MESALAMINE tablet, delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Zydus Pharmaceuticals USA Inc.

INN (Tarptautinis Pavadinimas):

MESALAMINE

Sudėtis:

MESALAMINE 1.2 g

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 adv

Produkto santrauka:

Mesalamine Delayed-Release Tablets USP, 1.2 g are pale red-brown, oval-shaped, biconvex, bevel film-coated tablets debossed with the '711' on one side and plain on other side and are supplied as follows: NDC 68382-711-64 in bottle of 34 tablets with child-resistant closure NDC 68382-711-19 in bottle of 120 tablets with child-resistant closure Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Zydus Pharmaceuticals USA Inc.
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Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
Rev.: 10/23
Revised: 10/2023
Document Id: d9ce9589-6aee-4dc3-a71b-f1c32ab9f552
34391-3
Set id: 533bfaf5-0add-4b49-a4f2-ddea2b83f65d
Version: 15
Effective Time: 20231026
Zydus Pharmaceuticals USA Inc.

Prekės savybės

MESALAMINE- MESALAMINE TABLET, DELAYED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
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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 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 PatientOnce Daily Mesalamine Delayed Release
Tablet Dosage
Week 0 to Week 8
Week 0 to 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 salicylates or aminosalicylates
or