Teraliv tablets 275mg, No. 12

• Diseases of the musculoskeletal system: rheumatic lesions of soft tissues; osteoarthritis of the peripheral joints and spine, incl. with radicular syndrome; tenosynovitis; bursitis.

• Pain syndrome of mild or moderate severity: neuralgia; ossalgia; myalgia; sciatica; post-traumatic pain syndrome (sprains and bruises), accompanied by inflammation; headache, migraine; algodismenorrhea; toothache.

• As part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome: pharyngitis; tonsillitis; otitis.

• Feverish syndrome with 'colds' and infectious diseases. Teraliv 275 is used for symptomatic therapy (to reduce pain, inflammation and reduce fever) and does not affect the progression of the underlying disease.

Inside. The tablets should be taken with sufficient water.

Adults and children 15 years of age and older: The usual daily dose used for pain relief is 2-3 tablets (550-825 mg). The maximum daily dose is 3 tablets (825 mg). Duration of use - no more than 5 days. When using the drug Teraliv 275 as an antipyretic agent, the initial dose is 2 tablets, then 1 tablet (275 mg) is taken every 8 hours.

For the prevention and treatment of migraine attacks, the initial recommended dose is 2 tablets (550 mg), if necessary, you can take 1 tablet (275 mg) every 8-12 hours. The maximum daily dose is 3 tablets (825 mg).

To relieve menstrual cramps and cramps, pain after the introduction of intrauterine devices and other gynecological pains, it is recommended to prescribe the drug in an initial dose of 2 tablets (550 mg), then 1 tablet (275 mg) every 8 hours.

Children: Teraliv 275 is contraindicated for use in children under 15 years of age.

Elderly patients (?65 years): the drug should be taken as needed every 12 hours. To reduce the risk of developing adverse events from the gastrointestinal tract, the drug should be taken in the minimum effective dose for the shortest possible course. If the patient has the impression that the effect of the drug is very strong or weak, then it should be reported to the attending physician or pharmacist.

Film-coated tablets of blue color, oval, biconvex; engraving 'NPS-275' on one side of the tablet; at the break, the tablet has a white core.

1 tab.

naproxen sodium 275 mg

Excipients: microcrystalline cellulose - 55 mg, povidone K30 - 12.5 mg, talc - 15.75 mg, magnesium stearate - 2.63 mg; film shell: blue opadry YS-1-4215 - 9 mg: macrogol 8000, indigo carmine, titanium dioxide, hypromellose.

• Hypersensitivity to naproxen or naproxen sodium;

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

• period after coronary artery bypass grafting;

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

• inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the acute phase;

• hemophilia and other bleeding disorders and hemostasis disorders;

• cerebrovascular bleeding or other bleeding;

• decompensated heart failure;

• severe liver failure or active liver disease;

• severe renal failure (CC less than 30 ml / min), progressive kidney disease;

• confirmed hyperkalemia;

• pregnancy;

• breastfeeding period;

• children under 15 years of age.

• With caution IHD, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, impaired renal function (CC 30-60 ml / min), history of the development of gastrointestinal ulcers, presence of Helicobacter pylori infection, use in elderly patients, systemic lupus erythematosus or mixed connective tissue diseases (Sharp's syndrome), long-term 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 glucocorticoids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

pharmachologic effect

Teraliv 275 is a naproxen drug that has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of the activity of cyclooxygenase-1 and -2 (COX-1, COX-2). The drug Teraliv 275, film-coated tablets, dissolves well, is rapidly absorbed from the gastrointestinal tract and provides a rapid onset of the analgesic effect.

Pharmacokinetics

Suction

It is quickly and completely absorbed from the gastrointestinal tract. Bioavailability - 95% (food intake practically does not affect either the completeness or the rate of absorption). The time to reach Cmax in blood plasma is 1-2 hours.

Distribution

Plasma protein binding> 99%. T1 / 2 - 12-15 hours. Metabolism occurs in the liver to dimethylnaproxen with the participation of the isoenzyme CYP2C9.

Withdrawal

Clearance - 0.13 ml / min / kg. It is excreted 98% by the kidneys, 10% is excreted unchanged, with bile - 0.5-2.5%. Css in blood plasma is determined after taking 4-5 doses of the drug (2-3 days). With renal failure, the accumulation of metabolites is possible.

