Naproxen
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Clinical Pharmacology
Pharmacotherapeutic group - nonsteroidal anti-inflammatory drug.
ATX Code: M01AE02
Pharmacological properties.
Bonifen forte, is a drug of naproxen, has analgesic, antipyretic and anti-inflammatory effects. The mechanism of action is associated with non-selective inhibition of the activity of cyclooxygenase 1 and 2 (COX-1, COX-2). Film-coated pills, Bonifen forte dissolves well, is quickly absorbed from the gastrointestinal tract and provides a quick onset of anesthetic effect.
Pharmacokinetics
Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (food intake practically does not affect either the fullness or the rate of absorption). The time to reach the maximum concentration is 1-2 hours, the association with plasma proteins is> 99%, the half-life 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 displayed on 98% of the kidneys, 10% of them are displayed in unchanged form; with bile - 0.5-2.5%. Equilibrium concentration is determined to receive 4-5 doses of the drug (2-3 days). In renal failure, accumulation of metabolites is possible.
Indications
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, tendonitis, bursitis)
Composition
1 tablet, film coated, contains:
CORE:
Active ingredient: naproxen sodium 550 mg.
Excipients: it looks like microcrystalline cellulose, talc, magnesium stearate, purified water.
Shell: Opadry dye YS-I-4216 (this ready-to-use mixture of titanium dioxide (171), macrogol, indigo carmine dye (E 132) and hypromellose.
Naproxen is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Bonifen | Krka dd Novo mesto AO | Slovenia | pills |
pills |
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Dosage and Administration
For oral use. Strictly follow the instructions of the doctor. You should not stop treatment or change the dosage without first consulting a doctor. Ask your doctor about the duration of use of the drug.
Adverse reactions
Side effects are most frequent with high doses of Bonifen forte:
Contraindications
Hypersensitivity to naproxen or naproxen sodium; with anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, nasal mucosa polyps, asthma);
Drug interactions
When treating with anticoagulants it should be borne in mind that naproxen may increase bleeding time. Do not use the drug at the same time as other NSAIDs (increased risk of side effects). Patients who simultaneously receive hydantoins, anticoagulants, or other drugs that bind to a large extent with plasma proteins, should monitor signs of potentiation of the action or overdose of these drugs. The drug Bonifen forte 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 the level of naproxen in the plasma. Cyclosporine increases the risk of developing renal failure. Naproxen slows the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of their toxic action. Antacid preparations containing magnesium and aluminum reduce naproxen absorption. It is necessary to inform your attending physician if you suffer from other diseases or allergies, or are taking any other medicines (including over-the-counter medication).
Pregnancy and Lactation
Bonifen forte is not recommended for use during pregnancy and lactation.
Special instructions
Do not exceed the doses indicated in the instructions. To reduce the risk of developing adverse events from the gastrointestinal tract (GIT), a minimum effective dose should be used with the shortest possible short course. If the pain and fever persist or become stronger, consult a doctor. Patients with bronchial asthma, with bleeding disorders, as well as patients with hypersensitivity to other analgesics before taking Forgesin forte should consult with your doctor. Caution should be given to patients with liver disease and renal failure. In patients with renal insufficiency, it is necessary to control the level of creatinine clearance. At the level of creatinine clearance below 20 ml / min: Naproxen is not recommended. In chronic alcohol and other forms of cirrhosis, the concentration of unbound naproxen increases, so lower doses are recommended for these patients. Bonifen forte should not be taken together with other anti-inflammatory and analgesic drugs, with the exception of doctor's prescriptions. Older patients are also recommended lower doses.
Overdosage
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).
A patient who has taken a randomly or deliberately large amount of Bonifen forte requires flushing the stomach and symptomatic therapy: activated charcoal, antacids, h2 receptor blockers, proton pump inhibitors. Hemodialysis is ineffective.
- Brand name: Bonifen
- Active ingredient: Naproxen
- Dosage form: Film Coated pills
- Manufacturer: Krka dd Novo mesto AO
- Country of Origin: Slovenia
Studies and clinical trials of Naproxen (Click to expand)
- Surfactant enhancement of (S)-naproxen ester productivity from racemic naproxen by lipase in isooctane
- Enzymatic resolution of (S)-(+)-Naproxen in a trapped aqueous–organic solvent biphase continuous reactor
- Lipase-catalyzed enantioselective esterification of S(+)-naproxen ester prodrugs in cyclohexane
- Optimization of intrinsic naproxen fluorescence by off-line and flow injection analysis
- Application of fluorimetry to the analysis of Naproxen and its complexation with modified β-cyclodextrins
- DOSE DEPENDENT PHARMACOKINETICS OF NAPROXEN IN MAN
- PARTIAL-AREA METHOD IN BIOEQUIVALENCE ASSESSMENT: NAPROXEN
- Pharmacokinetic and local tissue disposition studies of naproxen following topical and systemic administration in dogs and rats
- Baseline risk of gastrointestinal disorders among new users of meloxicam, ibuprofen, diclofenac, naproxen and indomethacin
- Anti-lymphoma effect of naproxen and indomethacin in a patient with relapsed diffuse large B-cell lymphoma
- The effect of naproxen on fever in children with malignancies
- Naproxen Derivatives by Enantioselective Decarboxylation
- A Computational Study of the Stereoselective Decarboxylation in the Synthesis of Naproxen
- NO-Donors (VII [1]): Synthesis and Cyclooxygenase Inhibitory Properties of N-and S-Nitrooxypivaloyl-cysteine Derivatives of Naproxen — A Novel Type of NO-NSAID
- Combination therapy with naproxen and aspirin in rheumatoid arthritis
- Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: A randomized, double-blind, placebo-controlled study
- Long-term followup of naproxen-induced pseudoporphyria in juvenile rheumatoid arthritis
- Naproxen thrombocytopenia
- Fast Attrition-Enhanced Deracemization of Naproxen by a Gradual In Situ Feed
- Fast Attrition-Enhanced Deracemization of Naproxen by a Gradual In Situ Feed
- Controlled release of naproxen from sodium alginate and poly(vinyl alcohol)/sodium alginate blend beads crosslinked with glutaraldehyde
- Preparation a novel pH-sensitive blend hydrogel based on polyaspartic acid and ethylcellulose for controlled release of naproxen sodium
- Synthesis of highly efficient D-naproxen imprinted polymer and investigation of their specific performance