Nobedolak
Nobedolac: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Nobedolak
ATX code: M01AB08
Active ingredient: etodolac (Etodolac)
Producer: Nobel Ilach Sanayi ve Tijaret A. Sh. (Nobel Ilac Sanayii Ve Ticaret, AS) (Turkey); JSC "Nobel Almaty Pharmaceutical Factory" (Republic of Kazakhstan)
Description and photo update: 09.10.2019
Prices in pharmacies: from 694 rubles.
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Nobedolac is an NSAID (non-steroidal anti-inflammatory drug) from the group of indoleacetic acid derivatives, anti-inflammatory, analgesic and antipyretic action.
Release form and composition
Dosage form - film-coated tablets: biconvex, oblong, NOBEL engraved on one side, and dividing risk on the other; the film coat is light pink, the core at the fracture is from almost white to white [7 pcs. in blisters made of polyvinyl chloride (PVC) / aluminum foil, 2 blisters with instructions for use in a cardboard box; 14 pcs. in blisters made of polyvinyl chloride (PVC) / aluminum foil, 1 or 2 blisters and instructions for use of Nobedolac in a cardboard box].
Composition for 1 tablet:
- active substance: etodolac DC - 98% (etodolac, calculated as anhydrous substance - 96–99.5%; povidone K30 - 0.5–4%), calculated as etodolac - 400 mg;
- auxiliary ingredients: microcrystalline cellulose M 102 - 245 mg; anhydrous lactose - 146.5 mg; anhydrous colloidal silicon dioxide (Aerosil 200) - 2 mg; croscarmellose sodium - 34.5 mg; magnesium stearate - 13 mg; povidone K30 - 16 mg;
- film coat: Opadry Pink OY-34948 [hypromellose (USP 2910) - 25.698 4 mg; macrogol 400 - 2.581 6 mg; iron dye red oxide E172 - 0.16 mg; titanium dioxide - 11.56 mg].
Pharmacological properties
Pharmacodynamics
The active component of Nobedolac, etodolac, is a derivative of indoleacetic acid, belongs to non-steroidal anti-inflammatory substances, has anti-inflammatory, analgesic and antipyretic effects.
Etodolac inhibits the enzymatic oxidation of arachidonic acid to prostaglandins, thereby reducing the sensitivity of receptors to pain mediators (bradykinin, histamine), a decrease in exudation and migration of leukocytes, as well as sensitization of thermoregulation centers located in the hypothalamus to the action of endogenous pyrogens.
Pharmacokinetics
Etodolac after oral administration from the gastrointestinal tract (gastrointestinal tract) is well absorbed. The absolute bioavailability of the substance is 80%. The simultaneous intake of the drug with food does not affect the absorption. C max (maximum concentration) of etodolac is achieved after one hour and the plasma is 18 mg / ml.
The substance binds to plasma proteins at the level of 95%, the size of the free fraction varies from 1.2 to 4.7%.
T 1/2 (half-life) ~ 7 hours. Etodolac is metabolized in the liver. It is excreted mainly by the kidneys (including in the form of metabolites up to 60%).
Indications for use
Nobedolac 400 mg tablets are recommended for the following conditions / diseases:
- inflammatory and degenerative pathologies of the musculoskeletal system: arthritis (rheumatoid, psoriatic, gouty), osteoarthritis, ankylosing spondylitis (ankylosing spondylitis);
- pain syndrome of various etiologies: arthralgia, ossalgia, myalgia, dentalgia, headache, post-traumatic pain syndrome accompanied by inflammation, algomenorrhea.
The drug is effective for symptomatic treatment of inflammation and pain relief at the time of use, but does not affect the progression of the underlying disease.
Contraindications
Absolute:
- heart failure in the stage of decompensation;
- period after CABG (coronary artery bypass grafting);
- aspirin bronchial asthma / triad [complete / incomplete combination of NSAID intolerance (including acetylsalicylic acid), bronchial asthma and recurrent polypous rhinosinusitis];
- erosive and ulcerative lesions of the gastric mucosa and / or duodenal ulcer, gastrointestinal bleeding in the active phase;
- intestinal inflammation (Crohn's disease or ulcerative colitis);
- rare genetic diseases: lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- cerebrovascular or other bleeding;
- decompensated liver failure or active liver disease;
- severe renal impairment with creatinine clearance (CC) less than 30 ml / min in patients not on dialysis, progressive kidney disease, including confirmed hyperkalemia;
- pregnancy and the period of breastfeeding;
- children and adolescents under 15 years old;
- intolerance to aspirin and pyrazolone drugs;
- increased individual sensitivity to the active substance of Nobedolac or auxiliary components.
With caution, Nobedolac tablets should be prescribed to patients with cerebrovascular diseases, coronary artery disease (ischemic heart disease), CHF (chronic heart failure), dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, hepatic failure, CRF (chronic renal failure) with CC 30-60 ml / min, with a history of gastrointestinal ulcers and Helicobacter pylori infection, in old age, with prolonged use of NSAIDs, frequent alcohol consumption, smoking, severe somatic diseases, in adolescence from 15 to 18 years old, as well as with concomitant anticoagulant therapy (warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (prednisolone), selective serotonin reuptake inhibitors (citalopram,fluoxetine, paroxetine, sertraline).
In order to reduce the likelihood of developing unwanted side effects from the gastrointestinal tract, it is required to use Nobedolac in the minimum effective dose for the minimum possible course.
