Index of drugs

Rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, osteoarthritis. acute inflammation of the musculoskeletal system, such as bursitis, tendinitis. Acute attack of gout. Weak to moderate pain of various origins, acute or chronic, including postoperative, post-traumatic and other pain; aching muscles, bones, joints, headaches, also migraines, toothache, neuralgia. Painful menstruation. Fever of various origins. Due to the slow penetration of Naproxen into joint cavities, its action in rheumatism occurs only a few to several hours after taking, which should be taken into account both when determining the method of administration and the evaluation of the response to treatment.

1 tabl powl. contains 275 mg or 550 mg naproxen sodium. The preparation contains lactose.

A non-steroidal anti-inflammatory drug with analgesic and antipyretic effects. The mechanism of anti-inflammatory action consists in inhibiting the activity of arachidonic acid cyclooxygenase, which leads to inhibition of prostaglandin synthesis. The anti-inflammatory effect of naproxen causes symptomatic improvement in rheumatic diseases. Naproxen in the form of the sodium salt is absorbed from the digestive tract faster than the free acid. Due to the fact that after absorption, the compound is present in body fluids as an anion, the effect of the sodium salt is practically identical to that of the free acid. Naproxen sodium is absorbed almost entirely from the gastrointestinal tract. The maximum serum concentration occurs after about 1 hour from administration and the analgesic effect occurs after 20 min. The food does not significantly affect the absorption. The drug is more than 99% bound to plasma proteins. T_0,5 in healthy people it is 12-15 h, which allows you to achieve a state of balance within 3 days from the beginning of treatment, while using naproxen 2 times a day. Joints penetrate the pond joints relatively slowly; 3-4 h after a single dose, the concentration in synovial fluid is 50% of serum concentration, while in 15 h - 74%. Also, the elimination of naproxen from joint cavities is slow. Steady state of naproxen concentration in synovial fluid is determined after about 7 days of use. Naproxen is metabolized in the liver to 6-desmetylon naproxen and is coupled with glucuronic acid; both metabolites have no pharmacological activity. Naproxen is mainly excreted in the urine in conjugate and unchanged form (10% of the dose).

Hypersensitivity to naproxen or other components of the preparation. Hypersensitivity to Acetylsalicylic acid or other NSAIDs, with symptoms of bronchial asthma, rhinitis, nasal polyps or urticaria. Active or in the history of peptic ulcer of the stomach and / or duodenum with bleeding or without bleeding. Severe heart failure. Severe hepatic failure. Severe renal failure. Hemorrhagic diathesis.

It must not be used together with medicines containing naproxen and other NSAIDs, including medicines from the group of selective COX-2 inhibitors and glucocorticosteroids due to the increased risk of serious side effects. Taking the medicine in the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. Elderly patients should be treated with caution and do not use the drug for a long time; if long-term treatment is necessary, the patient's condition should be regularly monitored. In patients with a history of a history of gastrointestinal tract, especially in the elderly, there is a risk of gastrointestinal haemorrhage, ulceration or perforation, which may have fatal consequences and which may not necessarily be preceded by warning signs. These patients should use the lowest dose of the medicine. If bleeding or ulceration of the digestive tract occurs, naproxen should be discontinued. Because of its anti-inflammatory and antipyretic effects, naproxen can mask the symptoms of infection and make diagnosis of the disease difficult.Patients with bronchial asthma or allergic diseases may experience bronchospasm. Naproxen reduces platelet aggregation and prolongs bleeding time. Caution should be exercised in patients with a history of hypertension or mild to moderate congestive heart failure, fluid retention and edema. Special care should be taken in patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease or cerebrovascular disease. Similar care should be taken before initiating long-term treatment in patients with cardiovascular risk factors (eg hypertension, hyperlipidemia, diabetes, and smoking). In patients with impaired renal function, naproxen should be used with caution; Periodic monitoring of plasma creatinine and / or creatinine clearance is recommended. Do not use the drug in patients with a creatinine clearance below 20 ml / min. In some patients, renal function should be monitored before starting naproxen and during treatment. This is particularly true for patients with impaired renal flow, resulting from decreased extracellular volume, liver cirrhosis, reduced sodium supply, congestive heart failure and a history of kidney disease. This group includes some elderly patients who may experience renal dysfunction and patients with diuretics. In these patients, a reduction in the daily dose should be considered. In patients with alcohol cirrhosis and other forms of cirrhosis, the lowest effective doses of naproxen should be used. During the use of the drug should be carefully observed patients with bleeding disorders or receiving anticoagulants (increased risk of bleeding). Anaphylactic reactions may affect patients with hypersensitivity to acetylsalicylic acid or other NSAIDs (including naproxen) as well as patients without hypersensitivity. They can also occur in patients with angioedema, bronchial asthma, rhinitis and nasal polyps. The occurrence of any eye discomfort during treatment with naproxen is an indication for an ophthalmologic examination. Discontinue treatment after the first symptoms of rash, damage to the oral mucosa or other signs of hypersensitivity. The use of naproxen can adversely affect female fertility and is not recommended in women who are planning to become pregnant. For women who have difficulty conceiving or who are being tested for infertility, discontinuation of naproxen should be considered. Naproxen should not be used concomitantly with other NSAIDs because of the increased risk of serious side effects. The use of the preparation as an analgesic and antipyretic in patients under 16 years is not recommended. It is allowed to use the drug in children over 5 years in juvenile rheumatoid arthritis - only under the supervision of a doctor. The preparation contains lactose - should not be used in patients with hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

