NAPIKOR [Naproxen] 500 mg Film-coated tablets

NAPIKOR

instructions for medical use of the medicinal product

Tradename

Napikor, Напикор

International non-proprietary name

Naproxen, Naproxen

Composition

Each film-coated tablet contains:

active substance: n aproxen USP 500 mg

excipients: croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, ethanol.

Dosage form

Tablets.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs ( NSAIDs) .

Pharmacological properties

Napicor is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. The active substance is naproxen.

Pharmacodynamics

The action of naproxen is associated with non-selective suppression of the activity of cyclooxygenase types 1 and 2, as a result of which the synthesis of prostaglandins, modulators of pain, fever and inflammation, is inhibited. It has a more prolonged effect compared to other non-steroidal anti-inflammatory drugs.

Pharmacokinetics

When taken orally, the drug is rapidly absorbed from the gastrointestinal tract (GIT), bioavailability is about 90%. Binding to plasma proteins is almost complete (up to 98%). The maximum concentration in the blood is reached after 2-3 hours. The half-life is about 12 hours. The drug is metabolized in the liver and excreted from the body mainly by the kidneys (up to 98%) in the form of conjugates or unchanged (10%). With bile, 0.5-2.5% of the drug is excreted. In case of impaired renal function due to chronic pyelonephritis, the accumulation of metabolites is possible.

Indications for use

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, juvenile chronic, gouty arthritis, ankylosing spondylitis (Bekhterev's disease), osteoarthritis.

Pain syndrome: myalgia, ossalgia, neuralgia, arthralgia, sciatica, headache (including migraine) and toothache, tendonitis, in oncological diseases, post-traumatic and postoperative pain syndrome, accompanied by inflammation, algomenorrhea, adnexitis, childbirth (as an analgesic and tocolytic).

Infectious and inflammatory diseases of ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media.

Feverish syndrome with "colds" and infectious diseases.

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

Contraindications

Hypersensitivity, erosive and ulcerative lesions of the gastrointestinal tract and duodenum, complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including history), severe renal failure (CC less than 30 ml/min), active gastrointestinal bleeding, inflammatory bowel disease, progressive kidney disease, severe liver failure or active liver disease, and documented hyperkalemia.

Carefully. Chronic heart failure, ischemic heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (CC 30-60 ml / min), history of ulcerative lesions of the gastrointestinal tract, the presence of H. pylori infection, long-term use of NSAIDs , alcoholism, severe somatic diseases, old age, simultaneous use of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective reuptake inhibitors serotonin (including citalopram, fluoxetine, paroxetine, sertraline).

Dosage and administration

inside. Tablets should be swallowed whole, without chewing, with a sufficient amount of liquid, can be taken with meals .

adults

In the acute stage of the disease - 0.5-0.75 g 2 times a day. The maximum daily dose is 1.75 g. For maintenance therapy, the average daily dose is 500 mg in 2 divided doses (morning and night).
In an acute attack of gout, the first dose is 825 mg; then - 275 mg every 8 hours.
With algomenorrhea - in the first dose of 500 mg, then 275 mg every 6-8 hours for 3-4 days. For migraine - 500 mg.

Children
At the age of 1 to 5 years - at a daily dose of 2.5-5 mg / kg in 1-3 doses, the course of treatment should not exceed 14 days.
In juvenile arthritis in children older than 5 years, the daily dose is 10 mg / kg.

The preferred dosage form for children is a suspension.

Special instructions and precautions

Do not exceed recommended doses.

Use with caution in diseases of the liver and kidneys, diseases

gastrointestinal tract in history, in the presence of dyspeptic symptoms. Napicor should be avoided within 48 hours prior to surgery.

In the process of treatment, systematic monitoring of the function of the liver and kidneys, the picture of peripheral blood is necessary.

In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen is increased, so lower doses are recommended in such patients.

Napicor should not be taken with other anti-inflammatory or pain medications unless directed by a physician.

If it is necessary to determine the concentration of 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Lower doses are recommended for elderly patients.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, one should refrain from activities that require increased concentration of attention and speed of psychomotor reactions.

Use during pregnancy and during breastfeeding

Use during pregnancy and during breastfeeding is contraindicated.

Interaction with other drugs

If you are taking any other medicines, be sure to inform your doctor, and if you are self-treating, consult your doctor about the possibility of using the drug.

With simultaneous administration, it can cause a decrease in the diuretic effect of furosemide; enhancing the effect of indirect anticoagulants.

Increases the toxicity of phenytoin, sulfonamides, methotrexate (blocks tubular secretion).

Reduces the hypotensive effect of beta-blockers.

Reduces the excretion of Li + and increases its concentration in plasma.

Antacids containing Mg2+ and Al3+ reduce the absorption of naproxen.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Side effect

Nausea, vomiting, epigastric discomfort, skin rash, urticaria, angioedema; headache, drowsiness, tinnitus, dizziness, weakness, slow reaction rate; erosive and ulcerative lesions of other parts of the gastrointestinal tract, bleeding and perforation of the gastrointestinal tract; thrombocytopenia, granulocytopenia, aplastic anemia, hemolytic anemia; hearing loss, impaired kidney or liver function.

NSAID-gastropathy (lesion of the antrum of the stomach in the form of erythema of the mucous membrane, hemorrhages, erosions and ulcers).

Overdose

Symptoms: heartburn, dyspepsia, nausea, vomiting, drowsiness.

Treatment: gastric lavage, activated charcoal - 0.5 g / kg.

Storage conditions

Store in a cool and dry place, at a temperature not exceeding 30º C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.