Dexonal tablets p / o 25mg, No. 10

The drug is intended for symptomatic treatment, reducing pain and inflammation at the time of use.

• Musculoskeletal pain (mild or moderate),

• algodismenorrhea,

• toothache.
  

DexonalЃ is taken orally with meals. Simultaneous food intake slows down the absorption of dexketoprofen, therefore, in case of acute pain, it is recommended to use the drug at least 30 minutes before a meal.
Depending on the intensity of the pain syndrome, the recommended dose for adults is 12.5 mg dexketoprofen (1/2 tablet of DexonalЃ) every 4-6 hours or 25 mg of dexketoprofen (1 tablet of DexonalЃ) every 8 hours.The
maximum daily dose is 75 mg ...
The drug is not intended for long-term therapy, the course of drug treatment should not exceed 3-5 days.
Patients 65 years of age and older

Elderly patients should take the drug starting with the minimum recommended dose. The maximum daily dose is 50 mg. If well tolerated, doses recommended for the general population may be used.
Patients with hepatic impairment
Patients with mild to moderate hepatic impairment should take the drug starting with the minimum recommended dose. The maximum daily dose is 50 mg.
The use of DexonalЃ in patients with severe hepatic insufficiency is contraindicated.
Patients with renal impairment
Patients with mild renal failure - chronic kidney disease, stage 2 (GFR 60-89 ml / min / 1.73 m2) should take the drug starting with the minimum recommended dose. The maximum daily dose is 50 mg. The use of the drug in patients with chronic kidney disease stages 3a (GFR 45-59 ml / min / 1.73 m2), 36 (GFR 30-44 ml / min / 1.73 m2) and 4 (GFR <30 ml / min / 1.73 m2) is contraindicated.

1 tablet contains:
active substance: dexketoprofen trometamol 36.9 mg, in terms of dexkegoprofen 25 mg;
excipients: microcrystalline cellulose, corn starch, sodium carboxymethyl starch (sodium starch glycolate), colloidal anhydrous silicon dioxide (aerosil), magnesium stearate;
excipients for the shell: hypromellose (hydroxypropyl methylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide.

• Hypersensitivity to dexketoprofen, other components of the drug and other NSAIDs;

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

• erosive and ulcerative lesions of the gastrointestinal tract in the acute stage;

• a history of gastrointestinal bleeding or perforation, including those associated with previous use of NSAIDs;

• gastrointestinal bleeding; other active bleeding (including suspected intracranial hemorrhage);

• inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute stage;

• severe liver failure (10-15 points on the Child-Pugh scale);

• progressive kidney disease, confirmed hyperkalemia;

• chronic kidney disease: stage 3a (glomerular filtration rate (GFR) 45-59 ml / min / 1.73 m2), 36 (GFR 30-44 ml / min / 1.73 m2) and 4 (GFR <30 ml / min / 1.73 m2);

• period after coronary artery bypass grafting;

• severe heart failure (NYHA class III-IV);

• hemorrhagic diathesis and other blood clotting disorders;

• age up to 18 years (due to the lack of data on efficacy and safety);

• pregnancy and breastfeeding period.

Carefully

Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease, history of liver disease, hepatic porphyria. chronic kidney disease, stage 2 (GFR 60-89 ml / min / 1.73 m2), chronic heart failure, arterial hypertension, a significant decrease in circulating blood volume (including after surgery), elderly patients over 65 years of age (including including those receiving diuretics, weakened patients and patients with low body weight), bronchial asthma, concomitant use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors reuptake of serotonin (including citalopram, fluoxetine, paroxetine, sertraline), ischemic heart disease, cerebrovascular diseases,dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, presence of Helicobacter pylori infection, systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, long-term use of non-steroidal anti-inflammatory drugs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

Pharmacological properties

Pharmacodynamics

Dexketoprofen trometamol, the active ingredient of DexonalЃ, belongs to non-steroidal anti-inflammatory drugs (NSAIDs) that have analgesic, anti-inflammatory and antipyretic effects. The mechanism of action of dexketoprofen is based on inhibition of prostaglandin synthesis at the level of cyclooxygenases (COX-1 and COX-2).
The analgesic effect occurs 30 minutes after taking the drug DexonalЃ inside, the duration of the therapeutic effect reaches 4-6 hours.

