How long can I take Ketonal tablets. Ketonal tablets - instructions for use. Influence on the ability to drive vehicles and work with mechanisms

Ketonal belongs to the potent drugs of the NSAID group. It is used to relieve pain, inhibition of inflammatory processes, lower body temperature during hyperthermia. Reception should be carried out exclusively as prescribed by a qualified specialist, since an overdose of Ketonal has serious consequences.

To avoid complications, you should strictly follow the instructions of the attending physician. In case of exceeding the dose - provide first aid in the event of pathological symptoms, clinical signs of overdose.

Ketonal effectively relieves pain of varying intensity, and therefore is popular among patients. However, it should be remembered that taking the drug can harm when:

individual intolerance to components, including salicylates (the likelihood of a cross-allergic reaction increases);
acute form of peptic ulcer of the duodenum, stomach;
non-ulcer dyspepsia syndrome;
severe forms of liver failure;
asthma attacks.

Drug therapy with Ketonal should be avoided when carrying a child, breastfeeding, in childhood (up to 14 years). Do not self-medicate. Before starting therapy, you should consult with a qualified specialist.

Use during pregnancy and lactation

At the moment, there is no evidence of the safety of the main active substance for the fetus. In medical practice, they try to avoid prescribing the drug to pregnant and lactating mothers.

Description and pharmacological action of the drug

The main active ingredient is ketoprofen, a non-steroidal anti-inflammatory drug. Pharmacological forms of release are:

capsules;
tablets;
injection;
gel for external use;
cream;
rectal suppositories.

In recent years, pharmaceutical companies have begun to produce a warming patch impregnated with the active substance - Ketonal Thermo. It is convenient to use for pain in the joints, back muscles and other parts of the body. Due to the warming effect, the patch provides relief from painful symptoms within 10 hours after fixation. To do this, it should be removed from the package and fixed on the skin in the area where uncomfortable, painful sensations are felt.

Therapeutic effect of the drug:

analgesic - relieves pain of varying intensity;
anti-inflammatory - inhibits the development of infectious and inflammatory processes;
antipyretic - reduces body temperature during hyperthermia, as a result of the development of various diseases.

The mechanism of action is based on the following principles:

blockade of prostaglandins;
inhibition of cyclooxygenase;
slowing down the production of bradykinin;
stabilization of lysosomal membranes.

After entering the digestive tract, it is quickly absorbed, reaching a maximum concentration:

when taken orally - after a few hours;
after parenteral administration - after 5 minutes;
rectally - after 60-80 minutes;
when using prolonged-release tablets - after 4 hours.

The half-life is approximately 2 hours. About 90% is filtered by the liver. With organ failure, the elimination period is increased by an hour. This should be considered when taking patients with a history of liver disease.

Storage conditions of the drug and expiration date Ketonal duo

To preserve the therapeutic properties, it is recommended to store the medicine:

at a temperature of + 15-25 degrees;
moderate humidity;
in a place inaccessible to children.

The packaging should be protected from direct sunlight.

Shelf life is 2 years from the date indicated on the package. After this period, the use of the drug is prohibited.

Use of the drug Ketonal with impaired renal function

Can cause acute renal failure. Therefore, it is prescribed with extreme caution to patients with severe pathologies of the urinary system.

In the presence of renal insufficiency, the doctor must adjust the therapeutic dose, taking into account the fact that the excretion of ketoprofen in this case will slow down by about an hour.

Conditions and symptoms of an overdose with Ketonal

The main causes of poisoning are:

taking during the day more than 300 mg of the drug or 6 tablets of the classical composition, or more than 2 tablets of Ketonal Duo in order to eliminate intense pain;
accidental drug use by a child;
combination with alcoholic beverages;
illiterate combination with other analgesics, including narcotic action, other medicines that have an amplifying effect.

Clinical signs of intoxication in Ketonal poisoning develop within an hour after the active ingredient is ingested. The severity of symptoms depends on the number of tablets taken. Intoxication manifests itself as follows:

acute or aching pain in the epigastric region;
dyspeptic symptoms, namely nausea, vomiting, heartburn, diarrhea;
eructation with a taste of acid;
increase in heart rate;
drop in blood pressure;
malaise, loss of strength;
dizziness;
headache.

In severe cases, there is a violation of consciousness.

Among the complications are:

internal (gastrointestinal) bleeding, manifested by dark vomiting, black loose stools, pallor of the skin, tachycardia, lowering blood pressure;
kidney failure, as a result of which the volume of urine excreted (oliguria) decreases, edema appears, blood pressure rises sharply;
liver dysfunction is expressed by yellowness of the skin, mucous membranes, an increase in the organ.

An overdose has a direct impact on the consequences for the health and life of the patient, so it is necessary to strictly follow medical prescriptions.

