Instructions Analgodex solution for injection 25 mg/ml ampoules 2 ml No. 5
Composition
active ingredient: dexketoprofen;
1 ml of solution contains 25 mg of dexketoprofen (in the form of dexketoprofen trometamol);
Excipients: sodium chloride, ethanol 96%, sodium hydroxide, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. Dexketoprofen. ATX code M01A E17.
Pharmacological properties
Pharmacodynamics.
Dexketoprofen trometamol is the tromethamine salt of (S)-(+)-2-(3-benzoylphenyl)propionic acid, which has analgesic, anti-inflammatory, and antipyretic effects and belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs).
The mechanism of action is based on a decrease in prostaglandin synthesis by inhibiting cyclooxygenase activity. In particular, the conversion of arachidonic acid into cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2a, PGD2 are formed, as well as prostacyclin PGI2 and thromboxanes ThA2 and ThB2. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug. Dexketoprofen has been shown to inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2. Dexketoprofen has been shown to have a pronounced analgesic effect with a rapid onset and peak within 45 minutes for various types of pain, including surgical pain (orthopedic, gynecological, abdominal), musculoskeletal pain (acute low back pain), and renal colic. The duration of analgesic effect after 50 mg of dexketoprofen is typically 8 hours. It is known that the use of dexketoprofen allows for a significant reduction in the dose of opiates when used concomitantly for postoperative pain relief. When patients who were given morphine for postoperative pain relief using a patient-controlled analgesia device were also given dexketoprofen, they required significantly less morphine (by 30–45%) than patients who received placebo with morphine.
Pharmacokinetics.
After intramuscular administration of dexketoprofen, the maximum concentration is reached on average after 20 minutes (10–45 minutes). It has been proven that with a single intramuscular or intravenous administration of 25–50 mg of dexketoprofen, the area under the concentration-time curve (AUC) is proportional to the dose. Pharmacokinetic studies of multiple administration have shown that AUC and Cmax after the last intramuscular or intravenous administration do not differ from these indicators after a single administration, which indicates the absence of cumulation. Similar to other drugs with a high degree of binding to plasma proteins (99%), the volume of distribution of dexketoprofen is on average 0.25 l/kg. The half-life is approximately 0.35 hours, and the half-life is 1–2.7 hours. Dexketoprofen is mainly metabolized by conjugation with glucuronic acid followed by renal excretion. After administration of dexketoprofen, only the S-(+) optical isomer is detected in the urine, indicating that the drug is not transformed into the R-(–) optical isomer. After administration of single and multiple doses, the exposure of the drug to healthy elderly volunteers (65 years and older) was significantly higher (up to 55%) than to young volunteers, but no statistically significant difference in the maximum concentration and time to reach it was observed. The mean half-life increased (up to 48%), and the determined total clearance decreased.
Preclinical safety data
Standard preclinical studies — safety pharmacology, genotoxicity, and immunopharmacology studies — revealed no special hazard for humans. Chronic toxicity studies in animals revealed a maximum no-effect dose of the drug that was 2 times the recommended human dose. At higher doses, the main adverse reactions in monkeys were blood in the stool, decreased body weight gain, and at the highest dose, gastrointestinal tract lesions in the form of erosions. These reactions occurred at doses that exposed the drug to 14–18 times the maximum human dose. No carcinogenicity studies were conducted in animals.
Like all NSAIDs, dexketoprofen can cause embryo or fetal death in animals by directly affecting its development, or indirectly by damaging the maternal gastrointestinal tract.
Indication
Symptomatic treatment of acute pain of moderate to severe intensity in cases where oral administration of the drug is inappropriate, such as postoperative pain, renal colic, and low back pain.
