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Name of the medicinal product
Enantyum 25 mg
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
PO and IV
Prophylaxis of organ rejection in patients receiving allogenic liver, kidney, or heart transplants. Used in conjunction with adrenal corticosteroids. Used in conjunction with azathioprine or mycophenolate mofetil in heart and kidney transplant patients.
As second-line therapy for the short-term and noncontinuous long-term treatment of moderate to severe atopic dermatitis.
PO and IV
Prophylaxis of rejection for patients receiving bone marrow, pancreas, pancreatic island cell, and small bowel transplantation; treatment of autoimmune disease (ie, rheumatoid arthritis); prevention and treatment of acute graft-versus-host disease following hematopoietic stem cell transplantation; treatment of Crohn disease; treatment of pyoderma gangrenosum.
Treatment of vitiligo; cutaneous lupus erythematosis; facial, flexural, and intertriginous psoriasis; oral or genital lichen planus; pyoderma gangrenosum.
Dosage (Posology) and method of administration
Tablet: General Population: According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hrs or 25 mg every 8 hrs. The total daily dose should not exceed 75 mg. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Enantyum 25 mg tablets are not intended for long-term use and the treatment must be limited to the symptomatic period.
Concomitant administration with food delays the absorption rate of the drug, thus in case of acute pain, it is recommended that administration is at least 30 min before meals.
Elderly: In elderly patients it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dosage may be increased to that recommended for the general population only after good general tolerance has been ascertained.
Hepatic Dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Enantyum 25 mg tablets should not be used in patients with severe hepatic dysfunction.
Renal Dysfunction: The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function. Enantyum 25 mg tablets should not be used in patients with moderate to severe renal dysfunction.
Injection: Adults: The recommended dose is 50 mg every 8-12 hrs. If necessary, the administration can be repeated 6 hrs apart. The total daily dose should not exceed 150 mg.
Enantyum 25 mg solution for injection or concentrate for solution for infusion is intended for short-term use and the treatment must be limited to the acute symptomatic period (not >2 days). Patients should be switched to an oral analgesic treatment when possible.
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
In case of moderate to severe postoperative pain, Enantyum 25 mg solution for injection or concentrate for solution for infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults.
Elderly: No dosage adjustment is generally necessary in elderly patients. However, because of the physiological decline in renal function in elderly patients a lower dose is recommended in case of mild renal function impairment: 50 mg total daily dose.
Liver Disease: The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate (Child-Pugh score 5-9) hepatic impairment and hepatic function should be closely monitored. Enantyum 25 mg solution for injection or concentrate for solution for infusion should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10-15).
Renal Dysfunction: The dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (CrCl 50-80 mL/min). Enantyum 25 mg solution for injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (CrCl <50 mL/min).
Administration: Injection: Enantyum 25 mg solution for injection or concentrate for solution for infusion can be administered either by IM or IV route:
Intramuscular Use: The content of 1 ampoule (2 mL) of Enantyum 25 mg solution for injection or concentrate for solution for infusion should be administered by slow injection deep into the muscle.
Intravenous Infusion: The diluted solution, should be administered as a slow IV infusion, lasting 10-30 min. The solution must be always protected from natural daylight.
Intravenous Bolus: If necessary, the content of 1 ampoule (2 mL) of Enantyum 25 mg solution for injection or concentrate for solution for infusion can be administered in a slow IV bolus over no less than 15 sec.
Instructions on Handling: When Enantyum 25 mg is administered IM or as IV bolus, the solution should be injected after its removal from the colored ampoule. For administration as IV infusion, the solution should be diluted aseptically and protected from natural daylight.
Absolute Contraindications:Not to be given to those patients who have history of stroke (cerebrovascular accident), heart attack (myocardial infarction), coronary artery bypass graft, uncontrolled hypertension, congestive heart failure (CHF) NYHA II-IV.
Contraindications:Enantyum 25 mg must not be administered in the following cases: Patients hypersensitive to Enantyum 25 mg, to any other NSAID, or to any of the excipients of Enantyum 25 mg; patients in whom substances with a similar action (eg, aspirin or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic edema; patients with active or suspected peptic ulcer/hemorrhage or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding) or chronic dyspepsia; history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; gastrointestinal bleeding or other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure; moderate to severe renal dysfunction (CrCl <50 mL/min); severely impaired hepatic function (Child-Pugh score 10-15); hemorrhagic diathesis and other coagulation disorders.
Injection: Enantyum 25 mg solution for injection or concentrate for solution for infusion is contraindicated for neuraxial (intrathecal or epidural) administration due to its ethanol content.
Use in Pregnancy & Lactation: Not to be used during the 3rd trimester of pregnancy and lactation period.
During the 3rd trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
At the end of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses and inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Enantyum 25 mg trometamol is contraindicated during the 3rd trimester of pregnancy.
It is not known whether Enantyum 25 mg is excreted in human milk.
Use in Children: Enantyum 25 mg has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and Enantyum 25 mg should not be used in children and adolescents.
Special warnings and precautions for use
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Enantyum 25 mg is used in the treatment of mild to moderate pain such as such as muscular pain, painful menstrual periods (dysmenorrhoea) and toothache.