Interactions of the drug "Ketonal" with other drugs

Simultaneous reception of Ketonal with medicines for various purposes has a certain effect on the body.

Possible consequences of the joint use of various groups of drugs with NSAIDs:

diuretics, drugs for hypertension cause a decrease in the hypotensive effect;
antiglycemic drugs, anticonvulsants enhance the effect of drugs in this group;
angiotensin-converting enzyme inhibitors (ACE inhibitors) provoke an increase in the nephrotoxic effect;
cytostatics stimulate an increase in toxicity (as well as lithium preparations, methotrexate).

Also, doctors do not advise combining Ketonal with other NSAID options, since the use of an additional amount of a similar active substance can lead to an overdose. Exceeding the maximum allowable norms of ketoprofen contributes to the development of often irreversible complications, up to clinical death.

Side effects

If the instructions are followed, the drug is well tolerated. The occurrence of adverse reactions is short-term and easily curable if first aid is provided in a timely manner.

With an overdose of Ketonal Duo and the usual drug, the following are most often observed:

pain in the epigastric region;
nausea;
stool disorders.

Less common are conditions such as:

headache;
dizziness;
violation of hematopoiesis;
anemia;
thrombocytopenia.

A decrease in platelet concentration can cause:

nosebleeds;
the occurrence of bruising;
formation of a petechial rash.

In the most rare cases, develops:

bronchospasm;
asthma attack;
depressed psycho-emotional state;
disorders of consciousness;
sleep disorders;
asthenia;
deterioration of vision.

With concomitant diagnoses of the digestive, excretory systems, the following may appear:

dysfunction of the liver, kidneys;
renal, hepatic insufficiency;
nephritis of drug etiology.

In clinical practice, cases have been recorded:

uterine bleeding;
myocardial infarction;
stroke.

In elderly patients, there is a tendency to form peptic ulcers during the period of drug therapy with Ketonal. In severe cases, death is possible.

First aid

As a result of an overdose, dangerous conditions develop, and any delay in providing first aid is fraught with the fact that a person may die. To prevent a fatal outcome, you need to know the ways that will help you urgently improve your well-being.

If you suspect that the permissible dose has been exceeded, you should immediately call an ambulance team. In the meantime, the victim needs to be given first aid, which includes:

gastric lavage - drink 0.5-1 l of purified water, induce vomiting by pressing two fingers at the base of the tongue;
take absorbents (activated carbon, Atoxil, Polysorb);
drink as much water as possible, but not immediately a large amount, but often and gradually drink in small sips.

If there are signs of internal bleeding, gastric lavage should not be done. In this case, you should put a cold on your stomach and wait for the arrival of doctors.

Qualified medical care consists in carrying out activities:

measurement of indicators of the physical state of the body (pulse rate, respiratory activity, blood pressure, saturation);
cleansing the stomach, intestines.
intravenous administration of solutions that normalize the electrolyte balance and eliminate dehydration.

In a serious condition, the patient is urgently hospitalized in the toxicology department of the hospital.

Ketonal is an effective analgesic, antipyretic, which is often used for various inflammatory processes, injuries and other pathologies. Certain factors can provoke an overdose of the drug, which entails serious consequences not only for health, but also for human life. To avoid complications, the recommended doses and frequency of use of the medication should be observed. In case of deterioration of the physical condition, it is necessary to seek qualified medical assistance.

Description

Light blue, round, biconvex film-coated tablets.

Compound

Each tablet contains 100 mg of ketoprofen.
Excipients
Tablet core: magnesium stearate, anhydrous colloidal silicon dioxide, povidone, corn starch, purified talc, lactose monohydrate. Tablet shell: hypromellose E464, macrogol 400, indigotin blue dye E132, titanium dioxide E171, purified talc, carnauba wax.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid.
ATX code: M01AE03.

