Nobedolac tablets p / o 400mg, No. 14

Inflammatory and degenerative diseases of the musculoskeletal system:

• psoriatic, rheumatoid, gouty arthritis;

• ankylosing spondylitis (ankylosing spondylitis);

• osteoarthritis.

Pain syndrome:

• myalgia;

• ossalgia;

• arthralgia;

• headache and toothache;

• post-traumatic pain syndrome accompanied by inflammation;

• algodismenorrhea.

Designed for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Adults and children over 18 years old:

The recommended daily dose of Nobedolac is 400-1200 mg.

The maximum daily dose is 1200 mg.

The drug is prescribed twice a day: 1 tablet in the morning and in the evening after meals.

If necessary, the dose can be increased to 3 tablets per day.

In patients weighing less than 60 kg, the maximum daily dose of the drug should not exceed 20 mg / kg.

In rheumatic diseases, the course of treatment depends on the effectiveness of therapy and the nature of the disease. Under the condition of a long course of therapy, the dose must be corrected every 2-3 weeks of using the drug.

In the treatment of pain conditions due to acute inflammatory processes (such as toothache, myositis, tendinitis), as well as postoperative pain syndromes, the course of treatment is 5 days. For headache and menstrual pain, Nobedolac is prescribed 1-2 tablets per day as needed, for no more than 3 days.

Light pink film-coated tablets, oblong, biconvex, scored on one side and engraved with 'NOBEL' embossing on the other; the core is white or almost white in cross section.

1 tab.

etodolac 400 mg *

* etodolac DC (98%) - 408 mg.

Excipients: anhydrous lactose - 146.5 mg, microcrystalline cellulose PH200 - 245 mg, croscarmellose sodium - 34.5 mg, colloidal anhydrous silicon dioxide (Aerosil 200) - 2 mg, magnesium stearate - 13 mg, povidone K30 - 16 mg.

• Hypersensitivity to the active substance or auxiliary components;

• intolerance to acetylsalicylic acid and pyrazolone drugs;

• contraindicated in the period after coronary artery bypass grafting;

• decompensated heart failure;

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history);

• erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

• inflammatory bowel disease (ulcerative colitis, Crohn's disease);

• rare hereditary diseases (lactose intolerance, lactase deficiency or glucose-galactose malabsorption);

• cerebrovascular bleeding or other bleeding;

• severe liver failure or active liver disease;

• severe renal failure in patients not undergoing dialysis (CC less than 30 ml / min), progressive kidney disease, incl. confirmed hyperkalemia;

• pregnancy, breastfeeding period;

• children under 15 years of age.

With care: coronary heart disease, cerebrovascular disease, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, liver failure, chronic renal failure (CC 30-60 ml / min). Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline). Children under the age of 18.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used in the smallest possible short course.

pharmachologic effect

Etodolac is an NSAID with analgesic, anti-inflammatory and antipyretic effects. The drug reduces the synthesis of prostaglandins from arachidonic acid, thereby reducing the sensitivity of receptors to pain mediators (histamine, bradykinin), reducing exudation, migration of leukocytes, as well as the sensitivity of hypothalamic centers of thermoregulation to the action of endogenous pyrogens.

Pharmacokinetics

It is well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam is 80%. Simultaneous food intake does not alter absorption. Cmax in plasma is reached after 60 minutes and is 18 ?g / ml.

Plasma protein binding is 95%, the free fraction is 1.2% -4.7%.

T1 / 2 - about 7 hours. Etodolac is metabolized in the liver and excreted mainly by the kidneys (up to 60% in the form of metabolites).

Side effect

From the digestive system: nausea, epigastric pain, diarrhea, bloating, erosion, ulcers, bleeding.

On the part of the skin: itching, rash, exudative erythema multiforme, hyperpigmentation, photosensitivity.

From the respiratory system: bronchospasm, rhinitis.

From the nervous system: dizziness, headache, fatigue.

From the side of the cardiovascular system: peripheral edema, increased blood pressure, palpitations, flushes of blood to the skin of the face.

From the side of hematopoiesis: increased activity of 'hepatic' transaminases, leukopenia, anemia, thrombocytopenia.

From the urinary system: violation of water and electrolyte metabolism, hypernatremia, hyperkalemia, increased serum creatinine, dysuric phenomena.

Allergic reactions: urticaria, Quincke's edema, anaphylactic shock, Lyell's syndrome, allergic interstitial nephritis.

Application during pregnancy and lactation

Contraindicated during pregnancy and breastfeeding.

Application for violations of liver function

Contraindicated in severe liver failure or active liver disease.

With care: liver failure.

Application for impaired renal function

Contraindicated in progressive kidney disease, incl. confirmed hyperkalemia, as well as with severe renal failure in patients not undergoing dialysis (CC less than 30 ml / min).

With care: chronic renal failure (CC 30-60 ml / min).

Application in children

Contraindicated in children under 15 years of age. With care, adolescents 15-18 years old.

special instructions

Caution should be exercised when using the drug in patients with a history of gastric ulcer and duodenal ulcer, as well as in patients on anticoagulant therapy. In such patients, the risk of erosive and ulcerative diseases of the gastrointestinal tract is increased. Care should be taken and the indicators of renal function should be monitored when using the drug in elderly patients, patients with chronic heart failure with clinical manifestations, in patients with cirrhosis of the liver, as well as in patients with hyiovolemia as a result of surgical interventions.

In patients with renal failure, if creatinine clearance is more than 30 ml / min, no dosage adjustment is required.

If during the treatment there are allergic reactions (itching, skin rash, urticaria, photosensitivity), it is necessary to stop taking the drug,

Influence on the ability to drive vehicles and use mechanisms

The use of the drug can cause undesirable effects in the form of headaches and dizziness. You should refuse to drive vehicles and maintain machines and mechanisms that require concentration.

Overdose

Symptoms: nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypernatremia, hypercalismia, edema, increased blood pressure, allergic interstitial nephritis, jaundice, hepatitis, bronchospasm.

Treatment: there is no specific antidote; in case of an overdose of the drug, gastric lavage, intake of activated charcoal (within the next hour), symptomatic therapy should be performed.

Drug interactions

With simultaneous use with other non-steroidal anti-inflammatory drugs (as well as with acetylsalicylic acid), the risk of erosive and ulcerative lesions and gastrointestinal bleeding increases.

With simultaneous use with antihypertensive drugs, it is possible to reduce the effectiveness of the latter.

With simultaneous use with lithium preparations, the development of accumulation of lithium and an increase in its toxic effect is possible (it is recommended to control the concentration of lithium in the blood). With simultaneous use with methotrexate, the side effect of the latter on the hematopoietic system increases (the risk of anemia and leukopenia, periodic monitoring of a general blood test is shown).

With simultaneous use with diuretics and cyclosporine, the risk of developing renal failure increases.

With simultaneous use with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin), the risk of bleeding increases (periodic monitoring of blood clotting indicators is required).