Product description
It has an analgesic effect, remaining in the body for up to 12-15 hours 1.1-Frickl et al. Efficacy and safety of naproxen sodium and ibuprofen in relation to analgesia after oral surgery. Ongoing Therapeutic Research. 1993;54(6): 619-27.
Composition
One tablet contains: Active ingredient: naproxen in terms of 100% substance – 250.00 mg; excipients: lactose monohydrate – 71.12 mg, potato starch-42.00 mg, povidone-16.00 mg, magnesium stearate-0.76 mg, tropeolin O dye-0.12 mg.
Clinical pharmacology
Pharmacodynamics : A nonsteroidal anti-inflammatory drug (NSAID), it has anti-inflammatory, analgesic and antipyretic effects associated with non-selective suppression of cyclooxygenase 1 and cyclooxygenase 2, which regulate prostaglandin synthesis. Pharmacokinetics: Absorption from the gastrointestinal tract is fast and complete, bioavailability is 95% (food intake practically does not affect either the completeness or the rate of absorption). The time to reach the maximum concentration (TCmax) is 2 hours, the binding to plasma proteins is 99%, and the half-life (T1 / 2) is 12-15 hours. Metabolism-in the liver to dimethylnaproxene with the participation of the CYP2C9 enzyme system. Clearance – 0.13 ml / min / kg. It is excreted 98% by the kidneys,10% of them are excreted unchanged; with bile – 0.5-2.5%. The steady-state concentration of the drug in blood plasma (Css) is determined after 2-3 days. In chronic renal failure, accumulation of metabolites is possible.
Indications
Mild to moderate pain syndrome: neuralgia, ossalgia, myalgia, lumboishialgia, post-traumatic pain syndrome (sprains and bruises) accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodismenorrhea, adnexitis, toothache. Symptomatic treatment of pain syndrome in diseases of the musculoskeletal system, including bursitis, tendovaginitis. 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 conditions in case of flu and colds. The drug is used for symptomatic therapy (to reduce pain, inflammation, and fever) and does not affect the progression of the underlying disease.
Use during pregnancy and lactation
The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).
Contraindications
Hypersensitivity to naproxen or naproxen sodium; complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including in the anamnesis). During the period of coronary artery bypass grafting. Erosive and ulcerative lesions of the stomach and duodenum in the acute phase (ulcerative colitis (UC), Crohn’s disease). Cerebrovascular bleeding or other bleeding and hemostatic disorders. Severe renal insufficiency (creatinine clearance less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease. Inhibition of bone marrow hematopoiesis. Pregnancy, breast-feeding period. Children under 12 years of age.
Side effects
Side effects are most common when using high doses of the drug: – from the digestive system: constipation, abdominal pain, dyspepsia, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding of the gastrointestinal tract, NSAIDs-gastropathy (damage to the antrum of the stomach in the form of erythema of the mucous membrane, hemorrhages, erosions and ulcers), increased activity of “liver” enzymes, impaired liver function, jaundice, bloody vomiting, melena– – from the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disorders, inability to concentrate, insomnia, malaise, slowing down the speed of psychomotor reactions, aseptic meningitis, cognitive dysfunction;– from the skin: itching, ecchymosis, increased sweating, purpura, alopecia, photodermatosis;– from the sensory organs: tinnitus, visual impairment, hearing impairment;– from the cardiovascular system: swelling of the face, limbs, shortness of breath, palpitations, occurrence or aggravation of existing chronic heart failure, vasculitis;-from the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual disorders;– from the hematopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia;– respiratory system disorders: eosinophilic pneumonitis;– allergic reactions: skin rash, urticaria, angioedema, toxic epidermal necrolysis, erythema multiforme, Stevens– Johnson syndrome;-others: thirst, hyperthermia, hyperglycemia, hypoglycemia, myalgia and muscle weakness.
Interaction
When using anticoagulants, it should be borne in mind that naproxen may increase the bleeding time. Do not use the drug simultaneously with other nonsteroidal anti-inflammatory drugs (increased risk of side effects).
With the simultaneous use of hydantoin derivatives, anticoagulants, or other drugs that bind significantly to plasma proteins, the effect of these drugs may be potentiated.
Naproxen may reduce the antihypertensive effects of propranolol and other beta-blockers, and may also increase the risk of renal failure associated with the use of ACE inhibitors.
Naproxen inhibits the natriuretic effect of furosemide.
Inhibition of renal lithium clearance leads to an increase in plasma lithium concentrations.
Taking probenecid increases the level of naproxen in 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.
How to take, course of use and dosage
Inside, adults and children over 12 years of age. Tablets should be taken whole, washed down with a sufficient amount of liquid, can be taken with meals. For pain relief, the initial dose is 500 mg, then, if necessary,500 mg every 12 hours or 250 mg every 8 hours. The usual daily dose used for pain relief is 500-1000 mg. To relieve pain in migraines, a dose of 500 mg twice a day is recommended. However, treatment should be discontinued if the frequency, intensity, and duration of migraine attacks do not decrease within 4-6 weeks. To relieve menstrual pain, pain after intrauterine device insertion and other gynecological pain (adnexitis), the initial dose is 500 mg, then, if necessary,250 mg every 6-8 hours for 3-4 days. For the symptomatic treatment of pain syndrome in diseases of the musculoskeletal system (bursitis, tendovaginitis), the usual daily dose of the drug is 500-1000 mg, one or two tablets twice a day in the morning and evening. When using the drug as an antipyretic, the initial dose is 500 mg, then, if necessary,250 mg every 8 hours. The drug is not recommended to be used as an analgesic for more than 5 days without consulting a doctor. If symptoms persist, you should consult a doctor.
Overdose
Significant overdose of the drug can be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, in severe cases-bloody vomiting, melena, impaired consciousness, convulsions and kidney failure. Treatment: gastric lavage, use of activated charcoal and symptomatic therapy: antacids, H%^%2-histamine receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.
Description
Tablets of light yellow color with minor inclusions, flat-cylindrical, with a chamfer and risk.
Special instructions
Do not exceed the dosage indicated in the instructions. To reduce the risk of adverse events from the gastrointestinal tract, 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, or hypersensitivity to other analgesics should consult their doctor before taking naproxen.
Caution should be exercised in patients with liver disease and renal insufficiency. In patients with renal insufficiency, creatinine clearance should be monitored. In chronic alcoholic and other forms of liver cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for such patients.
Naproxen should not be taken together with other anti-inflammatory and painkillers, except as directed 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 may affect the determination of 5-hydroxyindoleacetic acid in the urine.The use of naproxen, as well as other drugs that block prostaglandin synthesis, can affect fertility, so it is not recommended for women planning pregnancy.
Form of production
Tablets
Storage conditions
In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of reach of children.
Shelf
life is 3 years.
Active ingredient
Naproxen
Dosage form
Tablets
Purpose
For adults and Children over 6 years of age
Indications
Lumbago, Migraines, Sore Throats, Arthritis, Infectious Diseases, Osteoarthritis, Colds, Periarthritis, Swelling after injuries and operations, Flu, Rheumatoid Arthritis, Sciatica, Osteoarthritis
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