain from driving vehicles or other mechanisms.

Directions for use and doses

Doses are selected individually depending on the patient’s condition and his response to treatment.

The duration of treatment depends on the severity of the disease, but side effects can be minimized by using the lowest effective dose for the shortest possible time.

With the combined administration of various forms of the drug (capsules, tablets, suppositories, injection solution), the maximum daily dose ketoprofen should not exceed 200 mg.

Take capsules during meals with water or milk (at least 100 ml).

To prevent the negative effects of ketoprofen on the mucous membranes of organs gastrointestinal tract You can simultaneously take antacids and proton pump inhibitors after consulting your doctor.

Elderly patients. In elderly patients, the risk of adverse reactions increases and, if NSAID therapy is prescribed, it is recommended to use the minimum effective dose of ketoprofen. After 4 weeks from the start of treatment, it is necessary to monitor manifestations of gastrointestinal bleeding.

Children.

The drug should not be used in children.

Overdose

Symptoms: headache, dizziness, drowsiness, nausea, vomiting, diarrhea, abdominal pain. In severe intoxication, hypotension, respiratory depression, convulsions, gastrointestinal bleeding (ground, hematemesis), impaired renal function, and renal failure are observed.

Treatment: gastric lavage and application activated carbon. Symptomatic and supportive therapy to compensate for dehydration, control diuresis and correct acidosis, if any. If renal failure occurs, hemodialysis should be performed. There is no specific antidote.

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Adverse reactions

Classification side effects by organ system and frequency of manifestations: very often (≥ 1/10), often (≥ 1/100,<1/10), нечасто (≥ 1/1000, <1/100), редко (≥ 1 / 10000, <1/1000), очень редко (<1/10000), включая отдельные сообщения.

Side effects are usually temporary. Disorders of the digestive tract occur more often.

From the blood side: rarely - hemorrhagic anemia, thrombocytopenia, agranulocytosis, suppression of bone marrow function.

From the immune system: reactivity of the respiratory system, including bronchial asthma and its exacerbations very rarely - angioedema, anaphylactic reactions, including shock.

Mental disorders: rarely - mood swings.

From the nervous system: sometimes - headache, dizziness, drowsiness, discomfort, weakness, increased fatigue; rarely - paresthesia very rarely - convulsions, dysgeusia.

From the side of the organ of vision: rarely - blurred vision.

From the hearing organs: often - tinnitus.

From the cardiovascular system: often - edema; sometimes - heart failure, arterial hypertension, vasodilation.

The use of some NSAIDs (especially in high doses for a long time) may be associated with an increased risk of arterial thrombotic complications (for example, myocardial infarction or stroke) (see section "Peculiarities of use").

From the respiratory system: rarely - rhinitis; rarely - bronchospasm (mainly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), attacks of bronchial asthma.

From the digestive tract: very often - dyspepsia often - nausea, abdominal pain, diarrhea, constipation, flatulence, vomiting, stomatitis; gastritis was rarely observed; very rarely - intestinal perforation (as complications of diverticula), exacerbation of ulcerative colitis or Crohn's disease, enteropathy with perforation, stenosis. Peptic ulcers, perforation, or gastrointestinal bleeding may occur.

There have been reports of a case of rectal perforation in an elderly woman.

Ulceration, hemorrhage or perforation may develop in 1% of patients after 3-6 months of treatment or in 2-4% of patients after 1 year of treatment with NSAIDs.

From the digestive system: very rarely - increased levels of serum bilirubin, severe liver dysfunction, accompanied by jaundice and hepatitis.

From the skin: often - skin rash; sometimes - alopecia, eczema, purpura-like rash, itching, increased sweating, urticaria, exfoliative dermatitis rarely - photosensitivity, photodermatitis; very rarely - bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

From the urinary system: very rarely - abnormal renal function indicators, acute renal failure, interstitial nephritis, nephrotic syndrome.

Laboratory indicators: very often - deviation from the norm in liver function indicators; sometimes - increase in body weight; when treated with NSAIDs, ALT and AST levels increase significantly. Ketoprofen reduces platelet aggregation, thereby prolonging bleeding time.

Manufacturer

Lek Pharmaceutical company d.D., Slovenia

Release form

Compound

Active ingredient: Ketoprofen Concentration of active ingredient (mg): 150 mg

Pharmacological effect

Non-steroidal anti-inflammatory drug (NSAID). It has an analgesic, anti-inflammatory and antipyretic effect. Thanks to the inhibition of COX-1 and COX-2, and partially lipoxygenase, ketoprofen suppresses the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes. Ketoprofen does not have a negative effect on articular cartilage.

