Dexalgin® 25 (Dexalgin® 25)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceDexketoprofenDexketoprofen
Similar drugsTo uncover
  • Dexalgin®
    solution w / m in / in 
    Berlin-Chemie / Menarini Pharma, GmbH     Germany
  • Dexalgin®
    granules inwards 
    Berlin-Chemie, AG     Germany
  • Dexalgin® 25
    pills inwards 
    Berlin-Chemie / Menarini Pharma, GmbH     Germany
  • Dexketoprofen KERN PHARMA
    pills inwards 
    Kern Pharma S.L.     Spain
  • Dexonal®
    pills inwards 
    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
  • Flamadex®
    pills inwards 
    FarmSirma Soteks, ZAO     Russia
  • Flamadex®
    solution w / m in / in 
    FarmSirma Soteks, ZAO     Russia
    • Dosage form: & nbspfilm coated tablets

    Composition:

    Composition per one tablet:

    Core:

    Active substance:

    Dexketoprofen trometamol is 36.90 mg,

    (equivalent to dexketoprofen) is 25.00 mg.

    Excipients: cellulose microcrystalline - 141.20 mg, corn starch - 49.60 mg, sodium carboxymethyl starch (type A) - 27.10 mg, glycerol distearate - 5.20 mg.

    Film Sheath: hypromellose - 1,34 mg, titanium dioxide (E 171) - 0.36 mg, macrogol 6000 - 0.60 mg, propylene glycol - 0.42 mg.

    Description:

    Round biconvex tablets, coated with a white film coating, with a risk on both sides of the tablet.

    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drugs (NSAIDs)
    ATX: & nbsp

    M.01.A.E   Propionic acid derivatives

    M.01.A.E.17   Dexketoprofen

    Pharmacodynamics:

    Dexketoprofen trometamol, the active substance of the drug Dexalgin® 25, refers to non-steroidal anti-inflammatory drugs (NSAIDs), which exerts an analgesic, anti-inflammatory and antipyretic effect. The mechanism of action of dexketoprofen is based on inhibiting the synthesis of prostaglandins at the level of cyclooxygenases (COX-1 and COX-2).

    An analgesic effect occurs 30 minutes after ingestion, the duration of the therapeutic action is 4-6 hours.

    Pharmacokinetics:

    Suction. Time to reach the maximum concentration (TCmOh) dexketoprofen in the blood plasma after a single ingestion of a single dose averages 30 min (15-60 min). Simultaneous food intake slows down the absorption of dexketoprofen. The area under the concentration-time curve (AUC) after a single and repeated procedures are similar, which indicates the absence of cumulation of the drug.

    Distribution. Dexketoprofen is characterized by a high degree of binding to plasma proteins (99%). Average distribution volume (Vd) is less than 0.25 l / kg, the half-distribution period is about 0.35 h.

    Metabolism and excretion. The main way of metabolism of dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. The half-life period (T1 / 2) of dexketoprofen is 1.65 hours. In elderly people, the half-life is prolonged to 48% and the overall clearance of the drug decreases.

    Indications:

    Musculoskeletal pain (mild or moderately severe), algodismenorea, toothache.

    The drug is intended for symptomatic treatment, reducing pain and inflammation at the time of application.

    Contraindications:

    - hypersensitivity to dexketoprofen, other components of the drug and other NSAIDs;

    - complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis);

    - erosive-ulcerative lesions of the gastrointestinal tract in the stage of exacerbation;

    - gastrointestinal hemorrhages or perforations in the anamnesis, including those associated with prior NSAID administration;

    - gastrointestinal bleeding; other active bleeding (including a suspicion of intracranial hemorrhage);

    - Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute stage;

    - Hepatic insufficiency of severe severity (10-15 points on the Child-Pugh scale);

    - progressive kidney disease, confirmed hyperkalemia;

    - chronic kidney disease: stage 3a (glomerular filtration rate (GFR) 45-59 ml / min / 1.73 m2), 36 (GFR 30-44 ml / min / 1.73 m2) and 4 (GFR <30 ml / min / 1.73 m2).

    - period after aortocoronary shunting;

    - severe heart failure (III-IV classification class NYHA);

    - hemorrhagic diathesis and other disorders of blood coagulation;

    - age under 18 years (due to lack of data on efficiency and safety);

    - Pregnancy and the period of breastfeeding.

