Ketonal Aktiv, 40 mg 12 pcs.

.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system:

– rheumatoid arthritis;

– seronegative arthritis: Ankylosing spondylitis (Bechterew’s disease), psoriatic arthritis, reactive arthritis (Reiter’s disease);

– gout, pseudopodagra;

– osteoarthritis;

– tendinitis, bursitis, myalgia, neuralgia, radiculitis.

Pain syndrome, including mild, moderate and severe:

– headache;

– toothache;

– posttraumatic and postoperative pain syndrome;

– pain syndrome in cancer;

– algodysmenorrhea.

In children (over 6 years): short-term symptomatic treatment of inflammatory processes accompanied by pain syndrome in combination with or without fever in diseases of the musculoskeletal system, otitis media.

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

Active ingredient

Composition

One sachet (1 g) contains:

the active ingredient:

ketoprofen lysine salt – 40.0 mg (equivalent to 25.0 mg of ketoprofen);

excipients:

mannitol – 911.0 mg,

povidone (K 30) – 20.0 mg,

mint flavoring – 10.0 mg,

p> sodium chloride – 10.0 mg,

sodium saccharinate – 7.5 mg,

silicon dioxide colloid – 1.5 mg.

How to take, the dosage

Adults:

The contents of two sachets dissolve in half a cup of drinking water and take orally up to 3 times a day with meals.

In elderly patients, the dosage is determined by the doctor, and it is advisable to reduce the dosage by half.

In children (6 to 14 years of age):

The contents of one sachet dissolve in half a cup of drinking water and take orally up to 3 times a day with meals.

Children (14 to 18 years of age):

The dosages of the drug are the same as those for adults.

To reduce the risk of gastrointestinal adverse events, the lowest effective dose should be used for as short a course as possible.

Interaction

Combinations to avoid

Corticosteroids: increased risk of gastrointestinal mucosal ulceration and gastrointestinal bleeding.

Anticoagulants (parenteral heparin, warfarin): increased risk of bleeding caused by inhibition of platelet function and damage to the gastrointestinal mucosa. NSAIDs may increase the effects of anticoagulants such as warfarin.

Antiaggregants (clopidogrel, ticlopidine) and selective serotonin reuptake inhibitors: the risk of bleeding caused by inhibition of platelet aggregation and GI mucosal damage increases. Patients should be monitored if co-administration cannot be avoided.

Other NSAIDs, including high doses of salicylates (≥3 g/day): Concomitant administration of several NSAIDs may increase the risk of gastrointestinal mucosal ulceration and gastrointestinal bleeding due to synergistic effects.

Lithium: NSAIDs increase plasma levels of lithium (decrease renal excretion of lithium), which may reach toxic levels. This parameter should be monitored at the beginning of treatment, during dose adjustment and after discontinuation of ketoprofen treatment.

Methotrexate at high doses (more than 15 mg per week): hematotoxicity of methotrexate is increased because its excretion by kidneys when taking anti-inflammatory drugs is reduced.

When coadministration with methotrexate at low doses (less than 15 mg per week) it is necessary to perform a general blood test once a week during the first few weeks of treatment. More frequent monitoring of the patient’s clinical condition is mandatory in the presence of even a slight deterioration of renal function, as well as in elderly patients.

Hydantoin and sulfamides: the toxic effects of these agents may increase.

Combinations requiring precautions

Diuretics, angiotensin converting enzyme inhibitors (ACEs) and angiotensin II receptor antagonists: NSAIDs may decrease their effectiveness. In patients with impaired renal function (e.g., dehydrated or elderly patients), concomitant use of ACE inhibitors or angiotensin II receptor antagonists with drugs that inhibit the cyclooxygenase system may cause additional renal dysfunction, including acute renal failure, usually reversible. Patients should be adequately hydrated before starting concomitant therapy, and renal function should be monitored after initiation of therapy.

Pentoxifylline: increased risk of bleeding. More frequent monitoring of the patient’s clinical condition and monitoring of clotting time are mandatory.

Zidovudine: Increased risk of erythrocyte toxicity through effects on reticulocytes with development of severe anemia one week after initiation of NSAID treatment. A complete blood count and reticulocyte counts should be monitored 1-2 times per week after initiation of NSAID treatment.

Sulfonylurea: NSAIDs may increase the hypoglycemic effect of sulfonylurea by reducing its binding to plasma proteins.

Combinations to be considered

Beta-adrenoblockers: NSAIDs may decrease the hypotensive effect of beta-adrenoblockers due to inhibition of prostaglandin synthesis.

Cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity due to effects associated with renal prostaglandins. Renal function should be monitored when used together.

Trombolytics: increased risk of bleeding.

Probenecid: the concentration of ketoprofen in plasma may increase. This increase may be due to an inhibitory mechanism at the site of renal tubular secretion and glucuronoconjugation and requires adjustment of the ketoprofen dose.

Special Instructions

After 2 weeks of the drug use it is necessary to control liver function parameters (transaminases level).

The use of ketoprofen in patients with bronchial asthma may lead to an attack of bronchial asthma.

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

The drug may alter platelet properties, but does not replace the prophylactic effect of acetylsalicylic acid in cardiovascular disease.

The drug may mask signs of infectious diseases.

Elderly patients, patients with a history of peptic ulcer disease, and patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal reactions, co-administration of gastroprotective drugs (misoprostol or proton pump inhibitors) is indicated.