Pharmacokinetics

Absorption Ketonal Duo capsules are presented in a new dosage form, which differs from conventional capsules in the special release of the active substance. The capsules contain two types of pellets: white (about 60% of the total) and yellow (coated). Ketoprofen is quickly released from white pellets and slowly from yellow ones, which causes a combination of fast and prolonged action. The drug is well absorbed after oral administration. The bioavailability of ketoprofen in the form of regular capsules and capsules with modified release is 90%. Food intake does not affect the overall bioavailability (AUC ) ketoprofen, but reduces the rate of absorption. After oral administration of ketoprofen at a dose of 150 mg in the form of modified-release capsules, Cmax in blood plasma is 9036.64 ng/ml for 1.76 hours. Distribution: The binding of ketoprofen to plasma proteins (mainly albumin) is 99%. Vd - 0.1-0.2 l/kg. Ketoprofen penetrates well into the synovial fluid, where it reaches 30% of the plasma concentration. Significant concentrations of ketoprofen in the synovial fluid are stable and persist for up to 30 hours, resulting in a long-term reduction in pain and joint stiffness. Metabolism and excretion Ketoprofen undergoes intensive metabolism with the participation of microsomal liver enzymes. It binds to glucuronic acid and is excreted as a glucuronide. There are no active metabolites of ketoprofen. T1/2 - less than 2 hours. Approximately 80% of ketoprofen is excreted in the urine, mainly in the form of ketoprofen glucuronide (more than 90%). About 10% is excreted through the intestines. Pharmacokinetics in special clinical situations: In patients with liver failure, the plasma concentration of ketoprofen is increased by 2 times (probably due to hypoalbuminemia and the resulting high level of unbound active ketoprofen); such patients need to be prescribed the drug in a minimum therapeutic dose. In patients with renal failure, the clearance of ketoprofen is reduced, which requires dose adjustment. In elderly patients, the metabolism and excretion of ketoprofen is slow, but this is of clinical significance only for patients with reduced renal function.

Contraindications

Hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other non-steroidal anti-inflammatory drugs; complete and incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (including a history); peptic ulcer of the stomach or duodenum in the acute stage, ulcerative colitis, Crohn's disease in the acute phase, inflammatory bowel diseases in the acute stage; hemophilia and other bleeding disorders; children's age (up to 15 years); severe liver failure; severe renal failure (creatinine clearance (CC) less than 30 ml/min), progressive kidney disease; decompensated heart failure; postoperative period after coronary artery bypass surgery; gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); lactase deficiency, lactose intolerance, glucose-galactose malabsorption; chronic dyspepsia; III trimester of pregnancy; lactation period.

Use during pregnancy and breastfeeding

With long-term use of NSAIDs, it is necessary to monitor the state of the blood, as well as the functions of the kidneys and liver, especially in elderly patients (over 65 years old). Care must be taken and blood pressure should be monitored more often when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular diseases, which lead to fluid retention in the body. Like other NSAIDs, ketoprofen can mask signs of infectious diseases. Effects on the ability to drive vehicles and operate machinery There is no data on the negative effect of Ketonal Duo in recommended doses on the ability to drive a car or operate machinery. At the same time, patients who notice unusual effects when taking Ketonal Duo should be careful when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Directions for use and doses

Inside. The standard dose of Ketonal DUO for adults and children over 15 years of age is 150 mg/day (1 modified-release capsule). Capsules should be taken during or after meals with water or milk (the volume of liquid must be at least 100 ml). The maximum dose of ketoprofen is 200 mg/day.

Side effects

Ketoprofen can weaken the effect of diuretics and antihypertensive drugs, and enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin). Combined use with other NSAIDs, salicylates, corticosteroids, ethanol increases the risk of developing adverse events from the gastrointestinal tract. Simultaneous administration with anticoagulants, thrombolytics, antiplatelet agents increases the risk of bleeding. When NSAIDs are taken simultaneously with diuretics or ACE inhibitors, the risk of renal dysfunction increases. Increases plasma concentrations of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate. NSAIDs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.

Lek D.D.

Country of origin

Slovenia

Product group

Anti-inflammatory drugs (NSAIDs)

Release forms

10 - blisters (3) - cardboard packs.

Description of the dosage form

Modified release capsules with clear body and blue cap; size No. 1; contents of capsules - white and yellow pellets

pharmachologic effect

NSAIDs. It has analgesic, anti-inflammatory and antipyretic effects. Due to the inhibition of COX-1 and COX-2, and partially lipoxygenase, ketoprofen suppresses the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes. Ketoprofen does not have a negative effect on articular cartilage.

Pharmacokinetics

Absorption Ketonal® Duo capsules are presented in a new dosage form, which differs from conventional capsules in the special release of the active substance. The capsules contain two types of pellets: white (about 60% of the total) and yellow (coated). Ketoprofen is released quickly from white pellets and slowly from yellow ones, which results in a combination of fast and prolonged action. After taking the drug orally, ketoprofen is well absorbed from the gastrointestinal tract. The bioavailability of ketoprofen in the form of regular and modified-release capsules is 90%. When taken with food, it does not affect the overall bioavailability (AUC) of ketoprofen, but reduces the rate of absorption. After oral administration of ketoprofen at a dose of 150 mg in the form of modified-release capsules, Cmax in blood plasma is 9036.64 ng/ml for 1.76 hours. Distribution The binding of ketoprofen to plasma proteins (mainly albumin) is 99%. Vd - 0.1-0.2 l/kg. Ketoprofen penetrates well into the synovial fluid, where it reaches 30% of the plasma concentration. Significant concentrations of ketoprofen in the synovial fluid are stable and persist for up to 30 hours, resulting in a long-term reduction in pain and joint stiffness. Metabolism and excretion Ketoprofen undergoes intensive metabolism with the participation of microsomal liver enzymes. It binds to glucuronic acid and is excreted as a glucuronide. There are no active metabolites of ketoprofen. T1/2 - less than 2 hours. Approximately 80% of ketoprofen is excreted in the urine, mainly in the form of a glucuronide metabolite. 10% is excreted through the intestines. Pharmacokinetics in special clinical situations In patients with hepatic impairment, the plasma concentration of ketoprofen is increased by 2 times, probably due to hypoalbuminemia (and due to the 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, which requires dose adjustment. In elderly patients, the metabolism and excretion of ketoprofen are slowed down, but this is of clinical significance only for patients with reduced renal function.

Special conditions

With long-term use of NSAIDs, it is necessary to monitor the blood condition, as well as kidney and liver function, especially in elderly patients (over 65 years of age). It is necessary to be careful and monitor blood pressure more often when using ketoprofen to treat patients with arterial hypertension and cardiovascular diseases that lead to fluid retention in the body. Like other NSAIDs, ketoprofen can mask signs of infectious diseases. Effect on the ability to drive vehicles and operate machinery There is no data on the negative effect of Ketonal® Duo in recommended doses on the ability to drive a car or operate machinery. At the same time, patients who notice unusual effects when taking Ketonal® Duo should be careful when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Compound

ketoprofen 150 mg Excipients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, polysorbate 80. Composition of the pellet shell: eudragit RS 30D (copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate (1: 2: 0.1)), eudragit RL 30D (copoly ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate (1:2:0.2)), triethyl citrate, polysorbate 80, talc, iron (III) oxide yellow (E172), colloidal silicon dioxide. Capsule shell composition: gelatin, indigo carmine (E132), titanium dioxide (E171).

Ketonal DUO indications for use

Symptomatic treatment of painful and inflammatory processes of various origins. Inflammatory and degenerative diseases of the musculoskeletal system: - rheumatoid arthritis; - seronegative arthritis (ankylosing spondylitis / Bechterew's disease /, psoriatic arthritis, reactive arthritis / Reiter's syndrome/); - gout, pseudogout; - osteoarthritis. Pain syndrome: - headache; - tendinitis, bursitis, myalgia, neuralgia, radiculitis; - post-traumatic pain; - postoperative pain; - algodismenorrhea; - pain syndrome in cancer.

