Teraliv 275, 275 mg 24 pcs

A nonsteroidal anti-inflammatory drug.

The drug Teraliv 275 is naproxen, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of cyclooxygenase-1 and -2 (COX-1, COX-2) activity.

The drug Teraliv 275, film-coated tablets dissolves well, is quickly absorbed from the gastrointestinal tract and provides rapid onset of analgesic effect.

Indications

Diseases of the musculoskeletal system (rheumatic soft tissue lesions, osteoarthritis of the peripheral joints and spine, including radicular syndrome, tendovaginitis, bursitis).

Pain syndrome of mild to moderate severity: neuralgia, ossalgia, myalgia, lumboichialis, post-traumatic pain syndrome (sprains and contusions), accompanied by inflammation, headache, migraine, algodysmenorrhea, toothache.

In the complex treatment of infectious and inflammatory diseases of the ear, throat, nose with a pronounced pain syndrome (pharyngitis, tonsillitis, otitis).

Fever syndrome in “colds” and infectious diseases.

The drug Teraliv 275 is used for symptomatic therapy (to reduce pain, inflammation and decrease elevated body temperature) and has no effect on the progression of the underlying disease.

Active ingredient

Composition

1 tablet contains

Active ingredient:

Naproxen sodium 275 mg.

Auxiliary substances:

Microcrystalline cellulose 55.00 mg,

Povidone K-30 12.50 mg,

talc 15.75 mg,

magnesium stearate 2.63 mg;

film coating:

Operadige blue YS-1-4215 9 mg:

macrogoal 8000,

indigo carmine,

titanium dioxide,

hypromellose.

Interaction

When treating with anticoagulants, it should be borne in mind that naproxen may increase bleeding time. The drug Teraliv 275 should not be used simultaneously with acetylsalicylic acid, other NSAIDs, including selective cyclooxygenase-2 inhibitors (increased risk of side effects).

Patients concomitantly receiving guidantoins, anticoagulants or other drugs that bind significantly to plasma proteins should watch for signs of potentiation or overdose of these drugs.

The drug Teraliv 275 may decrease the antihypertensive effects of propranololol and other beta-adrenoblockers, and may increase the risk of renal failure associated with the use of angiotensin-converting enzyme inhibitors (ACEs).

NSAIDs may decrease 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 plasma lithium concentration. Probenecid administration increases the plasma concentration of naproxen. Cyclosporine increases the risk of renal failure.

Naproxen slows down excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of their toxic effects.

The antacids containing magnesium and aluminum decrease the absorption of naproxen.

Myelotoxic drugs increase the manifestation of hematoxicity of the drug.

According to in vitro studies, concomitant use of naproxen and zidovudine increases the concentration of zidovudine in plasma.

The concomitant use of corticosteroids may increase the risk of gastrointestinal ulceration or bleeding.

The use of NSAIDs may increase the effect of anticoagulants, such as warfarin.

The concomitant use of naproxen and antiplatelet drugs, selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

The concomitant use of NSAIDs for 8-12 days after mifepristone is not recommended.

The concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.

Directions for use

Ingestion. Tablets should be taken with enough water.

Adults and children 15 years 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). The duration of use is not more than 5 days.

If Teraliv 275 is used as an antipyretic, the initial dose is 2 tablets and then 1 tablet (275 mg) is taken every 8 hours.

To prevent and treat migraine attacks, the initial recommended dose is 2 tablets (550 mg), and if necessary, 1 tablet (275 mg) every 8-12 hours can be taken. The maximum daily dose is 3 tablets (825 mg).

To relieve menstrual pain and cramps, pain after IUD insertion, and other gynecological pain, a starting dose of 2 tablets (550 mg) is recommended, followed by 1 tablet (275 mg) every 8 hours.

Children

The drug Teraliv 275 is contraindicated for use in children under 15 years of age.

Patients of advanced age (≥65 years)

Patients older than 65 years should take the drug as needed every 12 hours.

To reduce the risk of gastrointestinal adverse events, the drug should be taken at the lowest effective dose for the shortest possible course.

If you get the impression that the effects of the drug are very strong or weak, inform your doctor or pharmacist.

Special Instructions

Do not exceed the doses indicated in the instructions. To reduce the risk of gastrointestinal adverse events, use the lowest effective dose for the shortest possible course.

If pain and fever persist or get worse, see a doctor. Patients with bronchial asthma, with blood clotting disorders, or with hypersensitivity to other analgesics should consult a physician before taking Teraliv 275.

Patients with liver disease and renal impairment should be prescribed with caution. In patients with renal insufficiency, creatinine clearance should be monitored. In CKR less than 30 ml/min, it is not recommended to use naproxen. In chronic alcoholic and other forms of liver cirrhosis the concentration of unbound naproxen is increased, therefore lower doses are recommended for such patients. After two weeks of using the drug it is necessary to monitor liver function parameters.

The drug Teraliv 275 should not be taken with other anti-inflammatory and pain medications except as directed by a physician.

Lower doses are also recommended for elderly patients.

Naproxen should be avoided for 48 hours before surgery. If 17-corticosteroid determination is necessary, the drug should be discontinued 48 hours before the study. Similarly, naproxen may affect the determination of 5-hydroxyindoleacetic acid in urine.

