Dexalgin, 25 mg 10 pcs

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drugs

ATX code: M01AE17

Pharmacological properties

Pharmacodynamics
Dexketoprofen trometamol, the tromethamine salt of the S-(+) enantiomer of propionic acid, refers to non-steroidal anti-inflammatory drugs (NSAIDs) and has analgesic anti-inflammatory and antipyretic effect. The mechanism of action of dexketoprofen is associated with a decrease in the synthesis of prostaglandins by inhibiting the activity of cyclooxygenases (COX-1 and COX-2). The drug inhibits conversion of arachidonic acid to cyclic endoperoxides PGG2 and PGH2, which produce prostaglandins PGE1, PGE2, PGE2α and PGD2, as well as prostacyclin PG12 and thromboxanes (TxA2 and TxB2). In addition, inhibition of prostaglandin synthesis can affect other inflammatory mediators such as kinins, providing not only direct but also indirect effects.

The inhibitory effect of dexketoprofen on COX-1 and COX-2 activity has been demonstrated in laboratory animals and in humans.

Clinical studies in various clinical models of pain have shown that dexketoprofen has pronounced analgesic activity. According to the data of studies the analgesic effect comes within 30 minutes after intake of the drug; duration of analgesic effect is 6 hours.
Faster absorption of dexketoprofen when taking in the form of pellets for preparation of oral solution compared to the tablet form may manifest itself in a more rapid onset of analgesic effect.

Pharmacokinetics

Intake
Dexetoprofen is quickly absorbed from the gastrointestinal tract (GIT) after oral administration with the time to reach the maximum concentration (MTmax) in the form of pellets for oral solution preparation 0.25-0.33 h. Simultaneous intake of food slows down absorption of dexketoprofen (increase
TCmax, decrease in Cmax), while AUC value does not change.

Distribution
The half-life of dexketoprofen is about 0.35 h. Mean volume of distribution of dexketoprofen is less than 0.25 l/kg as for the drug with high degree of binding to plasma proteins (99%).

Metabolism and excretion
After dexketoprofen use only its optical S-(+) isomer is detected in the urine, which indicates that the drug is not transformed into the optical R-(-) isomer in the human body. The main way of dexketoprofen metabolism is its conjugation with glucuronic acid with subsequent excretion by the kidneys. According to pharmacokinetic studies dexketoprofen AUC values after the last dose do not differ from AUC values after a single dose, indicating that there is no cumulation of the drug.

Indications

Symptomatic treatment of pain (mild and moderate) of various origins, including musculoskeletal pain, algomenorrhea (painful menstruation), toothache.
The drug is intended for symptomatic treatment, reducing pain and inflammation at the time of use.

Pharmacological effect

Pharmacotherapeutic group: non-steroidal anti-inflammatory drugs

ATX code: M01AE17

Pharmacological properties

Pharmacodynamics
Dexketoprofen trometamol, the tromethamine salt of the S-(+) enantiomer of propionic acid, is a nonsteroidal anti-inflammatory drug (NSAID) and has analgesic properties. anti-inflammatory and antipyretic effects. The mechanism of action of dexketoprofen is associated with a decrease in the synthesis of prostaglandins due to the suppression of the activity of cyclooxygenases (COX-1 and COX-2). The drug inhibits the conversion of arachidonic acid to the cyclic endoperoxides PGG2 and PGH2, which produce prostaglandins PGE1, PGE2, PGE2α‎ and PGD2, as well as prostacyclin PG12 and thromboxanes (TxA2 and TxB2). In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, providing not only direct but also indirect effects.

The inhibitory effect of dexketoprofen on the activity of COX-1 and COX-2 has been demonstrated in laboratory animals and in humans.

Clinical studies in various clinical models of pain have shown that dexketoprofen has pronounced analgesic activity. According to research, the analgesic effect occurs 30 minutes after taking the drug, the duration of the analgesic effect is 6 hours.
The observed faster absorption of dexketoprofen when taken in the form of granules for the preparation of an oral solution in comparison with the tablet form may manifest itself in a faster onset of analgesic effect.

Pharmacokinetics

Suction
Dexketoprofen after oral administration is rapidly absorbed from the gastrointestinal tract (GIT), the time to reach maximum concentration (TCmax) in the form of granules for the preparation of oral solution is 0.25–0.33 hours.
A comparison of the pharmacokinetic parameters of dexketoprofen in the form of tablets and in the form of granules for the preparation of an oral solution in doses of 12.5 mg and 25 mg showed that both dosage forms have similar bioavailability in terms of area under the concentration-time curve (AUC). The maximum concentration (Cmax) in blood plasma after taking dexketoprofen in the form of granules for the preparation of an oral solution is 30% higher than taking it in tablet form.
Concomitant food intake slows down the absorption of dexketoprofen (increases
TCmax, Cmax decreases), while the AUC value does not change.

Distribution
The half-life of dexketoprofen is about 0.35 hours. The average volume of distribution of dexketoprofen is less than 0.25 l/kg as a drug with a high degree of binding to plasma proteins (99%).

Metabolism and excretion
After using dexketoprofen, only its optical S-(+) isomer is detected in the urine, which indicates the absence of transformation of the drug into the optical R-(–) isomer in the human body. The main route of metabolism of dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. The half-life (T 1/2) of dexketoprofen is 1.65 hours.
According to pharmacokinetic studies, with repeated doses of dexketoprofen, the AUC values ​​after taking the last dose do not differ from the values ​​after a single dose, which indicates the absence of drug accumulation.

Special instructions

Caution should be exercised when used in patients with a history of allergic reactions.
Avoid using Dexalgin® in combination with other NSAIDs, including selective COX-2 inhibitors.
Undesirable side effects can be minimized by using the drug at the lowest effective dose for the minimum duration of use necessary to relieve symptoms.

Safety of use in relation to the gastrointestinal tract
There have been reports of gastrointestinal bleeding, ulcers or perforations (in some cases fatal) during the use of any NSAIDs at different stages of treatment, both with and without the appearance of warning symptoms, and regardless of the presence of serious gastrointestinal complications in the anamnesis. If gastrointestinal bleeding or ulcerative lesions develop while using the drug Dexalgin®, its use should be discontinued.

The risk of developing gastrointestinal bleeding, peptic ulcer or peptic ulcer perforation increases with increasing dose of NSAIDs, in patients with a history of ulcers particularly complicated by bleeding or perforation, as well as in elderly patients
(see section “Contraindications”).

Elderly patients
Elderly patients have an increased incidence of side effects from the use of NSAIDs, especially gastrointestinal bleeding and ulcer perforation, which can be life-threatening. Treatment of these patients should be started with the lowest dose possible.
(see section “Method of administration of the dose”).

If the patient has a history of esophagitis, gastritis and/or peptic ulcer, before starting treatment with dexketoprofen (as in the case of other NSAIDs), you should ensure that these diseases are in remission. In patients with symptoms of gastrointestinal pathology or chronic gastrointestinal diseases, monitoring should be carried out to detect digestive disorders, especially gastrointestinal bleeding. For these patients, as well as patients who require the simultaneous use of low-dose ASA or the use of other drugs that increase the risk of gastrointestinal disorders, combination therapy with protective drugs, such as misoprostol or proton pump inhibitors, should be considered (see section “Interactions with other drugs”).

The use of NSAIDs is contraindicated in patients with a history of gastrointestinal diseases, such as ulcerative colitis, Crohn’s disease, since there is a risk of exacerbation of these diseases
Patients with a history of side effects from the gastrointestinal tract, especially elderly patients. should report to the doctor any unusual gastrointestinal symptoms (especially symptoms that may indicate gastrointestinal bleeding), especially during the initial stages of treatment. The drug should be prescribed with caution to patients taking the drugs at the same time. which may increase the risk of ulceration or bleeding: oral corticosteroids, anticoagulants (eg warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as ASA.

Kidney safety
In patients with impaired renal function, the drug should be prescribed with caution, since the use of NSAIDs may cause deterioration in renal function, fluid retention in the body, and the development of edema.

Caution should be exercised when using Dexalgin® in patients concomitantly taking diuretics and patients who may develop hypovolemia, due to the increased risk of nephrotoxicity. During treatment, it is necessary to ensure adequate fluid intake to prevent dehydration and increased toxic effects on the kidneys.

Like other NSAIDs, Dexalgin® can lead to increased concentrations of creatinine and urea nitrogen in the blood plasma. Like other prostaglandin synthesis inhibitors, Dexalgin® may 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. Elderly patients are especially susceptible to impaired renal function. (see section “Method of administration and dosage”).

Safety of use in relation to the liver
In patients with impaired liver function, the drug should be prescribed with caution. As with the use of other NSAIDs, the drug can cause a short-term and slight increase in some “liver” parameters, as well as a pronounced increase in the activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). If these indicators increase, treatment with the drug should be stopped. Elderly patients are especially susceptible to liver dysfunction.

Safety of use in relation to the cardiovascular system and cerebral circulation
When used in patients with arterial hypertension or a history of mild or moderate heart failure, appropriate monitoring and recommendations are required. Particular care must be taken when treating patients with a history of cardiovascular disease, in particular with previous episodes of heart failure, since the use of NSAIDs may increase the risk of developing heart failure; Cases of fluid retention and edema associated with the use of NSAIDs have been described.

Clinical studies and epidemiological data allow us to conclude that. that NSAIDs, especially in high doses and with long-term use, may lead to a slight increase in the risk of arterial thrombosis (such as acute myocardial infarction or stroke). There is insufficient data to exclude the risk of these events when using dexketoprofen. In patients with uncontrolled arterial hypertension, coronary heart disease (CHD), congestive heart failure, peripheral arterial disease and/or cerebrovascular disease, Dexalgin® should be used with caution. A similar approach is applicable to patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by suppressing the synthesis of prostaglandins, and therefore the administration of dexketoprofen to patients taking drugs that affect hemostasis (for example, warfarin or other coumarins, or heparins) is not recommended.

Elderly patients are especially susceptible to cardiovascular dysfunction.
If the doctor decides on long-term use of dexketoprofen, monitoring of peripheral blood parameters and the functional state of the liver and kidneys is necessary.

Very rarely, serious skin reactions have been reported with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, some of which were fatal. The risk of developing such reactions in patients appears to be highest at the beginning of treatment, because Most of the described phenomena were observed in the first month of therapy. At the first appearance of a skin rash, damage to the mucous membranes or any other signs of hypersensitivity, the use of Dexalgin® should be discontinued.
Particular caution is required when prescribing the drug to patients with congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria), with dehydration, and immediately after extensive surgery.

If your doctor believes that long-term use of dexketoprofen is necessary, you should regularly monitor your liver function, kidney function, and complete blood count.
In very rare cases, severe hypersensitivity reactions (eg anaphylactic shock) have been observed. At the first signs of a severe hypersensitivity reaction, you should stop taking Dexalgin®. It is necessary to begin symptomatic treatment under the supervision of a qualified specialist.

Patients suffering from asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at higher risk of allergic reactions to ASA and/or NSAIDs than the rest of the population. The use of the drug may cause an asthma attack or bronchospasm, especially in patients with allergic reactions to ASA or NSAIDs.
In special cases, it is possible to develop severe infectious complications of the skin and soft tissues against the background of chickenpox. It is currently impossible to completely exclude the possibility of a relationship between the use of NSAIDs and the development of these infectious complications. Therefore, in case of chickenpox, the use of Dexalgin® should be avoided.
Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. If signs of infection or deterioration in health are detected while using the drug Dexalgin®, the patient should immediately consult a doctor.

The drug Dexalgin® contains sucrose (0.25 bread units in 1 sachet). This information should be taken into account by patients with diabetes mellitus. For patients with hereditary fructose intolerance, sucrase-isomaltase deficiency and glucose-galactose malabsorption syndrome, Dexalgin® is contraindicated. Pediatric population
Safety of use in children has not been established.

Impact on the ability to drive vehicles and other mechanisms
Dexalgin® may cause side effects such as a feeling of drowsiness, blurred vision or drowsiness. In such cases, the ability to quickly respond, navigate a road situation, and control machinery may be reduced.

Active ingredient

Dexketoprofen

Composition

Active ingredient:
Dexketoprofen trometamol 36.90 mg,
(equivalent to dexketoprofen) – 25.00 mg.
Excipients: ammonium glycyrrhizinate, neohesperidin-dihydrochalcone, quinoline yellow dye (E104), lemon flavor, sucrose.

Pregnancy

The use of Dexalgin® during pregnancy and breastfeeding is contraindicated.

Suppression of prostaglandin synthesis may adversely affect pregnancy and/or embryonic and fetal development. The results of epidemiological studies indicate that drugs that suppress prostaglandin synthesis, used in the early stages of pregnancy, can increase the risk of spontaneous abortion. as well as the development of heart defects and non-fusion of the anterior abdominal wall in the fetus; Thus, the absolute risk of developing cardiovascular abnormalities increased from approximately less than 1% to 1.5%. The risk is believed to increase with increasing dose and duration of use.
In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can lead to the development of cardiopulmonary pathology in the fetus (premature closure of the ductus arteriosus and hypertension in the pulmonary artery system) and renal dysfunction, which can progress and lead to renal failure with the development of oligohydramnios. In addition, even when used in low doses, the mother at the end of pregnancy and the newborn may experience an increase in bleeding time associated with the antiplatelet effect of the drug, as well as suppression of uterine contractility, leading to delayed labor or prolonged labor.
There is no information about the penetration of dexketoprofen into breast milk.

The drug Dexalgin®, like other NSAIDs, can reduce female fertility, so it is not recommended for women planning pregnancy. In women having problems conceiving or undergoing examination for infertility, discontinuation of dexketoprofen should be considered.

Contraindications

– hypersensitivity to dexketoprofen, other components of the drug and any NSAIDs:
– development of asthma attacks, bronchospasm, acute rhinitis or nasal polyps, the appearance of urticaria or angioedema when using drugs with a similar effect (for example, acetylsalicylic acid (ASA) and other NSAIDs);
– history of photoallergic or phototoxic reactions when using ketoprofen or fibrates;
– history of gastrointestinal bleeding, ulcers or perforations, including those associated with previous use of NSAIDs;
– chronic dyspepsia;
– erosive and ulcerative lesions of the gastrointestinal tract in the acute stage;
– gastrointestinal bleeding; other active bleeding (including suspected intracranial hemorrhage);
– Crohn’s disease, ulcerative colitis;
– severe liver failure (10-15 points on the ChildPugh scale);
– progressive kidney disease, confirmed hyperkalemia;
– chronic kidney disease (CKD): stage 3a (glomerular filtration rate (GFR) 45-49 ml/min/1.73 m2), stage 3b (GFR 30-44 ml/min/1.73 m2), stage 4 (GFR 15-29 ml/min/1.73 m2) stage 5 (GFR < 15 ml/min/1.73 m2);
– period after coronary artery bypass grafting;
– severe heart failure;
– hemorrhagic diathesis and other blood clotting disorders;
– severe dehydration (due to vomiting, diarrhea or insufficient fluid intake);
– age under 18 years (due to lack of safety data);
– pregnancy and breastfeeding period;
– sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution
When using the drug if you have the conditions listed in this section, you should consult your doctor.
History of liver disease, hepatic porphyria (including acute intermittent porphyria), chronic kidney disease, stage 2 (GFR 60-89 ml/min/1.73 m2), chronic heart failure, arterial hypertension, dehydration, significant decrease in circulating blood volume (including after surgery), in elderly patients over 65 years of age (including those receiving diuretics, weakened patients and patients with low body weight in patients immediately after major surgical interventions, bronchial asthma, simultaneous use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel) selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine sertraline), coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, Helicobacter pylori infection. systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, hematopoietic disorders, long-term use of NSAIDs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

Side Effects

Side effects, the association of which with dexketoprofen according to clinical studies (dosage form tablets) is recognized as at least possible, as well as side effects which were reported after the release of the drug Dexalgin® in the form of granules for the preparation of solution on the market, are listed below in accordance with the system-organ classification and WHO classification according to descending frequency of occurrence: very often (≥ 1/10), often (≥ 1/100, < 1/10) uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000). very rare (< 1 10000), including individual messages.
Due to the fact that the Cmax of dexketoprofen when taken in the form of granules for the preparation of a solution for oral administration in the blood plasma is higher than when taken in the form of tablets, an increased risk of side effects (including from the gastrointestinal tract) cannot be ruled out.

Blood and lymphatic system disorders
Very rare: neutropenia, thrombocytopenia.

Immune system disorders Rare: laryngeal edema;
Very rare: anaphylactic reactions. including anaphylactic shock.

Metabolic and nutritional disorders
Rarely: anorexia.

Mental disorders
Uncommon: insomnia, feeling of restlessness.

Nervous system disorders
Uncommon: headache, feeling dazed, drowsiness;
Rarely: paresthesia, fainting.

Visual disorders
Very rare: blurred vision.