Ketonal DUO contraindications

- history of bronchial asthma, rhinitis, urticaria caused by taking acetylsalicylic acid or other NSAIDs; - peptic ulcer of the stomach and duodenum in the acute phase; - NUC, Crohn's disease in the acute phase, inflammatory bowel diseases in the acute phase; - hemophilia and other bleeding disorders; - severe liver failure; - severe renal failure; - progressive kidney diseases; - decompensated heart failure; - postoperative period after coronary artery bypass grafting; - gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); - chronic dyspepsia; - children under 15 years of age; - III trimester of pregnancy; - lactation period (breastfeeding); - hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other non-steroidal anti-inflammatory drugs

Ketonal DUO dosage

150 mg

Ketonal DUO side effects

From the digestive system: common - dyspepsia (nausea, diarrhea or constipation, flatulence, vomiting, decreased or increased appetite), abdominal pain, stomatitis, dry mouth; uncommon (with long-term use in large doses) - ulceration of the gastrointestinal mucosa, impaired liver function; rare - perforation of the gastrointestinal tract, exacerbation of Crohn's disease, melena, gastrointestinal bleeding, transient increase in the level of liver enzymes. From the side of the central nervous system: common - headache, dizziness, sleep disturbance, fatigue, nervousness, nightmares; rare - migraine, peripheral polyneuropathy; very rare - hallucinations, disorientation and speech disorder. From the senses: rare - tinnitus, change in taste, blurred vision, conjunctivitis. From the cardiovascular system: uncommon - tachycardia, arterial hypertension, peripheral edema. From the hematopoietic system: decreased platelet aggregation; rare - anemia, thrombocytopenia, agranulocytosis, purpura. From the urinary system: rare - impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria (more often develops in people taking NSAIDs and diuretics for a long time). Allergic reactions: common - skin reactions (itching, urticaria); uncommon - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.

Drug interactions

Ketoprofen may weaken the effect of diuretics and antihypertensive drugs, and enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin). Combined use with other NSAIDs, salicylates, corticosteroids, ethanol increases the risk of developing adverse events from the gastrointestinal tract. Simultaneous administration with anticoagulants, thrombolytics, and antiplatelet agents increases the risk of bleeding. When taking NSAIDs concomitantly with diuretics or ACE inhibitors, the risk of renal dysfunction increases. Increases plasma concentrations of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate. NSAIDs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.

Overdose

nausea, vomiting, abdominal pain, hematemesis, melena, impaired consciousness, respiratory depression, convulsions, renal dysfunction and renal failure.

Storage conditions

keep away from children

Information provided

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Ketonal Duo – a drug from the category of non-steroidal anti-inflammatory drugs. It is best known as a medicine that eliminates severe pain of various origins. However, it is also used to relieve various inflammations and inflammatory processes.

About the drug

Ketonal Duo has anti-inflammatory and analgesic effect, and is also able to reduce fever. Thanks to the double structure of the capsules, the medicine quickly penetrates the organ and quickly begins to exert its therapeutic effect, while the effect of the drug continues for a long time, up to about 30 hours.

The medication is 90% absorbed by the body, while 80% of the medication is excreted through the kidneys, and the rest through the digestive organs.

Manufacturer

The drug is created by Lek, a company located in Slovenia.
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Irina Martynova. Graduated from Voronezh State Medical University named after. N.N. Burdenko. Clinical resident and neurologist of the BUZ VO \"Moscow Polyclinic\".

Release form and composition

Medicine Available in modified release capsules. Capsules consisting of pellets of two colors - yellow and white. The active component in the structure of the medicine is ketoprofen in an amount of 0.15 g. Additional substances lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, polysorbate 80.

The pellet shell consists of eudragit RS 30D, RL 30D, triethyl citrate, polysorbate 80, talc, iron, yellow oxide or E172, colloidal dioxide.

Capsule shell made of gelatin, indigo carmine or E132, titanium dioxide or E171.

The tablets are packed in blisters, each of which contains ten pieces, and the blisters are in cardboard packaging.

Ketonal Duo capsules differ from regular Ketonal in the amount of active substance in one dose; Ketonal contains only 0.05 mg in its structure. ketoprofen. In addition, Duo capsules have a modified release, unlike simple Ketonal. However, the advantage of the latter is the multiplicity of dosage forms - tablets, solution, suppositories, cream, gel.

Directions for use and dosage

Instructions for use of Ketonal Duo are as follows. Medicine taken orally, that is, inside. The usual dose of the medication is 0.15 g. in a day.

Take capsules after meals or with meals. Take it with water or milk, but the amount of liquid should not be less than 0.1 liter.

Ketonal Duo can have a strong effect, so it is important to follow the dosage and not exceed the maximum dose of the drug, which is 200 mg/day.

Indications for use

It is used in the treatment of diseases of the musculoskeletal system that are inflammatory and degenerative in nature. These include:

rheumatoid arthritis;
Bekhterev's disease;
Reiter's syndrome;
inflammation of the joints in patients with psoriasis;
gout, incl. pseudogout;
osteoarthritis.

Used to reduce and eliminate pain, such as:

headache;
for inflammation of the joint capsule;
with inflammation of the tendons;
muscle pain;
neuralgia;
radiculitis;
pain after injuries and operations;
algosmenorrhea (pain during menstruation);
in oncology.

Contraindications

Medicine has some contraindications to treatment. It should not be used for diseases such as:

bronchial asthma, inflammation of the nasal mucosa, a history of urticaria, which were triggered by taking acetylsalicylic acid or certain NSAIDs;
stomach and duodenal ulcers during exacerbation;
nonspecific ulcerative colitis and Crohn's disease during exacerbation;
intestinal inflammation during exacerbation;
chronic bleeding and other pathologies in blood clotting;
severe liver and kidney insufficiency;
developing kidney pathologies;
decompensated heart failure;
after coronary artery bypass surgery;
bleeding or suspicion of bleeding from the digestive organs, brain, etc.;
chronic digestive disorder;
age up to 15 years;
third trimester of pregnancy;
lactation;
special sensitivity to the composition of the drug, salicylates and other NSAIDs.

Use with caution when:

peptic ulcer pathology, history of bronchial asthma;
the presence of symptoms of diseases of the heart, brain, periphery of the arteries;
dyslipidemia;
developing liver diseases;
increasing the amount of bilirubin;
kidney failure;
chronic heart failure;
high blood pressure;
blood diseases;
dehydration of the body;
diabetes mellitus;
smoking, alcoholism.

special instructions

Among the special instructions, it is worth noting the moment of monitoring the state of the blood, liver and kidney activity, in particular in elderly people over 65 years of age, if the medication is taken for a fairly long period.

When treating patients with high blood pressure and cardiovascular pathologies that retain fluid in the body, it is necessary to frequently monitor the pressure in the arteries and exercise caution.

Ketonal Duo has the properties to mask the symptoms of infectious pathologies.

The medication is not taken for severe liver and kidney failure due to contraindications.

Use by pregnant and lactating women

The drug can be used in the treatment of pregnant women in the first and second trimesters of pregnancy if the possible benefit to the mother is higher than the probable risk to the child.

Breastfeeding women are not recommended to take the medicine.

Use in children and the elderly

Children under 15 years of age are contraindicated to take the medication, but older people can, but with caution and special care, and in compliance with all recommendations.

Adverse reactions and overdose

Ketonal Duo, if the dosage is not followed, can cause negative consequences in the form of an overdose. This may result in:

nausea and vomiting reactions;
pain in the abdominal area;
vomiting reactions with bleeding, melena;
disorder of consciousness;
respiratory depression;
convulsive reactions;
impaired renal function, incl. renal failure.

In case of overdose, you should consult a specialist. As first aid, you should rinse your stomach and drink activated charcoal.

The medication can provoke adverse reactions, including negative reactions from the digestive organs, central nervous system, sensory organs, heart, hematopoietic system, genitourinary organs, allergic reactions and some others may also occur.

Interaction with other drugs

The drug does not always interact well with other medications.

Name	Reaction
Diuretics, antihypertensive drugs	Ketonal Duo is able to weaken their effect
Hypoglycemic (oral) and some anti-seizure drugs	Ketonal can enhance their effects
Parallel use with NSAIDs, salicylates, corticosteroids, ethanol	The risk of negative phenomena in the digestive organs increases
Anticoagulants, thrombolytics, antiplatelet agents	Increased risk of bleeding
Diuretics or ACE inhibitors	Increased risk of kidney dysfunction
Cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate	Increases their content in plasma
Mifepristone	Reduces their effectiveness. In this regard, treatment with Ketonal Duo can be started no earlier than 8 to 12 days after discontinuation of the first one.

Storage and release from pharmacies

Storage conditions are standard - no higher than 25 0 C heat and in a place far from children. Shelf life – 24 months.

Dispensed without a doctor's prescription.

Analogues

The drug has a number of analogues, similar in active component - ketoprofen.

Ketonal duo instructions for use of capsule 150. Ketonal duo - description of the drug, instructions for use, reviews. Directions for use and dosage

Compound

Dosage form

Pharmacological group

Pharmacological properties

Indications

Contraindications

Interaction with other drugs and other types of interactions

Features of application

Directions for use and doses

Overdose

Adverse reactions