Dexonal - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Dexonal

Dexonal: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Dexonal

ATX code: M01AE17

Active ingredient: dexketoprofen (Dexketoprofen)

Manufacturer: JSC "Pharmaceutical Enterprise" Obolenskoe "(Russia)

Description and photo update: 2019-13-11

Prices in pharmacies: from 208 rubles.

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Dexonal is a non-steroidal anti-inflammatory drug (NSAID) with an analgesic effect.

Release form and composition

Dosage form - film-coated tablets: biconvex, round, white or almost white, with a risk; the core in a cross section is almost white or white (in a cardboard box 1, 3 or 5 packs of cell contour containing 10 tablets, and instructions for the use of Dexonal).

Composition of 1 tablet:

• active substance: dexketoprofen trometamol - 36.9 mg (corresponds to the content of dexketoprofen - 25 mg);
• auxiliary components: magnesium stearate, aerosil (colloidal anhydrous silicon dioxide), sodium starch glycolate (sodium carboxymethyl starch), corn starch, microcrystalline cellulose;
• shell: titanium dioxide, polyethylene glycol 6000 (macrogol 6000), hydroxypropyl methylcellulose (hypromellose).

Pharmacological properties

Pharmacodynamics

Dexonal's active substance, dexketoprofen trometamol, is an NSAID with antipyretic, anti-inflammatory and analgesic properties. Due to the combination of dexketoprofen with trometamol, a high rate of absorption of the drug in the gastrointestinal tract and the rapid development of an analgesic effect are provided, the mechanism of which is based on inhibition of prostaglandin synthesis at the level of cyclooxygenases (COX-1 and COX-2).

The dexketoprofen molecule is an innovative product of genetically engineered biotechnology and is an active dextrorotatory isomer of ketoprofen, an analgesic with high anti-inflammatory efficacy.

The pharmacologically inactive levorotatory isomer, toxic and causing an increased risk of digestive tract lesions, was excluded from the composition, which allowed:

1. It is clinically significant to reduce the dose of the drug to obtain an adequate therapeutic effect;
2. Reduce the risk of negative side reactions, which made it possible to use Dexonal even in patients with concomitant pathologies;
3. To reduce the toxicity of the drug, which is important if it is necessary to take it repeatedly.

After half an hour after oral administration of the drug, anesthetic effect occurs. The duration of the therapeutic action reaches from 4 to 6 hours.

Pharmacokinetics

• absorption: after a single intake of a single dose of dexketoprofen, the time to reach the maximum concentration (T _Cmax) is on average 30 minutes (varies from 15 minutes to 1 hour). The absorption is slowed down by the simultaneous intake of pills with the tablets. There is no accumulation of the drug, as indicated by the similarity of the area under the concentration-time curve (AUC) after its single and repeated administration;
• distribution: dexketoprofen has a high degree of binding to blood plasma proteins (99%). On average, the volume of distribution (Vd) is less than 0.25 liters per 1 kg, and the half-distribution is about 0.35 hours;
• metabolism and excretion: conjugation with glucuronic acid followed by excretion by the kidneys is the main pathway of dexketoprofen metabolism. Its half-life (T _1/2) is 1.65 hours. In elderly patients, there is a decrease in the total clearance and an increase in the half-life of the drug (up to 48%).

Indications for use

Dexonal is prescribed for toothache, algodismenorrhea, mild or moderate musculoskeletal pain.

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

Contraindications

Absolute:

• confirmed hyperkalemia;
• progressive kidney disease;
• chronic kidney disease: stage 3a - glomerular filtration rate (GFR, ml per minute / 1.73 m ²) from 45 to 59; stage 3b - GFR 30 to 44; stage 4 - GFR less than 30;
• severe liver failure (on the Child-Pugh scale from 10 to 15 points);
• severe heart failure (NYHA classification - III – IV functional class);
• period after coronary artery bypass grafting;
• hemorrhagic diathesis and other blood clotting disorders;
• ulcerative colitis, Crohn's disease and other inflammatory bowel pathologies in the acute stage;
• gastrointestinal or other active bleeding, including suspected intracranial hemorrhage;
• a history of perforation or bleeding of the gastrointestinal tract (GIT), including those associated with previous NSAID therapy;
• exacerbation of erosive and ulcerative lesions of the gastrointestinal tract;
• incomplete or complete combination of intolerance to acetylsalicylic acid (ASA) or other NSAIDs, including a history, with bronchial asthma and recurrent polyposis of the nose and paranasal sinuses;
• pregnancy and lactation;
• age under 18;
• individual intolerance to the components of the drug and other NSAIDs.