Pharmacokinetics
Absorption. The time to reach the maximum concentration (TCmax) of dexketoprofen in blood plasma after a single single dose is an average of 30 minutes (15-60 minutes). Simultaneous food intake slows down the absorption of dexketoprofen. The areas under the concentration-time curve (AUC) after single and repeated doses are similar, which indicates the absence of drug accumulation.
Distribution. Dexketoprofen is characterized by a high degree of binding to blood plasma proteins (99%). The average value of the volume of distribution (Vd) is less than 0.25 l / kg, the half-distribution is about 0.35 hours.
Metabolism and excretion. The main route of metabolism of dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. The half-life (T?) Of dexketoprofen is 1.65 hours. In the elderly, there is an elongation of the half-life of up to 48%, and a decrease in the total clearance of the drug.

Application during pregnancy and during breastfeeding

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

Side effect

On the part of the blood and lymphatic system

Very rare: neutropenia, thrombocytopenia.
Immune system disorders
Rarely: laryngeal edema.
Very rare: anaphylactic reactions, including anaphylactic shock.
From the nervous system
Uncommon: headache, dizziness, drowsiness.
Rarely: paresthesias, syncope (transient short-term syncope).
From the side of the psyche
Uncommon: insomnia, feeling of anxiety.
On the part of the organ of hearing and labyrinthine disorders
Uncommon: vertigo.
Very rare: tinnitus.
From the side of the organ of vision
Very rare: blurred vision.
From the side of the cardiovascular system
Uncommon: a feeling of palpitations, a feeling of heat, hyperemia of the skin.
Rarely: increased blood pressure.
Very rare: tachycardia, decreased blood pressure.
From the respiratory system
Rarely: bradypnea.
Very rare: bronchospasm, shortness of breath.
From the gastrointestinal tract
Often: nausea, vomiting, abdominal pain, dyspepsia, diarrhea.
Uncommon: gastritis, constipation, dry mouth, flatulence.
Rarely: erosive and ulcerative lesions of the gastrointestinal tract (GIT), bleeding from an ulcer or its perforation.
Very rare: damage to the pancreas.
From the liver and biliary tract
Rarely: hepatitis, increased activity of 'liver' enzymes (ACT and ALT).
Very rare: liver damage.
From the kidneys and urinary tract
Rarely: polyuria, acute renal failure.
Very rare: nephritis or nephrotic syndrome.
Reproductive system disorders
Rarely: in women - menstrual irregularities, in men - transient dysfunction of the prostate gland with prolonged use.
From the musculoskeletal system
Rarely: back pain.
Skin and subcutaneous tissue disorders :
Uncommon: skin rash.
Rarely: urticaria, acne, increased sweating.
Very rare: severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)), angioedema, facial edema, allergic dermatitis, photosensitivity, pruritus.
From the side of metabolism :
Rarely: anorexia.
General disorders :
Uncommon: increased fatigue, asthenia, chills, general malaise.
Very rare: peripheral edema.
As with the use of other NSAIDs, the following side effects may develop:
aseptic meningitis, which develops mainly in patients with systemic lupus erythematosus or systemic connective tissue diseases, hematological disorders (thrombocytopenic purpura, aplastic and hemolytic anemias, in rare cases - agranulocytosis and bone marrow hypoplasia ).

Overdose

Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.
Treatment: symptomatic therapy, if necessary - gastric lavage, intake of activated carbon, hemodialysis is ineffective.

Interaction with other medicinal products

The following interactions are typical for all NSAIDs.
Undesirable combinations

With other NSAIDs, including salicylates in high doses (more than 3 g / day): the simultaneous use of several NSAIDs due to a synergistic effect increases the risk of gastrointestinal bleeding and ulcers.
With anticoagulants: dexketoprofen, like other NSAIDs, can enhance the effect of anticoagulants such as warfarin due to its high binding to blood plasma proteins, inhibition of platelet aggregation and damage to the gastrointestinal mucosa. If necessary, simultaneous use requires careful monitoring of the patient's condition and regular monitoring of laboratory parameters.
With heparin: with simultaneous use, the risk of bleeding increases (due to inhibition of platelet aggregation and a damaging effect on the mucous membrane of the gastrointestinal tract). If necessary, simultaneous use requires careful monitoring of the patient's condition and regular monitoring of laboratory parameters.
With glucocorticosteroids: with simultaneous use, the risk of ulcerative lesions of the gastrointestinal tract and bleeding increases.
With lithium preparations: NSAIDs increase the concentration of lithium in the blood plasma up to toxic, and therefore this indicator must be monitored when used with dexketoprofen, changing the dosage, and also after discontinuing NSAIDs.
With methotrexate in high doses (15 mg / week or more): an increase in the hematological toxicity of methotrexate is possible due to a decrease in its renal clearance when used simultaneously with NSAIDs.
With hydantoins and sulfonamides: it is possible to increase their toxic effect.
Combinations requiring caution
With diuretics, angiotensin-converting enzyme (AIF) inhibitors, aminoglycoside antibiotics, angiotensin II receptor antagonists: simultaneous use with NSAIDs is associated with the risk of developing acute renal failure in dehydrated patients (decreased glomerular filtration due to decreased synthesis of prostaglandins). With the simultaneous use of NSAIDs, they can reduce the antihypertensive effect of some drugs. With the simultaneous use of dexketoprofen and diuretics, it is necessary to make sure that the patient does not have signs of dehydration, and also to monitor renal function at the beginning of simultaneous use.
With methotrexate in low doses (less than 15 mg / week): an increase in the hematological toxicity of methotrexate is possible due to a decrease in its renal clearance against the background of simultaneous use with NSAIDs. It is necessary to count blood cells at the beginning of simultaneous use. In the presence of impaired renal function, even in a mild degree, as well as in the elderly, careful medical supervision is necessary.
With pentoxifylline: may increase the risk of bleeding. Close clinical monitoring and regular checking of bleeding time (blood clotting time) is necessary.
With zidovudine: there is a risk of increased toxic effect on erythrocytes due to exposure to reticulocytes, with the development of severe anemia a week after starting the use of NH1VP. It is necessary to conduct a general blood test with counting the number of reticulocytes 1-2 weeks after the start of NSAID therapy.
With oral hypoglycemic agents: NSAIDs can enhance the hypoglycemic effect of sulfonylureas due to the displacement of sulfonylureas from the sites of binding to blood plasma proteins.
Combinations that must be taken into account
With adrenergic blockers: when used simultaneously with NSAIDs, the antihypertensive effect of adrenergic blockers may decrease due to inhibition of prostaglandin synthesis.
With cyclosporine and tacrolimus: NSAIDs can increase nephrotoxicity, which is mediated by the action of renal prostaglandins. With simultaneous use, it is necessary to monitor kidney function.
With thrombolytics: the risk of bleeding increases.
The risk of bleeding from the gastrointestinal tract increases with simultaneous use with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) and anticoagulants.
With probenecid: an increase in the concentration of NSAIDs in the blood plasma is possible, which may be due to the inhibitory effect of probenecid on renal tubular secretion and / or conjugation with glucuronic acid; dose adjustment of NSAIDs may be required.
With cardiac glycosides: Concomitant use with NPVG1 can lead to an increase in the concentration of glycosides in the blood plasma.
With mifepristone: due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of inhibitors of prostaglandin synthesis, NSAIDs should not be used earlier than 8-12 days after discontinuation of mifepristone.
With quinolones: data obtained in experimental studies on animals indicate a high risk of developing seizures when using NSAIDs with quinolones in high doses.
If necessary, the simultaneous use of the drug DexonalЃ with the above drugs, you should consult your doctor.

special instructions

Undesirable side effects can be minimized by using the drug in the lowest effective dose with the minimum duration of use necessary to relieve pain.
The risk of complications from the gastrointestinal tract increases in patients with a history of gastrointestinal ulceration, in elderly patients, with an increase in the dose of NSAIDs; therefore, the use of the drug in this category of patients should be started with the lowest recommended dose.
Patients of the above categories, as well as patients who require the simultaneous use of low doses of acetylsalicylic acid or other drugs that increase the risk of complications from the gastrointestinal tract, are advised to use additional gastroprotectors (misoprostol or proton pump blockers).
Patients taking antiplatelet agents or anticoagulants, glucocorticosteroids at the same time also increase the risk of gastrointestinal bleeding.
Patients with a history of gastrointestinal disorders or gastrointestinal diseases should be closely monitored. In case of gastrointestinal bleeding or ulcerative lesions, the drug should be discontinued.
The drug should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since an exacerbation of these diseases is possible.
All NSAIDs can inhibit platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. In this regard, the use of DexonalЃ in patients who are simultaneously taking drugs that affect the hemostasis system, such as warfarin, coumarin derivatives and heparins, is not recommended.
Like other NSAIDs, DexonalЃ can lead to an increase in the concentration of creatinine and nitrogen in the blood plasma. Like other inhibitors of prostaglandin synthesis, DexonalЃ can have side effects on the urinary system, which can lead to the development of glomerulonephritis. interstitial nephritis, papillary necrosis, nephrotic syndrome, and acute renal failure. Caution should be exercised when using the drug in patients simultaneously using diuretics and in patients who may develop hypovolemia, due to an increased risk of nephrotoxicity.
As with the use of other NSAIDs, against the background of the use of the drug DexonalЃ, there may be a slight transient increase in some 'liver' enzymes. In the elderly, it is necessary to monitor liver and kidney function. In case of a significant increase in the corresponding indicators, the use of DexonalЃ should be discontinued.
Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. In case of detection of signs of infection or deterioration of health while using the drug DexonalЃ. the patient should immediately consult a doctor. The drug can cause fluid retention in the body, therefore, in patients with arterial hypertension, with renal and / or heart failure, DexonalЃ should be used with extreme caution. If the condition worsens, the drug should be discontinued.
In patients with uncontrolled arterial hypertension. ischemic heart disease, congestive heart failure, peripheral arterial disease and / or cerebrovascular disease, the drug should be used with caution. A similar approach is applicable to patients with risk factors for the development of cardiovascular diseases (arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).
Care must be taken when prescribing the drug to patients with a history of cardiovascular disease, especially patients with heart failure, due to the possible risk of progression.
Clinical studies and epidemiological data suggest that NSAIDs, especially in high doses and with prolonged use, may lead to a small risk of developing acute myocardial infarction or stroke. There are insufficient data to exclude the risk of these events when using dexketoprofen.
Elderly patients are especially susceptible to adverse reactions when using NSAIDs, including the risk of gastrointestinal bleeding and perforation, life-threatening the patient, and decreased kidney, liver and heart function. When using the drug DexonalЃ in this category of patients, proper clinical control is required.
There is evidence of the occurrence of rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) with the use of NSAIDs. At the first manifestations of a skin rash, damage to the mucous membranes or other signs of an allergic reaction, you should immediately stop taking DexonalЃ and consult a doctor.

Influence on the ability to drive vehicles and mechanisms

Due to the possible appearance of dizziness and drowsiness during the period of taking the drug, the ability to concentrate and the speed of psychomotor reactions in patients may decrease, especially in the first hour after administration. Therefore, during the period of use of the drug, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.