Contraindication
if substances with a similar effect, such as acetylsalicylic acid or other NSAIDs, provoke the patient to develop attacks of bronchial asthma, bronchospasm, acute rhinitis or cause the appearance of nasal polyps, urticaria or angioedema;
if the patient experienced photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;
active phase of peptic ulcer disease or gastrointestinal bleeding, suspected or recurrent peptic ulcer disease, or history of bleeding (two or more confirmed cases of ulcer or bleeding), or chronic dyspepsia;
gastrointestinal bleeding, other bleeding in the active phase or increased bleeding;
history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
Crohn's disease or nonspecific ulcerative colitis;
history of bronchial asthma;
severe heart failure;
moderate or severe renal impairment (creatinine clearance < 50 ml/min);
severe liver dysfunction (10–15 points on the Child-Pugh scale);
hemorrhagic diathesis and other blood clotting disorders;
Third trimester of pregnancy and breastfeeding period.
Due to the ethanol content, ANALGODEX is not used for neuraxial (intrathecal or epidural) administration.
Interaction with other medicinal products and other types of interactions
The following combinations of dexketoprofen are not recommended:
Other NSAIDs. The simultaneous use of several NSAIDs increases the risk of gastrointestinal ulcers and bleeding due to mutual enhancement of their effects. It is not recommended to use other NSAIDs, including high doses of salicylates (≥ 3 g/day), simultaneously with dexketoprofen.
Anticoagulants. NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to blood plasma proteins, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If concomitant use is necessary, it should be carried out under close medical supervision and with appropriate laboratory parameters.
Heparin. The risk of bleeding (due to inhibition of platelet function and damage to the gastric and duodenal mucosa) increases with the simultaneous use of NSAIDs with heparin. If concomitant use is necessary, it should be carried out under close medical supervision and with appropriate laboratory parameters.
Corticosteroids: Concomitant use of NSAIDs with corticosteroids increases the risk of gastrointestinal ulcers and bleeding.
Lithium. Some NSAIDs increase the level of lithium in the blood, which can lead to intoxication (reduced renal excretion of lithium). Therefore, when starting dexketoprofen, when adjusting the dose or discontinuing the drug, it is necessary to monitor the level of lithium in the blood.
Methotrexate in high doses (more than 15 mg per week). Due to the decrease in renal clearance of methotrexate against the background of the use of NSAIDs, its negative effect on the blood system is generally increased.
Hydantoin derivatives and sulfonamides. The toxicity of these substances may be increased when used concomitantly with NSAIDs.
NSAIDs should be used with caution with:
diuretics, angiotensin-converting enzyme (ACE) inhibitors, aminoglycosides and angiotensin II receptor antagonists. Dexketoprofen reduces the effectiveness of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., in cases of dehydration or in the elderly), the use of cyclooxygenase inhibitors concomitantly with ACE inhibitors, angiotensin II receptor antagonists or aminoglycosides may lead to a deterioration in renal function, which is usually reversible. When using dexketoprofen with any diuretic, it is necessary to ensure that the patient is not dehydrated, and at the beginning of treatment it is necessary to monitor renal function;
methotrexate in low doses (less than 15 mg per week): due to the decrease in renal clearance of methotrexate against the background of the use of NSAIDs, its negative effect on the blood system in general is increased. In the first weeks of simultaneous use, it is necessary to conduct a blood test every week. Even with a slight violation of renal function, as well as in elderly patients, treatment should be carried out under strict medical supervision;
Pentoxifylline: there is a risk of bleeding. It is necessary to increase monitoring and check the bleeding time more often;
zidovudine: there is a risk of increased toxicity to erythrocytes due to the effect on reticulocytes, which leads to severe anemia after the 1st week of NSAID use. Within 1-2 weeks after starting NSAID use, a blood test should be performed and the reticulocyte count checked;
Sulfonylureas: NSAIDs can enhance the hypoglycemic effect of these agents by displacing sulfonylureas in their binding to plasma proteins.
