• Code CAS
Most popular brand: Naprosyn
Active ingredient: Naproxen
Available dosage forms: 250, 275, 500 mg
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Naproxen general information
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Naproxen (Naproxen): instruction, and the use of a formula
Therapeutic substances naproxen
The nosological classification (ICD – 10)
Feature substances naproxen
NSAIDs. Naproxen ; white or almost white, crystalline powder. Lipid soluble, practically insoluble in water at low pH. freely soluble in water at high pH. octanol / water at a pH of 7.4 is 1,6 – 1,8. Molecular weight 230,26.
naproxen sodium salt ; white crystalline compound, or white – cream colored freely soluble in water at neutral pH. Molecular weight 252,24.
Mode of action – anti-inflammatory, analgesic, antipyretic, antiagregatine.
Reduces the activity of cyclooxygenase (COX – 1 and COX – 2), resulting in impaired synthesis of GHGs. After oral naproxen and naproxen sodium is rapidly and completely absorbed from the gastrointestinal tract. bioavailability ; 95%. C max in the blood is reached after 2 – 4 h after administration of naproxen and 1 – 2 h after administration of sodium naproxen. Protein binding is ; 98 – 99%. The concentration of naproxen in plasma increases proportionally to the dose, in excess of a single dose of 500 mg proportionality broken. T 1/2 from plasma ; . 12 – 17 h Biotransformiroetsa 6 – O – dezmetilnaproksen. The volume of distribution of naproxen ; 0.16 l / kg and clearance ; 0.13 ml / min / kg. The equilibrium concentration of naproxen is achieved after 4-5 days of continuous use. Approximately 95% is excreted in the urine, < 1% ; in the form of 6 – O – dezmetilnaproksena, < 1% ; as unchanged drug (66 – 92% ; in the form of their conjugates), < 3% ; faeces. In renal insufficiency, possible accumulation of metabolites.
in the plasma concentration required for the development of an analgesic effect is achieved faster when taken in the form of the sodium salt of naproxen, naproxen than oral.
Limits the development of exudative and the proliferative phase of inflammation, has antipyretic action slows during the free-radical reactions. It is the weakening or disappearance of pain (including pain in the joints at rest and in motion), reducing morning stiffness and swelling of joints, increases range of motion. Anti-inflammatory effect occurs at the end of the first week of treatment.
Carcinogenicity In the 24 -. Month study in rats at doses of 8, 16 and 24 mg / kg / day (50, 100 and 150 mg / m 2) carcinogenic effects of naproxen is not revealed. The maximum dose used was 0.28 MRDCH.
Application of the substance naproxen
Inflammatory and degenerative diseases of the musculo – skeletal system, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome in exacerbation of gout, juvenile rheumatoid arthritis; pain: neuralgia, myalgia, ossalgia, sciatica, headache and tooth pain, tendonitis, pain in cancer, postoperative pain, accompanied by inflammation, musculoskeletal injuries – skeletal system and soft tissue, adnexitis, primary dysmenorrhea; pain and fever in infectious – inflammatory diseases of the upper respiratory tract (in the complex therapy).
Hypersensitivity, “Aspirin” asthma, “Aspirin” triad (a combination of asthma, recurrent nasal polyposis, and paranasal sinuses and intolerance of aspirin and drugs pirazolonovogo series), erosive – ulcerative lesions of the gastrointestinal tract in the acute phase of the breach of blood, liver and / or renal insufficiency, children under 1 year.
Restrictions on the use
Severe heart failure, adolescence (16).
Application of pregnancy and breastfeeding
Teratogenic effects. In studies of reproduction in animals when administered to rats in doses of naproxen 20 mg / kg / day (125 mg / m 2 / day), which is approximately equivalent to 0.23 MRDCH. rabbits ; 20 mg / kg / day (220 mg / m 2 / day), or 0.27 MRDC. mice ; 170 mg / kg / day (510 mg / m 2 / day), or 0.28 MRDC. there was no evidence of impaired fertility or harm to the fetus.
However, reproductive studies in animals do not always predict effects in humans. Adequate and well-controlled studies in pregnant women have not performed. Pregnancy is possible if the expected effect of therapy outweighs the potential risk to the fetus.
Nonteratogenic effects. Since it is known that the means of inhibiting the synthesis of GHGs. used to delay preterm labor, it increases the risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, intracranial hemorrhage. The use of naproxen in the later period of pregnancy may lead to birth delay, persistent pulmonary hypertension, renal dysfunction, abnormal levels of prostaglandin E in premature infants. Since the known effects of this class of substances on the cardio – vascular system of the fetus (closing arterial duct) use in the III trimester of possible.
Category effects on the fetus by FDA ; C.
Naproxen defined in breast milk of women (concentration of approximately 1% serum). Because of possible adverse effects of substances that inhibit the synthesis of GHGs. in infants, nursing mothers should not use naproxen.
Side effects of substance naproxen
The side effects most commonly encountered in clinical trials (possibly associated with the use of naproxen):
From the digestive tract: 3 – 9% ; heartburn, abdominal pain, nausea, constipation; & Gt; 1% ; diarrhea, dyspepsia, stomatitis; & Lt; 1% ; bloating, bleeding / perforation, gastrointestinal ulcer (gastroduodenal), vomiting, increase in liver transaminases.
From the nervous system and sensory organs: 3 – 9% ; headache, drowsiness, dizziness, tinnitus, visual impairment, hearing impairment; & Gt; 1% ; vertigo.
From the cardio – vascular system and blood (blood, hemostasis): > 1% ; palpitations; & Lt; 1% ; anemia, increased bleeding time.
From the respiratory system: 3 – 9% ; dyspnea.
For the skin: 3 – 9% ; ecchymosis.
With the genitourinary system: < 1% ; impairment of renal function.
Allergic reactions: 3 – 9% ; itching, skin rash, anaphylactoid reactions.
Other: 3 – 9% ; edema; & Gt; 1% ; excessive sweating, purpura, thirst.
Side effects occurred at a frequency < 1% in clinical trials and post-marketing studies (possibly associated with the use of naproxen):
From the digestive tract: colitis, hematemesis, jaundice, pancreatitis, melena.
With the genitourinary system: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.
From the cardio – vascular system and blood (blood, hemostasis): agranulocytosis, eosinophilia, granulocytopenia, leukopenia, thrombocytopenia.
From the nervous system and sensory organs: depression, abnormal dreams, inability to concentrate, insomnia, malaise, myalgia, muscle weakness.
Side effects occurred at a frequency < 1% (a causal relationship has not been established with the use of naproxen):
From the cardio – vascular system and blood (blood, hemostasis): aplastic anemia, hemolytic anemia.
From the nervous system and sensory organs: aseptic meningitis, cognitive dysfunction.
From the digestive tract: nepepticheskoe ulceration of the gastrointestinal tract. ulcerative stomatitis.
Allergic reactions: epidermal necrolysis, erythema multiforme, Stevens – Johnson syndrome, urticaria; photosensitivity reaction, similar epidermolysis bullosa porfiricheskomu.
Other: vasculitis, hyper – / hypoglycemia, alopecia, fotodermatit.
Increases hydantoin toxicity, indirect anticoagulants, sulfonamides, methotrexate (block tubular secretion). Reduces natriuretic and diuretic effect of furosemide, hypotension caused by beta – blockers. Reduces excretion of lithium salts and increases its concentration in plasma. Antacids containing aluminum and magnesium, and sucralfate may reduce the absorption of naproxen.
Symptoms: drowsiness, weakness, dizziness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient abnormal liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation, vomiting; possible bleeding from the gastrointestinal tract; rare ; hypertension, acute renal failure, respiratory depression, coma.
Treatment: gastric lavage, emesis induction and / or administration of activated charcoal (60 – 100 g ; adults, 1 – 2 g / kg ; children) and / or the appointment of osmotic laxatives, symptomatic and supportive therapy. A specific antidote is not found. Forced diuresis, alkalization of urine or dialysis is not effective because – due to high protein binding.
Dosing and Administration
Inside, average adult dose ; 250 – 500 mg 2 times a day with a maximum single dose of ; 500 mg, the maximum daily ; 1750 mg in two divided doses (morning and night).
The average daily intake for children from 1 year to 5 years ; 2,5 – 10 mg / kg of body weight in 1 – 3 receptions, children over 5 years ; 10 mg / kg per day in 2 divided doses, the usual duration of treatment ; 2 weeks (the preferred dosage form is a suspension for children); in juvenile arthritis in children older than 5 years, the daily dose is 10 mg / kg.
Precautions substances naproxen
If you need long-term use to control the function of the liver and kidneys, of peripheral blood.
If you want to determine the 17 – keto steroids or 5 – oxyindoleacetic acid treatment should be suspended for 48 hours prior to the study.