Hearing and labyrinth disorders
Uncommon: dizziness;
Very rare: ringing in the ears.

Cardiac disorders
Uncommon: palpitations;
Very rare: tachycardia.

Vascular system disorders
Uncommon: hot flashes;
Rarely: increased blood pressure;
Very rare: decreased blood pressure.

Disorders of the respiratory system, chest and mediastinal organs
Rarely: bradypnea;
Very rare: bronchospasm, shortness of breath.

Gastrointestinal disorders
Common: nausea and/or vomiting, abdominal pain, diarrhea, dyspepsia;
Uncommon: gastritis, constipation, dry mouth, flatulence;
Rare: peptic ulcer, ulcer bleeding or ulcer perforation;
Very rare: pancreatitis.

Disorders of the liver and biliary tract
Rare: liver cell damage.

Skin and subcutaneous tissue disorders
Uncommon: skin rash;
Rarely: urticaria, me, increased sweating;
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis
(Lyell’s syndrome), Quincke’s edema, facial edema, photosensitivity reaction, skin itching.

Musculoskeletal and connective tissue disorders
Rarely: back pain.

Renal and urinary tract disorders
Rarely: polyuria, acute renal failure;
Very rare: nephritis or nephrotic syndrome.

Disorders of the reproductive system and mammary glands
Rarely: menstrual irregularities, dysfunction of the prostate gland.

Systemic disorders and reactions at the injection site
Uncommon: fatigue, pain, asthenia, muscle rigidity, general malaise;
Rarely: peripheral edema.

Additional research methods
Rarely: changes in liver function tests.
The most commonly observed side effects are from the gastrointestinal tract. Peptic ulcers, perforation or gastrointestinal bleeding may develop, sometimes with death, especially in elderly patients. According to available data, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic symptoms, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease occurred with the use of the drug. Gastritis was observed less frequently. Edema, increased blood pressure, and heart failure have also been reported with the use of NSAIDs.

Based on clinical trial and epidemiological data, the use of some NSAIDs, especially in high doses and for long periods of time, may be associated with a slight increase in the risk of developing pathology caused by arterial thrombosis (for example, myocardial infarction or stroke) (see section “Special Instructions”).
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 other systemic connective tissue diseases, hematological disorders (thrombocytopenic purpura, aplastic and hemolytic anemia, in rare cases – agranulocytosis and bone marrow hypoplasia).

To monitor the balance of benefit and risk when using a drug, it is necessary to report the occurrence of side effects. If the side effects described above are observed, or they are observed to a more pronounced degree, or if you have noted any other side effects, then please. Tell your doctor immediately. Health care professionals should report adverse events through the national pharmacovigilance system.

Interaction

The interactions listed below are common to all NSAIDs.

Undesirable combinations
With other NSAIDs, including selective cyclooxygenase-2 inhibitors and salicylates in high doses (more than 3 g/day): simultaneous use of several NSAIDs due to a synergistic effect may increase the risk of developing gastrointestinal ulcers and gastrointestinal bleeding.
With anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin due to their high degree of binding to plasma proteins, inhibition of platelet function and damage to the gastrointestinal mucosa. If simultaneous use is necessary, careful monitoring of the patient’s condition and regular monitoring of laboratory parameters is required.

With heparin: with simultaneous use, the risk of bleeding increases (due to inhibition of platelet function and damaging effects on the gastrointestinal mucosa). If simultaneous use is necessary, careful monitoring of the patient’s condition and regular monitoring of laboratory parameters is required.
With glucocorticosteroids: with simultaneous use, the risk of ulcerative lesions of the gastrointestinal tract and bleeding increases.

With lithium preparations (described in relation to several NSAIDs): NSAIDs increase the concentration of lithium in the blood plasma up to toxic (reduced excretion of lithium through the kidneys) and therefore the concentration of lithium in the blood plasma must be monitored at the beginning of treatment with dexketoprofen, when adjusting its dose and discontinuing the drug.
With methotrexate in high doses (15 mg/week or more): increased hematological toxicity of methotrexate is possible due to a decrease in its renal clearance when used simultaneously with NSAIDs.

Hydantoin and sulfonamides: their toxic effects may be enhanced.

Combinations requiring caution
With diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), aminoglucoside antibiotics and angiotensin II receptor antagonists: dexketoprofen, when used simultaneously, may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous use of drugs that have an inhibitory effect on COX. ACE inhibitors, angiotensin II receptor antagonists or antibiotics from the aminoglycoside group can lead to worsening renal failure (usually reversible).

When using dexketoprofen and diuretics simultaneously, it is necessary to ensure that the patient has no signs of dehydration, and also monitor renal function at the beginning of use and during treatment (periodically).
The simultaneous use of Dexalgin® and potassium-sparing diuretics can lead to the development of hyperkalemia. It is necessary to regularly monitor the potassium content in the blood plasma.

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 during simultaneous use with NSAIDs. Weekly blood cell counts are necessary during the first weeks of concomitant use. In the presence of even mild renal dysfunction. as well as in elderly people, careful medical supervision is necessary.
With pentoxifylline: there may be an increased risk of bleeding. Close clinical monitoring and regular checking of bleeding time are necessary.
With zidovudine: there is a risk of increased toxicity to red blood cells due to effects on reticulocytes with the development of severe anemia one week after starting NSAID use. It is necessary to conduct a general blood test with counting the number of reticulocytes 1-2 weeks after starting NSAID therapy.

With hypoglycemic agents for oral administration: NSAIDs may enhance the hypoglycemic effect of sulfonylureas due to the displacement of sulfonylurea from sites of binding to plasma proteins.
Combinations to consider
With beta-blockers: When used concomitantly with NSAIDs, the antihypertensive effect of beta-blockers may be reduced due to inhibition of prostaglandin synthesis.

With cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. If used concomitantly, monitor renal function.
With thrombolytics: the risk of bleeding increases.
The risk of developing gastrointestinal bleeding increases when used simultaneously with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) and antiplatelet agents (including ASA and clopidogrel).
With probenecid: an increase in the concentration of dexketoprofen in the blood plasma is possible, which may be due to the inhibitory effect of probenecid on renal tubular secretion and conjugation with glucuronic acid: NSAID dose adjustment may be required.

With cardiac glycosides: simultaneous use with NSAIDs may lead to an increase in the concentration of cardiac glycosides in the blood plasma.

With mifepristone: There is a theoretical risk of alteration in the effectiveness of mifepristone by prostaglandin synthetase inhibitors. Limited data suggest that concomitant use of mifepristone with an NSAID on the day of prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical abortion agents.

With quinolones: data obtained from experimental studies in animals indicate a high risk of developing seizures when NSAIDs are used concomitantly with quinolones in high doses.

With tenofovir: when used simultaneously with NSAIDs, the concentration of urea nitrogen and creatinine in the blood plasma may increase, therefore, renal function should be monitored to assess the possible effect of the simultaneous use of these drugs.

With deferasirox: When used concomitantly with NSAIDs, the risk of gastrointestinal toxicity may increase. When using dexketoprofen in combination with deferasirox, careful monitoring of the patient’s condition is necessary.
With pemetrexed: when used concomitantly with NSAIDs, the elimination of pemetrexed may be reduced; therefore, special caution must be exercised when using NSAIDs in high doses. In patients with mild renal insufficiency (chronic kidney disease stage 2 (GFR 60-89 ml/min/1.73 m2), concomitant use of pemetrexed and NSAIDs should be avoided for two days before and two days after taking pemetrexed.

If it is necessary to use Dexalgin® simultaneously with the above medications, you should consult your doctor.

Overdose

Symptoms: symptoms of an overdose of Dexalgin® are unknown. Similar drugs cause disorders of the gastrointestinal tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache).

Treatment: In case of accidental or excessive use of the drug, symptomatic treatment appropriate to the patient’s condition should be started immediately. When an adult or child takes the drug at a dose of more than 5 mg/kg, it is necessary to take activated charcoal orally within an hour. Dexketoprofen can be removed from the body by dialysis.

Storage conditions

At a temperature not higher than 25 oC
Keep the medicine out of the reach of children!

Shelf life

4 years. Do not use after the expiration date stated on the package.

Organization receiving complaints from consumers:

LLC “Berlin-Chemie/A. Menarini”, Russia

123112, Moscow, Presnenskaya embankment, building 10, Business Center “Tower on the Embankment”, Block B, tel. (495) 785-01-00, fax (495) 785-01-01.

Manufacturer

Laboratorios Menarini S.A./Berlin-Chemie AG, Spain