Possible interactions should be considered when used with:
beta-blockers: NSAIDs can weaken their antihypertensive effect by inhibiting prostaglandin synthesis;
cyclosporine and tacrolimus: possible increase in nephrotoxicity due to the effect of NSAIDs on renal prostaglandins. In combination therapy, renal function should be monitored;
antiplatelet agents and selective serotonin reuptake inhibitors: the risk of gastrointestinal bleeding increases;
probenecid: an increase in the concentration of dexketoprofen in the blood plasma is possible, which is likely due to inhibition of renal tubular secretion and conjugation of the drug with glucuronic acid and requires correction of the dose of dexketoprofen;
cardiac glycosides: NSAIDs can increase the concentration of glycosides in blood plasma;
mifepristone: due to the theoretical possibility of a decrease in the effectiveness of mifepristone under the influence of prostaglandin synthetase inhibitors, NSAIDs should be prescribed only 8–12 days after mifepristone therapy;
quinolone: results of animal studies have shown that the use of quinolone derivatives in high doses in combination with NSAIDs increases the risk of seizures;
tenofovir: when used simultaneously with NSAIDs, the concentration of urea nitrogen and creatinine in the blood plasma may increase, therefore, to assess the possible synergistic effect of these drugs, it is necessary to monitor renal function;
deferasirox: when used simultaneously with NSAIDs, the risk of gastrointestinal toxicity increases. When using the drug simultaneously with deferasirox, careful patient monitoring is necessary;
Pemetrexed: Concomitant use with NSAIDs may reduce the excretion of pemetrexed, therefore special caution should be exercised when using NSAIDs in high doses. Patients with mild to moderate renal impairment (creatinine clearance 45 to 79 ml/min) should avoid NSAIDs for two days before and two days after taking pemetrexed.
Application features
Use with caution in patients with a history of allergic conditions. Avoid using ANALGODEX in combination with other NSAIDs, including selective COX-2 inhibitors. Adverse reactions can be reduced by using the lowest effective dose for the shortest time necessary to improve the condition.
Effects on the gastrointestinal tract
Gastrointestinal bleeding, ulceration or perforation, in some cases fatal, have been reported at various stages of NSAID treatment, regardless of the presence of warning symptoms or a history of serious gastrointestinal disease. If gastrointestinal bleeding occurs, the drug should be discontinued. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dose, in patients with a history of ulcer, especially if complicated by bleeding or perforation, and in the elderly.
Elderly patients are at increased risk of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, sometimes fatal. Treatment should be initiated at the lowest effective dose in these patients. NSAIDs should be used with caution in patients with a history of gastrointestinal disease, as there is a risk of exacerbation of these conditions.
Before starting the use of dexketoprofen trometamol in patients with a history of esophagitis, gastritis and/or peptic ulcer disease, it is necessary to ensure that these diseases are in remission. In patients with symptoms of gastrointestinal pathology or with a history of gastrointestinal diseases, it is necessary to monitor the condition of the gastrointestinal tract during treatment for possible disorders, especially gastrointestinal bleeding. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as there is a risk of their exacerbation.
For such patients and patients taking low-dose acetylsalicylic acid or other agents that increase the risk of gastrointestinal adverse reactions, combination therapy with protective agents, such as misoprostol or proton pump inhibitors, should be considered.
Patients, especially the elderly, who have a history of adverse reactions from the digestive tract, should inform their doctor about all unusual symptoms related to the digestive system, in particular gastrointestinal bleeding, especially in the initial stages of treatment.
Effects on the kidneys
The drug should be prescribed with caution to patients with impaired renal function, since the use of NSAIDs may lead to deterioration of renal function, fluid retention in the body and the appearance of peripheral edema. Due to the increased risk of nephrotoxicity, ANALGODEX should be used with caution in treatment with diuretics, as well as in patients who may develop hypovolemia. During treatment, adequate fluid intake should be ensured to prevent dehydration and the associated increased toxicity.
Like all NSAIDs, dexketoprofen can increase blood urea nitrogen and creatinine levels in the blood plasma. Like other prostaglandin synthesis inhibitors, its use can be accompanied by adverse reactions from the kidneys, leading to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.
Most kidney dysfunction occurs in elderly patients.
The drug should be prescribed with caution to patients with impaired liver function. Like other NSAIDs, dexketoprofen may cause a temporary slight increase in the values of some liver tests, as well as a significant increase in the level of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). If these values increase, the use of the drug ANALGODEX should be discontinued.
Most liver dysfunction occurs in elderly patients.
Effects on the cardiovascular and cerebrovascular systems
Patients with arterial hypertension and/or mild to moderate congestive heart failure should be closely monitored by a physician due to possible fluid retention and peripheral edema.
Particular caution should be exercised when treating patients with a history of heart disease, in particular with previous episodes of heart failure, since the risk of heart failure is increased with the use of dexketoprofen (fluid retention and edema have been reported in association with the use of NSAIDs).
Clinical and epidemiological data suggest that the use of some NSAIDs, especially at high doses and over a long period, slightly increases the risk of arterial thrombotic events, such as myocardial infarction or stroke. There is insufficient evidence to exclude such a risk with dexketoprofen. Accordingly, dexketoprofen should be prescribed to patients with uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease only after careful assessment of their condition. Careful assessment should also be carried out before starting long-term treatment in patients with risk factors for cardiovascular disease, such as hypertension, hyperlipidemia, diabetes mellitus, smoking.
Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis. It is known that the simultaneous use of dexketoprofen trometamol and low molecular weight heparin in prophylactic doses in the postoperative period does not affect coagulation parameters. However, patients who use dexketoprofen trometamol simultaneously with drugs that affect hemostasis, such as warfarin, other coumarins or heparins, should be under close medical supervision.
Most cardiovascular system dysfunctions occur in elderly patients.
Skin reactions
Very rare cases of serious skin reactions (some fatal) have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk is greatest at the beginning of treatment, particularly within the first month of therapy. If skin rash, signs of mucosal involvement or other symptoms of hypersensitivity occur, ANALGODEX should be discontinued.
Other information
Particular caution is required when prescribing the drug to patients:
with hereditary disorders of porphyrin metabolism (for example, in acute intermittent porphyria);
with dehydration;
immediately after major surgical interventions.
If the doctor considers that long-term use of dexketoprofen is necessary, liver and kidney function should be monitored regularly.
In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of severe hypersensitivity reactions after administration of the drug, treatment should be discontinued. Depending on the symptoms, any necessary treatment in such cases should be carried out under medical supervision.
Patients with asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than other patients. The use of this medicinal product may cause asthma attacks or bronchospasm, especially in patients with allergy to acetylsalicylic acid or NSAIDs.
Severe infectious complications of the skin and soft tissues may develop in the setting of chickenpox. To date, the role of NSAIDs in the exacerbation of this infectious process cannot be ruled out. Therefore, dexketoprofen is not recommended for use in chickenpox.
The drug should be administered with caution to patients with hematopoietic disorders, systemic lupus erythematosus, and mixed connective tissue diseases.
Each ampoule of the drug ANALGODEX contains 200 mg of ethanol (per dose), which is equivalent to 5 ml of beer or 2.08 ml of wine. The drug may have a negative effect on people suffering from alcoholism. The ethanol content should be taken into account when using the drug in the 1st and 2nd trimesters of pregnancy, in patients at risk, for example, with liver disease, and in patients with epilepsy. ANALGODEX contains less than 1 mmol sodium (23 mg) per dose, i.e. it is practically sodium-free.
Use during pregnancy or breastfeeding
The use of the drug ANALGODEX is contraindicated in the third trimester of pregnancy and during breastfeeding.
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. It is known that the use of drugs that inhibit prostaglandin synthesis in early pregnancy increases the risk of miscarriage, fetal heart defects and non-union of the anterior abdominal wall. Thus, the absolute risk of developing cardiovascular anomalies increased from < 1% to approximately 1.5%. It is believed that the risk of such events increases with increasing dose of the drug and duration of therapy.
The use of prostaglandin synthesis inhibitors in animals has caused an increase in pre- and post-implantation losses and increased embryo-fetal mortality. In addition, in animals treated with prostaglandin synthesis inhibitors during the period of organogenesis, an increased incidence of fetal malformations, including cardiovascular anomalies, was observed. However, studies of dexketoprofen trometamol in animals have not revealed reproductive toxicity.
Dexketoprofen should be prescribed in the first and second trimesters of pregnancy only if clearly needed. Women planning pregnancy and women in the first and second trimesters of pregnancy should use the lowest effective dose of dexketoprofen for the shortest possible duration of treatment.
In the third trimester of pregnancy, the use of all prostaglandin synthesis inhibitors causes:
risks to the fetus:
cardiopulmonary toxic syndrome (with obstruction of the ductus arteriosus and pulmonary hypertension);
impaired kidney function, which may progress to renal failure with the development of oligohydramnios;
Risks for mother and baby at the end of pregnancy:
prolongation of bleeding time (effect of inhibiting platelet aggregation), which is possible even when using low doses;
Delayed uterine contractions with corresponding delayed labor and prolonged labor.
Breast-feeding.
There is no data on the penetration of dexketoprofen into breast milk. The use of ANALGODEX is contraindicated during breastfeeding.
Fertility
Like all other NSAIDs, dexketoprofen may reduce female fertility and is therefore not recommended for use in women planning pregnancy.
Like all other NSAIDs, dexketoprofen may impair female reproductive function and is therefore not recommended for use in women attempting to conceive. If a woman has difficulty conceiving or is undergoing investigation of infertility, discontinuation of ANALGODEX should be considered. Dexketoprofen should only be used during the first and second trimesters of pregnancy if clearly needed.
Ability to influence reaction speed when driving vehicles or other mechanisms
Dizziness, drowsiness and increased fatigue may occur while using ANALGODEX. In such cases, the ability to react quickly, navigate the road situation and drive vehicles or other mechanisms may deteriorate.
Method of administration and doses
Adults.
The recommended dose is 50 mg every 8–12 hours. If necessary, a second dose should be administered after 6 hours. The maximum daily dose should not exceed 150 mg. ANALGODEX is intended for short-term treatment, therefore it should be used only during the period of acute pain (no longer than 2 days). Patients should be transferred to oral analgesics, if possible. Adverse reactions can be reduced by using the lowest effective dose for the shortest possible time necessary to improve the condition. For moderate or severe postoperative pain, ANALGODEX can be used according to indications in the same recommended doses in combination with opioid analgesics.
Elderly patients.
Dose adjustment is usually not necessary. However, due to physiological decline in renal function, a lower maximum daily dose of 50 mg is recommended in mild renal impairment.
Patients with impaired liver function.
For patients with mild or moderate liver disease (Child-Pugh score 5-9), the maximum daily dose should be reduced to 50 mg and liver function should be closely monitored. In severe liver disease (Child-Pugh score 10-15), ANALGODEX is contraindicated.
Patients with renal impairment.
For patients with mild renal impairment (creatinine clearance 50–80 ml/min), the maximum daily dose should be reduced to 50 mg. In patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min), ANALGODEX is contraindicated.
ANALGODEX should not be used in children and adolescents due to the lack of data on its efficacy and safety.
Intramuscular injection.
The injection solution should be injected slowly deep into the muscle.
Intravenous infusion.
For intravenous infusion, the contents of the ampoule (2 ml) should be diluted in 30–100 ml of 0.9% sodium chloride solution, glucose solution or lactated Ringer's solution. The infusion solution should be prepared under aseptic conditions, avoiding exposure to natural daylight. The prepared solution should be clear. The infusion should be carried out within 10–30 minutes. Avoid exposure to natural daylight on the prepared solution.
Dexketoprofen diluted in 0.9% sodium chloride solution or glucose solution can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
Dexketoprofen should not be mixed in an infusion solution with promethazine and pentazocine.
Intravenous injection (bolus administration).
If necessary, the contents of 1 ampoule (2 ml of solution for injection) are administered intravenously over at least 15 seconds.
The drug can be mixed in small volumes (e.g., in a syringe) with injectable solutions of heparin, lidocaine, morphine, and theophylline.
Dexketoprofen should not be mixed in small volumes (e.g. in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine and hydrocortisone due to the formation of a white precipitate.
For intramuscular or intravenous injection, the drug should be administered immediately after withdrawal from the ampoule. The solution for intravenous infusion should be used immediately after preparation.
When storing diluted solutions in polyethylene bags or in products made of ethyl vinyl acetate, cellulose propionate, low density polyethylene and polyvinyl chloride designed for administration, no changes in the content of the active substance due to sorption were observed.
ANALGODEX is intended for single use, therefore the remains of the finished solution should be poured out. Before administration, it is necessary to make sure that the solution is clear and colorless. A solution containing visible foreign inclusions should not be used.
