Ketonal duo - instructions for use. Ketonal duo, capsules with modified release Ketonal duo 150 instructions for use

Lek d.d./Novartis Neva Ltd., Slovenia, Symptomatic therapy of painful and inflammatory processes of various origins, including: - 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, sciatica; post-traumatic and postoperative pain syndrome; pain syndrome in oncological diseases; algomenorrhea.

Symptomatic therapy of painful and inflammatory processes of various origins, including: 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, sciatica; - post-traumatic and postoperative pain syndrome; - pain syndrome in oncological diseases; - algomenorrhea.

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 a meal with water or milk (the volume of liquid should be at least 100 ml). The maximum dose of ketoprofen is 200 mg/day.

Hypersensitivity to ketoprofen or other components of the drug, as well as salicylates, thiaprofenic acid 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 history); - erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; - ulcerative colitis, Crohn's disease; - hemophilia and other blood clotting disorders; - severe liver failure; - active liver disease; - severe renal failure (CC less than 30 ml / min); - progressive kidney disease; - decompensated heart failure; - postoperative period after coronary artery bypass grafting; - gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); - diverticulitis; - inflammatory bowel disease; - confirmed hyperkalemia; - chronic dyspepsia; - children's age up to 15 years; - III trimester of pregnancy; - the period of breastfeeding; - lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome. With caution, the drug should be prescribed for a history of peptic ulcer disease, a history of bronchial asthma, clinically significant cardiovascular, cerebrovascular and peripheral arterial diseases, dyslipidemia, progressive liver disease, liver failure, hyperbilirubinemia, alcoholic cirrhosis of the liver, renal failure (CC 30- 60 ml / min), chronic heart failure, arterial hypertension, blood diseases, dehydration, diabetes mellitus, history of the development of gastrointestinal ulcers, the presence of Helicobacter pylori infection, with severe somatic diseases, smoking, concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (eg, acetylsalicylic acid), oral corticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, sertraline), long-term use of NSAIDs, elderly patients (including those taking diuretics), patients with decreased ionic bcc.

Ketonal DUO: instructions for use and reviews

Ketonal DUO is a drug with analgesic, anti-inflammatory and antipyretic effects.

Release form and composition

Dosage form of release of Ketonal DUO - capsules with modified release: size No. 1; case - transparent, cap - blue; capsules contain yellow and white pellets (10 pcs. in blisters, in a cardboard bundle 1-3 blisters).

Composition of 1 capsule:

• active substance: ketoprofen - 150 mg;
• auxiliary components: lactose monohydrate - 20 mg; croscarmellose sodium - 10 mg; povidone - 5 mg; microcrystalline cellulose - 34 mg; polysorbate-80 - 1 mg;
• capsule shell: titanium dioxide (E 171) - 0.9%; indigo carmine (E 132) - 0.4%; gelatin - up to 100%;
• pellet shell: colloidal silicon dioxide - 0.2 mg; talc - 0.2 and 1.760 mg; Eudragit RL 30 D [copolymer of methyl methacrylate, ethyl acrylate and trimethylammonioethyl methacrylate (2: 1: 0.2)] - 4.908 mg; eudragit RS 30 D [copolymer of methyl methacrylate, ethyl acrylate and trimethylammonioethyl methacrylate (2: 1: 0.1)] - 4.908 mg; iron oxide (III) yellow (E 172) - 0.08 mg; triethyl citrate - 0.88 mg; polysorbate-80 - 0.008 mg.

Pharmacological properties

Pharmacodynamics

Ketonal DUO is one of the non-steroidal anti-inflammatory drugs (NSAIDs). It has analgesic, antipyretic and anti-inflammatory effects.

Due to the inhibition of COX-1 and COX-2 (cyclooxygenase) and (partly) lipoxygenase, ketoprofen stabilizes lysosomal membranes and inhibits the synthesis of bradykinin and prostaglandins.

Ketoprofen does not have a negative effect on articular cartilage.

Pharmacokinetics

Ketonal DUO is presented in a new dosage form, which differs from conventional capsules in a special release of the active substance. The capsules contain 2 types of pellets: about 60% of the total amount are white, the rest are yellow (coated). The active substance is released quickly from white pellets, slowly from yellow ones. This leads to a combination of prolonged and rapid action.

