Deceta

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEKETA (DEKETA)

Composition:

Active substance: dexketoprofen;

1 ml of injectable solution contains dexketoprofen trometamol 36.9 mg, equivalent to dexketoprofen 25 mg (1 ampoule of 2 ml contains dexketoprofen trometamol 73.81 mg, equivalent to dexketoprofen 50 mg);

Excipients: ethanol 96%, sodium chloride, sodium hydroxide, water for injections.

Pharmaceutical form. Injectable solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. ATC code M01AE17.

Pharmacological Properties

Pharmacodynamics.

Dexketoprofen trometamol is the tromethamine salt of (S)-(+)-2-(3-benzoylphenyl) propionic acid, exerting analgesic, anti-inflammatory, and antipyretic effects, and belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs).

Mechanism of action

The mechanism of action of NSAIDs is based on reducing the synthesis of prostaglandins by inhibiting cyclooxygenase activity. Specifically, the conversion of arachidonic acid into cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2α, PGD2, as well as prostacyclin PGI2 and thromboxanes TxА2 and TxВ2 are formed. In addition, inhibition of prostaglandin synthesis may affect other mediators of inflammation such as kinins, which may also indirectly influence the primary action of the drug.

Inhibitory effects of dexketoprofen trometamol on the activity of cyclooxygenase-1 and cyclooxygenase-2 have been demonstrated in laboratory animals and in humans.

Clinical efficacy and safety

Clinical studies in various types of pain have demonstrated that dexketoprofen trometamol exerts a pronounced analgesic effect. The analgesic effect of dexketoprofen trometamol administered intramuscularly or intravenously to patients with moderate to severe pain has been studied in various pain conditions associated with surgical procedures (orthopedic and gynecological surgeries, abdominal operations), as well as musculoskeletal pain (acute low back pain) and renal colic. In these studies, the analgesic effect of the drug began rapidly and reached its maximum within the first 45 minutes. The duration of analgesic action after administration of 50 mg of dexketoprofen trometamol is typically 8 hours. Clinical studies have shown that the use of dexketoprofen allows a significant reduction in opioid dosage when used concomitantly for postoperative pain management. In patients receiving morphine via a patient-controlled analgesia device for postoperative pain, the addition of dexketoprofen trometamol resulted in a significantly lower morphine requirement (by 30–45%) compared to patients receiving placebo.

Pharmacokinetics.

Absorption

After intramuscular administration of dexketoprofen trometamol in humans, maximum concentration is reached approximately within 20 minutes (10–45 minutes). It has been demonstrated that after single intramuscular or intravenous administration of 25–50 mg of the drug, the area under the plasma concentration-time curve (AUC) is dose-proportional.

Distribution

Similar to other drugs with a high degree of plasma protein binding (99%), the volume of distribution of dexketoprofen averages 0.25 L/kg. The distribution half-life is approximately 0.35 hours, and the elimination half-life is 1–2.7 hours.

Pharmacokinetic studies with repeated administration of the drug demonstrated that Cmax and AUC after the last intramuscular or intravenous dose did not differ from those after single administration, indicating absence of drug accumulation.

Biotransformation and elimination

Metabolism of dexketoprofen occurs mainly via conjugation with glucuronic acid followed by renal excretion. After administration of dexketoprofen trometamol, only the S-(+) optical isomer is detected in urine, indicating absence of transformation of the drug into the R-(–) optical isomer in humans.

Elderly patients

After administration of single and multiple doses, the extent of drug exposure in elderly healthy volunteers (aged 65 years and older) participating in the study was significantly higher (up to 55%) compared to younger volunteers; however, no statistically significant differences in maximum concentration or time to reach maximum concentration were observed. The mean elimination half-life increased (by up to 48%), and total clearance decreased.

Preclinical safety data

Standard preclinical studies—pharmacological safety, genotoxicity, and immunopharmacology—did not reveal any specific hazard for humans. Chronic toxicity studies in animals identified a no-observed-adverse-effect level (NOAEL) that was 2 times higher than the recommended human dose. When higher doses were administered to monkeys, the main adverse reactions were fecal blood, reduced body weight gain, and, at the highest dose, gastrointestinal lesions such as erosions. These effects occurred at exposure levels 14–18 times higher than those observed at the maximum recommended human dose. Carcinogenicity studies in animals have not been conducted.

Like all NSAIDs, dexketoprofen may cause embryonic or fetal death in animals, either directly by affecting embryonic/fetal development or indirectly via maternal gastrointestinal toxicity.

Clinical characteristics.

Indications.

The medicinal product Diceta is indicated for symptomatic treatment of moderate to severe acute pain when oral administration of dexketoprofen is inappropriate, such as in postoperative pain, renal colic, and low back pain.

Contraindications.

• Hypersensitivity to dexketoprofen, to any other nonsteroidal anti-inflammatory drug (NSAID), or to excipients of the medicinal product;
• if substances of similar action, e.g., acetylsalicylic acid or other NSAIDs, provoke asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria, or angioedema;
• if photoallergic or phototoxic reactions occurred during treatment with ketoprofen or fibrates;
• gastrointestinal bleeding or perforation in medical history associated with NSAID therapy;
• active peptic ulcer / gastrointestinal bleeding or history of gastrointestinal bleeding, ulcers, or perforations;
• chronic dyspepsia;
• active bleeding or increased bleeding tendency;
• Crohn’s disease or ulcerative colitis;
• severe heart failure;
• moderate to severe renal impairment (creatinine clearance ≤ 59 mL/min);
• severe hepatic impairment (Child–Pugh score 10–15 points);
• hemorrhagic diathesis and other coagulation disorders;
• severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• third trimester of pregnancy and breastfeeding period.

Due to the ethanol content, the medicinal product Diceta is contraindicated for neuraxial (intrathecal or epidural) administration.

Interaction with other medicinal products and other forms of interaction

Concomitant use of the following agents with NSAIDs is not recommended:

• other NSAIDs (including selective cyclooxygenase-2 inhibitors), including salicylates at high doses (≥ 3 g/day). Concomitant use of multiple NSAIDs increases the risk of gastrointestinal ulceration and gastrointestinal bleeding due to mutual enhancement of effects;
• anticoagulants: NSAIDs enhance the effect of anticoagulants, e.g., warfarin, due to high plasma protein binding of dexketoprofen, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If concomitant use is necessary, it should be performed under medical supervision with monitoring of relevant laboratory parameters;
• heparin: increased risk of bleeding (due to inhibition of platelet function and damage to gastric and duodenal mucosa). If concomitant use is necessary, it should be performed under medical supervision with monitoring of relevant laboratory parameters;
• corticosteroids: increased risk of gastrointestinal ulceration and gastrointestinal bleeding;
• lithium (reports with several NSAIDs): NSAIDs increase blood lithium levels, potentially leading to toxicity (reduced renal excretion of lithium). Therefore, lithium blood levels should be monitored at the start of dexketoprofen treatment, during dose adjustments, or upon discontinuation of the medicinal product;
• high-dose methotrexate (≥ 15 mg per week): due to reduced renal clearance of methotrexate with NSAID use, overall hematological toxicity of methotrexate is enhanced;
• hydantoin derivatives and sulfonamides: possible increase in toxicity of these agents.

Concomitant use of the following agents with NSAIDs requires caution:

• diuretics, angiotensin-converting enzyme (ACE) inhibitors, aminoglycoside antibiotics, and angiotensin II receptor antagonists. Dexketoprofen reduces the effectiveness of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., due to dehydration or in elderly patients), concomitant use of cyclooxygenase inhibitors with ACE inhibitors, angiotensin II receptor antagonists, or aminoglycoside antibiotics may worsen renal function, which is usually reversible. When using dexketoprofen with any diuretic, ensure the patient is not dehydrated and monitor renal function at the beginning of treatment;
• low-dose methotrexate (< 15 mg per week): reduced renal clearance of methotrexate with NSAID use enhances its overall hematological toxicity. Weekly blood tests are required during the first weeks of concomitant use. Treatment should be closely monitored by a physician, especially in patients with even mild renal impairment or elderly patients;
• pentoxifylline: risk of bleeding. Monitoring should be intensified, and bleeding time should be checked more frequently;
• zidovudine: risk of increased toxic effects on erythrocytes due to effects on reticulocytes, which after 1 week of NSAID use may lead to severe anemia. Blood tests and reticulocyte count should be performed within 1–2 weeks after starting NSAID treatment;
• sulfonylurea preparations: NSAIDs may enhance the hypoglycemic effect of these agents by displacing sulfonylureas from plasma protein binding sites.

Potential interactions should be considered when using the following agents:

• beta-blockers: NSAIDs may reduce their antihypertensive effect by inhibiting prostaglandin synthesis;
• cyclosporine and tacrolimus: possible increased nephrotoxicity due to NSAID effects on renal prostaglandins. Renal function should be monitored during combination therapy;
• thrombolytic agents: increased risk of bleeding;
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding;
• probenecid: possible increase in dexketoprofen plasma concentration, likely due to inhibition of tubular secretion and conjugation of the drug with glucuronic acid, requiring dose adjustment of dexketoprofen;
• cardiac glycosides: NSAIDs may increase glycoside plasma concentrations;
• mifepristone: theoretically, there is a risk of altered mifepristone efficacy due to prostaglandin synthetase inhibitors. Limited data suggest that concomitant administration of NSAIDs on the same day as prostaglandin does not adversely affect mifepristone or prostaglandin efficacy regarding cervical ripening or contractility, nor does it reduce the clinical efficacy of drugs for medical termination of pregnancy;
• quinolone antibiotics: animal studies indicate that high-dose quinolone derivatives combined with NSAIDs increase the risk of seizures;
• tenofovir: when used concomitantly with NSAIDs, plasma urea nitrogen and creatinine concentrations may increase; therefore, renal function should be monitored to assess potential effects of combined use;
• deferasirox: concomitant use with NSAIDs increases the risk of gastrointestinal toxicity. Careful patient monitoring is required when using this medicinal product with deferasirox;
• pemetrexed: concomitant use with NSAIDs may reduce pemetrexed elimination; therefore, particular caution is required when using NSAIDs at high doses. Patients with mild to moderate renal impairment (creatinine clearance 45–79 mL/min) should avoid NSAID use for two days before and two days after pemetrexed administration.

Special precautions for use

Use with caution in patients with a history of allergic conditions. Avoid using the medicinal product Diceta in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Gastrointestinal safety

Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, have been reported with all NSAIDs at various stages of treatment, regardless of the presence of warning symptoms or a history of serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, the medicinal product should be discontinued.

The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcer, particularly complicated by bleeding or perforation, and in elderly patients.

Elderly patients. Elderly patients have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, sometimes fatal. Treatment of such patients should begin with the lowest possible dose. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn’s disease), as there is a risk of exacerbation. When using any NSAID in patients with a history of esophagitis, gastritis, and/or peptic ulcer, it must be ensured that these conditions are in remission. Patients with existing gastrointestinal symptoms or a history of gastrointestinal disorders should be monitored for possible gastrointestinal disturbances during treatment, particularly gastrointestinal bleeding. For such patients and those taking low-dose acetylsalicylic acid or other agents increasing the risk of gastrointestinal adverse reactions, concomitant therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

Patients, especially elderly ones, with a history of gastrointestinal adverse reactions should inform their physician about any unusual gastrointestinal symptoms, including gastrointestinal bleeding, particularly at the beginning of treatment.

The medicinal product should be prescribed with caution to patients concurrently using agents that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents like acetylsalicylic acid.

Renal safety

The medicinal product should be used with caution in patients with impaired renal function, as NSAIDs may worsen kidney function, cause fluid retention, and edema. Due to the increased risk of nephrotoxicity, the medicinal product should be used cautiously in patients receiving diuretics or those at risk of hypovolemia. During treatment, adequate fluid intake should be maintained to prevent dehydration, which may exacerbate renal toxicity. Like other NSAIDs, the medicinal product may increase plasma urea nitrogen and creatinine levels. Similar to other prostaglandin synthesis inhibitors, its use may be associated with renal adverse reactions, including glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, and acute renal failure. Renal function disturbances occur most frequently in elderly patients.

Hepatic safety

The medicinal product should be used with caution in patients with impaired liver function. Similar to other NSAIDs, dexketoprofen may cause transient and mild elevations in certain liver parameters, as well as marked increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity. If such increases occur, therapy should be discontinued.

Hepatic function disturbances occur most frequently in elderly patients.

Cardiovascular and cerebrovascular safety

Patients with arterial hypertension and/or mild to moderate heart failure require monitoring and medical advice. Particular caution is required when treating patients with a history of heart disease, especially previous episodes of heart failure (as dexketoprofen trometamol may increase the risk of heart failure), since NSAID therapy may cause fluid retention and edema. Clinical studies and epidemiological data suggest a slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) with some NSAIDs, particularly at high doses and prolonged use. Data to exclude such risks with dexketoprofen are insufficient. Therefore, dexketoprofen should be prescribed only after careful assessment of the patient’s condition in cases of uncontrolled arterial hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. Similarly careful assessment is required before initiating long-term treatment in patients with cardiovascular risk factors (e.g., arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).

Non-selective NSAIDs can reduce platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. The concomitant use of dexketoprofen trometamol and low-molecular-weight heparin at prophylactic doses in the postoperative period has been studied in clinical trials, with no effect on coagulation parameters observed. However, patients receiving dexketoprofen trometamol together with agents affecting hemostasis, such as warfarin, other coumarin derivatives, or heparins, require close medical supervision. Cardiovascular function disturbances occur most frequently in elderly patients.

Skin reactions

There have been reports of very rare cases of serious skin reactions (some fatal) associated with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The highest risk likely occurs early in treatment, with most cases appearing within the first month of therapy. If skin rashes, signs of mucosal involvement, or other signs of hypersensitivity occur, the medicinal product Diceta should be discontinued.

Other information

Special caution is required when prescribing the medicinal product to patients:

• with inherited porphyrin metabolism disorders (e.g., acute intermittent porphyria);
• with dehydration;
• immediately after major surgical procedures.

If prolonged use of dexketoprofen is considered necessary by the physician, liver and kidney function should be monitored regularly.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If signs of severe hypersensitivity reactions occur after administration of Diceta, treatment should be discontinued. Any necessary treatment in such cases should be administered under medical supervision, depending on the symptoms.

Patients suffering from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than other patients. Prescribing dexketoprofen may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Severe infectious complications of the skin and soft tissues may occur during chickenpox. Data to rule out a role of NSAIDs in exacerbating this infectious process are lacking. Therefore, Diceta is not recommended during chickenpox.

Diceta should be administered with caution to patients with coagulation disorders, systemic lupus erythematosus, and mixed connective tissue diseases.

Masking of symptoms of underlying infections. Dexketoprofen may mask symptoms of infection, potentially delaying appropriate treatment and worsening infection outcomes. Such masking has been observed in bacterial community-acquired pneumonia and bacterial complications of chickenpox. When this medicinal product is used to relieve pain associated with infection, monitoring for infection is recommended. In outpatient settings, patients should consult a physician if symptoms persist or worsen.

Excipients

Diceta contains up to 200 mg of ethanol per dose (2 ml of solution), equivalent to 5 ml of beer or 2.08 ml of wine per dose.

Harmful for patients with alcoholism. Caution is required when used in pregnant women, breastfeeding women, children, patients with liver disease, and patients with epilepsy.

The medicinal product contains less than 1 mmol of sodium (23 mg) per 2 ml of solution, i.e., practically sodium-free.

Use during pregnancy or breastfeeding

The use of the medicinal product Diceta is contraindicated during the third trimester of pregnancy and during breastfeeding.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. According to epidemiological studies, the use of prostaglandin synthesis inhibitors in early pregnancy increases the risk of miscarriage, congenital heart defects, and abdominal wall defects in the fetus. For example, the absolute risk of cardiovascular malformations increases from <1% to approximately 1.5%. It is believed that the risk of such events increases with higher doses of dexketoprofen and longer duration of therapy. In animal studies, prostaglandin synthesis inhibitors caused increased pre- and post-implantation losses and increased embryofetal mortality. Furthermore, in animals treated with prostaglandin synthesis inhibitors during organogenesis, the incidence of fetal developmental abnormalities, including cardiovascular malformations, increased. However, animal studies with dexketoprofen trometamol did not reveal reproductive toxicity.

Use of Diceta from the 20th week of pregnancy may cause oligohydramnios due to fetal renal dysfunction. This effect may occur soon after starting treatment and is usually reversible upon discontinuation of the drug. Additionally, cases of arterial duct constriction have been reported after second-trimester treatment, most of which resolved after stopping therapy. Therefore, Diceta should not be prescribed during the first and second trimesters of pregnancy except in cases of extreme necessity. If Diceta is used in women attempting to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. Fetal monitoring for oligohydramnios and arterial duct constriction should be considered if Diceta is used for several days starting from the 20th week of pregnancy. Diceta use should be discontinued if oligohydramnios or arterial duct constriction is detected.

During the third trimester, all prostaglandin synthesis inhibitors may cause:

Risks for the fetus:

• cardiopulmonary toxic syndrome (premature constriction/closure of the arterial duct and pulmonary hypertension);
• impaired renal function (see above), potentially progressing to renal failure and oligohydramnios;

Risks at the end of pregnancy for mother and child:

• prolonged bleeding time (due to inhibition of platelet aggregation), which may occur even with low doses;
• delayed uterine contractions, leading to prolonged labor.

Breastfeeding

There are no data on the passage of dexketoprofen into breast milk. The medicinal product Diceta is contraindicated during breastfeeding.

Fertility

Like all other NSAIDs, dexketoprofen trometamol may reduce female fertility and therefore is not recommended for women planning pregnancy. If a woman experiences difficulties conceiving or is undergoing infertility evaluation, discontinuation of the medicinal product should be considered.

Ability to affect reaction speed when driving or operating machinery.

Dizziness, visual disturbances, or drowsiness may occur during treatment with Diceta. In such cases, the ability to react quickly, orient in traffic situations, and drive or operate machinery may be impaired.

Method of Administration and Dosage

Adults. The recommended dose is 50 mg every 8–12 hours. If necessary, the dose may be repeated after 6 hours. The maximum daily dose should not exceed 150 mg. The medicinal product is intended for short-term use; therefore, it should be administered only during the period of acute pain (no more than 2 days). Patients should be switched to oral analgesics as soon as possible. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. For moderate to severe postoperative pain, dexketoprofen may be used as indicated, at the same recommended doses, in combination with opioid analgesics.

Elderly patients. Dose adjustment is generally not required. However, due to the physiological decline in renal function, a lower dose of dexketoprofen is recommended: namely, a maximum daily dose of 50 mg in cases of mild renal impairment.

Liver disease. In patients with mild or moderate hepatic impairment (5–9 points on the Child–Pugh scale), the maximum daily dose should be reduced to 50 mg, and liver function should be closely monitored. Dexketoprofen is contraindicated in patients with severe hepatic impairment (10–15 points on the Child–Pugh scale).

Renal dysfunction. In patients with mild renal impairment (creatinine clearance 60–89 mL/min), the maximum daily dose should be reduced to 50 mg. Dexketoprofen is contraindicated in patients with moderate or severe renal impairment (creatinine clearance <59 mL/min).

Children and adolescents. The medicinal product should not be administered to children and adolescents due to the lack of data on efficacy and safety in pediatric patients.

