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

Active ingredient

Composition

Active ingredient:
Dexketoprofen trometamol 36.90 mg (Dexketoprofen equivalent) – 25.00 mg.
Excipients: ammonium glycyrrhizinate, neogesperidin dihydrochalcon, quinoline yellow dye (E104), lemon flavoring, sucrose.

How to take, the dosage

The contents of one sachet is dissolved in a glass of water, stirring until completely dissolved (a translucent yellow solution with lemon odor is obtained). The resulting solution should be taken immediately after preparation.
Simultaneous intake of food slows down absorption of Dexketoprofen, so in case of acute pain it is recommended to use the drug less than 15 minutes before meals.

Adults
Depending on the origin and severity of the pain syndrome, the recommended dose for adults is 25 mg dexketoprofen every 8 hours. The maximum daily dose is 75 mg.

The side effects of the drug can be minimized by using the lowest effective dose for the minimum period necessary to relieve symptoms.

The drug Dexalgin® is not intended for long-term therapy, the course of treatment with the drug should be limited to the period of symptoms, but should not exceed 3-5 days.

Patients in the elderly
Older patients should take Dexalgin® starting with a lower dose (maximum daily dose is 50 mg). The dose may be increased to the recommended dose for adults only in case of good tolerance. Due to the increased likelihood of side effects, elderly patients should be particularly closely monitored.

Patients with hepatic impairment
Patients with mild to moderate hepatic impairment should take Dexalgin® starting with a lower dose (maximum daily dose is 50 mg). Close monitoring of the patient’s condition is recommended. The use of Dexalgin® in patients with hepatic insufficiency of severe degree of severity is contraindicated.

Patients with renal insufficiency
Patients with mild renal insufficiency – CKD, stage 2 (FFR 60-89mL/min/1.7 m2), the initial maximum daily dose should be decreased to
50 mg/day.

The use of Dexalgin® preparation in patients with moderate to severe renal insufficiency (CKD, stage Za (FFR 45-59 ml/min/1.73 m2 ), stage 3b (FFR 30-44 ml/min/1.73 m2), stage 4 (FFR 15-29 ml/min/1.73 m2), stage 5 (FFR < 15 ml/min/1.73 m2) is contraindicated.

Pediatric patients
Efficacy and safety of Dexalgin in children have not been studied, the use of the drug in children is contraindicated.

Interaction

The following interactions are common to all NSAIDs.

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

With heparin: concomitant use increases the risk of bleeding (due to inhibition of platelet function and damaging effect on the gastrointestinal mucosa). In case of necessity of concomitant use it is required a careful control of the patient’s condition and regular monitoring of laboratory parameters.
With glucocorticosteroids: concomitant use increases the risk of gastrointestinal ulcers and bleeding.

With lithium preparations (described for several NSAIDs): NSAIDs increase the concentration of lithium in blood plasma up to toxic (decreases excretion of lithium through the kidneys) in connection with which the concentration of lithium in blood plasma should be controlled in the beginning of dexectoprofen treatment, when adjusting the dose and discontinuing the drug.
With methotrexate at high doses (15 mg/week or more): hematologic toxicity of methotrexate may increase due to decreased renal clearance in concurrent use with NSAIDs.

Hydantoin and sulfonamides: possible increase in their toxic effects.

Combinations requiring caution
With diuretics, angiotensin converting enzyme inhibitors (ACE inhibitors), antibiotics from the group of aminoglucosides and angiotensin II receptor antagonists: dexketoprofen may decrease the effect of diuretics and other hypotensive agents when used concomitantly. In some patients with impaired renal function (e.g. patients with dehydration or elderly patients with impaired renal function) concomitant use of COX-inhibiting agents, ACE inhibitors, angiotensin II receptor antagonists or antibiotics from aminoglycoside group may lead to worsening of renal failure section (usually reversible character).

In concomitant usage of Dexalgin® and diuretics it is necessary to make sure that the patient does not suffer from signs of dehydration, and also to monitor renal function in the beginning of usage and during the treatment (periodically).
Simultaneous usage of Dexalgin® and potassium-saving diuretics can cause hyperkalemia. It is necessary to monitor regularly potassium content in blood plasma.

With methotrexate at low dose (less than 15 mg/week): hematologic toxicity of methotrexate may increase due to decreased renal clearance in concomitant use with NSAIDs. During the first weeks of concomitant use weekly blood cell counts are required. In the presence of even mild renal dysfunction, as well as in elderly persons, close medical supervision is required.
With pentoxifylline: increased risk of bleeding is possible. Close clinical monitoring and regular checking of bleeding time is necessary.
With zidovudine: there is a risk of increased toxic effect on red blood cells due to the effect on reticulocytes with the development of severe anemia one week after the start of NSAID use. It is necessary to perform a general blood test with reticulocyte count 1-2 weeks after the start of NSAID therapy.

