PENTASA- mesalamine capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Avera McKennan Hospital

INN (International Name):

MESALAMINE

রচনা:

MESALAMINE 250 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis. PENTASA is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.

পণ্য সারাংশ:

PENTASA controlled-release 250 mg capsules are supplied in bottles of 240 capsules (NDC 54092-189-81). Each green and blue capsule contains 250 mg of mesalamine in controlled-release beads. PENTASA controlled-release capsules are identified with a pentagonal starburst logo and the number 2010 on the green portion and PENTASA 250 mg or S429 250 mg on the blue portion of the capsules. NDC 69189-0189-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Shire US Inc . 300 Shire Way, Lexington, MA 02421, USA PENTASA is a registered trademark of Ferring B.V. © 2015 Shire US Inc. Rev. 10/2015

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

PENTASA- MESALAMINE CAPSULE
AVERA MCKENNAN HOSPITAL
----------
PENTASA
(MESALAMINE)
CONTROLLED-RELEASE CAPSULES 250 MG
PRESCRIBING INFORMATION AS OF 10/2015
RX ONLY
DESCRIPTION
PENTASA (mesalamine) for oral administration is a controlled-release
formulation of mesalamine, an
aminosalicylate anti-inflammatory agent for gastrointestinal use.
Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. It has a
molecular weight of 153.14.
The structural formula is:
Each 250 mg capsule contains 250 mg of mesalamine. It also contains
the following inactive ingredients:
acetylated monoglyceride, castor oil, colloidal silicon dioxide,
ethylcellulose, hydroxypropyl
methylcellulose, starch, stearic acid, sugar, talc, and white wax. The
capsule shell contains D&C
Yellow #10, FD&C Blue #1, FD&C Green #3, gelatin, titanium dioxide,
and other ingredients.
Each 500 mg capsule contains 500 mg of mesalamine. It also contains
the following inactive
ingredients: acetylated monoglyceride, castor oil, colloidal silicon
dioxide, ethylcellulose,
hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and
white wax. The capsule shell
contains FD&C Blue #1, gelatin, titanium dioxide, and other
ingredients.
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. The usual oral
dose of sulfasalazine for active ulcerative colitis in adults is 2 to
4 g per day in divided doses. Four
grams of sulfasalazine provide 1.6 g of free mesalamine to 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, ie, prostanoids, and through the lipoxygenase
pathways, ie, leukotrienes
(LTs) and hydroxyeicosatetraenoic acids (HETEs), is increased in
patients with chronic inflammatory
bowel disease, and it is possible that me