Relative (Dexonal tablets are used under medical supervision):

• chronic kidney disease, stage 2 - GFR from 60 to 89 ml per minute / 1.73 m ²;
• hepatic porphyria, history of liver pathology;
• chronic heart failure;
• cardiac ischemia;
• arterial hypertension;
• ulcerative colitis;
• peptic ulcer of the stomach and duodenum;
• Crohn's disease;
• diabetes;
• a significant decrease in the volume of circulating blood, including after surgery;
• bronchial asthma;
• cerebrovascular diseases;
• hyperlipidemia and dyslipidemia;
• peripheral arterial pathology;
• presence of Helicobacter pylori infection;
• systemic lupus erythematosus and other systemic pathologies of connective tissue;
• tuberculosis;
• severe osteoporosis;
• severe somatic diseases;
• alcoholism;
• smoking;
• combined treatment: selective serotonin reuptake inhibitors, including sertraline, paroxetine, fluoxetine and citalopram; antiplatelet agents, including clopidogrel and ASA; anticoagulants, including warfarin; glucocorticosteroids, including prednisolone;
• long-term NSAID therapy;
• elderly age (over 65 years), including in patients who took diuretics, patients with low body weight or weak.

Dexonal, instructions for use: method and dosage

Dexonal tablets are taken orally, at the same time as food. Since food intake slows down the absorption of dexketoprofen, in case of acute pain, the drug should be taken at least half an hour before meals.

The recommended dose of Dexonal for adults, depending on the intensity of pain, is half a tablet (12.5 mg) every 4-6 hours or 1 tablet (25 mg) every 8 hours. The maximum daily dose is 3 tablets (75 mg).

The drug is not intended for long-term use, so therapy should not last more than 3-5 days.

Elderly patients, patients with mild to moderate hepatic impairment or mild renal impairment should start taking the drug with the minimum recommended dose. The maximum daily dose for them is 2 tablets (50 mg). With good tolerance, elderly patients can be prescribed the usual dosage of Dexonal.

Side effects

Possible side effects of Dexonal [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01%, including isolated messages - very rare]:

• blood and lymphatic system: very rarely - thrombocytopenia, neutropenia;
• immune system: rarely - laryngeal edema; very rarely - anaphylactic reactions, including anaphylactic shock;
• nervous system: infrequently - drowsiness, dizziness, headache; rarely - transient short-term fainting (syncope), paresthesia;
• psyche: infrequently - anxiety, insomnia;
• organ of hearing and labyrinthine disorders: infrequently - vertigo; very rarely - tinnitus;
• organ of vision: very rarely - blurred vision;
• cardiovascular system: infrequently - hyperemia of the skin, a feeling of heat, a feeling of palpitations; rarely - an increase in blood pressure; very rarely - lowering blood pressure, tachycardia;
• respiratory system: rarely - bradypnea; very rarely - shortness of breath, bronchospasm;
• Gastrointestinal tract: often - diarrhea, dyspepsia, abdominal pain, nausea, vomiting; infrequently - flatulence, dry mouth, constipation, gastritis; rarely - perforation or bleeding from an ulcer, erosive and ulcerative lesions of the gastrointestinal tract; very rarely - damage to the pancreas;
• hepatobiliary system: rarely - increased activity of liver enzymes (aspartate aminotransferase, alanine aminotransferase), hepatitis; very rarely - liver damage;
• kidneys and urinary tract: rarely - acute renal failure, polyuria; very rarely - nephrotic syndrome or nephritis;
• reproductive system: rarely - menstrual irregularities in women, transient dysfunction of the prostate gland during prolonged therapy in men;
• musculoskeletal system: rarely - back pain;
• skin and subcutaneous tissue: infrequently - skin rash; rarely - increased sweating, acne, urticaria; very rarely - itching, photosensitivity, allergic dermatitis, facial edema, angioedema, Lyell's syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome (severe skin reactions);
• metabolism: rarely - anorexia;
• general disorders: infrequently - general malaise, chills, asthenia, increased fatigue; very rarely - peripheral edema;
• possible side effects inherent in NSAIDs: hematological disorders (hemolytic and aplastic anemia, thrombocytopenic purpura), aseptic meningitis, which develops mainly against the background of systemic connective tissue pathologies or systemic lupus erythematosus; rarely - bone marrow hypoplasia, agranulocytosis.

Overdose

• the main symptoms of a dexketoprofen overdose: insomnia, disorientation, dizziness, headache, anorexia, abdominal pain, nausea;
• therapy: symptomatic, if necessary - taking activated carbon, gastric lavage; the use of hemodialysis is ineffective.

special instructions

Possible side effects of Dexonal can be minimized by using it in the lowest effective dose for a minimum period sufficient to relieve pain.