After oral administration, Ketonal DUO is well absorbed.

The bioavailability of the substance in the form of conventional capsules / capsules with modified release is 90%.

The overall bioavailability (AUC) of ketoprofen is not affected by food intake, but the absorption rate decreases. After oral administration of 150 mg Ketonal DUO Cmax (maximum concentration of the substance) in the blood plasma is reached in 1.76 hours and is 9036.64 ng / ml.

99% of ketoprofen binds to plasma proteins (mainly to albumins). The volume of distribution is 0.1–0.2 l/kg. The substance penetrates well into the synovial fluid and reaches 30% of the plasma concentration. Significant concentrations in the synovial fluid remain stable for up to 30 hours, as a result of which joint stiffness and pain are reduced for a long time.

Ketoprofen with the participation of microsomal liver enzymes undergoes intensive metabolism. Binding occurs with glucuronic acid, is excreted in the form of glucuronide. Ketoprofen has no active metabolites. The half-life is less than 2 hours.

Approximately 80% of ketoprofen is excreted in the urine, mainly (more than 90%) - in the form of ketoprofen glucuronide, about 10% is excreted through the intestines.

The plasma concentration of ketoprofen in liver failure increases by 2 times (probably due to hypoalbuminemia and the associated high level of unbound active ketoprofen). In this group of patients, the drug should be prescribed in the minimum therapeutic dose.

In renal insufficiency, the clearance of ketoprofen is reduced, and dose adjustment is required.

Indications for use

Capsules Ketonal DUO 150 mg are prescribed for the symptomatic treatment of inflammatory / painful processes of various etiologies, including:

• diseases of the musculoskeletal system of inflammatory and degenerative etiology: rheumatoid arthritis, gout, pseudogout, seronegative arthritis (including psoriatic arthritis, ankylosing spondylitis, reactive arthritis), osteoarthritis;
• pain syndrome: headache, algomenorrhea, neuralgia, tendinitis, myalgia, bursitis, sciatica, post-traumatic and postoperative pain, pain syndrome in oncological diseases.

Contraindications

Absolute:

• exacerbation of peptic ulcer of the stomach and duodenum;
• indications of a history of rhinitis, bronchial asthma, urticaria associated with taking acetylsalicylic acid and other NSAIDs;
• nonspecific ulcerative colitis,
• exacerbation of inflammatory bowel disease;
• exacerbation of Crohn's disease;
• severe hepatic and (or) renal failure;
• hemophilia and other blood clotting disorders;
• decompensated heart failure;
• progressive kidney disease;
• postoperative period after coronary artery bypass grafting;
• chronic dyspepsia;
• cerebrovascular, gastrointestinal and other bleeding (including the presence of suspicion of them);
• age up to 15 years;
• III trimester of pregnancy and the period of breastfeeding;
• individual intolerance to the components of the drug, as well as salicylates or other NSAIDs.

Relative (diseases / conditions in the presence of which the appointment of Ketonal DUO requires caution):

• indications in the anamnesis of peptic ulcer, peptic ulcer of the gastrointestinal tract and bronchial asthma;
• clinically expressed cerebrovascular and cardiovascular diseases;
• peripheral arterial disease;
• progressive liver disease;
• dyslipidemia;
• hyperbilirubinemia;
• chronic heart failure;
• kidney failure;
• arterial hypertension;
• diabetes;
• blood diseases;
• dehydration;
• alcoholism;
• smoking;
• long-term use of NSAIDs;
• concomitant use with the following drugs: anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid), oral glucocorticosteroids (prednisolone), selective serotonin reuptake inhibitors (sertraline, citalopram);
• I-II trimesters of pregnancy.

Instructions for use Ketonal DUO: method and dosage

Capsules Ketonal DUO 150 mg are taken orally with water or milk (at least 100 ml), preferably during or after meals.

The standard dose is 1 capsule per day.

The maximum daily dose of ketoprofen is 200 mg.

Side effects

Possible adverse reactions (> 10% - very often; > 1% and< 10% – часто; >0.1% and< 1% – нечасто; >0.01% and< 0,1% – редко; < 0,01% – очень редко):

• urinary system: rarely - impaired renal function, nephrotic syndrome, interstitial nephritis, hematuria (more often occurs in patients taking diuretics and NSAIDs for a long time);
• cardiovascular system: infrequently - peripheral edema, arterial hypertension, tachycardia;
• central nervous system: often - nightmares, sleep disturbances, dizziness, headache, nervousness, fatigue; rarely - peripheral polyneuropathy, migraine; very rarely - speech disorder, disorientation, hallucinations;
• digestive system: often - dyspepsia (in the form of nausea, diarrhea or constipation, flatulence, vomiting, decrease or increase in appetite), stomatitis, abdominal pain, dry mouth; infrequently (with prolonged use of high doses) - ulceration of the mucous membrane of the gastrointestinal tract, impaired hepatic function; rarely - perforation of the organs of the gastrointestinal tract, gastrointestinal bleeding, melena, transient increase in the level of liver enzymes, exacerbation of Crohn's disease;
• hematopoietic system: decreased platelet aggregation; rarely - thrombocytopenia, anemia, purpura, agranulocytosis;
• allergic reactions: often - skin reactions (in the form of itching, urticaria); infrequently - anaphylactoid reactions, shortness of breath, rhinitis, angioedema, bronchospasm;
• sensory organs: rarely - conjunctivitis, change in taste, tinnitus, blurred vision;
• others: rarely - menometrorrhagia, hemoptysis.

Overdose

The main symptoms are vomiting (including blood), convulsions, respiratory depression, nausea, abdominal pain, melena, impaired consciousness, impaired renal function and renal failure.

Therapy: gastric lavage, activated charcoal; symptomatic treatment. The effect on the gastrointestinal tract can be reduced by the use of prostaglandins, proton pump inhibitors and histamine H2 receptor blockers.

special instructions

When conducting long-term therapy, monitoring of the state of the blood, as well as renal / hepatic function, is required, especially in elderly patients.

Against the background of arterial hypertension and cardiovascular diseases, which can lead to fluid retention in the body, taking Ketonal DUO requires caution and more frequent monitoring of blood pressure.

It must be taken into account that the drug can mask the signs of infectious diseases.

Influence on the ability to drive vehicles and complex mechanisms

When driving vehicles, it is necessary to take into account the individual patient's response to the therapy.

Use during pregnancy and lactation

• III trimester of pregnancy, lactation period - taking Ketonal DUO is contraindicated;
• I-II trimesters of pregnancy - therapy can be carried out with caution in cases where the expected benefit is higher than the potential harm.

Application in childhood

According to the instructions, Ketonal DUO is not prescribed for children under 15 years of age.

For impaired renal function

Contraindication to taking Ketonal DUO is severe renal failure.

For impaired liver function

Contraindication to taking Ketonal DUO is severe liver failure.

drug interaction

Possible interactions:

• diuretics and antihypertensives: weakening their action;
• other NSAIDs, salicylates, glucocorticosteroids, ethanol: an increase in the likelihood of adverse effects from the digestive system;
• oral hypoglycemic and some anticonvulsants (phenytoin): enhancing their action;
• mifepristone: a decrease in its effectiveness (you should not start taking Ketonal DUO earlier than 8-12 days after the abolition of mifepristone);
• anticoagulants, thrombolytics, antiplatelet agents: an increase in the likelihood of bleeding;
• cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate: an increase in their plasma concentration;
• diuretics or angiotensin-converting enzyme inhibitors: increased risk of impaired renal function.

Analogues

Analogues of Ketonal DUO are Arketal Rompharm, Fastum gel, Valusal, Bystrumgel, Flamax, Bystrumcaps, Artrozilen, Ketonal, OKI, Artrum, Febrofid, Pentalgin, Flexen, Ketoprofen, etc.

Terms and conditions of storage

Store in a place protected from light at temperatures up to 25 °C. Keep away from children.

Shelf life - 2 years.

