Teraliv 275mg pills, 12pcs

Composition

Auxiliary substances:

microcrystalline cellulose-55 mg,

povidone K 30-12.5 mg,

talc-15.75 mg,

magnesium stearate-2.63 mg;

film coating:

opadrai blue YS-1-4215 – 9 mg:

macrogol 8000,

indigo carmine,

titanium dioxide,

hypromellose.

Pharmacological action

The drug Teraliv 275 is a naproxen, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of cyclooxygenase-1 and -2 activity (COX-1, COX-2). The drug Teraliv 275, film-coated tablets, dissolves well, is quickly absorbed from the gastrointestinal tract and provides a rapid onset of an analgesic effect. Pharmacokineticsabsorption is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability – 95% (food intake practically does not affect either the fullness or the rate of absorption). The time to reach Cmax in blood plasma is 1-2 hours. Distribution Binding to plasma proteins >99%. T1 / 2 – 12-15 h. Metabolism occurs in the liver to dimethylnaproxene with the participation of the SUR2C9 isoenzyme. Elimination 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). In case of renal failure, accumulation of metabolites is possible.

Indications

for Diseases of the musculoskeletal system:

• rheumatic soft tissue disease;
• osteoarthritis of the peripheral joints and spine, including those with radicular syndrome;
• tendovaginitis;
• bursitis.

Mild or moderate pain syndrome:

• neuralgia;
• ossalgia;
• myalgia;
• lumboishialgia;
• 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 media.

Febrile syndrome in “colds” and infectious diseases.

The drug Teraliv 275 is used for symptomatic therapy (to reduce pain, inflammation and reduce elevated body temperature) and does not affect the progression of the underlying disease.

Contraindications

• Hypersensitivity to naproxen or naproxen sodium;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance of acetylsalicylic acid and other NSAIDs (including in the anamnesis);
• the period after the coronary artery bypass surgery;
• erosive and ulcerative changes in the mucous of the stomach or duodenal ulcer,
• active gastrointestinal bleeding;
• inflammatory bowel disease (ulcerative colitis, Crohn’s disease) in the acute phase;
• hemophilia and other disorders of blood coagulation and hemostatic disorders;
• cerebrovascular bleeding or other bleeding;
• decompensated heart failure.
• severe hepatic insufficiency or active liver disease;
• severe renal insufficiency (creatinine clearance less than 30 ml / min), progressive kidney disease;
• confirmed hyperkalemia;
• pregnancy;
• breast-feeding period;
• children under 15 years of age.

Use with caution IIBS, cerebrovascular diseases, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial diseases, smoking, impaired renal function (creatinine clearance 30-60 ml/min), history of gastrointestinal ulceration, 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 (e. g., warfarin), antiplatelet agents (e. g., acetylsalicylic acid, clopidogrel), oral glucocorticoids (e. g., prednisone), selective serotonin reuptake inhibitors (e. g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Adverse events that may occur during treatment with naproxen are classified according to the following frequency of occurrence: very common (> 1/10), common (≥1/100 to >< 1/10), uncommon (≥1/1000 to < 1/100), rare (≥1/10000 to < 1/1000), very rare (In each group, adverse events are listed in descending order of severity. From the gastrointestinal tract: the most common adverse events were observed from the gastrointestinal tract. Peptic ulcer, perforation or gastrointestinal bleeding may occur, sometimes with fatal outcome, especially in elderly patients (see section “Special instructions”). From the blood and lymphatic system: infrequently – eosinophilia, granulocytopenia, leukopenia, thrombocytopenia. From the nervous system: often-headache, vertigo, dizziness, drowsiness; infrequently-depression, sleep disorders, inability to concentrate, insomnia, malaise. From the side of the organ of vision: often-visual impairment. From the side of the organ of hearing and labyrinth disorders: often-tinnitus, hearing impairment; infrequently-hearing loss. From the heart: often-swelling, palpitation; infrequently-congestive heart failure. Respiratory, thoracic, and mediastinal disorders: common-dyspnea; uncommon-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. From the skin and subcutaneous tissues: often-pruritus, skin rash, ecchymosis, purpura; infrequently-alopecia, photodermatosis; very rarely-bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders: infrequently-myalgia and muscle weakness. From the side of the kidneys and urinary tract: infrequently-glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis. Common disorders: often-thirst, increased sweating; infrequently-hypersensitivity reactions, menstrual disorders, hyperthermia (chills and fever). Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and with long-term therapy) may be associated with a slight increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke). Undesirable effects, the causal relationship of which with the use of naproxen is not established on the part of the blood and lymphatic system: aplastic anemia, hemolytic anemia. Nervous system disorders: aseptic meningitis, cognitive dysfunction. Skin and subcutaneous tissue disorders: erythema multiforme, photosensitivity reactions similar to late cutaneous porphyria and epidermolysis bullosa, urticaria. Vascular disorders: vasculitis. Common disorders: angioedema, hyperglycemia, hypoglycemia. If the patient notices such phenomena, then you should stop taking the drug and, if possible, consult a doctor.