With oral hypoglycemic agents: NSAIDs may increase the hypoglycemic effect of sulfonylurea drugs due to displacement of sulfonylurea from plasma protein binding sites.
Combinations to be taken into consideration
With β-adrenoblockers: Simultaneous use with NSAIDs may decrease antihypertensive effect of β-adrenoblockers due to inhibition of prostaglandin synthesis.

With cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. With thrombolytics: increased risk of bleeding.
Increased risk of gastrointestinal bleeding when concomitant use with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) and antiaggregants (including ASA and clopidogrel).
With probenecid: increase of plasma concentration of dexketoprofen is possible, which may be due to the inhibitory effect of probenecid on renal tubular secretion and conjugation with glucuronic acid: it may be necessary to adjust the dose of NSAIDs.

With cardiac glycosides: Concomitant use with NSAIDs may lead to increased plasma concentrations of cardiac glycosides.

With mifepristone: There is a theoretical risk that the efficacy of mifepristone may be altered by prostaglandin synthetase inhibitors. Limited data suggest that concomitant use of mifepristone with NSAIDs on the day of prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility or decrease the clinical effectiveness of medical abortion products.

With quinolones: Data from experimental animal studies indicate a high risk of seizures when NSAIDs are used concomitantly with quinolones at high doses.

With tenofovir: concomitant use of NSAIDs may increase plasma concentrations of urea nitrogen and creatinine; therefore, renal function should be monitored to evaluate the possible effects of concomitant use of these drugs.

With deferasirox: Concomitant use with NSAIDs may increase the risk of gastrointestinal toxicity. When using dexectoprofen together with deferasirox it is necessary to monitor the patient’s condition closely.
With pemetrexed: concomitant use with NSAIDs may reduce excretion of pemetrexed; therefore special care should be taken when using NSAIDs in high doses. In patients with mild renal impairment (chronic kidney disease, stage 2 (GFR 60-89 ml/min/1.73 m2), concomitant administration of pemetrexed and NSAIDs should be avoided for two days before and two days after pemetrexed administration.

If simultaneous use of Dexalgin® with the above drugs is necessary, a physician should be consulted.

Special Instructions

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

Gastrointestinal safety
There have been reports of gastrointestinal bleeding, ulcers or perforations (in some cases fatal) with any NSAID during different stages of treatment, with or without precursor symptoms, and regardless of a history of serious gastrointestinal complications. If gastrointestinal bleeding or ulcerative lesions develop during the use of Dexalgin®, its administration should be discontinued.

The risk of gastrointestinal bleeding, peptic ulcer, or perforation increases with increasing dosage of NSAIDs, in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients
(see section “Contraindications”).

Patients in the elderly
Elderly patients have an increased incidence of side effects with NSAIDs, especially such as gastrointestinal bleeding and ulcer perforation, which may be life threatening. Treatment of these patients should be started with the lowest possible dose.

If a patient has a history of esophagitis, gastritis and/or peptic ulcer disease, before starting dexectoprofen treatment (as in case of other NSAIDs) it should be made sure that these diseases are in remission. In patients with symptoms of GI pathology or chronic GI disease, monitoring should be carried out to detect digestive disorders, especially gastrointestinal bleeding. For these patients, as well as for patients who need concomitant use of ASA at low doses or other drugs that increase the risk of gastrointestinal disorders, the possibility of combined therapy with proton pump inhibitors, such as misoprostol or proton pump inhibitors, should be considered (see section “Interaction with other medicinal products”).

The use of NSAIDs is contraindicated in patients with a history of GI diseases, such as ulcerative colitis, Crohn’s disease, because there is a risk of exacerbation of these diseases
Patients with a history of GI side effects, especially elderly patients should inform the physician of any unusual gastrointestinal symptoms (especially symptoms that may indicate gastrointestinal bleeding), especially in the initial stages of treatment. Caution should be exercised when prescribing the drug in patients concomitantly taking agents that may increase the risk of ulceration or bleeding: oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors or antiaggregants such as ASA.

Kidney safety
In patients with impaired renal function, the drug should be prescribed with caution because renal function may worsen with NSAID use, fluid retention and edema development.

Precaution is required when using Dexalgin® in patients concomitantly taking diuretics and in patients with possible development of hypovolemia due to increased risk of nephrotoxicity. During treatment it is necessary to ensure adequate fluid intake to prevent dehydration and increase the toxic effect on the kidneys.