Side effect

The most frequently observed adverse events were from the gastrointestinal tract. Possible development of peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see section 'Special instructions'). Blood and lymphatic system disorders: infrequently - eosinophilia, granulocytopenia, leukopenia, thrombocytopenia. From the nervous system: often - headache, vertigo, dizziness, drowsiness; infrequently - depression, sleep disturbances, inability to concentrate, insomnia, malaise. From the side of the organ of vision: often - visual impairment. On the part of the organ of hearing and labyrinth disorders: often - tinnitus, hearing impairment; infrequently - hearing loss. From the side of the heart: often - swelling, palpitations; infrequently - congestive heart failure. From the respiratory system,organs of the chest and mediastinum: often - shortness of breath; infrequently - eosinophilic pneumonia. From the gastrointestinal tract: often - constipation, abdominal pain, dyspepsia, nausea, diarrhea, stomatitis, flatulence; infrequently - gastrointestinal bleeding and / or perforation of the stomach, bloody vomiting, melena, vomiting; very rarely - relapse or exacerbation of ulcerative colitis or Crohn's disease; frequency unknown - gastritis. From the liver and biliary tract: infrequently - increased activity of liver enzymes, jaundice. On the part of the skin and subcutaneous tissues: often - itching, skin rash, ecchymosis, purpura; infrequently - alopecia, photodermatosis; very rarely - bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. From the musculoskeletal system and connective tissue: infrequently - myalgia and muscle weakness. From the kidneys and urinary tract:infrequently - glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis. General disorders: often - thirst, increased sweating; infrequently - hypersensitivity reactions, menstrual irregularities, hyperthermia (chills and fever). During the treatment of NSAIDs, it was reported the appearance of edema and symptoms of heart failure, an increase in blood pressure. Clinical studies and epidemiological data indicate that the use of some NSAIDs (especially high doses and with prolonged therapy) may be associated with a slight increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke). Adverse effects, the causal relationship of which with the use of naproxen has not been established.From the blood and lymphatic system: aplastic anemia,hemolytic anemia. From the nervous system: aseptic meningitis, cognitive dysfunction. On the part of the skin and subcutaneous tissues: erythema multiforme, photosensitivity reactions, like tardive cutaneous porphyria and epidermolysis bullosa, urticaria. From the side of the vessels: vasculitis. General disorders: angioedema, hyperglycemia, hypoglycemia. If the patient noticed such phenomena, then stop taking the drug and, if possible, consult a doctor.If the patient noticed such phenomena, then stop taking the drug and, if possible, consult a doctor.If the patient noticed such phenomena, then stop taking the drug and, if possible, consult a doctor.

Application during pregnancy and lactation

The use of the drug Teraliv 275 during pregnancy and during breastfeeding is contraindicated. The use of naproxen, like other drugs that block the synthesis of prostaglandins, can affect fertility, therefore it is not recommended for women planning a pregnancy.

special instructions

Do not exceed the doses indicated in the instructions. 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. If pain and fever persist or become worse, see your doctor. Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics should consult a doctor before taking Teraliv 275. Caution should be given to patients with liver disease and renal failure. In chronic alcoholic and other forms of liver cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for such patients. After two weeks of using the drug, it is necessary to monitor liver function indicators.In patients with renal insufficiency, CC should be monitored. When CC is less than 30 ml / min, it is not recommended to use naproxen. Teraliv 275 should not be taken together with other anti-inflammatory and analgesic medications, unless prescribed by a doctor. Lower doses are also recommended for elderly patients. You should avoid taking naproxen for 48 hours before surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study. Similarly, naproxen can affect the determination of 5-hydroxyindoleacetic acid in urine. Each tablet of Teraliv 275 contains approximately 25 mg of sodium. When limiting salt intake, this must be taken into account.Influence on the ability to drive vehicles and mechanisms Naproxen slows down the reaction rate in patients. This should be taken into account when driving and performing tasks requiring increased attention.

Overdose

Symptoms: a significant overdose of naproxen can be characterized by drowsiness, dyspeptic disorders (heartburn, nausea, vomiting, abdominal pain), weakness, tinnitus, irritability, in severe cases - bloody vomiting, melena, impaired consciousness, convulsions and renal failure.

Treatment: a patient who has accidentally or intentionally taken a large amount of Teraliv 275 needs to wash the stomach, take activated charcoal and carry out symptomatic therapy: antacids, histamine H2 receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Drug interactions

When treating with anticoagulants, it should be borne in mind that naproxen can increase bleeding time. Do not use Teraliv 275 simultaneously with acetylsalicylic acid, other NSAIDs, including selective COX-2 inhibitors (increased risk of side effects). Patients who are simultaneously receiving hydantoins, anticoagulants or other drugs that bind to a large extent with blood plasma proteins should watch for signs of potentiation of the action or overdose of these drugs. Teraliv 275 may reduce the antihypertensive effect of propranolol and other beta-blockers, and may also increase the risk of renal failure associated with the use of ACE inhibitors. NSAIDs can reduce the diuretic effect of diuretics.Under the action of naproxen, the natriuretic effect of furosemide is inhibited. Diuretics may increase the risk of NSAID nephrotoxicity. Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in the blood plasma. Taking probenecid increases the concentration of naproxen in the blood plasma. Cyclosporine increases the risk of developing renal failure. Naproxen slows down the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of developing their toxic effects. Antacids containing magnesium and aluminum reduce the absorption of naproxen. Myelotoxic drugs increase the manifestations of the drug's hematoxicity. According to in vitro studies, the simultaneous use of naproxen and zidovudine increases the concentration of zidovudine in the blood plasma.Concomitant use of corticosteroids may increase the risk of gastrointestinal ulcers or bleeding. NSAIDs can enhance the effects of anticoagulants such as warfarin. The simultaneous use of naproxen and antiplatelet drugs, selective serotonin reuptake inhibitors, increases the risk of gastrointestinal bleeding. It is not recommended to take NSAIDs at the same time for 8-12 days after using mifepristone. Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.It is not recommended to take NSAIDs at the same time for 8-12 days after using mifepristone. Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.It is not recommended to take NSAIDs at the same time for 8-12 days after using mifepristone. Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.