Pharmacological properties

Pharmacodynamics
Ketoprofen - the active substance of the drug - inhibits the synthesis of prostaglandins and leukotrienes, blocking the enzyme cyclooxygenase (cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2)), which catalyzes the synthesis of prostaglandins in the metabolism of arachidonic acid.
Ketoprofen stabilizes lysosomal membranes in vitro and in vivo, at high concentrations inhibits the synthesis of leukotrienes in vitro and has anti-bradykinin activity in vivo.
The mechanism of antipyretic action of ketoprofen is unknown. Perhaps ketoprofen inhibits the synthesis of prostaglandins in the central nervous system (most likely in the hypothalamus).
In some women, ketoprofen reduces the symptoms of primary dysmenorrhea, probably by suppressing the synthesis and / or effectiveness of prostaglandins.
Pharmacokinetics
Ketoprofen is well absorbed in the gastrointestinal tract. After taking 100 mg of ketoprofen orally, its peak plasma concentration (10.4 μg / ml) is reached in 1 hour 22 minutes. The bioavailability of ketoprofen after oral administration at a dose of 50 mg is 90% and increases linearly with increasing dose. Ketoprofen is a racemic mixture, but the pharmacokinetics of the two enantiomers are similar.
99% of ketoprofen binds to plasma proteins, mainly to the albumin fraction. The volume of distribution in tissues is 0.1-0.2 l / kg. Ketoprofen penetrates into the synovial fluid. Three hours after the appointment of 100 mg of ketoprofen, its plasma concentration is about 3 μg / ml, and the concentration in the synovial fluid is 1.5 μg / ml. After nine hours, its plasma concentration is about 0.3 μg / ml, and the concentration in the synovial fluid is 0.8 μg / ml. This means that ketoprofen slowly penetrates into the synovial fluid and is also slowly excreted from it, while its plasma concentration decreases further. If ketoprofen is taken with food, absorption slows down and plasma concentrations decrease slightly, but bioavailability remains the same. After oral administration of 50 mg of ketoprofen with meals four times a day, a peak concentration of 3.9 μg / ml was reached in 1.5 hours compared to 2.0 μg / ml after two hours when taking ketoprofen on an empty stomach. Equilibrium concentrations of ketoprofen are established 24 hours after its administration. In elderly patients, the equilibrium concentration was reached after 8.7 hours and was 6.3 μg / ml.
Ketoprofen is extensively metabolized by hepatic microsomal enzymes. It binds to glucuronic acid and is excreted in this form from the body. After oral administration, its plasma clearance is 1.16 ml / min / kg. Due to its rapid metabolism, its biological half-life is only two hours. Up to 80% of ketoprofen is excreted in the urine, mainly (over 90%) as ketoprofen glucuronide, and about 10% is excreted in the feces.
Special patient groups
With liver damage
In patients with hepatic insufficiency, probably due to hypoalbuminemia (free biologically active ketoprofen), the concentration of ketoprofen almost doubles, which requires the appointment of a minimum daily dose that provides a sufficient therapeutic effect.
with kidney damage
In patients with renal insufficiency, the clearance of ketoprofen is reduced. Therefore, in severe renal insufficiency, a dose reduction is required.

Indications for use

Ketonal forte is a non-steroidal antirheumatic drug with anti-inflammatory, analgesic and antipyretic effects. It is used for pain relief in a number of pain syndromes and for the treatment of inflammatory, degenerative and metabolic rheumatic diseases. Indications for use:
- rheumatoid arthritis;
- ankylosing spondylitis;
- acute gout;
- osteoarthritis of various localization;
- sciatica, sciatica;
- myalgia;
- tendinitis, tendovaginitis, bursitis, synovitis, capsulitis;
- bruises, damage to ligaments, dislocations;
- sprains, muscle tears
- phlebitis, superficial thrombophlebitis, lymphangitis;
- painful inflammatory diseases in dentistry, otolaryngology, urology and pulmonology.

Contraindications

Hypersensitivity to ketoprofen or any of the excipients of the drug;
- a history of rhinitis, bronchospasm, bronchial asthma, urticaria or allergic-type reactions after the use of ketoprofen or similar active substances, such as other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates (eg, acetylsalicylic acid); in such patients, severe (in rare cases fatal) anaphylactic reactions are described (see "Side effect");
- severe heart failure;
- treatment of pain in the perioperative period during coronary artery bypass grafting (CABG);
- chronic dyspepsia in history;
- peptic ulcer in the acute phase, as well as gastrointestinal bleeding, ulcer or perforation in history;
- predisposition to bleeding;
- severe impairment of kidney function;
- severe liver dysfunction;
- the last trimester of pregnancy (see "Pregnancy and lactation");
- children.