The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy. The drug should be discontinued in women with fertility problems or who are undergoing fertility studies.

The drug does not affect low-calorie and controlled diets and can be used in patients with diabetes.

The drug is gluten-free, so it can be used in patients with celiac disease.

The drug does not contain aspartame, so it can be used in patients with phenylketonuria.

Cardiovascular and cerebrovascular effects

Patients with arterial hypertension and/or with moderate heart failure accompanied by fluid retention and edema (history) associated with NSAID use require close monitoring and medical consultation.

Clinical studies and epidemiologic data indicate that use of some NSAIDs (especially in high doses over a long period of time) may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). There is insufficient data to rule out the above risk for ketoprofen lysine salt.

Patients with uncontrolled arterial hypertension, heart failure, established coronary heart disease, peripheral artery disease and/or cerebrovascular disease should use ketoprofen lysine salt only after a thorough evaluation. Patients with risk factors for cardiovascular disease (e.g., arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) should undergo the same examination before starting long-term treatment.

The drug has limited and moderate effect on the ability to operate vehicles or machinery due to possible dizziness and somnolence.

If drowsiness, dizziness or seizures are noted after using the drug, driving and operating machinery, as well as other activities requiring concentration, should be avoided.

Contraindications

– Hypersensitivity to the active substance and other components of the drug, as well as to other NSAIDs;

– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including anamnesis);

– erosive-ulcerative lesions of the stomach and duodenum in the acute stage;

– active gastrointestinal, cerebrovascular or other bleeding;

– inflammatory bowel disease (ulcerative colitis, Crohn’s disease) in the acute stage;

– hemophilia or other blood clotting disorders;

– decompensated heart failure;

– period after coronary artery bypass grafting;

– severe hepatic insufficiency or active liver disease;

– severe renal insufficiency (creatinine clearance (CK) <30 ml/min), advanced renal disease;

– confirmed hyperkalemia;

– childhood (under 6 years);

– pregnancy (III trimester) and breastfeeding.

. Gastric and duodenal ulcer, ulcerative colitis, Crohn’s disease, liver disease (history), hepatic porphyria, chronic renal failure (CK 30-60 ml/min), chronic heart failure, arterial hypertension, significant reduction in circulating blood volume (including after surgery), elderly patients (including those receiving diuretics, weakened patients and those with low body weight), bronchial asthma, concomitant use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes, peripheral artery disease, smoking, Helicobacter pylori infection, long-term use of NSAIDs, tuberculosis, severe osteoporosis, alcoholism, severe medical conditions, pregnancy (I, II trimester).

Side effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: Very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000) and very rare (< 1 /10000); frequency unknown (frequency of events cannot be determined from available data).

Blood and lymphatic system disorders

Rare: hemorrhagic anemia;

frequency unknown: thrombocytopenia, thrombocytopenic purpura, agranulocytosis, bone marrow dysfunction, leukocytopenia, leukocytosis, inflammation of lymph vessels, vasculitis.

Immune system disorders

incidence unknown: anaphylactic reactions (including anaphylactic shock).

Nervous system and sensory system disorders

infrequent: headache, dizziness, drowsiness;

rarely: paresthesias, blurred vision, tinnitus;

frequent unknown: seizures, dysgeusia, mood changes, irritability, insomnia.

Cardiovascular disorders

frequency unknown: heart failure, tachycardia, palpitations, hypertension, hypotension, vasodilation.

Respiratory system disorders

rarely: bronchial asthma;

incidence unknown: bronchospasm (especially in patients with confirmed hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnea, laryngeal edema and spasm.

Gastrointestinal disorders

often: nausea, vomiting, dyspepsia, abdominal pain;

infrequently: constipation, diarrhea, abdominal bloating, gastritis;

rarely: stomatitis, gastric and duodenal ulcer;

frequent unknown: exacerbation of ulcerative colitis and Crohn’s disease, gastrointestinal bleeding, perforation, heartburn.

Hepatic and biliary tract disorders

rare rare: hepatitis, increased activity of “hepatic” transaminases and increased serum bilirubin concentration caused by liver disorders.

Skin and subcutaneous tissue disorders

infrequent: rash, itching;

frequency unknown: Photosensitization reactions, alopecia, urticaria, angioneurotic edema, bullous skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), erythema and exanthema, maculopapular rash, dermatitis.

Renal and urinary tract disorders

frequency unknown: acute renal failure, tubulointerstitial nephritis and nephritic syndrome, abnormal renal function values.

Other

infrequent: edema, fatigue;

frequent unknown: allergic and anaphylactoid reactions, oral mucosal edema, periorbital edema.

In case of any side effect, the drug should be stopped immediately and a physician should be consulted.

Overdose

Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases the symptoms were limited to lethargy, drowsiness, nausea, vomiting and epigastric pain.

Aid measures for overdose

A specific antidote is not known. As symptomatic measures, while ensuring vital functions (stabilization of circulation, respiration, elimination of acidosis), drugs and procedures that reduce resorption and accelerate elimination (medical charcoal, forced diuresis) are indicated.

Pregnancy use

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

In the first and second trimesters of pregnancy the drug may be administered only if the expected benefits to the mother exceed the potential risk to the fetus.

The drug should not be used during breastfeeding.

Similarities