It should not be used during pregnancy, except when it is absolutely necessary. The use of naproxen during pregnancy requires careful consideration of potential benefits for the mother and the fetus, especially in the first and third trimester of pregnancy. Do not use the drug while breastfeeding.

Common: nausea, indigestion, heartburn, abdominal pain, dizziness, headaches, a feeling of emptiness in the head. Uncommon: vomiting, constipation, diarrhea, abdominal discomfort, skin rashes, pruritus, urticaria, lethargy, insomnia, drowsiness. Rare: gastrointestinal bleeding, peptic ulcer and / or duodenal ulcer (bleeding and perforation or not), angioneurotic edema, renal failure, peripheral edema, fever. Very rare: pancreatitis, inflammation of the lining of the stomach or intestines, jaundice, hepatitis, alopecia, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, erythema nodosum, lichen planus, systemic lupus erythematosus, pemphigus-like reactions, bladder discrete epidermis, purpura, petechiae, haemorrhagic diathesis, hyperhidrosis, glomerulonephritis, interstitial nephritis, nephrotic syndrome, haematuria, hyperkalemia, increase in serum creatinine, renal papillary necrosis, seizures, sleep disturbances, depression, aseptic meningitis, concentration and cognitive function, dyspnoea, edema, palpitations, hypertension, heart failure, increased risk of arterial blockages (e.g.myocardial infarction or stroke), vasculitis, thrombocytopenia, granulocytopenia, agranulocytosis, eosinophilia, leukopenia, aplastic anemia, haemolytic anemia, bronchial asthma, eosinophilic pneumonia, pulmonary edema, visual disturbances, corneal opacities, optic nerve thyroiditis, retrobulbar section of the nerve optic, optic disc edema, tinnitus, impaired hearing, including hearing loss, muscle aches or weakness, hypersensitivity to light, anaphylactic reactions, including fatal shock, excessive thirst, fatigue, oral mucositis with ulcerations, oesophagitis , increased creatinine, abnormal liver function tests, hyperkalemia.

Orally. Adults. Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, osteoarthritis: 550-1100 mg daily in 2 divided doses, every 12 hours. If a dose of 1100 mg is necessary, 1 tablet may be used. 550 mg twice daily or 2 tablets. 550 mg single dose (morning or evening). In the following cases, in the acute phase of the disease, a loading dose of 825 mg or 1100 mg should be administered: in patients reporting increased night pain or morning stiffness, in patients who have changed treatment from a high dose of another anti-rheumatism drug to Naproxen, in degenerative arthritis, when the main symptom is pain.Acute inflammation of the musculoskeletal system, poor to moderate pain of various origins, dysmenorrhea, fever of various origins: the starting dose is 550 mg, followed by 275 mg every 6-8 h, if necessary, not exceeding 1375 mg on the first day and 1100 mg on the following days of use.Acute attack of goutThe starting dose is 825 mg, followed by 275 mg every 8 hours until the onset of pain.Migraine headaches: at the first symptoms of the approaching attack of 825 mg. In addition, a dose of 275 mg - 550 mg may be used during the day, if necessary, but not earlier than 1 hour after the first dose. The maximum daily dose is 1375 mg. The lowest effective dose of the drug should be used in the elderly. Children over 5 years.Juvenile rheumatoid arthritis: 10 mg / kg daily in 2 divided doses (5 mg / kg twice daily). It is not recommended for children under 16 in other indications.
The drug is used during or after meals. The tablets should not be divided.