Special instructions and precautions

The simultaneous use of the drug with NSAIDs, including selective COX-2 inhibitors, should be avoided.
The elderly are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see Doses and Administration).
Bleeding, ulcers and perforations in the gastrointestinal tract
Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, has been described for all NSAIDs and may occur at any time during treatment, with or without prior symptoms or history of severe gastrointestinal disease.
Reception of Ketonal forte may be associated with a high risk of severe gastrointestinal toxicity, which is typical for some other NSAIDs, especially when taking high doses (see also "Doses and method of administration" and "Contraindications").
The risk of gastrointestinal bleeding, ulcers or perforation increases with increasing doses of NSAIDs, in patients with a history of peptic ulcer, especially complicated by bleeding or perforation (see "Contraindications"), as well as in the elderly. Treatment of these patients should be initiated at the lowest available dose.
For these patients, as well as for patients taking low-dose acetylsalicylic acid concomitantly or other drugs that increase the risk of gastrointestinal complications, combination therapy with protective drugs (eg, misoprostol or proton pump blockers) should be considered (see below and "Interaction with other medicinal products and other forms of interaction").
Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Particular care should be taken when administered concomitantly with drugs that can increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid (see "Interaction with other medicinal products and other forms of interaction”).
If patients develop gastrointestinal bleeding or ulcers during treatment with Ketonal forte, the drug should be discontinued.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as they may experience exacerbations of these diseases (see "Side Effects").
Cardiovascular and cerebrovascular effects. Patients with a history of arterial hypertension and / or congestive heart failure of mild to moderate severity require appropriate monitoring and consultation, since fluid retention and edema have been reported with the use of NSAIDs.
The use of some NSAIDs (especially at high doses and with long-term treatment) may be associated with an increased risk of arterial thrombosis (eg, myocardial infarction or stroke) (see "Special Instructions and Precautions"). There are insufficient data to rule out such a risk for ketoprofen.
In patients with uncontrolled arterial hypertension, congestive heart failure, established diagnosis of coronary heart disease, peripheral arterial disease and / or cerebrovascular disease, treatment with Ketonal forte should be carried out only after a thorough assessment of the benefits and risks. Similarly, it is necessary to proceed in a similar way before prescribing long-term treatment for patients with risk factors for cardiovascular diseases (eg arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).
Patients suffering from bronchial asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyposis are more likely to experience allergic reactions after taking acetylsalicylic acid and/or NSAIDs than other patients. The appointment of Ketonal forte can cause an attack of bronchial asthma or bronchospasm, especially in patients with allergies to acetylsalicylic acid or NSAIDs (see "Contraindications").
In patients with heart failure, cirrhosis and nephrotic syndrome, as well as in patients taking diuretics, and in patients with chronic renal failure, especially the elderly, renal function should be carefully monitored at the beginning of treatment. In such patients, the appointment of Ketonal forte can cause a decrease in renal blood flow due to inhibition of prostaglandin synthesis and lead to decompensation of kidney function.
In patients with abnormal liver function tests or a history of liver disease, blood transaminase levels should be monitored periodically, especially during prolonged therapy.
Rare cases of jaundice and hepatitis have been described in connection with the use of ketoprofen.
Treatment should be discontinued if visual disturbances occur, such as blurred vision. The drug is prescribed with caution to persons suffering from alcohol dependence.
Very rarely, NSAID-related severe skin reactions (some of them fatal), such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see "Side Effects"). The greatest risk of developing these reactions is at the beginning of the course of treatment; in most cases, reactions occur in the first month of treatment. Ketonal forte should be discontinued at the first appearance of a skin rash, mucosal lesions, or other signs of hypersensitivity.
Ketonal forte may mask signs and symptoms of infectious diseases, such as fever.
Before extensive surgical interventions, the drug must be canceled.
The use of Ketonal forte can reduce fertility, so it is not recommended for women planning a pregnancy. In women who have difficulty getting pregnant or who are being examined for infertility, discontinuation of Ketonal forte should be considered.
Ketonal forte tablets contain lactose. Therefore, they should not be taken by patients with hereditary galactose intolerance, lactase deficiency or malabsorption of glucose and galactose.

Pregnancy and lactation

Inhibition of prostaglandin synthesis can have a negative impact on pregnancy and / or development of the embryo / fetus. In the first and second trimesters of pregnancy, the drug should not be prescribed unless absolutely necessary. If Ketonal forte is used by a woman who is trying to become pregnant or is in the first or second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
In the third trimester of pregnancy, the use of Ketonal forte is contraindicated.
There are no data on the penetration of the drug into milk. It is not recommended to prescribe Ketonal forte to nursing mothers.

Influence on the ability to drive vehicles and work with mechanisms

The drug may cause side effects from the central nervous system, such as dizziness, drowsiness or convulsions; in this case, you should not drive vehicles or work with mechanisms.

Doses and method of application

For oral administration.
Undesirable effects can be minimized if the drug is taken at the lowest effective dose for the shortest possible time necessary to relieve symptoms.
The usual dose is 1-2 tablets per day, between meals.
The maximum daily dose of ketoprofen is 200 mg. Before starting treatment at a dose of 200 mg per day, the possible risks and benefits should be carefully weighed. The use of higher doses is not recommended (see also "Special instructions and precautions").
Elderly patients and patients with impaired renal function
It is recommended to reduce the initial dose and prescribe maintenance therapy using the lowest effective dose. If the drug is well tolerated, dose adjustments may be considered on an individual basis.
Patients with impaired liver function
Such patients should be carefully monitored and the drug should be used at the lowest effective daily dose.
Children
The safety and efficacy of ketoprofen in children has not been studied.

