Motrin tablets 250mg, No. 20

• Pain syndrome of mild and moderate severity: neuralgia, ossalgia, myalgia, lumboischialgia, post-traumatic pain syndrome (sprains and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodischialgia adnexitis, toothache.

• Symptomatic therapy 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).

• Fever with flu and colds.

• The drug is used for symptomatic therapy (to reduce pain, inflammation and reduce fever) and does not affect the progression of the underlying disease.

Inside, for adults and children over 12 years old. The tablets should be taken whole with a sufficient amount of liquid, can be taken with meals.

For pain relief, the starting dose is 500 mg, followed by 500 mg every 12 hours or 250 mg every 8 hours if necessary.

The usual daily dose used for pain relief is 500 to 1000 mg.

To relieve migraine pain, 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 the introduction of an intrauterine device and other gynecological pains (adnexitis), the initial dose is 500 mg, then, if necessary, 250 mg every 6-8 hours for 3-4 days.

For symptomatic treatment of pain 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 in the evening.

When using the drug as an antipyretic agent, the initial dose is 500 mg, then, if necessary, 250 mg every 8 hours. The drug is not recommended to be used as an anesthetic for more than 5 days without consulting a doctor. If symptoms persist, seek medical attention.

One tablet contains:

active substance: 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, dye tropeolin O - 0.12 mg.

• Hypersensitivity to naproxen or naproxen sodium; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history). During the period of coronary artery bypass grafting. Erosive and ulcerative lesions of the stomach and duodenum 12 in the acute phase (ulcerative colitis (UC), Crohn's disease).

• Cerebrovascular bleeding or other bleeding and hemostasis disorders.

• Severe renal failure (creatinine clearance less than 30 ml / min), incl. confirmed hyperkalemia, progressive kidney disease.

• Oppression of bone marrow hematopoiesis. Pregnancy, breastfeeding period.

• Children under 12 years of age.

Pharmacological properties

Pharmacodynamics

Non-steroidal anti-inflammatory drug (NSAID), has anti-inflammatory, analgesic and antipyretic effects associated with non-selective suppression of the activity of cyclooxygenase 1 and cyclooxygenase 2, which regulate the synthesis of prostaglandins.

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 connection with plasma proteins is 99%, the half-life (T1 / 2) is 12-15 hours. Metabolism is in the liver to dimethylnaproxen with the participation of the CYP2C9 enzyme system. Clearance - 0.13 ml / min / kg. It is excreted by 98% by the kidneys, 10% of them are excreted unchanged; with bile - 0.5-2.5%. The equilibrium concentration of the drug in blood plasma (Css) is determined after 2-3 days. In chronic renal failure, the accumulation of metabolites is possible.

Side effect

Side effects are most common when using high doses of the drug:

- on the part of 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, abnormal liver function, jaundice, bloody vomiting, melena;

- from the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disturbances, inability to concentrate, insomnia, malaise, slowing down of the speed of psychomotor reactions, aseptic meningitis, cognitive dysfunction;

- on the part of the skin: itching, ecchymosis, excessive sweating, purpura, alopecia, photodermatosis;

- from the senses: tinnitus, visual impairment, hearing impairment;

- on the part of the cardiovascular system: swelling of the face, limbs, shortness of breath, palpitations, the onset or aggravation of existing chronic heart failure, vasculitis;

- on the part of the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularities;

- from the hematopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia;

- from the respiratory system: 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.

Overdose

A 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 renal failure.

Treatment: gastric lavage, intake of activated charcoal and symptomatic therapy: antacids, blockers of H2-histamine receptors, proton pump inhibitors. Hemodialysis is ineffective.

Interaction with other medicinal products

When treating with anticoagulants, it should be borne in mind that naproxen can increase bleeding time. The drug should not be used concurrently with other non-steroidal anti-inflammatory drugs (increased risk of side effects).

With the simultaneous use of hydantoin derivatives, anticoagulants or other drugs that bind largely to plasma proteins, the effect of these drugs can be potentiated.

Naproxen 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.

Under the action of naproxen, the natriuretic effect of furosemide is inhibited.

Inhibition of renal clearance of lithium leads to an increase in plasma lithium concentrations.

Taking probenecid increases plasma levels of naproxen.

Cyclosporine increases the risk of developing renal failure.

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

Antacids containing magnesium and aluminum reduce the absorption of naproxen.

special instructions

Do not exceed the doses indicated in the instructions. To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible course. If pain and fever persist or become worse, see your doctor.

Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics should consult a doctor before taking naproxen.

Caution should be given to patients with liver disease and renal failure. 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 with other anti-inflammatory or pain relievers unless 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 can interfere with the determination of 5-hydroxyindoleacetic acid in urine. The use of naproxen, like other drugs that block the synthesis of prostaglandins, can affect fertility, therefore it is not recommended for women planning a pregnancy.