MESALAMINE suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)

Commercializzato da:

Franklin Pharmaceutical LLC

INN (Nome Internazionale):

MESALAMINE

Composizione:

MESALAMINE 4 g in 60 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Scheda tecnica

MESALAMINE- MESALAMINE SUSPENSION
FRANKLIN PHARMACEUTICAL LLC
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MESALAMINE RECTAL SUSPENSION ENEMA 4 GRAMS/UNIT (60 ML)
RX ONLY
DESCRIPTION
The active ingredient in Mesalamine Rectal Suspension Enema, a
disposable (60 mL) unit, is
mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically,
mesalamine is 5-amino-2-
hydroxybenzoic acid.
The empirical formula is C H NO , representing a molecular weight of
153.14.
The structural formula is:
Each rectal suspension enema unit contains 4 grams of mesalamine. In
addition to mesalamine the
preparation contains the inactive ingredients carbomer 934P, edetate
disodium, potassium acetate,
potassium metabisulfite, purified water and xanthan gum. Sodium
benzoate is added as a preservative.
The disposable unit consists of an applicator tip protected by a
polyethylene cover and lubricated with
USP white petrolatum. The unit has a one-way valve to prevent back
flow of the dispensed product.
CLINICAL PHARMACOLOGY
Sulfasalazine is split by bacterial action in the colon into
sulfapyridine (SP) and mesalamine (5-ASA). It
is thought that the mesalamine component is therapeutically active in
ulcerative colitis [A.K. Azad Khan
_et al,_ LANCET 2:892-895 (1977)]. The usual oral dose of
sulfasalazine for active ulcerative colitis in
adults is two to four grams per day in divided doses. Four grams of
sulfasalazine provide 1.6 g of free
mesalamine to the colon. Each Mesalamine Rectal Suspension Enema
delivers up to 4 g of mesalamine
to the left side of the colon.
The mechanism of action of mesalamine (and sulfasalazine) is unknown,
but appears to be topical rather
than systemic. Mucosal production of arachidonic acid (AA)
metabolites, both through the
cyclooxygenase pathways, i.e., prostanoids, and through the
lipoxygenase pathways, i.e., leukotrienes
(LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in
patients with chronic inflammatory
bowel disease, and it is possible that mesalamine diminishes
inflammation by block cyclooxygenase and
inhibiting prostaglandin