Side effect

Edema, high blood pressure, and heart failure have been reported in association with treatment with non-selective NSAIDs.
If severe side effects occur, treatment should be discontinued.
Adverse effects are distributed according to the classes of organ systems, according to the frequency of occurrence and descending severity: very frequent (≥ 1/10); frequent (≥ 1/100,<1/10); нечастые (≥ 1/1 000, <1/100); редкие (≥ 1/10 000, <1/1 000); очень редкие (< 1/10 000); частота не установлена (частота не может быть установлена по имеющимся данным).
Blood and lymphatic system disorders
- Rare: posthemorrhagic anemia;
- Frequency not established: agranulocytosis, thrombocytopenia, bone marrow failure.
Immune System Disorders
- Frequency not established: anaphylactic reactions (including shock).
Mental disorders
- Frequency not established: Mood variability.
Nervous System Disorders
- Uncommon: headache, dizziness, drowsiness;
- Rare: paresthesia;
- Frequency not established: convulsions, dysgeusia.
Violations of the organ of vision
- Rare: blurred vision (see "Special instructions and precautions").
Hearing and labyrinth disorders
- Rare: ringing in the ears.
Heart disorders
- Frequency not established: heart failure.
Vascular disorders
- Frequency not established: arterial hypertension, vasodilation.
Respiratory, thoracic and mediastinal disorders
- Rare: bronchial asthma;
- Frequency not established: bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis.
Gastrointestinal disorders
- Frequent: dyspepsia, nausea, abdominal pain, vomiting;
- Infrequent: constipation, diarrhea, flatulence, gastritis;
- Rare: stomatitis, peptic ulcer;
- Frequency not established: exacerbation of ulcerative colitis and Crohn's disease, gastrointestinal bleeding and perforation, melena, hematemesis.
The most common adverse reactions include reactions from the gastrointestinal tract. Perhaps the development of peptic ulcers, perforations and bleeding in the gastrointestinal tract, which sometimes, especially in elderly patients, can be fatal (see "Special instructions and precautions").
Liver and biliary tract disorders
- Rare: hepatitis, elevated transaminases, elevated serum bilirubin due to hepatitis.
Skin and subcutaneous tissue disorders
- Infrequent: rash, itching;
- Frequency not established: photosensitivity reaction, alopecia, urticaria, angioedema, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Renal and urinary tract disorders
- Frequency not established: acute renal failure, tubulointerstitial nephritis, nephritic syndrome, abnormal kidney function tests.
General disorders and disorders at the injection site
- Infrequent: edema;
- Frequency not established: fatigue.
Laboratory and instrumental data
- Rare: weight gain.
Data show that the use of a number of non-selective NSAIDs (especially at high doses and for a long time) may be associated with an increased risk of arterial thrombosis (for example, myocardial infarction or stroke) (see "Special Instructions and Precautions").

Interaction with other medicinal products and other forms of interaction

Not recommended drug combinations
Other NSAIDs (including selective cyclooxygenase-2 inhibitors) and salicylates in high doses: increased risk of developing ulcers and bleeding in the gastrointestinal tract.
Anticoagulants(heparin and warfarin) andplatelet aggregation inhibitors(eg, ticlopidine, clopidogrel): increased risk of bleeding (see "Special instructions and precautions"). If necessary, joint use requires close medical supervision.
Lithium: risk of increased plasma lithium levels, which can sometimes reach toxic levels due to decreased renal excretion of lithium. If necessary, the concentration of lithium in plasma should be carefully monitored and the dose of lithium should be adjusted during and after treatment with NSAIDs.
Methotrexate at doses greater than 15 mg/week: increased risk of hematotoxicity of methotrexate, especially if it was used in high doses (> 15 mg / week), which is probably due to displacement of methotrexate from protein binding and a decrease in its renal clearance.
Combinations requiring caution
Diuretics: in patients taking diuretics, especially in patients with dehydration, there is an increased risk of renal failure due to a decrease in renal blood flow due to inhibition of prostaglandin synthesis. Such patients need to adequately compensate for fluid deficiency before the start of the joint use of such drugs, and at the beginning of treatment, monitor kidney function (see "Special Instructions and Precautions").
Angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists. In patients with impaired renal function (eg, patients with dehydration or the elderly), the concomitant use of an ACE inhibitor or angiotensin II receptor antagonist and drugs that inhibit cyclooxygenase may cause additional deterioration in renal function, including possible acute renal failure.
Methotrexate at doses below 15 mg/week: in the first weeks of combined treatment, it is necessary to monitor the detailed blood picture once a week. In case of any impairment of renal function and in elderly patients, monitoring should be carried out more often.
Corticosteroids: increased risk of ulcers or bleeding in the gastrointestinal tract (see "Special instructions and precautions").
Pentoxifylline: increases the risk of bleeding. More frequent clinical monitoring and more frequent control of bleeding time are needed.
Combinations to consider
Antihypertensivedrugs(beta-blockers, ACE inhibitors, diuretics): ketoprofen reduces the effect of antihypertensive drugs (inhibition of the synthesis of vasodilatory prostaglandins).
Thrombolytics: increased risk of bleeding.
Selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding (see "Special instructions and precautions").

Best before date

5 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Marketing authorization holder and manufacturer
Lek d.d., Verovshkova 57, Ljubljana, Slovenia.

Lek D.D. Master Pharm Polska Sp.z.o.o. Salutas Pharma GmbH Sandoz Ilach Sanai Ve Tijaret A.S. Zhuhai Guojia New Material Co.,Ltd.

Country of origin

Germany China Poland Russia Slovenia Turkey

Product group

Anti-inflammatory drugs (NSAIDs)

Non-steroidal anti-inflammatory drug (NSAID)

Release form

10 - blisters (3) - packs of cardboard. 10 tablets in a pack of 2 ml - dark glass ampoules (5) - blisters (2) - cardboard packs. 2 ml - dark glass ampoules (5) - blisters (5) - cardboard packs. 20 - dark glass bottles (1) - cardboard packs 25 - dark glass bottles (1) - cardboard packs 6 - strips (2) - cardboard packs. 6 - strips (2) - packs of cardboard. tube - 30g tube - 50g tube - 50g tube 100g pack 10pcs

Description of the dosage form

Gel for external use 2.5% Opaque capsules, No. 3, with a white body and a blue cap; the contents of the capsules are loose or compressed white powder with a yellowish tint. Modified release capsules with clear body and blue cap; size #1; the contents of the capsules are white and yellow pellets Cream for external use 5% white or almost white, homogeneous Cream for external use 5% white or almost white, homogeneous. patch Solution for intravenous and intramuscular injection is colorless or slightly yellowish, transparent Solution for intravenous and intramuscular administration is colorless or slightly yellowish, transparent. Light blue, round, biconvex film-coated tablets. Rectal suppositories Tablets of prolonged action white, round, biconvex. Light blue film-coated tablets, round, biconvex

pharmachologic effect

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID). Ketoprofen has anti-inflammatory, analgesic and antipyretic effects. Ketoprofen blocks the action of the enzyme cyclooxygenase 1 and 2 (COX1 and COX2) and, in part, lipoxygenase, which leads to suppression of prostaglandin synthesis (including in the central nervous system (CNS), most likely in the hypothalamus). Stabilizes liposomal membranes in vitro and in vivo; at high concentrations in vitro, ketoprofen inhibits the synthesis of bradykinin and leukotrienes. Ketoprofen does not adversely affect the condition of the 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

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. Influence on the ability to drive vehicles and mechanisms: There are no data on the negative effect of Ketonal® in recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who experience drowsiness, dizziness 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 speed of psychomotor reactions.

Compound

iron powder, water, salt, activated carbon. 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). Ketoprofen 50 mg Excipients: methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, isopropyl myristate, white petrolatum, Elfakos ST9, propylene glycol glyceryl oleate, magnesium sulfate, water Ketoprofen 100 mg Excipients: solid fat, glyceryl caprylocaprate (miglyol 812). ketoprofen 25 mg Excipients: carbomer, trolamine (triethanolamine), ethanol 96%, lavender essential oil, water. Ketoprofen50 mg Excipients: methylhydroxybenzoate, propylhydroxybenzoate, propylene glycol, isopropyl myristate, white petrolatum, Elfacos ST9, propylene glycol glyceryl oleate, magnesium sulfate, water Ketoprofen50 mg Excipients: propylene glycol, ethanol, benzyl alcohol, sodium hydroxide, water for injection. size:100mmX133mm; iron powder, water, salt, activated carbon

Ketonal indications for use

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; tendinitis, bursitis, myalgia, neuralgia, sciatica; - pain syndrome, including mild, moderate and severe: headache; toothache; post-traumatic and postoperative pain syndrome; pain syndrome in oncological diseases; algomenorrhea.

Ketonal 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 dosage

100 mg 150 mg 2.5% 5% 50 mg 50 mg/ml

Ketonal side effects

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100,

drug interaction

Ketoprofen may weaken the effect of diuretics and antihypertensives and increase the effect of oral hypoglycemic drugs and some anticonvulsants (phenytoin). Combined use with other NSAIDs, salicylates, glucocorticosteroids, ethanol increases the risk of adverse events from the gastrointestinal tract. Simultaneous use with anticoagulants (heparin, warfarin), thrombolytics, antiplatelet agents (ticlopidine, clopidogrel), pentoxifylline increases the risk of bleeding. Simultaneous use with potassium salts, potassium-sparing diuretics, ACE inhibitors, NSAIDs, low molecular weight heparins, cyclosporine, tacrolimus and trimethoprim increases the risk of hyperkalemia. Increases the concentration in the blood plasma of cardiac glycosides, blockers of "slow" calcium channels, lithium preparations, cyclosporine, methotrexate and digoxin. Increases the toxicity of methotrexate and the nephrotoxicity of cyclosporine. Simultaneous use with probenecid significantly reduces the clearance of ketoprofen in plasma. Combined use with glucocorticosteroids and other NSAIDs (including selective COX2 inhibitors) increases the likelihood of side effects (in particular, from the gastrointestinal tract). NSAIDs may reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after the abolition of mifepristone.

