Active substanceNaproxenNaproxen
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Dosage form: & nbspfilm-coated tablets
Composition:

1 tablet coated with film shell, contains:

active substance: naproxen sodium 275 mg / 550 mg;

Excipients: calcium stearate 3.5 mg / 7.0 mg, copovidone 10.0 mg / 20.0 mg, silicon dioxide colloid (aerosil) 5.0 mg / 10.0 mg, lactose monohydrate 18.3 mg / 36.6 mg, microcrystalline cellulose 38.2 mg / 76.4 mg;

auxiliary substances for shells: hypromellose (hydroxypropylmethylcellulose) 4.72 mg / 9.44 mg, copovidone 1.32 mg / 2.64 mg, macrogol 6000 (polyethylene glycol 6000) 1.32 mg / 2.64 mg, talc 1.32 mg / 2.64 mg, titanium dioxide 1.32 mg / 2.64 mg.

Description:

At a dosage of 275 mg: pills, film-coated white or almost white, round, biconvex form. On cross section internal layer white or white with yellowish shade of color.

At a dosage of 550 mg: pills, film-coated white or almost white, biconvex, oblong with rounded ends with a risk. On the cross-section, the inner layer is white or white with a yellowish tint of color.

Pharmacotherapeutic group:NSAIDs
ATX: & nbsp

M.02.A.A.12   Naproxen

Pharmacodynamics:

Ultrazir Ultra, is a drug of naproxen, has analgesic, antipyretic and anti-inflammatory action. The mechanism of action is associated with a non-selective inhibition of cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2) activity.

The tablets, covered with a film membrane, dissolve well, are quickly absorbed from the gastrointestinal tract (GIT) and provide a rapid onset of the analgesic effect.

Pharmacokinetics:

Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (eating practically does not affect either the completeness or the rate of absorption). Time to reach the maximum concentration (TCmax) - after 1-2 hours, communication with plasma proteins> 99%.

The half-life (T1 / 2) is 12-15 hours. Metabolism is in the liver to dimethylnaproxen with the participation of isoenzyme CYP2C9. 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 equilibrium concentration is determined by taking 4-5 doses of the drug (2-3 days). With chronic renal failure (CRF), metabolites can be accumulated.

Indications:

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

  • Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, rheumatic soft tissue, osteoarthritis of peripheral joints and spine, including radicular syndrome, tenosynovitis, bursitis).
  • Pain syndrome weak or moderate severity: neuralgia, ossalgiya, myalgia, sciatica, post-traumatic pain (sprains and injuries), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, tuberculosis , adnexitis, toothache.
  • In the complex treatment of infectious and inflammatory diseases of the ear, nose and throat with severe pain (pharyngitis, tonsillitis, otitis media).
  • Feverish syndrome with "colds" and infectious diseases.
Contraindications:
  • Hypersensitivity to naproxen; with anamnestic data fit bronchial, rhinitis, urticaria, after receiving aspirin or other nonsteroidal anti-inflammatory drug (NSAID) (complete or incompletesyndrome intolerance of acetylsalicylic acid - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma).
  • The period after aortocoronary bypass surgery.
  • Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding.
  • Inflammatory bowel disease, in the exacerbation phase (nonspecific ulcerative colitis (NJC), Crohn's disease).
  • Cerebrovascular bleeding or other bleeding and hemostasis.
  • Severe renal insufficiency (creatinine clearance less than 20 ml / min).
  • Inhibition of bone marrow hematopoiesis.
  • Pregnancy, the period of breastfeeding.
  • Children and teenagers under 15 years of age.
Carefully:

Chronic heart failure, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance from 20 to 60 ml / min, history of gastrointestinal lesions, infection Helicobacter pylori, long-term use of NSAIDs, frequent alcohol use, severe somatic diseases, advanced age, simultaneous intake of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (incl.acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including 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.

Pregnancy and lactation:

Algesir Ultra is not recommended for use during pregnancy and lactation.

Dosing and Administration:

Inside. Tablets should be taken without chewing, with enough water or other liquid, possibly applied during meals. The usual daily dose used to relieve pain is 550-1100 mg.

With very severe pain and no history of gastrointestinal diseases, the doctor can increase the daily dose to 1650 mg, but not more than 2 weeks.

When using the drug as an antipyretic agent, the initial dose is 550 mg, then 275 mg is taken every 6-8 hours.

To relieve pain during migraine, 550 mg twice daily is recommended. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks.At the first signs of a migraine attack, 825 mg should be taken and, if necessary, another 275-550 mg after 30 minutes.

To ease menstrual pain, pain after the introduction of IUDs (intrauterine spirals) and other gynecological pains (adnexitis), it is recommended that the drug be administered at an initial dose of 550 mg, followed by 275 mg every 6-8 hours.

With an acute attack of gout, the initial dose is 825 mg, then 550 mg after 8 hours, and then 275 mg every 8 hours until the seizure stops.

In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is 550 mg to 1100 mg, twice daily in the morning and evening. The initial daily dose, ranging from 825 mg to 1,650 mg, is recommended for patients with severe night pain and / or severe morning stiffness, patients transferred to treatment with naproxen from high doses of other NSAIDs, and patients whose pain is the leading symptom. Usually the daily dose is 550-1100 mg, administered in two divided doses.

Side effects:

From the digestive system: gastropathies associated with the use of non-steroidal anti-inflammatory drugs (lesions of the antrum of the stomach in the form of erythema of the mucosa, hemorrhages,erosions and ulcers), nausea, vomiting, epigastric discomfort, abdominal pain, diarrhea, constipation, ulcerative stomatitis, bleeding and perforation of the gastrointestinal tract, increased activity of liver enzymes, impaired liver function, jaundice, hepatitis, vomiting with blood, melena.

From the central nervous system: dizziness, headache, drowsiness, depression, sleep disturbance, insomnia, malaise, myalgia and muscle weakness, difficulty concentrating and slowing the reaction rate, cognitive dysfunction, aseptic meningitis.

From the skin: itching, ecchymosis, increased sweating, thrombocytopenic purpura, alopecia, photodermatosis.

From the sense organs: noise in the ears, hearing loss, impaired vision.

From the side of the cardiovascular system: swelling, shortness of breath, palpitations, congestive heart failure, vasculitis.

From the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularity.

From the hemopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia.

From the respiratory system: eosinophilic pneumonia.

Allergic reactions: skin rash, hives, angioedema, epidermal toxic necrolysis (Lyell's syndrome), multiforme exudative erythema, Stevens-Johnson syndrome.

Other: thirst, hyperthermia, hyperglycemia, hypoglycemia.

Overdose:

A significant overdose of the drug may be characterized by drowsiness, dyspeptic disorders (heartburn, nausea, vomiting, abdominal pain), weakness, tinnitus, in severe cases - vomiting with blood, melena, seizures and kidney failure.

Treatment: gastric lavage, Activated carbon - 0.5 g / kg, symptomatic therapy. Hemodialysis is not effective.

Interaction:
Do not use the drug simultaneously with other non-steroidal anti-inflammatory drugs (the risk of side effects increases).

With the simultaneous use of phenytoin, diphenine, anticoagulants or other medications that bind to a large extent with plasma proteins, it is possible to increase the effect or overdose of these drugs.The Algesir Ultra drug may reduce the antihypertensive effect of propranolol or other beta-blockers, and may increase the risk of renal failure associated with the use of ACE inhibitors. Under the action of naproxenum, natriuretic action of furosemide is inhibited.

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

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in the plasma. The use of probenecid increases the concentration of naproxen in the plasma. Cyclosporin 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.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Do not exceed the doses specified in the instructions to reduce the risk of developing adverse events from the gastrointestinal tract should use the minimum effective dose of the minimum possible short course.

If pain and fever persists or worsens, you should consult your doctor.

When treating anticoagulants, it should be borne in mind that naproxen can increase bleeding time.

Patients with bronchial asthma, with blood clotting disorder, and also patients with hypersensitivity to other analgesics before taking Algesir Ultra should consult with 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 level of creatine clearance. At a creatinine clearance level below 20 ml / min, it is not recommended to prescribe the drug.

In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, therefore, such patients are recommended lower doses.

Algezir Ultra should not be taken with other anti-inflammatory and analgesic drugs, except for doctor's prescriptions.

Older patients are recommended lower doses.

Avoid taking the drug for 48 hours before surgery.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. Naproxen can also influence the result of determining the concentration of 5-xyindolylacetic acid in the urine.

Each Ultra Alzira Ultra tablet contains approximately 25 mg of sodium. If you limit salt intake, this must be taken into account.

Form release / dosage:Tablets coated with a film coat of 275 and 550 mg.
Packaging:For 5, 10, 12 and 15 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil printed lacquered. For 1, 2, 3, 5, 6 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.
Storage conditions:

List B.

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:LSR-002736/09
Date of registration:07.04.2009 / 28.03.2013
Expiration Date:Unlimited
The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp06.07.2017
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