MESALAMINE tablet, delayed release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

MESALAMINE

Sammensætning:

MESALAMINE 1.2 g

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)] . Risk Summary Published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ). There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations) . In animal reproduction studies, there were no ad

Produkt oversigt:

Mesalamine delayed-release tablets are available as red-brown, ellipsoidal, film-coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476. NDC 54092-100-01 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets. Store at room temperature 15°C to 25°C (59°F to 77°F); excursions permitted to 30°C (86°F). See USP Controlled Room Temperature.

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

MESALAMINE- MESALAMINE TABLET, DELAYED RELEASE
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESALAMINE DELAYED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MESALAMINE
DELAYED-RELEASE TABLETS.
MESALAMINE DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions, Renal Impairment (5.1)
11/2022
INDICATIONS AND USAGE
Mesalamine delayed-release tablets are an aminosalicylate indicated
for the:
induction and maintenance of remission in adult patients with mildly
to moderately active ulcerative
colitis. (1)
treatment of mildly to moderately active ulcerative colitis in
pediatric patients weighing at least 24 kg.
(1)
DOSAGE AND ADMINISTRATION
Administration Instructions
Evaluate renal function prior to initiation of mesalamine
delayed-release tablets and periodically while
on therapy. (2, 5.1)
Swallow mesalamine delayed-release tablets whole; do not split or
crush. (2)
Administer mesalamine delayed-release tablets with food. (2)
Drink an adequate amount of fluids. (2, 5.8)
Recommended Dosage in Adults
_For induction of remission_: 2.4 g to 4.8 g (two to four 1.2-g
tablets) once daily. (2)
_For maintenance of remission_: 2.4 g (two 1.2-g tablets) once daily.
(2)
Recommended Dosage in Pediatric Patients
The recommended dosage for treatment of mildly to moderately active
ulcerative colitis in pediatric
patients weighing at least 24 kg who can swallow tablets whole is
shown below: (2)
WEIGHT OF PEDIATRIC PATIENT
ONCE DAILY MESALAMINE DELAYED-RELEASE TABLETS DOSAGE
WEEK 0 TO WEEK 8
AFTER WEEK 8
24 kg to 35 kg
2.4 g
(two 1.2-g tablets)
1.2 g
(one 1.2-g tablet)
Greater than 35 kg to 50 kg
3.6 g
(three 1.2-g tablets)
2.4 g
(two 1.2-g tablets)
Greater than 50 kg
4.8 g
(four 1.2-g tablets)
2.4 g
(two 1.2-g tablets)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 1.2 g (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicyla