LIALDA mesalamine tablet delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

MESALAMINE

Sudėtis:

MESALAMINE 1.2 g

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

New Drug Application

Prekės savybės

LIALDA- MESALAMINE TABLET, DELAYED RELEASE
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIALDA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LIALDA.
LIALDA (MESALAMINE) DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
LIALDA is a locally acting 5-aminosalicylic acid (5-ASA) indicated for
the induction of remission in adults with active, mild to
moderate ulcerative colitis and for the maintenance of remission of
ulcerative colitis. ( 1)
DOSAGE AND ADMINISTRATION
For induction of remission of active, mild to moderate ulcerative
colitis, two to four 1.2 g tablets taken once daily with food.
( 1, 2)
For maintenance of remission of ulcerative colitis, two 1.2 g tablets
taken once daily with food. ( 1, 2)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 1.2 g ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to salicylates or
aminosalicylates or to any of the ingredients of LIALDA tablets. ( 4)
WARNINGS AND PRECAUTIONS
Renal impairment may occur. Assess renal function at the beginning of
treatment and periodically during treatment. (
5.1)
Mesalamine-induced acute intolerance syndrome has been reported.
Observe patients closely for worsening of these
symptoms while on treatment. ( 5.2)
Use caution when treating patients who are hypersensitive to
sulfasalazine. ( 5.3)
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and
pericarditis) have been reported. ( 5.3)
Hepatic failure has been reported in patients with pre-existing liver
disease. Use caution when treating patients with
liver disease. ( 5.4)
Upper GI tract obstruction may delay onset of action. ( 5.5)
Use of mesalamine may lead to spuriously elevated test results when
measuring urinary normetanephrine by liquid
chromatography with electrochemical detection. ( 5.6)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 2%) are ulcerative
colitis, headache, flatulence, liver fun