Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol
Arpimed LLC
N02BE01
paracetamol
500mg
tablets
(200/20x10/) in blister
OTC
Registered
2019-12-17
SUMMARY PRODUCT CHARACTERISTIC (SPC) PARACETAMOL GIGAfarm 500 MG TABLETS TRADE NAME – PARACETAMOL GIGAfarm 500 mg tablets INTERNATIONAL NON-PROPERTY NAME – PARACETAMOL COMPOSITION Each tablet_ _of _PARACETAMOL GIGAfarm 500 mg _contains: _ACTIVE INGREDIENT: _PARACETAMOL – 500 mg; _INACTIVE _ _INGREDIENTS:_ microcrystalline cellulose, lactose monohydrate, maize starch, povidone, magnesium stearate, talc purified. CHEMICAL NAME AND CAS NUMBER 4´-Hydroxyacetanilide; 103-90-2. PHARMACOLOGICAL GROUP AND ATC CODE Analgesic and antipyretic; ATC code - N02BE01. PHARMACOLOGICAL ACTION PARACETAMOL has analgesic, antipyretic and weak inflammatory action. The mechanism of action is associated with inhibition of prostaglandin synthesis and the influence on the thermoregulation center in the hypothalamus. PHARMACOKINETICS PARACETAMOL is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses. PARACETAMOL is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of PARACETAMOL varies from about 1 to 3 hours. PARACETAMOL is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged PARACETAMOL. A minor hydroxylated metabolite (_N_-acetyl-_p_-benzoquinoneimine), is usually produced in very small amounts by cytochrome P450 isoenzymes (mainly CYP2E1 and CYP3A4) in the liver and kidney. It is usually detoxified by conjugation with glutathione but may accumulate following PARACETAMOL overdosage and cause tissue damage. USES Pain syndrome of mild to moderate intensity of different genesis (including headache, toothache, neuralgia, myalgia, arthralgia); Catarrhal fever and infectious and inflammatory diseases; ADMINISTRATION The usual ADULT AND CHILDREN OVER 12 YEARS SINGLE DOSE Läs hela dokumentet