Like other NSAIDs, Dexalgin® may increase plasma creatinine and urea nitrogen concentrations. Like other prostaglandin synthesis inhibitors, Dexalgin® may have adverse effects on the urinary system, which may 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 “Dosage and administration”).

Hepatic safety
In patients with impaired liver function, the drug should be prescribed with caution. As with other NSAIDs, the drug may cause short term and slight increase of some “liver” parameters as well as marked increase of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity. In case of increase of the above-mentioned parameters the drug treatment should be discontinued. Elderly patients are especially susceptible to impaired liver function.

Cardiovascular and cerebral safety
Appropriate monitoring and recommendations are required when used in patients with a history of arterial hypertension or mild to moderate heart failure. Particular caution should be exercised when treating patients with a history of cardiovascular disease, particularly prior episodes of heart failure, as NSAID use may increase the risk of heart failure; cases of fluid retention and edema associated with NSAID use have been described.

Clinical studies and epidemiologic data suggest that NSAIDs, particularly at high doses and with long-term use, may slightly increase 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 dexectoprofen. 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. The same approach is applicable to patients with risk factors of cardiovascular diseases (e.g., arterial hypertension, hyperlipidemia. diabetes mellitus. smoking).
Non-selective NSAIDs can decrease platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis, therefore it is not recommended to prescribe dexectoprofen to patients taking drugs that affect hemostasis (e.g., warfarin or other coumarins or heparins).

Elderly patients are especially susceptible to cardiovascular dysfunction.
If the physician decides on the long-term use of dexectoprofen it is necessary to monitor the peripheral blood parameters and the functional state of the liver and kidneys.

Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which resulted in death, have been very rare during the use of NSAIDs. The risk of developing such reactions in patients seems to be the highest at the beginning of treatment, since most of the described phenomena were observed in the first month of therapy. If the first signs of skin rash, lesions of mucous membranes or any other signs of hypersensitivity appear, the use of Dexalgin® should be stopped.
Particular caution is required when administering the drug to patients with congenital disorders of porphyrin metabolism (for example, in acute intermittent porphyria), with dehydration, immediately after major surgical interventions.

If the physician considers that long-term use of dexketoprofen is necessary, the liver function, renal function, and general blood counts should be monitored regularly.
In very rare cases severe hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of severe hypersensitivity reactions it is necessary to stop taking Dexalgin®. Symptomatic treatment should be started under the supervision of a qualified specialist.

Patients with asthma combined 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 asthma attack or bronchospasm, especially in patients with allergic reactions to ASA or NSAIDs.
In special cases, the development of severe infectious complications of the skin and soft tissue against chickenpox is possible. 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, the use of Dexalgin® should be avoided in chickenpox.
Like other NSAIDs, dexectoprofen may mask the symptoms of infectious diseases. If there are signs of infection or if there is a deterioration of well-being during the use of Dexalgin® , the patient should immediately consult a physician.

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

Influence on the ability to drive vehicles and other mechanisms
Dexalgin® may cause adverse effects such as a feeling of stupefaction, visual impairment or drowsiness. In such cases, the ability to react quickly, navigate on the road and operate machinery may be impaired.

Synopsis

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 similar action (such as acetylsalicylic acid (ASA) and other NSAIDs);
– photoallergic or phototoxic reactions when using ketoprofen or fibrates in the history;
– gastrointestinal bleeding, ulcers or perforations in the history, including those associated with previous NSAID use;
– Chronic dyspepsia;
– gastrointestinal erosive lesions in aggravation stage;
– gastrointestinal bleeding; other active bleeding (including suspected intracranial hemorrhage);
– Crohn’s disease, ulcerative colitis;
– severe hepatic insufficiency (10-15 points by Child-Pugh scale);
– progressive renal disease, confirmed hyperkalemia;
– chronic renal 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/1.7 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;
– sugar/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution
Pepper use the drug in the presence of the conditions specified in this section should consult a physician.
Hepatic diseases in anamnesis, hepatic porphyria (including acute intermittent porphyria), chronic kidney disease, stage 2 (FFR 60-89 ml/min/1.7 m2), chronic heart failure, arterial hypertension, dehydration, a significant decrease in circulating blood volume (including after surgical intervention).including after surgical intervention), 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, concomitant use of glucocorticosteroids (incl.including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel) selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes, peripheral arterial disease, smoking, Helicobacter pylori infection. systemic lupus erythematosus (SLE) and other systemic connective tissue diseases, bleeding disorders, long-term use of NSAIDs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

Side effects

The side effects whose association with dexketoprofen has been recognized as at least possible in clinical trials (tablet dosage form), as well as the side effects reported since the market launch of Dexalgin® in solution granules, are listed below according to the system-organ classification and the WHO classification of the descending frequency of occurrence: very common (≥ 1/10), common (≥ 1/100, <1/10) infrequent (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000). Very rare (<1,10000), including individual reports.
Due to the fact that Cmax in dexketoprofen oral solution pellets is higher in plasma than in tablet form, we cannot rule out an increased risk of side effects (including gastrointestinal disorders).