    Carefully:

    Stomach and duodenal ulcer, ulcerative colitis, Crohn's disease, liver disease in history, hepatic porphyria, chronic kidney disease, stage 2 (GFR 60-89 ml / min / 1.73 m2), chronic heart failure, arterial hypertension, a significant decrease in the volume of circulating blood (including after surgery), elderly patients over 65 years of age (incl.weakened patients with low body weight), bronchial asthma, simultaneous reception of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, bug idol), selective inhibitors of re-uptake serotonin (including citalopram, fluoxetine, paroxetine, sertraline), ischemic heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, infection Helicobacter pylori, systemic lupus erythematosus (SLE) and other systemic diseases of connective tissue, long-term use of non-steroidal anti-inflammatory drugs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

    Pregnancy and lactation:

    Use of the drug Dexalgin® 25 during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    The drug Dexalgin® 25 is taken orally during meals. Simultaneous food intake slows down the absorption of dexketoprofen, so in case of acute pain, the use of the drug is recommended at least 30 minutes before meals.

    Depending on the intensity of the pain syndrome, the recommended adult dose is 12.5 mg of dexketoprofen (7g tablets of Dexalgin® 25) every 4 to 6 hours or 25 mg of dexketoprofen (1 tablet of Dexalgin® 25) every 8 hours. The maximum daily dose - 75 mg.

    The drug Dexalgin® 25 is not intended for long-term therapy, the course of treatment with the drug should not exceed 3-5 days.

    Patients 65 years of age or older

    Older patients should take Dexalgin® 25, starting at the minimum recommended dose. The maximum daily dose is 50 mg. In case of good tolerability, doses recommended for the general population may be used.

    Patients with hepatic insufficiency

    Patients with mild to moderate hepatic insufficiency should take Dexalgin® 25, starting at the minimum recommended dose. The maximum daily dose is 50 mg.

    The use of the drug Dexalgin® 25 in patients with hepatic insufficiency of severe severity is contraindicated.

    Patients with renal insufficiency

    Patients with mild renal insufficiency - chronic disease kidney, stage 2 (GFR 60-89 ml / miy/ 1.73 m2) should take the drug Dexalgin® 25, starting with the minimum recommended dose. The maximum daily dose is 50 mg. Use of Dexalgin® 25 in patients with chronic kidney disease of stages 3a (GFR 45-59 mL / min / 1.73 m2), 36 (GFR 30-44 ml / min / 1.73 m2) and 4 (GFR <30 ml / min / 1.73 m2) is contraindicated.

    Side effects:

    Possible side effects are given in accordance with World Health Organization classifications below in descending frequency: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100 ), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), including individual messages.

    Violations of the blood and lymphatic system

    Rarely: neutropenia, thrombocytopenia.

    Immune system disorders

    Rarely: laryngeal edema;

    Rarely: anaphylactic reactions, including anaphylactic shock.

    Disturbances from the nervous system

    Infrequently: headache, dizziness, drowsiness;

    Rarely: paresthesia, syncopal conditions (transient brief syncope).

    Disorders from the psyche

    Infrequently: insomnia, a feeling of anxiety.

    Hearing disorders and labyrinthine disorders

    Infrequently: vertigo;

    Rarely: noise in ears.

    Disturbances on the part of the organ of sight

    Rarely: blurred vision.

    Disorders from the cardiovascular system

    Infrequently: feeling of palpitation, a feeling of heat, hyperemia of the skin;

    Rarely: increased blood pressure;

    Rarely: tachycardia, lowering blood pressure.

    Disturbances from the respiratory system

    Rarely: bradypnoe;

    Rarely: bronchospasm, shortness of breath.

    Disorders from the gastrointestinal tract

    Often: nausea, vomiting, abdominal pain, indigestion, diarrhea;

    Infrequently: gastritis, constipation, dry mouth, flatulence;

    Rarely: erosive-ulcerative lesions of the gastrointestinal tract (GIT), bleeding from the ulcer or its perforation;

    Rarely: defeat of the pancreas.

    Disturbances from the liver and bile ducts

    Rarely: hepatitis, increased activity of "liver" enzymes (ALT, ACT);

    Rarely: liver damage.

    Disorders from the kidneys and urinary tract

    Rarely: polyuria, acute renal failure;

    Rarely: nephritis or nephrotic syndrome.

    Disorders from the reproductive system

    Rarely: in women - a menstrual cycle, in men - transient dysfunction of the prostate gland with prolonged use.

    Disorders from the musculoskeletal system

    Rarely: backache.

    Disturbances from the skin and subcutaneous tissues

    Infrequently: skin rash;

    Rarely: urticaria, acne, increased sweating;

    Rarely: severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)), angioedema, facial edema, allergic dermatitis, photosensitivity, skin itching.

    Metabolic disorders

    Rarely: anorexia.

    Common violations

    Infrequently: increased fatigue, asthenia, chills, general malaise;

    Rarely: peripheral edema.

    As with other NSAIDs, the following side effects may develop: aseptic meningitis, which develops primarily in patients with systemic lupus erythematosus or other systemic connective tissue diseases, hematologic disorders (thrombocytopenic purpura, aplastic and hemolytic anemia, in rare cases, agranulocytosis and bone marrow hypoplasia).