The likelihood of developing complications from the gastrointestinal tract increases with a history of ulcerative lesions of the digestive tract, in elderly patients and with an increase in the dose of NSAIDs. In such cases, Dexonal should be taken with the lowest recommended dose. In addition, like patients who need the combined use of low doses of ASA or other drugs that increase the risk of developing complications from the gastrointestinal tract, they need additional intake of gastroprotective agents (proton pump blockers or misoprostol).

The risk of gastrointestinal bleeding increases with the simultaneous administration of glucocorticosteroids, anticoagulants, or antiplatelet agents.

Patients with a history of gastrointestinal pathologies or gastrointestinal disorders should be under close medical supervision. With the development of ulcerative lesions or gastrointestinal bleeding, Dexonal is canceled.

The drug is prescribed with caution in case of gastrointestinal pathologies in history (Crohn's disease, ulcerative colitis), since taking NSAIDs can serve to exacerbate them.

All NSAIDs, by inhibiting prostaglandin synthesis, can prolong bleeding and inhibit platelet aggregation. In this regard, taking pills is not recommended in combination therapy with drugs that affect the hemostasis system (heparins, coumarin derivatives, warfarin).

Against the background of treatment with dexketoprofen, like other NSAIDs, the concentration of nitrogen and creatinine in the blood plasma may increase. Like other inhibitors of prostaglandin synthesis, the drug can cause side effects from the urinary system, which is why there is a possibility of acute renal failure, nephrotic syndrome, papillary necrosis, interstitial nephritis and glomerulonephritis. With caution, Dexonal should be used when taking diuretics in combination and in cases of an existing risk of hypovolemia, due to the increased likelihood of nephrotoxicity.

NSAIDs, including Dexonal, can lead to a slight transient increase in the concentration of some liver enzymes. In elderly patients, monitoring of renal and liver function is required. If there is an increase in the corresponding indicators, the treatment is canceled.

Taking dexketoprofen, like other NSAIDs, can mask the manifestations of infectious pathologies. If symptoms of infection or deterioration in well-being are found, the patient should seek medical attention. Since the drug can cause fluid retention in the body, it is prescribed with extreme caution in arterial hypertension, heart and / or renal failure. If the patient's condition worsens, therapy is stopped.

In cases of cerebrovascular pathologies, peripheral arterial disease, congestive heart failure, coronary heart disease and uncontrolled arterial hypertension, the use of Dexonal requires caution. A similar approach is applicable in the presence of risk factors for the occurrence of cardiovascular diseases (smoking, diabetes mellitus, hyperlipidemia, arterial hypertension).

Caution in prescribing Dexonal should be observed in cases of a history of cardiovascular disease, especially in heart failure. This is due to the potential risk of their progression.

Ongoing clinical studies and available epidemiological data indicate that taking NSAIDs, especially in high doses and over a long period, may slightly increase the risk of stroke or myocardial infarction. At the moment, there is not enough information to exclude the risk of such events when using Dexonal.

There are reports of the development in rare cases of skin reactions while taking NSAIDs - toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis. The appearance of the first signs of a skin rash, mucosal lesions or other symptoms of allergic reactions requires immediate discontinuation of Dexonal and seeking medical attention.

Influence on the ability to drive vehicles and complex mechanisms

Since drowsiness and dizziness may appear while taking Dexonal, care must be taken during the treatment period when driving and engaging in potentially hazardous activities.

Application during pregnancy and lactation

Dexonal is not prescribed during pregnancy / lactation.

Pediatric use

Dexonal is not prescribed to patients under 18 years of age, since there are no data on the safety and effectiveness of its use in this age category.

With impaired renal function

Reception of Dexonal is contraindicated in progressive kidney disease and chronic kidney disease stages 3a, 3b and 4. Prescribing the drug in chronic kidney disease stage 2 requires caution.

For violations of liver function

Dexonal is not prescribed for patients with severe hepatic impairment. The drug is used with caution in patients with hepatic porphyria and a history of liver pathologies.

Use in the elderly

Prescribing Dexonal requires caution and proper clinical monitoring in elderly patients over the age of 65, including patients who have taken diuretics, patients with low body weight or weak. This is due to the adverse reactions most often observed in patients of this age group in the treatment of NSAIDs (including the development of perforations and gastrointestinal bleeding, decreased heart, liver and kidney function).

Drug interactions

Dexketoprofen is characterized by the same interaction reactions as for all NSAIDs:

Possible interactions:

• tacrolimus, cyclosporine: their nephrotoxicity may increase, which is associated with the action of renal prostaglandins. This combination requires monitoring of renal function;
• β-blockers: it is possible to reduce their antihypertensive effect due to inhibition of prostaglandin synthesis;
• thrombolytics: the likelihood of bleeding increases;
• sertraline, fluoxetine, citalopram (serotonin reuptake inhibitors), anticoagulants: the risk of bleeding from the gastrointestinal tract increases;
• probenecid: an increase in the concentration of dexketoprofen in blood plasma is likely, which is associated with inhibition of renal tubular secretion and / or conjugation with glucuronic acid of probenecid; in this case, dose adjustment of NSAIDs may be required;
• cardiac glycosides: their concentration in blood plasma may increase;
• Mifepristone: Theoretically, there is a possibility of its effectiveness changing under the influence of inhibitors of prostaglandin synthesis. Dexonal should be taken no earlier than 8-12 days after discontinuation of mifepristone treatment;
• high-dose quinolones: presumably there is an increased risk of seizures (based on experimental animal studies).

The drugs / substances that are undesirable to be used in combination with Dexonal include:

• other NSAIDs, including high doses of salicylates (more than 3 g per day): through a synergistic effect, the risk of ulcers and gastrointestinal bleeding increases;
• anticoagulants (warfarin): it is possible to enhance their effect due to damage to the gastrointestinal mucosa, inhibition of platelet aggregation and a high degree of binding of dexketoprofen to blood plasma proteins. When taken in combination, it is required to carefully monitor the patient's condition and regularly monitor laboratory parameters;
• heparin: the likelihood of bleeding increases, which is associated with a damaging effect on the gastrointestinal mucosa and inhibition of platelet aggregation. When taken in combination, it is required to carefully monitor the patient's condition and regularly monitor laboratory parameters;
• glucocorticosteroids: the risk of bleeding and gastrointestinal ulceration increases;
• lithium preparations: there is an increase in the concentration of lithium (up to toxic) in the blood plasma, because of which this indicator should be controlled during the period of simultaneous treatment with dexketoprofen, when the dosage is changed and after its cancellation;
• methotrexate in high doses (15 mg at 7 days or more): its hematological toxicity may increase, which is associated with a decrease in its renal clearance during combination therapy with NSAIDs;
• hydantoin, sulfonamides: their toxic effect may increase.

When using dexketoprofen in combination with the following substances / drugs, care must be taken:

• angiotensin II receptor antagonists, aminoglycoside antibacterial agents, angiotensin-converting enzyme inhibitors, diuretics: patients with dehydration have a risk of acute renal failure (decreased glomerular filtration due to decreased prostaglandin synthesis). A decrease in the antihypertensive effect of some drugs is possible when used with NSAIDs. Before starting treatment with diuretics with dexketoprofen, it is important to make sure that the patient does not show signs of dehydration, and also to monitor kidney function at the beginning of therapy;
• low doses of methotrexate (less than 15 mg at 7 days): hematological toxicity may increase, due to a decrease in its renal clearance. At the beginning of combined use, blood cells should be counted. Elderly patients, as well as with impaired renal function, including mild, should be closely monitored;
• pentoxifylline: there is a possibility of bleeding. It is required to conduct careful clinical monitoring and regularly check the blood clotting time (bleeding time);
• zidovudine: it is possible to increase its toxic efficacy against erythrocytes due to the effect on reticulocytes, and the occurrence of severe anemia 7 days after starting the use of NSAIDs. After 7-14 days from the start of combined use, a general blood test is required with counting the number of reticulocytes;
• oral hypoglycemic drugs: by displacing sulfonylureas from the sites of binding to blood plasma proteins, the hypoglycemic effect of the drugs in which it is included may increase.

Before using Dexonal at the same time as other medicines, it is recommended to consult a doctor.

Analogs

Dexketoprofen, Flamadex, Dexketoprofen trometamol, Dexalgin, Dexketoprofen-SZ, Ketodexal, Dexketoprofen KERN PHARMA, etc. are analogs of Dexonal.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Dexonal

According to reviews, Dexonal is a safe, fast-acting and effective long-acting drug used to relieve acute pain.

Among the shortcomings, patients note the presence of a wide list of contraindications and side effects.

Dexonal price in pharmacies

The approximate price of Dexonal (10 coated tablets in a package) varies from 206 to 215 rubles.

Dexonal: prices in online pharmacies

Drug name Price Pharmacy

Dexonal 25 mg film-coated tablets 10 pcs. 208 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!