Interaction

When using anticoagulants, it should be borne in mind that naproxen may increase the bleeding time. Do not use Teraliv 275 concomitantly with acetylsalicylic acid, other NSAIDs, including selective COX-2 inhibitors (increased risk of side effects). Patients receiving concomitant treatment with hydantoins, anticoagulants, or other drugs that bind significantly to plasma proteins should monitor for signs of potentiation 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 may reduce the diuretic effect of diuretics. Naproxen inhibits the natriuretic effect of furosemide. Diuretics may increase the risk of nephrotoxicity of NSAIDs. Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in blood plasma. Taking probenecid increases the concentration of naproxen in the blood plasma. Cyclosporine increases the risk of developing kidney failure. Naproxen slows down the excretion of methotrexate, phenytoin, and sulfonamides, increasing the risk of their toxic effects. Antacids containing magnesium and aluminum reduce the absorption of naproxen. Myelotoxic drugs increase the manifestations of hematoxicity of the drug. According to in vitro studies, the concomitant use of naproxen and zidovudine increases the concentration of zidovudine in blood plasma. Concomitant use of corticosteroids may increase the risk of ulceration or gastrointestinal bleeding. NSAIDs may enhance the effects of anticoagulants such as warfarin.Simultaneous use of naproxen and antiplatelet drugs, selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding. Concomitant use of NSAIDs for 8-12 days after mifepristone use is not recommended. Concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.

How to take, course of use and dosage

Inside. Tablets should be taken with a sufficient amount of water. Adults and children 15 years and older: usually the daily dose used for pain relief is 2-3 tablets (550-825 mg). The maximum daily dose is 3 tablets (825 mg). Duration of application-no more than 5 days. When using the drug Teraliv 275 as an antipyretic, 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 pain and cramps, pain after the introduction of intrauterine devices and other gynecological pain, 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 gastrointestinal adverse events, the drug should be taken at the lowest effective dose in the shortest possible course. If the patient has the impression that the effect of the drug is very strong or weak, then you should inform your doctor or pharmacist about this.

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 kidney failure. Treatment: a patient who has accidentally or intentionally taken a large amount of Teraliv 275 should wash his stomach, take activated charcoal and conduct symptomatic therapy: antacids, histamine H2-receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Special instructions

Do not exceed the dose indicated in the instructions. To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course. If the pain and fever persist or become worse, you should consult a doctor. Patients with bronchial asthma, blood clotting disorders, and hypersensitivity to other analgesics should consult their doctor before taking Teraliv 275. Caution should be exercised in patients with liver disease and renal insufficiency. 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, monitoring of liver function indicators is necessary. In patients with renal insufficiency, creatinine clearance should be monitored. When creatinine clearance is less than 30 ml/min, naproxen is not recommended. Teraliv 275 should not be taken together with other anti-inflammatory and analgesic medications, except as prescribed by a doctor. Lower doses are also recommended for elderly patients. Naproxen should be avoided for 48 hours prior to surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study. Similarly, naproxen may affect the determination of 5-hydroxyindoleacetic acid in the urine. Each tablet of Teraliv 275 contains approximately 25 mg of sodium. When limiting salt intake, this should be taken into account. Effect on the ability to drive vehicles and mechanisms Minaproxen slows down the reaction rate in patients. This should be taken into account when driving a car and performing tasks that require increased attention.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 5 years.

Active ingredient

Naproxen

Dosage form

Tablets

Purpose

Children over 15 years of age, For adults, For adults as prescribed by a doctor

Indications

Dislocations and Sprains, Sciatica, Lumbago, Osteoarthritis, Bruises, Arthrosis and Arthritis, Bursitis