The use of naproxen, as well as other drugs that block the synthesis of prostaglandins, may affect fertility, so it is not recommended for women who plan to become pregnant.

Each tablet of Teraliv 275 contains approximately 25 mg of sodium. This should be considered when limiting salt intake.

Naproxen slows reaction time in patients. This should be considered when driving and performing tasks requiring increased attention.

Synopsis

Oval biconvex film-coated tablets, blue in color. On one side of the tablet is engraved “NPS-275”. On the fracture the tablet has a core of white color.

Features

It is quickly and completely absorbed from the gastrointestinal tract. Bioavailability is 95% (food intake has practically no effect on the completeness or speed of absorption). Time to reach maximum concentration is 1-2 hours. Blood plasma protein binding is 99 %. The elimination half-life is 12-15 hours. Metabolism occurs in the liver to dimethylnaproxen with the participation of SUR2C9 isoenzyme. Clearance is 0.13 ml/min/kg. It is excreted 98% by kidneys, 10% is excreted unchanged, 0.5-2.5% – in bile. The equilibrium concentration in blood plasma is determined after 4-5 doses of the drug (2-3 days).

In case of renal insufficiency cumulation of metabolites is possible.

Contraindications

Hypersensitivity to naproxen or sodium naproxen.

The complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis, and intolerance to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (including history).

The period after coronary artery bypass grafting.

Erotic ulcerative changes of the mucosa of the stomach or 12 duodenum, active gastrointestinal bleeding.

Inflammatory bowel disease (non-specific ulcerative colitis, Crohn’s disease) in the acute phase.

Hemophilia and other disorders of blood clotting and hemostasis disorders.

Cerebrovascular bleeding or other bleeding disorders.

Decompensated heart failure.

Developed hepatic insufficiency or active liver disease.

Developed renal insufficiency (creatinine clearance (CK) less than 30 ml/min), advanced renal disease, confirmed hyperkalemia.

Pregnancy, period of breast-feeding.

Children under 15 years of age.

Coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, renal function impairment (CK 30-60 ml/min), anamnestic evidence of gastrointestinal (GI) ulcer development, 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), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticoids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Unwanted effects that may develop during treatment with naproxen are classified according to the following frequency of occurrence: Very common (> 1/10), common (≥1/100 to < 1/10), infrequent (≥1/1000 to < 1/100), rare (≥1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (cannot be determined based on available data).

Gastrointestinal disorders: Gastrointestinal adverse events have been observed most frequently. Possible development of peptic ulcer, perforation or gastrointestinal bleeding, sometimes with fatal outcome, especially in elderly patients (see section “Special indications”).

In each group, the adverse events are listed in descending order of severity.

Blood and lymphatic system disorders

Infrequent: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia.

Nervous system disorders

Often: headache, vertigo, dizziness, somnolence.

Infrequent: depression, sleep disturbances, inability to concentrate, insomnia, malaise.

Visual disturbances

Often: visual disturbances.

Hearing and labyrinth disorders

Often: tinnitus, hearing impairment.

Infrequent: decreased hearing.

Heart disorders

Often: swelling, palpitations.

Infrequent: congestive heart failure.

Respiratory system, thorax and mediastinum disorders

Often: dyspnea.

Infrequent: eosinophilic pneumonia.

Gastrointestinal disorders

Often: constipation, abdominal pain, dyspepsia, nausea, diarrhea, stomatitis, flatulence.

Infrequent: gastrointestinal bleeding and/or gastric perforation, bloody vomiting, melena, vomiting.

Very rare: relapse or exacerbation of ulcerative colitis or Crohn’s disease.

Prevalence unknown: gastritis.

Liver and biliary tract disorders

Infrequent: increased activity of “liver” enzymes, jaundice.

Skin and subcutaneous tissue disorders

Often: skin itching, skin rash, ecchymosis, purpura.

Infrequent: alopecia, photodermatosis.

very rarely: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Muscular and connective tissue disorders

Infrequent: myalgia and muscle weakness.

Renal and urinary tract disorders

Infrequent: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.

General disorders and disorders at the site of administration

Often: thirst, increased sweating.

Infrequent: hypersensitivity reactions, menstrual irregularities, hyperthermia (chills and fever).

The occurrence of edema and symptoms of heart failure and increased blood pressure have been reported during NSAID therapy.

Clinical studies and epidemiologic data suggest that use of some NSAIDs (especially high doses and long-term therapy) may be associated with a slightly increased risk of arterial thrombosis (e.g., myocardial infarction or stroke).

Unwanted effects with no causal relationship to the use of naproxen

Disorders 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.

General disorders and disorders at the site of administration: angioedema, hyperglycemia, hypoglycemia.

If you notice these changes, stop taking the drug and see your doctor, if possible.

Overdose

Symptoms

A significant overdose of naproxen may be characterized by drowsiness, dyspeptic disorders (heartburn, nausea, vomiting, abdominal pain), weakness, tinnitus, irritability, in severe cases – bloody vomiting, melena, impaired consciousness, seizures and renal failure.

Treatment

Patient who has accidentally or intentionally taken a large amount of Teraliv 275 should wash the stomach, take activated charcoal and apply symptomatic therapy: antacids, H2 receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Similarities