Method of Administration

Intramuscular injection. The injection solution should be administered slowly and deeply into the muscle.

Intravenous infusion. For intravenous infusion, the contents of a 2 mL ampoule should be diluted in 30–100 mL of 0.9% sodium chloride solution, glucose solution, or Ringer’s lactate solution. The infusion solution should be prepared under aseptic conditions and protected from exposure to natural daylight. The prepared solution must be clear and transparent. The infusion should be administered over 10–30 minutes. The prepared solution must be protected from exposure to natural daylight.

Deketa medicinal product, diluted in 100 mL of 0.9% sodium chloride solution or glucose solution, may be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.

Deketa medicinal product must not be mixed in the infusion solution with promethazine or pentazocine.

Intravenous injection (bolus administration).

If necessary, the contents of one ampoule (2 mL of injection solution) may be administered intravenously over at least 15 seconds.

Deketa medicinal product may be mixed in small volumes (e.g., in a syringe) with injection solutions of heparin, lidocaine, morphine, and theophylline.

Deketa medicinal product must not be mixed in small volumes (e.g., in a syringe) with dopamine, promethazine, pentazocine, pethidine, or hydrocortisone solutions, as a white precipitate may form.

Deketa medicinal product may only be mixed with the medicinal products listed above.

When administered intramuscularly or intravenously by injection, Deketa should be administered immediately after being drawn from the ampoule. The solution for intravenous infusion should be used immediately after preparation. Subsequently, responsibility for storage conditions and duration lies with the healthcare professional. The prepared solution retains its properties for 24 hours at 25°C, provided it is protected from daylight.

No changes in active substance content due to adsorption have been observed during storage of diluted solutions of the drug in polyethylene bags or in administration devices made of ethyl vinyl acetate, cellulose propionate, low-density polyethylene, or polyvinyl chloride.

The prepared medicinal product Deketa is intended for single use only; any remaining solution must be discarded. Before administration, it is essential to ensure that the solution is clear and colorless. Solutions containing particulate matter must not be used.

Children.

The medicinal product should not be administered to children and adolescents due to the lack of data on efficacy and safety in pediatric patients.

Overdose.

Symptoms of overdose are unknown. Similar medicinal products may cause gastrointestinal disturbances (vomiting, anorexia, abdominal pain) and nervous system effects (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment appropriate to the patient’s condition should be initiated immediately. Dexketoprofen trometamol can be removed from the body by dialysis.

Adverse reactions.

The table below lists adverse reactions whose association with dexketoprofen trometamol is considered at least possible based on clinical data, as well as adverse reactions reported during the post-marketing period.

Gastrointestinal disorders were observed most frequently.

Peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients. According to available data, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic symptoms, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease may occur during treatment with dexketoprofen. Gastritis has been observed less frequently. Edema, arterial hypertension, and heart failure, which may be caused by NSAID use, have also been reported. As with other NSAIDs, the following adverse reactions are possible: aseptic meningitis, which generally occurs in patients with systemic lupus erythematosus or mixed connective tissue diseases, and blood disorders (purpura, aplastic and hemolytic anemia; rarely agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), are also possible.

According to clinical studies and epidemiological data, the use of certain NSAIDs, especially at high doses and over prolonged periods, may be associated with a small increased risk of arterial thrombotic events such as myocardial infarction and stroke.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy to the State Expert Center of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua.

Shelf life.

4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Incompatibilities.

The medicinal product Deketa must not be mixed in small volumes (e.g., in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine, or hydroxyzine, as precipitation may occur.

Diluted infusion solutions prepared as described in the section "Administration and dosage" must not be mixed with promethazine or pentazocine.

Packaging.

2 mL in an ampoule; 6 ampoules in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

VEM Ilac San. ve Tic. A.S.

Manufacturer's address and place of business.

Cerkezkoy Organize Sanay Bölgesi, Karaagac Mahallesi, Fatih Bulvari No: 38, Kapakli/Tekirdag / Turkey.