Overdose

As with other NSAIDs, overdose of ketoprofen may cause nausea, vomiting, abdominal pain, hematemesis, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure. In case of overdose, gastric lavage and the use of activated charcoal are indicated. Treatment is symptomatic; the effect of ketoprofen on the gastrointestinal tract can be reduced by drugs that reduce the secretion of the gastric glands (for example, proton pump inhibitors) and prostaglandins.

Storage conditions

keep away from children

Information provided

Description of the dosage form

Release form, composition and packaging

Capsules opaque, #3, with white body and blue cap; the contents of the capsules are loose or compressed white powder with a yellowish tint.

Excipients: magnesium stearate, colloidal silicon dioxide, corn starch, povidone, talc, lactose.

Shell composition: hypromellose, macrogol 400, indigo carmine (E132), titanium dioxide, talc, carnauba wax.

20 pcs. - dark glass bottles (1) - packs of cardboard.

Prolonged release tablets white, round, biconvex.

Excipients: propylene glycol, ethanol, benzyl alcohol, sodium hydroxide, water for injections.

2 ml - dark glass ampoules (5) - blisters (2) - cardboard packs.
2 ml - dark glass ampoules (5) - blisters (5) - cardboard packs.

Clinical and pharmacological group

NSAIDs

pharmachologic effect

NSAIDs, a derivative of propionic acid. It has analgesic, anti-inflammatory and antipyretic effects. By inhibiting COX-1 and COX-2 and, in part, lipoxygenase, ketoprofen inhibits the synthesis of prostaglandins and bradykinin, and stabilizes lysosomal membranes.

Ketoprofen does not adversely affect the condition of the articular cartilage.

Pharmacokinetics

Suction

When taken orally, ketoprofen is easily absorbed from the gastrointestinal tract. Bioavailability - 90%. When taking the drug at a dose of 100 mg, Cmax in blood plasma is reached after 1 hour 22 minutes and is 10.4 μg / ml. Eating does not affect the bioavailability of Ketoprofen.

C max for parenteral administration is 15-30 minutes.

Distribution

V d is 0.1-0.2 l / kg. Plasma protein binding is 99%. Ketoprofen penetrates well into the synovial fluid.

Metabolism

It undergoes intensive metabolism in the liver through microsomal enzymes, conjugates with glucuronic acid.

breeding

T 1/2 of ketoprofen - 1.6-1.9 hours. Ketoprofen is mainly metabolized in the liver. About 80% of ketoprofen is excreted in the urine, mainly as a conjugate with glucuronic acid (90%). About 10% is excreted unchanged through the intestines.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency, ketoprofen is excreted more slowly, T 1/2 increases by 1 hour.

In patients with hepatic insufficiency, ketoprofen may accumulate in the tissues.

In elderly patients, the metabolism and excretion of ketoprofen are slower, but this is of clinical importance only for patients with reduced renal function.

Indications for the use of the drug

- symptomatic therapy of inflammatory and degenerative diseases of the musculoskeletal system (including rheumatoid arthritis, seronegative arthritis / ankylosing spondylitis, psoriatic arthritis, reactive arthritis /), osteoarthritis, gout, pseudogout);

- pain syndrome (including headache, myalgia, neuralgia, sciatica, post-traumatic and postoperative pain, pain syndrome in oncological diseases, algomenorrhea).

Dosing regimen

Adults the drug is prescribed for 1-2 caps. 2-3 times / day, or 1 tab. 2 times / day, or 1 tab. prolonged action 1 time / day. Capsules and tablets should be taken during or immediately after a meal, without chewing, drinking plenty of water or milk (liquid volume - at least 100 ml).

Oral forms can be combined with the use of rectal suppositories or dosage forms of Ketonal for external use (cream, gel).

The maximum daily dose (including the use of various dosage forms) is 200 mg.

The solution is administered in / m or / in. In / m enter 100 mg 1-2 times / day. In / in the infusion administration of ketoprofen is carried out only in a hospital.

Short IV infusion: 100-200 mg, diluted in 100 ml of 0.9% sodium chloride solution, is administered over 0.5-1 hour. Re-introduction is possible after 8 hours.

Continuous IV infusion: 100-200 mg, diluted in 500 ml of an infusion solution (0.9% sodium chloride solution, lactated Ringer's solution, 5% dextrose solution), is administered over 8 hours. Re-introduction is possible after 8 hours.

Parenteral administration can be combined with the use of oral forms (capsules, tablets) or rectal suppositories. The maximum daily dose (including the use of various dosage forms) is 200 mg.

Side effect

The frequency of occurrence of adverse reactions: very common (> 10%), common (> 1%, but<10%), нераспространенные (>0.1% but<1%), редкие (>0.01% but<0.1%), очень редкие (<0.01%).

From the digestive system: common - dyspepsia (nausea, flatulence, diarrhea or constipation, 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, bleeding from the gastrointestinal tract, transient increase in the level of liver enzymes.

From the side of the central nervous system and peripheral nervous system: common - headache, dizziness, drowsiness, fatigue, nervousness, nightmares; rare - migraine, peripheral neuropathy; very rare - hallucinations, disorientation, speech disorder.

From the sense organs: rare - tinnitus, change in taste, blurred vision, conjunctivitis.

From the side of 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 liver function, interstitial nephritis, nephrotic syndrome, hematuria (with long-term use of NSAIDs and diuretics).

Allergic reactions: common - itching, urticaria; uncommon - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.

Others: rare - hemoptysis, menometrorrhagia.

Contraindications to the use of the drug

- peptic ulcer of the stomach and duodenum in the acute phase;

- UC, Crohn's disease;

- hemophilia and other bleeding disorders;

- severe liver failure;

- severe renal failure;

- uncompensated heart failure;

- postoperative period after coronary artery bypass grafting;

- gastrointestinal, cerebrovascular and other bleeding or suspected bleeding;

- chronic dyspepsia;

- III trimester of pregnancy;

- lactation (breastfeeding);

- children's age up to 15 years;

- hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs;

- indications in the anamnesis of bronchial asthma, urticaria and rhinitis caused by taking acetylsalicylic acid or other NSAIDs.

FROM caution the drug should be prescribed for a history of peptic ulcer disease, clinically significant cardiovascular, cerebrovascular diseases, peripheral arterial disease, dyslipidemia, liver failure, renal failure, chronic heart failure, arterial hypertension, blood diseases, dehydration, diabetes mellitus, history of development ulcerative lesions of the gastrointestinal tract, smoking, concomitant therapy with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid), oral corticosteroids (prednisolone), selective serotonin reuptake inhibitors (citalopram, sertraline).

The use of the drug during pregnancy and lactation

The use of Ketonal in the III trimester of pregnancy is contraindicated. The use of Ketonal in the I and II trimesters of pregnancy is possible only if the potential benefit to the mother outweighs the risk to the fetus.

If it is necessary to use Ketonal during lactation, the issue of stopping breastfeeding should be resolved.

Application for violations of liver function

Application for violations of kidney function

Contraindicated in severe renal impairment.

special instructions

Ketonal ® can be washed down with milk or taken with antacids to reduce the frequency of gastrointestinal disorders (milk and antacids do not affect the absorption of ketoprofen).

With long-term use of Ketonal, as well as other NSAIDs, regular monitoring of hematological parameters, indicators of liver and kidney function is required, especially in elderly patients.

Ketoprofen should be used with caution in patients with arterial hypertension and heart disease, accompanied by fluid retention in the body, blood pressure monitoring is recommended.

Ketonal ® may mask the symptoms of infectious diseases.

Due to the photosensitivity of the drug, vials with an infusion solution should be wrapped in dark paper or foil.

Influence on the ability to drive vehicles and control mechanisms

There are no data on the negative effect of Ketonal at recommended doses on the ability to drive a car and work with mechanisms. However, when using the drug, caution should be exercised in persons whose activities require rapid psychomotor reactions (driving a car, working with mechanisms).

Overdose

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

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy. The use of histamine H 2 -receptor blockers, proton pump inhibitors, prostaglandin inhibitors is shown. There is no specific antidote.

drug interaction

Ketoprofen reduces the effect of diuretics, antihypertensive drugs.

Enhances the effect of oral hypoglycemic drugs.

With simultaneous use with other NSAIDs, salicylates, corticosteroids and ethanol, the risk of developing gastrointestinal bleeding increases.

With simultaneous use with anticoagulants, thrombolytics, antiplatelet agents, the risk of bleeding increases.

The risk of developing renal dysfunction increases when taken with diuretics or ACE inhibitors.

With simultaneous use, it increases the concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate.

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

Ketonal ® can be combined with centrally acting analgesics. The solution can be mixed with morphine in one vial. Do not mix in the same vial with tramadol due to precipitation.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Shelf life of coated tablets, prolonged-release tablets, capsules - 5 years, solution for intramuscular and intravenous administration - 3 years.

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.