    Overdose:

    Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.

    Treatment: symptomatic therapy, if necessary - gastric lavage, reception of activated charcoal; hemodialysis is ineffective.

    Interaction:

    The following interactions are typical for all NSAIDs.

    Unwanted combinations

    With other NSAIDs, including salicylates in high doses (more than 3 g / day): simultaneous application of several NSAIDs due to synergistic effect increases the risk of developing gastrointestinal bleeding and ulcers.

    With anticoagulants: dexketoprofen, like other NSAIDs, can enhance the effect of anticoagulants, such as warfarin in connection with the high degree of binding to blood plasma proteins, inhibition of platelet aggregation and damage to the mucous membrane of the gastrointestinal tract. In the case of the need for simultaneous use, careful monitoring of the patient's condition and regular monitoring of laboratory parameters are necessary.

    With heparin: with simultaneous use increases the risk of bleeding (due to the inhibition of platelet aggregation and damage to the mucous membrane of the gastrointestinal tract).In the case of the need for simultaneous use, careful monitoring of the patient's condition and regular monitoring of laboratory parameters are necessary.

    With glucocorticosteroids: with simultaneous use increases the risk of ulcerative lesions of the gastrointestinal tract and bleeding.

    With lithium preparations: NSAIDs increase the concentration of lithium in the blood plasma down to toxic, therefore, this indicator should be monitored with simultaneous use with dexketoprofen, dosage changes, and after the abolition of NSAIDs.

    With methotrexate in high doses (15 mg / week and more): it is possible to increase hematological toxicity of methotrexate due to a decrease in its renal clearance with simultaneous use with NSAIDs.

    With hydantoins and sulfonamides: it is possible to intensify their toxic effects. Combinations, requiring caution

    With diuretics, angiotensin-converting enzyme (ACE) inhibitors, antibiotics from the aminoglycoside group, antagonists of the angiotensin-II: concurrent use with NSAIDs is associated with a risk of developing acute renal failure in dehydrated patients (reduced glomerular filtration due to reduced synthesis of prostaglandins).With the simultaneous use of NSAIDs can reduce the antihypertensive effect of certain drugs. When concomitantly using dexketoprofen and diuretics, it is necessary to make sure that the patient has no signs of dehydration, and also at the beginning of simultaneous application to monitor kidney function.

    With methotrexate in low doses (less than 15 mg / week): possibly increasing hematological toxicity of methotrexate in connection with a decrease in its renal clearance against the background of simultaneous use with NSAIDs. It is necessary to count the blood cells at the beginning of the simultaneous application. In the presence of a violation of kidney function, even mild, as well as in the elderly, careful medical supervision is necessary.

    With pentoxifylline: possibly increased risk of bleeding. A thorough clinical monitoring and regular checking of bleeding time (blood clotting time) is necessary.

    FROM zidovudine: there is a risk of increasing the toxic effect on erythrocytes due to exposure to reticulocytes, with the development of severe anemia a week after the initiation of NSAID use.It is necessary to conduct a general blood test with counting the number of reticulocytes 1-2 weeks after the initiation of therapy with NSAIDs.

    FROM by oral hypoglycemic agents: NSAIDs can enhance hypoglycemic effect of sulfonylurea preparations due to the displacement of sulfonylurea from binding sites to plasma proteins.

    Combinations, which must be taken into account

    FROM βadrenoblockers: When used simultaneously with NSAIDs, the antihypertensive effect may decrease βadrenoblockers due to inhibition of prostaglandin synthesis.

    With cyclosporine and tacrolimus: NSAIDs can increase nephrotoxicity, which is mediated by the action of renal prostaglandins. With simultaneous use, it is necessary to monitor kidney function.

    With thrombolytics: increased risk of bleeding.

    The risk of bleeding from the gastrointestinal tract increases with simultaneous application with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline) and anticoagulants.

    With probenecid: possibly an increase in the concentration of NSAIDs in the blood plasma,which may be due to the inhibitory effect of probenecid on renal tubular secretion and / or conjugation with glucuronic acid; may need to adjust the dose of NSAIDs.

    With cardiac glycosides: simultaneous use with NSAIDs may lead to an increase in the concentration of cardiac glycosides in blood plasma.

    With mifepristone: in connection with the theoretical risk of changing the effectiveness of mifepristone under the influence of inhibitors of prostaglandin synthesis, NSAIDs should not be used earlier than through 8-12 day after the abolition of mifepristone.

    With quinolones: the data obtained in experimental studies on animals indicate a high risk of seizures with the simultaneous use of NSAIDs with quinolones in high doses.

    In case of simultaneous use of the drug Dexalgin® 25 with the above medicines should consult a doctor.

    Special instructions:

    Unwanted side effects can be minimized by using the drug at the lowest effective dose with the minimum duration of application necessary to relieve the pain syndrome.