Instructions for the medical use of the drug

Description of the pharmacological action

Indications for use

Rheumatoid arthritis;
- seronegative spondyloarthritis (including ankylosing spondylitis, psoriatic arthritis, reactive arthritis);
- gout, pseudogout;
- arthrosis;
- extra-articular rheumatism (including tendinitis, bursitis, capsulitis of the shoulder joint);
- pain syndrome (including post-traumatic, postoperative, algomenorrhea, with bone metastases in patients with cancer).

Release form

capsules with modified release 150 mg; blister 10, cardboard pack 2;
capsules with modified release 150 mg; blister 10, cardboard pack 3;
Compound
Modified release capsules 1 caps.
pellet core
active substance:
ketoprofen 150 mg
excipients: MCC; lactose monohydrate; povidone; croscarmellose sodium; polysorbate 80
pellet shell: Eudragit RS 30D (ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate copolymer); Eudragit RL 30D (ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate copolymer); triethyl citrate; polysorbate 80; talc; iron (III) oxide yellow (E172); silicon dioxide colloidal
composition of the capsule shell: gelatin; indigo carmine (E132); titanium dioxide (E171)
in a blister 10 capsules; in a pack of cardboard 2 or 3 blisters.

Pharmacodynamics

NSAIDs. It has a pronounced analgesic and anti-inflammatory effect.
The mechanism of action of Ketonal DUO is associated with inhibition of the biosynthesis of prostaglandins and leukotrienes by suppressing the activity of COX-1 and COX-2, which catalyze the synthesis of prostaglandins from arachidonic acid. Ketoprofen stabilizes lysosome membranes and has anti-bradykinin activity.

Pharmacokinetics

Ketonal DUO capsules contain two types of pellets: standard (white) and coated (yellow). Ketoprofen is rapidly released from white pellets (60% of the total) and slowly from yellow pellets (40% of the total), which allows a combination of fast and prolonged action. The effect begins to appear 20 minutes after taking the drug.
Suction
The drug is well absorbed from the gastrointestinal tract and its oral bioavailability is 90%. Eating does not affect the overall bioavailability, but reduces the rate of absorption.
After oral administration of ketoprofen at a dose of 150 mg, Tmax is 1.76 hours.
Distribution
Binding to blood proteins (mainly albumin fraction) - 99%. Vd is 0.1-0.2 l / kg. Ketoprofen penetrates into the synovial fluid and reaches a concentration there equal to 50% of the plasma level (1.5 μg / ml).
Metabolism
Ketoprofen is metabolized in the liver.
breeding
T1 / 2 of ketoprofen (from white pellets) is 2 hours. About 60-75% of ketoprofen is excreted in the urine, mainly in the form of a conjugate with glucuronic acid, less than 10% is excreted with feces.
Due to the modified release of the active substance from yellow pellets coated with a special enteric coating, the duration of the effect of Ketonal DUO reaches 18-20 hours, which allows you to take the drug 1 time.

Use during pregnancy

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Use in impaired renal function

The use of the drug is contraindicated in severe violations of kidney function.

Other special occasions when taking

The use of the drug is contraindicated in severe violations of liver function.

Contraindications for use

Diseases of the gastrointestinal tract in the acute phase (gastritis, peptic ulcer);
- severe violations of liver function;
- severe violations of kidney function;
- disorders of the hematopoietic system (including leukopenia, thrombocytopenia, hemocoagulation disorders);
- pregnancy;
- lactation period (breastfeeding);
- children's age up to 15 years;
- hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs (history of indications of bronchospasm, urticaria or rhinitis associated with taking acetylsalicylic acid).

Side effects

From the digestive system: often - loss of appetite, nausea, vomiting (including blood), flatulence, abdominal pain, constipation, diarrhea (such adverse events can be avoided by taking the drug after meals); very rarely - impaired liver function.
From the side of the central nervous system: rarely - headache, dizziness, drowsiness, depression, insomnia, nervousness; very rarely - visual disturbances, tinnitus.
Allergic reactions: rarely - skin rash, anaphylactic shock, bronchospasm, asthma attack.
From the hematopoietic system: very rarely - agranulocytosis, thrombocytopenia, anemia.
Others: rarely - peripheral edema; very rarely - impaired renal function.
As a rule, unwanted side effects are mild.

Dosage and administration

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

The maximum dose of ketoprofen is 200 mg/day.

Overdose

Symptoms: nausea, vomiting (including blood), abdominal pain, black feces, impaired consciousness, respiratory depression, convulsions, impaired renal and hepatic function.
Treatment: gastric lavage, activated charcoal, symptomatic treatment - weakening the effects of ketoprofen with histamine H2 receptor blockers, proton pump inhibitors and prostaglandins. There is no specific antidote.

Interactions with other drugs

Ketoprofen can weaken the effect of diuretics and antihypertensive drugs and increase the effect of oral hypoglycemic and some anticonvulsants (phenytoin).

Combined use with other NSAIDs, salicylates, corticosteroids, ethanol increases the risk of adverse events from the gastrointestinal tract. Simultaneous administration with anticoagulants, thrombolytics, antiplatelet agents increases the risk of bleeding.

Concomitant use of NSAIDs with diuretics or ACE inhibitors increases the risk of impaired renal function. Increases the plasma concentration of cardiac glycosides, BCC, lithium preparations, cyclosporine, methotrexate.

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

Special instructions for admission

With prolonged use of NSAIDs, it is necessary to monitor the state of the blood, as well as the functional state of the kidneys and liver, especially in elderly patients (over 65 years of age).

It is necessary to be careful and control blood pressure more often when using ketoprofen for the treatment of patients suffering from hypertension, cardiovascular diseases that lead to fluid retention in the body. Like other NSAIDs, ketoprofen may mask signs of infectious disease.

Influence on the ability to concentrate

There are no data on the negative effect of Ketonal® DUO at recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who notice non-standard effects when taking Ketonal® DUO should be careful when engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Storage conditions

List B.: In a place protected from light, at a temperature not exceeding 25 ° C.

Best before date

Belonging to ATX-classification:

** The Medication Guide is for informational purposes only. For more information, please refer to the manufacturer's annotation. Do not self-medicate; Before you start using Ketonal duo, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee of the positive effect of the drug.

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Ketoprofen should not be combined with other NSAIDs and / or COX2 inhibitors. With long-term use of NSAIDs, it is necessary to periodically evaluate a clinical blood test, monitor kidney and liver function, especially in elderly patients (over 65 years), and conduct a fecal occult blood test. Care must be taken and blood pressure monitored more often when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular diseases that lead to fluid retention in the body. In the event of violations of the organs of vision, treatment should be stopped immediately. Like other NSAIDs, ketoprofen may mask the symptoms of infectious and inflammatory diseases. In case of detection of signs of infection or deterioration of health during the use of the drug, you should immediately consult a doctor. If there is a history of contraindications from the gastrointestinal tract (bleeding, perforation, peptic ulcer), long-term therapy and the use of high doses of ketoprofen, the patient should be under close medical supervision. Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when using ketoprofen in patients with heart or kidney failure, as well as in the treatment of elderly patients taking diuretics and patients who, for whatever reason, have a decrease in circulating volume blood. The drug should be discontinued before major surgery. The use of ketoprofen can affect female fertility, so patients with infertility (including those undergoing examination) are not recommended to use the drug. There are no data on the negative effect of the drug in recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who experience drowsiness, dizziness, convulsions or other unpleasant sensations from the nervous system, including visual impairment, while using the drug, should refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and psychomotor speed. reactions. With caution - a history of bronchial asthma, clinically significant cardiovascular, cerebrovascular and peripheral arterial diseases, dyslipidemia, progressive liver disease, hyperbilirubinemia, alcoholic cirrhosis of the liver, liver failure, renal failure (CC 30-60 ml / min), chronic heart failure, hypertension, blood disorders, dehydration, diabetes mellitus, presence of Helicobacter pylori infection, severe physical illness, older age, smoking, concomitant therapy with anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, nicorandil), oral glucocorticosteroids (eg , prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, sertraline), patients with a decrease in circulating blood volume, long-term use of NSAIDs. Inhibition of prostaglandin synthesis may have an undesirable effect on the course of pregnancy and/or embryonic development. Data obtained in the course of 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 risk increases with increasing dose and duration of treatment. It is possible to use the drug for pregnant women in the I and II trimesters of pregnancy only if the intended benefit to the mother justifies the possible risk to the fetus. In the case of proven benefits of using ketoprofen in women in the first and second trimesters of pregnancy and in women planning pregnancy, the minimum effective dose of the drug and the duration of treatment should be followed. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can have a toxic effect on the fetus, leading to premature closure of the ductus arteriosus and pulmonary hypertension, as well as renal dysfunction, which can lead to renal failure and the development of oligohydramnios. In pregnant women during the third trimester of pregnancy, weakness of the labor activity of the uterus and an increase in bleeding time may develop even with low doses of ketoprofen. Therefore, the use of ketoprofen during the third trimester of pregnancy is contraindicated. To date, there are no data on the release of ketoprofen into breast milk, so the use of ketoprofen is not recommended during breastfeeding.

Lek D.D.

Country of origin

Slovenia

Product group

Anti-inflammatory drugs (NSAIDs)

Release form

• 10 - blisters (3) - packs of cardboard.

Description of the dosage form

• Modified release capsules with clear body and blue cap; size #1; the contents of the capsules are 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 inhibits the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes. Ketoprofen does not adversely affect articular cartilage.

Pharmacokinetics

Absorption Ketonal® Duo capsules are presented in a new dosage form that differs from conventional capsules in a special release of the active substance. Capsules contain two types of pellets: white (about 60% of the total) and yellow (coated). Ketoprofen is rapidly released from white pellets and slowly from yellow ones, resulting in a combination of fast and prolonged action. After oral administration, Ketoprofen is well absorbed from the gastrointestinal tract. The bioavailability of ketoprofen in the form of regular capsules and capsules with modified release is 90%. When eating, 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 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, as a result of which pain and stiffness of the joints decrease for a long time. 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 as a glucuronide metabolite. 10% is excreted through the intestines. Pharmacokinetics in special clinical situations In patients with hepatic insufficiency, 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 should be prescribed the drug in the minimum therapeutic dose. In patients with renal insufficiency, the clearance of ketoprofen decreases, which requires dose adjustment. In elderly patients, the metabolism and excretion of ketoprofen is slowed down, but this is of clinical importance only for patients with reduced renal function.

Special conditions

With prolonged 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 of age). It is necessary to be careful and control blood pressure more often when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular diseases that lead to fluid retention in the body. Like other NSAIDs, ketoprofen may mask signs of infectious disease. Influence on the ability to drive vehicles and control mechanisms There are no data on the negative effect of Ketonal® Duo at recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who notice non-standard effects when taking Ketonal® Duo should be careful when engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Compound

• ketoprofen 150 mg Excipients: microcrystalline cellulose, lactose monohydrate, povidone, sodium croscarmellose, 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 (copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate (1: 2: 0.2)), triethyl citrate, polysorbate 80, talc, iron (III) oxide yellow (E172), colloidal silicon dioxide. The composition of the capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171).

Ketonal DUO indications for use

• Symptomatic therapy 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, sciatica; - post-traumatic pain; - postoperative pain; - algomenorrhea; - pain syndrome in oncological diseases.

Ketonal DUO contraindications

• - bronchial asthma, rhinitis, history of 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 disease in the acute stage; - hemophilia and other blood clotting disorders; - severe liver failure; - severe renal failure; - progressive kidney disease; - decompensated heart failure; - postoperative period after coronary artery bypass grafting; - gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding); - chronic dyspepsia; - children's age up to 15 years; - 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 prolonged use in high 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 side of the cardiovascular system: uncommon - tachycardia, arterial hypertension, peripheral edema. From the side of 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 develop in people who take NSAIDs and diuretics for a long time). Allergic reactions: common - skin reactions (itching, urticaria); uncommon - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.

drug interaction

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

Overdose

nausea, vomiting, abdominal pain, vomiting of blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure.

Storage conditions

• keep away from children

Information provided