Children.
ANALGODEX should not be used in children and adolescents due to the lack of data on its efficacy and safety.
Overdose
Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment should be immediately initiated according to the patient's condition. Dexketoprofen trometamol is removed from the body by dialysis.
Adverse reactions
The following categories are used to classify the frequency of adverse reactions:
very common (≥1/10), common (≥1/100 - <1/10), uncommon (≥1/1000 - <1/100), rare (≥1/10000 - <1/1000), very rare (<1/10000) or unknown (cannot be estimated from the available data).
The following are listed by organ system and frequency of occurrence, adverse reactions whose relationship to dexketoprofen trometamol is considered at least possible according to clinical studies, as well as adverse reactions reported after the marketing of dexketoprofen trometamol.
Blood/lymphatic system disorders
Uncommon: anemia.
Very rare: neutropenia, thrombocytopenia.
On the part of the immune system
Rare: laryngeal edema.
Very rare: anaphylactic reactions, including anaphylactic shock.
Nutritional and metabolic disorders
Rare: hyperglycemia, hypoglycemia, hypertriglyceridemia, anorexia, lack of appetite.
Mental disorders
Uncommon: insomnia, anxiety.
From the nervous system
Uncommon: headache, dizziness, drowsiness.
Rare: paresthesia, fainting.
From the organs of vision
Uncommon: blurred vision.
From the hearing organs
Uncommon: vertigo.
Rare: ringing in the ears.
From the heart
Uncommon: palpitations.
Rare: extrasystole, tachycardia.
From the vascular system
Uncommon: hypotension, hot flashes.
Rare: arterial hypertension, superficial vein thrombophlebitis.
Respiratory, thoracic and mediastinal disorders
Rare: bradypnea.
Very rare: bronchospasm, shortness of breath.
From the digestive tract
Common: nausea, vomiting.
Uncommon: abdominal pain, dyspepsia, diarrhoea, constipation, haematemesis, dry mouth
Rare: peptic ulcer, bleeding or perforation.
Very rare: pancreatitis.
Hepatobiliary system
Rare: hepatitis, jaundice.
Very rare: hepatocellular pathology.
Skin and subcutaneous tissue disorders
Uncommon: dermatitis, itching, rash, increased sweating.
Rare: urticaria, acne.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity.
Musculoskeletal and connective tissue disorders
Rare: muscle rigidity, joint stiffness, muscle cramps, back pain.
Renal and urinary disorders
Rare: acute renal failure, polyuria, renal pain, ketonuria, proteinuria.
Very rare: nephritis, nephrotic syndrome.
From the reproductive system
General disorders and administration site conditions
Common: injection site pain, injection site reactions including inflammation, haematoma, bleeding.
Uncommon: fever, fatigue, pain, chills, asthenia, malaise.
Rare: tremor, peripheral edema.
Laboratory indicators
Rare: liver function test abnormalities.
The most common adverse reactions were gastrointestinal disorders.
Possible development of peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients. According to available data, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic phenomena, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease may occur against the background of the drug. Gastritis is observed less often. Edema, arterial hypertension and heart failure, which may be caused by the use of NSAIDs, have also been noted. As with the use of 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 reactions (purpura, aplastic and hemolytic anemia, rarely - agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), are possible.
As shown by the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses and for a long time, slightly increases the risk of developing pathology caused by arterial thrombosis, such as myocardial infarction and stroke.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
After dilution, store the solution for 24 hours at 2–8 °C.
Incompatibility.
ANALGODEX should not be mixed in small volumes (e.g. in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine and hydrocortisone, as a white precipitate forms.
Diluted infusion solutions prepared as described in the section "Method of administration and dosage. Intravenous infusion" must not be mixed with promethazine or pentazocine.
Packaging
2 ml in an ampoule, 5 ampoules in a blister pack, 1 blister pack in a cardboard box.
Vacation category
According to the recipe.
Producer
Steryl-Jen Life Sciences (P) Ltd.
Location of the manufacturer and address of its place of business.
No. 45, Mangalam Main Road, Villianur Commune, Puducherry, 605110, India.
