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Tablet: Treatment of pain of mild to moderate intensity eg, musculoskeletal, dysmenorrheal and dental pain.
Injection: Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate eg, postoperative, renal colic and low back pain.
Uses of Arveles in details
Arveles is used in the treatment of mild to moderate pain such as such as muscular pain, painful menstrual periods (dysmenorrhoea) and toothache.
Each tablet contains Dexketoprofen equivalent to Arveles 25 mg.
Arveles, an arylpropionic acid derivative, is the S(+)-enantiomer of ketoprofen. Arveles 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). Arveles is C16H1403·C4H11NO3 with a molecular weight of 375.42.
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.
Arveles 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. Arveles 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. Arveles 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.
Arveles 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, Arveles 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. Arveles 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). Arveles 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: Arveles 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 Arveles 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 Arveles 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 Arveles 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.
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 Arveles 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 Arveles.
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: Arveles 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 Arveles 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 Arveles 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 Arveles.
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: Arveles 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.
Arveles must not be mixed with other medicinal products except those mentioned in Instructions for Use and Handling under Cautions for Usage.
Arveles side effects
The adverse reactions reported as at least possibly related with Arveles in clinical trials, as well the adverse reactions reported after the marketing of Arveles 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).
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:Arveles must not be administered in the following cases: Patients hypersensitive to Arveles, to any other NSAID, or to any of the excipients of Arveles; 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: Arveles 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, Arveles is contraindicated during the 3rd trimester of pregnancy.
It is not known whether Arveles is excreted in human milk.
Use in Children: Arveles has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and Arveles should not be used in children and adolescents.
Active ingredient matches for Arveles:
Dexketoprofen in Turkey.
List of Arveles substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Deksalgin (Bosnia & Herzegowina, Turkey)|
|Desketo (Chile, Italy)|
|Tablet; Oral; Dexketoprofen Trometamol 25 mg (Malesci)|
|Dexak SL (Poland)|
|Dexalgin (Austria, Georgia)|
|Injectable; Injection; Dexketoprofen Trometamol 25 mg / ml|
|Tablet, Film-Coated; Oral; Dexketoprofen Trometamol 25 mg|
|Dexalgin - 10 Tablets||$ 10.40|
|Dexalgin 25 (Russia)|
|Dexcetoprofeno Combino (Portugal)|
|Dexketo care (Egypt)|
|Dexketoprofen (Colombia, Denmark, Estonia, Finland, France, Indonesia, Italy, Latvia, Lithuania, Luxembourg, Peru, Poland, Portugal, Slovakia, Slovenia, Spain, Switzerland)|
|Dexketoprofen Rompharm (Romania)|
|Dexketoprofen Sandoz (Denmark)|
|Dexketoprofen Trometamol Yarindo (Indonesia)|
|Dexketoprofene Sandoz (Italy)|
|Dexketoprofeno Actavis (Spain)|
|Dexketoprofeno Apotex (Spain)|
|Dexketoprofeno Cinfa (Spain)|
|Dexketoprofeno Fermon (Spain)|
|Dexketoprofeno Kern Pharma (Spain)|
|Dexketoprofeno Mabo (Spain)|
|Dexketoprofeno Mylan (Spain)|
|Dexketoprofeno Normon (Spain)|
|Dexketoprofeno Pensa (Spain)|
|Dexketoprofeno Qualigen (Spain)|
|Dexketoprofeno Ratiopharm (Spain)|
|Dexketoprofeno Sandoz (Spain)|
|Dexketoprofeno Stada (Spain)|
|Dexketoprofeno Tarbis (Spain)|
|Dexketoprofeno Tecnigen (Spain)|
|Dexketoprofeno Teva (Spain)|
|Dexketoprofeno Vir (Spain)|
|Dexketoprofeno Zentiva (Spain)|
|Dexketoproteg (El Salvador, Guatemala)|
|Dexofen (Bulgaria, Sweden)|
|Dexoket (Czech Republic)|
|Dexomen (Bosnia & Herzegowina, Serbia)|
ReviewsThe results of a survey conducted on ndrugs.com for Arveles are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Arveles. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
4 consumers reported time for resultsTo what extent do I have to use Arveles before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Arveles. To get the time effectiveness of using Arveles drug by other patients, please click here.
14 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology