Motrin - instructions for use, dose, side effects, contraindications

Active substanceNaproxenNaproxen

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OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Motrin®

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Johnson & Johnson, LLC Russia

Dosage form: & nbsppills

Composition:

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.

Description:

Tablets of light yellow color with insignificant impregnations, flat-cylindrical, with a facet and a risk.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.12 Naproxen

Pharmacodynamics:

Non-steroidal anti-inflammatory drug (NSAID), has anti-inflammatory, analgesic and antipyretic effect associated with non-selective inhibition of cyclooxygenase 1 and cyclooxygenase 2, regulating the synthesis of prostaglandins.

Pharmacokinetics:

Gastrointestinal absorptionshe path is fast andthe 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) -2 h, the connection with plasma proteins - 99%, half-life (T_1/2) - 12-15 hours Metabolism - in the liver to dimethylnaproxen with the participation of the enzyme system CYP2C9. Clearance - 0.13 ml / min / kg.Listed at 98 % kidneys, 10% of them are excreted unchanged; with bile - 0,5-2,5%. The equilibrium concentration of the drug in the blood plasma (Css) is determined after 2-3 days. With chronic renal failure, cumulation of metabolites is possible.

Indications:

Pain syndrome of mild and moderate severity: neuralgia, ossalgia, myalgia, lumboschialgia, posttraumatic pain syndrome (distension and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodismenorea, adnexitis, toothache.

Symptomatic therapy of pain syndrome in diseases of the musculoskeletal system, including bursitis, tendovaginitis.

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

Feverish conditions for flu and colds.

The drug is used for symptomatic therapy (to reduce pain, inflammation and reduce elevated body temperature) and the progression of the underlying disease is not affected.

Contraindications:

Hypersensitivity to naproxen or naproxen sodium; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis). During the period of aortocoronary shunting. Erosive-ulcerative lesions of the stomach and duodenum in the phase of exacerbation (ulcerative colitis (YAC), Crohn's disease).

Cerebrovascular bleeding or other bleeding and hemostasis disorders.

Severe renal insufficiency (creatinine clearance less than 30 ml / min), incl. confirmed hyperkalemia, progressive kidney disease. Inhibition of bone marrow hematopoiesis.

Pregnancy, the period of the breast feeding.

Children under 12 years.

Carefully:Coronary heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance - 30-60 ml / min, anamnestic data on the development of gastrointestinal ulcer, infection Helico-Youthe root, old age, long-term use of non-steroidal anti-inflammatory drugs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline). To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used as little as possible. Children under 16 years.

Dosing and Administration:

Inside, adults and children over 12 years.

Tablets should be taken whole, squeezed with a sufficient amount of liquid, can be taken while eating.

To ease the pain, 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 to relieve pain is 500 to 1000 mg.

To remove the pain syndrome with migraine, 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 ease menstrual pain, pain after intrauterine device spiral 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 symptomatic therapy of pain syndrome in diseases of the musculoskeletal system (bursitis, tendovaginitis), the usual daily dose of the drug is 500-1000 mg, according to 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 for use as an anesthetic for more than 5 days without consulting a doctor. If symptoms persist, consult a physician.

Side effects:

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

- from the digestive system: constipation, abdominal pain, indigestion, nausea, diarrhea, ulcerative stomatitis, erosive-ulcerative lesions and bleeding of the gastrointestinal tract,NSAID-gastropathy (lesion of the antral part of the stomach in the form of erythema of the mucosa, 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 of the speed of psychomotor reactions, aseptic meningitis, cognitive dysfunction;

- from the skin: itching, ecchymosis, increased sweating, purpura, alopecia, photo dermatosis;

- 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 irregularities;

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

- from the respiratory system: eosinophilic pneumonitis;

- allergic reactions: skin rash, hives, angioedema, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome;

- others: thirst, hyperthermia, hyperglycemia, hypoglycemia, myalgia and muscle weakness.

Overdose:

A significant drug overdose 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, reception of activated charcoal and symptomatic therapy: antacids, H2-histamine receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.

Interaction:

When treating anticoagulants, it should be borne in mind that naproxen can increase bleeding time. Do not use the drug simultaneously 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 to a large extent with plasma proteins, the effect of these drugs may be potentiated.

Naproxen can 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 naproxenum, natriuretic action of furosemide is inhibited. Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in the plasma.

The use of probenecid increases the level of naproxen in plasma.

Cyclosporine increases the risk of developing kidney failure.

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

Antacid preparations containing magnesium and aluminum reduce the absorption of naproxen.

Special instructions:

Do not exceed the dosage indicated in the instructions. To reduce the risk of developing adverse events from the gastrointestinal tract, use the minimum effective dose as short a course as possible.If pain and fever persists or worsens, you should consult your doctor.

Patients with bronchial asthma, with blood clotting disorders, and also patients with hypersensitivity to other analgesics before taking naproxen should consult a doctor.

Caution should be given to patients with liver disease and kidney failure. In patients with renal insufficiency, it is necessary to control the clearance of creatinine. In chronic alcoholic and other forms of cirrhosis of the liver, the concentration of unbound naproxen increases, therefore, such patients are recommended to have lower doses.

Naproxen should not be taken with other anti-inflammatory and analgesic drugs, except for prescribing a doctor. Older patients are also recommended lower doses. You should avoid taking naproxen within 48 hours before surgery. If necessary, the definition of 17-corticosteroid drug should be discontinued 48 hours before the study. Similarly, naproxen can affect the determination of 5-hydroxyindoleacetic acid in urine.The use of naproxen, as well as other drugs blocking the synthesis of prostaglandins, can affect fertility, so it is not recommended for women planning a pregnancy.

Form release / dosage:

Tablets 250 mg.

Packaging:

For 10 tablets in a planar cell package.

1, 2 or 3 contour mesh packages together with instructions for use in a cardboard bundle.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N002874 / 01

Date of registration:15.08.2008 / 16.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp31.05.2018

Illustrated instructions

Instructions

Motrin® (Motrin®)