Nobedolak, instructions for use: method and dosage
Nobedolac tablets are intended for oral administration.
The recommended daily dose for adult patients (over 18 years old) is from 400 to 1200 mg. Tablets are taken twice a day, 1 pc., In the morning and evening after meals.
If necessary, the dose can be increased to a maximum daily dose of 1200 mg (3 tablets).
With a patient's body weight less than 60 kg, the maximum dose of Nobedolac per day should not be higher than 20 mg / kg.
Duration of the therapeutic course:
- rheumatic diseases: the duration of treatment is determined by a specialist depending on the clinical efficacy of the drug and the nature of the disease; if a long course is prescribed, dose adjustment is required every 2-3 weeks;
- pain syndrome due to acute inflammatory processes (myositis, toothache, tendinitis), postoperative pain syndrome: course of treatment - 5 days;
- headache and menstrual pain: 1-2 tablets per day; the course of treatment is no more than 3 days.
Side effects
- digestive system: epigastric pain, nausea, diarrhea, erosion, ulcers, bloating, bleeding;
- central and peripheral nervous system: headache, dizziness, fatigue;
- skin and subcutaneous fat: rash, itching, exudative erythema multiforme, photosensitization, hyperpigmentation;
- cardiovascular system: an increase in blood pressure (BP), peripheral edema, flushing of the face, palpitations;
- urinary system: violation of water and electrolyte balance, hyperkalemia, hypernatremia, dysuria, increased serum creatinine concentration;
- respiratory system: rhinitis, bronchospasm;
- hematopoietic system: increased activity of hepatic transaminases, anemia, leukopenia, thrombocytopenia;
- immune system: urticaria, anaphylactic shock, Quincke's edema, Lyell's syndrome, interstitial nephritis due to an allergic reaction.
Overdose
Symptoms of an overdose of etodolac are nausea / vomiting, epigastric pain, bleeding in the gastrointestinal tract, hyperkalemia, hypernatremia, increased blood pressure, edema, allergic interstitial nephritis, bronchospasm, jaundice, hepatitis.
The specific antidote for etodolac is unknown. It is recommended to wash the stomach and give the patient activated charcoal as soon as possible, after which, if necessary, the doctor should prescribe symptomatic treatment.
special instructions
If allergic reactions such as skin rash, itching, photosensitivity or urticaria develop during therapy, Nobedolac should be stopped immediately.
Influence on the ability to drive vehicles and complex mechanisms
During the use of Nobedolac, undesirable side effects such as headache and dizziness may occur. In this regard, during the period of therapy, one should refuse to perform types of work that require increased concentration of attention and high speed of psychomotor reactions, including driving vehicles and servicing complex machines and mechanisms.
Application during pregnancy and lactation
Nobedolac therapy is contraindicated for pregnant and breastfeeding women.
Pediatric use
Nobedolac is contraindicated in pediatric patients under 15 years of age.
Adolescents from 15 to 18 years old should be careful when taking the drug.
With impaired renal function
Progressive kidney disease, including confirmed hyperkalemia, as well as severe impairment of renal function with CC less than 30 ml / min in patients not on dialysis, are absolute contraindications for the use of Nobedolac.
Patients with chronic renal failure (with CC from 30 to 60 ml / min), the drug must be taken with caution.
In renal failure with a CC of more than 30 ml / min, no correction of the Nobedolac dosage regimen is required.
For violations of liver function
Decompensated liver failure or liver disease in the active stage are absolute contraindications for the use of Nobedolac.
Patients with hepatic impairment must take the drug with caution.
Use in the elderly
During therapy with Nobedolac, elderly patients should be careful.
Drug interactions
- other NSAIDs (including acetylsalicylic acid): simultaneous administration with etodolac increases the risk of erosive and ulcerative pathologies and bleeding from the gastrointestinal tract;
- antihypertensive drugs: probably a decrease in their effectiveness;
- lithium preparations: etodolac promotes the development of lithium accumulation and an increase in its toxic effect; if there is a justified need for this combination, it is necessary to control the level of lithium in the blood;
- methotrexate: Nobedolac enhances its negative side effect on the hematopoietic system, increasing the likelihood of anemia and leukopenia; it is required to periodically monitor a general blood test;
- diuretics and cyclosporine: in combination with etodolac, increase the risk of impaired renal function;
- anticoagulants (heparin, warfarin, ticlopidine), thrombolytic drugs (streptokinase, fibrinolysin): the risk of bleeding increases; it is required to periodically monitor blood clotting indicators.
Analogs
The analogues of Nobedolac are Alental, Algezir Ultra, Acetylsalicylic acid, Diclofenac, Ibuprofen, Indomethacin, Ketonal, Ketoprofen, Meloxicam, Nalgezin, Nurofen, Sulindak, Upsarin Upsa, Etodin Fort, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nobedolak
In reviews of Nobedolac, patients characterize it as a very effective pain reliever with a strong anti-inflammatory effect. At the same time, the drug is not recommended to be used as a regular (household) pain reliever, since strong side reactions are possible.
As a disadvantage, it is noted that despite the fact that the drug is quite expensive, it is not sold in all pharmacies.
The price of Nobedolac in pharmacies
Approximate price of Nobedolac 400 mg (film-coated tablets) for 14 pcs. in the package is 408 rubles.; for 28 pcs. - from 653 to 890 rubles.
Nobedolac: prices in online pharmacies
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Drug name Price Pharmacy |
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Nobedolac 400 mg film-coated tablets 28 pcs. 694 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, 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!
