Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MESALAZINE
DARYA-VARIA LABORATORIA TBK - Indonesia
MESALAZINE
1500 MG
GRANULA
DUS,35 SACHET
LOSAN PHARMA Gmbh - Germany
2019-08-13
SALOFALK ® MESALAZINE ENTERIC-COATED GRANULES1.5 G COMPOSITION - Each sachet of 2.79 g Salofalk ® 1.5g granules contains: Mesalazine ………………………………...............… 1.5 g PHARMACEUTICAL FORM Enteric-coated granules Description: stick-formed or round, greyish white granules PHARMACOLOGY PHARMACODYNAMIC Pharmacotherapeutic group: Aminosalicylic acid and similar agents ATC code: A07EC02 The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role. Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5- aminosalicylic acid / 5-ASA) may also function as a radical scavenger of reactive oxygen compounds. Mesalazine, orally administered, acts predominantly locally at the gut mucosa and in the submucosal tissue from the luminal side of the intestine. It is important, therefore, that mesalazine is available at the regions of inflammation. Systemic bioavailability/plasma concentrations of mesalazine are therefore of no relevance for therapeutic efficacy, but rather a factor for safety. In order to realise this, Salofalk ® granules are gastric juice resistant and release mesalazine in a pH-dependent manner, due to a Eudragit L coating, and prolonged manner, due to the matrix granule structure. PHARMACOKINETIC General considerations of mesalazine: _Absorption: _ Mesalazine absorption is highest in proximal and lowest in distal gut areas. _Biotransformation _ Mesalazine is metabolised both pre-systemically by the intestinal mucosa and the liver to the pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation seems to be independent of the acetylator phenotype of the patient. Some acetylation also occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA is 43% and 78%, respectively. _Elimination: _ Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally (varies betw Baca dokumen lengkapnya