Disorders of the blood and lymphatic system
Very rare: neutropenia, thrombocytopenia.

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

Metabolic and nutritional disorders
Rare: anorexia.

Mental disorders
Infrequent: insomnia, feeling of anxiety.

Nervous system disorders
Infrequent: headache, feeling stunned, sleepiness;
Rarely: paraesthesia, fainting.

VIight disorders
Very rare: blurred vision.

Hearing organ and labyrinth disorders
Infrequent: dizziness;
Very rare: tinnitus.

Heart disorders
Infrequent: palpitations;
Very rare: tachycardia.

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

Respiratory system, thoracic and mediastinal organs disorders
Rare: bradypnea;
Very rare: bronchospasm, dyspnea.

Gastrointestinal tract disorders
Often: nausea and/or vomiting, abdominal pain, diarrhea, dyspepsia;
Infrequent: Gastritis, constipation, dry mouth, flatulence;
Rarely: peptic ulcer, ulcer bleeding or ulcer perforation;
Very rare: pancreatitis.

Liver and biliary tract disorders
Rare: damage to liver cells.

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

Muscular and connective tissue disorders
Rarely: back pain.

Rarely: polyuria, acute renal failure;
Very rarely: nephritis or nephrotic syndrome.

Rare: disorders of the reproductive system and mammary glands
Rare: menstrual disorders, prostate disorders.

Systemic disorders and reactions at the site of administration
Infrequent: fatigue, pain, asthenia, muscle stiffness, general malaise;
Rare: peripheral edema.

Additional methods of investigation
Rarely: changes of liver function tests.
Most often there are side effects on the gastrointestinal tract. Peptic ulcer, perforation or gastrointestinal bleeding are possible, sometimes with lethal outcome especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic complaints, abdominal pain, melena, bloody vomiting, ulcerative stomatitis, worsening of colitis and Crohn’s disease have been reported. Gastritis has been less frequently reported. Edema, increased blood pressure, and development of heart failure have also been reported when using NSAIDs.

According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses and for a long time, may be accompanied by a slight increase in the risk of pathology caused by arterial thrombosis (eg, myocardial infarction or stroke) (see section “Cautions”).
As with the use of other NSAIDs, the following side effects may develop: aseptic meningitis, developing 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).

The occurrence of side effects should be reported to monitor the benefit-risk ratio when using the drug. If the side effects described above occur, or if they are more severe, or if you notice any other side effects, please tell your doctor immediately. Healthcare professionals must report side effects through the national pharmacovigilance system.

Overdose

Symptoms: the symptoms of overdose of Dexalgin® are unknown. Similar drugs cause gastrointestinal disorders (vomiting, anorexia, abdominal pain) and nervous system disorders (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. If an adult or child takes the drug in a dose of more than 5 mg/kg, activated charcoal should be taken orally within one hour. Dexetoprofen may be eliminated from the body by dialysis.

Pregnancy use

The use of the drug Dexalgin® is contraindicated in pregnancy and during breast-feeding.

The inhibition of prostaglandin synthesis may adversely affect pregnancy and/or development of the embryo and fetus. Epidemiologic studies have shown that drugs that inhibit prostaglandin synthesis when used early in pregnancy can increase the risk of spontaneous abortion as well as fetal heart defects and anterior abdominal wall abscesses; thus, the absolute risk of cardiovascular anomalies increased from approximately less than 1% to 1.5%. The risk is thought to increase with increasing dose and duration of use.
In the third trimester of pregnancy, all prostaglandin synthesis inhibitors can lead to fetal cardiopulmonary abnormalities (premature closure of the arterial duct and hypertension in the pulmonary artery system) and impaired renal function, which may 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 in the newborn may have increased bleeding time due to the antiaggregant effect of the drug, as well as suppression of uterine contractile activity, leading to delayed labor or prolonged labor.
No data on penetration of dexectoprofen into the mother’s milk.

Dexalgin®, like other NSAIDs, may decrease female fertility, so it is not recommended for women who are planning to become pregnant. In women who have problems with conception or are undergoing evaluation for infertility, dexectoprofen should be considered for withdrawal.

Similarities