    The risk of complications from the gastrointestinal tract is increased in patients with peptic ulcer disease in the anamnesis, in elderly patients, with an increase in the dose of NSAIDs; therefore, the use of Dexalgin® 25 in this category of patients should start with the lowest recommended dose.

    Patients of the above categories, as well as patients who require the simultaneous use of low doses of acetylsalicylic acid or other agents that increase the risk of complications from the gastrointestinal tract, it is recommended additionally simultaneous application of gastroprotectors (misoprostol or proton pump blockers).

    In patients who simultaneously take antiplatelet or anticoagulants, glucocorticosteroids also increase the risk of gastrointestinal bleeding.

    Patients with impaired gastrointestinal tract or gastrointestinal diseases in a history should be under close medical supervision. In the case of gastrointestinal bleeding or ulcerative lesions, use of the drug Dexalgin® 25 should be discontinued.

    The drug Dexalgin ® 25 should be used with caution in patients with gastrointestinal ailments in history (ulcerative colitis, Crohn's disease), as possible exacerbation of these diseases.

    All NSAIDs can inhibit platelet aggregation and increase bleeding time by inhibiting the synthesis of prostaglandins. In this regard, the use of the drug Dexalgin® 25 in patients who simultaneously take drugs that affect the hemostasis system, such as warfarin, coumarin derivatives and heparins, is not recommended.

    Like other NSAIDs, the drug Dexalgin® 25 can lead to an increase in the concentration of creatinine and nitrogen in the blood plasma. Like other inhibitors of prostaglandin synthesis, Dexalgin® 25 can have a side effect on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Care should be taken when using the drug in patients who simultaneously use diuretics and patients who may develop hypovolemia, due to the increased risk of nephrotoxicity.

    As with the application of other NSAIDs, against the background of therapy with the drug Dexalgin® 25 there may be a slight transient increase in the activity of "liver" enzymes. Older patients need to monitor liver and kidney function. In the case of a significant increase in the relevant indicators, the use of the drug Dexalgin® 25 should be discontinued.

    Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. In case of signs of infection or deterioration of well-being against the background of the use of the drug Dexalgin® 25, the patient should immediately consult a doctor.

    The drug can cause fluid retention in the body, so in patients with hypertension, with renal and / or heart failure, Dexalgin® 25 should be used with extreme caution. In case of worsening, the use of Dexalgin® 25 should be discontinued.

    In patients with uncontrolled hypertension, ischemic heart disease, congestive heart failure, peripheral arterial disease and / or cerebrovascular disease, the drug should be used with caution.A similar approach is applicable to patients with risk factors for developing cardiovascular diseases (hypertension, hyperlipidemia, diabetes, smoking).

    Caution should be exercised when prescribing Dexalgin® to 25 patients with a history of cardiovascular disease, especially patients with heart failure, because of the possible risk of progression. Clinical studies and epidemiological data suggest that NSAIDs, especially in high doses and with long-term use, can lead to an insignificant risk of developing acute myocardial infarction or stroke. To exclude the risk of these events, the use of dexketoprofen does not suffice.

    Elderly patients are particularly susceptible to adverse reactions with NSAIDs, including the risk of gastrointestinal bleeding and perforations that threaten the patient's life, reduce kidney, liver and heart function. When using Dexalgin® 25 in this category of patients, proper clinical control is necessary.

    There are data on the occurrence of rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome,toxic epidermal necrolysis) when using NSAIDs. At the first manifestations of skin rash, lesions of mucous membranes or other signs of an allergic reaction, taking Dexalgin® 25 should be stopped immediately and consult a doctor.

    Effect on the ability to drive transp. cf. and fur:In connection with the possible occurrence of dizziness and drowsiness during the use of the drug Dexalgin® 25, the ability to concentrate and speed of psychomotor reactions in patients may decrease, especially in the first hour after admission. Therefore, during the use of the drug Dexalgin® 25 caution should be exercised when driving vehicles and engaging in potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated 25 mg.

    Packaging:

    For 10 tablets in a planar cell package (blister) [PVC / aluminum foil or aluminum foil / aluminum foil].

    For 1, 3 or 5 blisters with instructions for use in a cardboard bundle.

    Storage conditions:

    Blister [PVC / aluminum foil]

    In dry, dark place at a temperature of no higher than 25 ° C.

    Blister [aluminum foil / aluminum foil]

    At a temperature of no higher than 30 ° C.

    Keep the medicine out of the reach of children!

    Shelf life:

    Blister [PVC / aluminum foil] - 2 years.

    Blister [aluminum foil / aluminum foil] - 3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015044 / 01
    Date of registration:22.07.2008 / 22.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany
    Information update date: & nbsp20.03.2017
    Illustrated instructions
      Instructions
      Up