NALGEZIN
Active material: Naproxen
When ATH: M01AE02
CCF: NSAIDs
ICD-10 codes (testimony): J06.9, J10, K08.8, M25.5, M54, M79.1, N94.4, N94.5, R50, R51, R52.0, R52.2
When CSF: 05.01.01.06
Manufacturer: KRKA d.d. (Slovenia)
Pharmaceutical form, composition and packaging
| ◊ Pills, Film-coated | 1 tab. |
| naproxen sodium | 275 mg |
Excipients: povidone, microcrystalline cellulose, talc, magnesium stearate, Purified water.
The composition of the shell: Titanium dioxide (E171), macrogol, dye indigo carmine (E132), gipromelloza.
10 PC. – blisters (1) – packs cardboard.
Pharmacological action
NSAIDs. It has mainly analgesic, and also antipyretic and anti-inflammatory action. The mechanism of action is associated with inhibition of the enzyme COX, which leads to inhibition of prostaglandin synthesis from arachidonic acid.
Inhibits platelet aggregation.
Pharmacokinetics
Absorption
After taking the drug inside the naproxen sodium is rapidly and completely absorbed from the gastrointestinal tract, reaching analgesic plasma concentrations rapidly, than naproxen. Cmax plasma levels achieved after 1-2 h after a single dose of naproxen sodium and after 2-4 hours after receiving naproxen (depending on meals). Receiving both food affects the rate of absorption, but it has no effect on the duration. Naproxen concentration in plasma increases in proportion to the increase in dose. Exceeding single dose 500 mg of proportionality is violated.
Distribution
Css achieved after administration 4-5 doses (ie. on 2-3 day dosing) depending on the selected scheme prescribing. After taking the drug in high doses of naproxen concentration in plasma ranges from 23 ug / ml to 49 ug / ml. At a concentration of up to 50 ug / ml naproxen largely bound to plasma albumin (to 99.5%). At higher concentrations, it increases the number of non bound fraction (at concentrations 473 ug / ml unbound fraction of 2.4%). Use of the drug in high doses increases the clearance of unbound plasma protein fraction of naproxen sodium. Vd is 10% of body weight.
Metabolism and excretion
About 30% biotransformiruetsya 6 dimetilnaproksen, practical neaktivnыy metabolite, biological activity does not exceed 1% compared to naproxen.
About 10% excreted unchanged, 60% – in the form of naproxen, associated with glucuronic acid and other conjugates. 95% the dose is excreted in the urine, 5% – with feces. T1/2 It is independent of concentration in plasma and the dose and is 12-15 no. Renal clearance of naproxen is independent of its concentration in plasma.
Testimony
- Headache;
- toothache;
- Myalgia;
- Back pain;
- Pain during menstruation;
- Moderate arthritis pain;
- Pain and fever in infectious and inflammatory diseases of the upper respiratory tract.
Dosage regimen
Bonifen appointed interior 1 tab. every 8-12 no, the maximum daily dose – 3 tab.
Elderly (senior 65 years) appoint not more than 2 tab. / day.
The tablets should be taken with plenty of fluids.
Side effect
From the digestive system: heartburn, nausea, abdominal distention, erosive and ulcerative lesions and bleeding gastrointestinal.
CNS: headache, dizziness, hearing loss.
Allergic reactions: skin rash, hives.
Other: possible violations of breath or hematopoiesis (thrombocytopenia, anemia), especially in individuals, predisposed to the disease; abnormalities in the liver and kidneys.
Contraindications
- cardiovascular diseases;
- Hepatitis;
- Renal dysfunction;
- Gastric ulcer and duodenal ulcer;
- Diseases of the digestive tract (children);
- Children up to age 12 years;
- Hypersensitivity to naproxen, naproxen sodium, aspirin or other NSAIDs.
Pregnancy and lactation
Do not appoint Bonifen during pregnancy and lactation (breast-feeding).
Cautions
Precautions should be prescribed to patients with bronchial asthma, bleeding disorders.
Before carrying out tests to determine the function of the adrenal glands 48 h should stop taking Bonifen, because the drug can affect the results of the study. Also Bonifen may affect the determination of 5-HIAA in the urine.
The patient should be informed, it should not be administered the drug more 5 days as an analgesic and more 3 days as antipyretic.
Bonifen should not be administered concurrently with other anti-inflammatory and analgesic drugs.
1 tablet contains Bonifen 25 mg of sodium, which should be considered for patients, a diet with a reduced salt content.
Overdose
Symptoms: heartburn, nausea, vomiting, drowsiness.
Treatment: gastric lavage, followed by the appointment of activated charcoal. If necessary spend symptomatic therapy. Hemodialysis is ineffective because of the high degree of protein binding naproxen.
Drug Interactions
Not applicable clinically significant interactions with warfarin Bonifen, tolʙutamidom.
Naproxen may reduce the antihypertensive effect of propranolol and other beta-blockers.
With simultaneous use of naproxen with acetylcholinesterase inhibitors increases the risk of renal failure.
Naproxen inhibits the natriuretic effect of furosemide.
Naproxen inhibits the renal clearance of lithium, thereby increasing the lithium concentration in plasma.
Receiving probenecid increases the concentration in plasma naproxen.
Antacids, containing magnesium and aluminum, reduce the absorption of naproxen.
In an application with indirect anticoagulants, hydantoin may increase their activities.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored at temperatures not exceeding 25 ° C. Shelf life – 5 years.