Interaction with other medicinal products and other forms of interaction
The following interactions apply to NSAIDs in general: Inadvisable Combinations: Other NSAIDs, Including High Doses of Salicylates (≥3 g/day): Administration of several NSAIDs together may increase the risk of gastrointestinal ulcers and bleeding, via a synergistic effect.
Anticoagulants: NSAIDs may enhance the effects of anticoagulants eg, warfarin, due to the high plasma protein-binding of Enantyum 25 mg and the inhibition of platelet function and damage to the gastroduodenal mucosa. If the combination cannot be avoided, close clinical observation and monitoring of laboratory values should be carried out.
Heparins: Increased risk of hemorrhage (due to the inhibition of platelet function and damage to the gastroduodenal mucosa). If the combination cannot be avoided, close clinical observation and monitoring of laboratory values should be carried out.
Corticosteroids: There is an increased risk of gastrointestinal ulceration or bleeding.
Lithium (Described with Several NSAIDs): NSAIDs increase blood lithium levels, which may reach toxic values (decreased renal excretion of lithium). This parameter therefore requires monitoring during the initiation, adjustment and withdrawal of treatment with Enantyum 25 mg.
Methotrexate Used at High Doses of ≥15 mg/week: Increased hematological toxicity of methotrexate via a decrease in its renal clearance by anti-inflammatory agents in general.
Hydantoins and Sulphonamides: The toxic effects of these substances may be increased.
Combinations Requiring Precautions: Diuretics, Angiotensin-converting Enzyme (ACE) Inhibitors and Angiotensin II Receptor Antagonists: Enantyum 25 mg may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (eg, dehydrated or elderly patients with compromised renal function), the co-administration of agents that inhibit cyclooxygenase and ACE inhibitors or angiotensin II receptor antagonists may result in further deterioration of renal function, which is usually reversible. In case of combined prescription of Enantyum 25 mg and a diuretic, it is essential to ensure that the patient is adequately hydrated and to monitor renal function at the start of the treatment.
Methotrexate Used at Low Doses <15 mg/week: Increased hematological toxicity of methotrexate via a decrease in its renal clearance by anti-inflammatory agents in general. Weekly monitoring of blood count during the 1st weeks of the combination. Increased surveillance in the presence of even mildly impaired renal function, as well as in the elderly.
Pentoxyfylline: Increased risk of bleeding. Intensify clinical monitoring and check bleeding time more often.
Zidovudine: Risk of increased red cell line toxicity via action on reticulocytes, with severe anemia occurring 1 week after the NSAID is started. Check complete blood count and reticulocyte count 1-2 weeks after starting treatment with the NSAID.
Sulfonylureas: NSAIDs can increase the hypoglycemic effect of sulfonylureas by displacement from plasma protein-binding sites.
Combinations Needing to be Taken Into Account: Beta-blockers: Treatment with an NSAID may decrease their antihypertensive effect via inhibition of prostaglandin synthesis.
Cyclosporin and Tacrolimus: Nephrotoxicity may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combination therapy, renal function has to be measured.
Thrombolytics: Increased risk of bleeding.
Anti-platelet Agents and Selective Serotonin Reuptake Inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Probenecid: Plasma concentrations of Enantyum 25 mg may be increased; this interaction can be due to an inhibitory mechanism at the site of renal tubular secretion and of glucuronoconjugation and requires adjustment of the dose of Enantyum 25 mg.
Cardiac Glycosides: NSAIDs may increase plasma glycoside concentration.
Mifepristone: Because of a theoretical risk that prostaglandin synthetase inhibitors may alter the efficacy of mifepristone, NSAIDs should not be used for 8-12 days after mifepristone administration.
Quinolone Antibiotics: Animal data indicate that high doses of quinolones in combination with NSAIDs can increase the risk of developing convulsions.
Incompatibilities: Injection: Enantyum 25 mg solution for injection or concentrate for solution for infusion must not be mixed in a small volume (eg, in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine or hydroxyzine, as this will result in a precipitation of the solution.
The diluted solutions for infusion obtained as stated in Instructions for Use and Handling under Cautions for Usage, must not be mixed with promethazine or pentazocine.
Enantyum 25 mg must not be mixed with other medicinal products except those mentioned in Instructions for Use and Handling under Cautions for Usage.
The adverse reactions reported as at least possibly related with Enantyum 25 mg trometamol in clinical trials, as well the adverse reactions reported after the marketing of Enantyum 25 mg tablets and solution for injection or concentrate for solution for infusion are tabulated as follows, classified by system organ class and ordered by frequency:
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed. Edema, hypertension and cardiac failure have been reported in association with NSAIDs treatment.
As with other NSAIDs the following undesirable effects may appear: Aseptic meningitis, which might predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease; hematological reactions (purpura, aplastic and hemolytic anemia and rarely agranulocytosis and medullar hypoplasia).
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).
Qualitative and quantitative composition
Each tablet contains Dexketoprofen trometamol equivalent to Enantyum 25 mg 25 mg.
Enantyum 25 mg, an arylpropionic acid derivative, is the S(+)-enantiomer of ketoprofen. Enantyum 25 mg trometamol is the tromethamine salt of S-(+)-2-(3-benzoylphenyl)propionic acid, an analgesic, anti-inflammatory and antipyretic drug, which belongs to the nonsteroidal anti-inflammatory drugs (NSAIDs). Enantyum 25 mg is C16H1403·C4H11NO3 with a molecular weight of 375.42.
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