MESALAMINE capsule, delayed release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Greenstone LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

MESALAMINE delayed-release capsules is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. MESALAMINE delayed-release capsules is indicated for the maintenance of remission of ulcerative colitis in adults. MESALAMINE delayed-release capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of MESALAMINE delayed-release capsules [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 ), Description ( 11 ) ] . Risk Summary There are no adequate and well controlled studies of MESALAMINE delayed-release capsules use in pregnant women. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. No evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. MESALAMINE delayed-release capsules should be used during pregnancy only if clearly needed. Human Data Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes. Animal data Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm to the fetus. These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area. Mesalamine and its N-acetyl metabolite are present in human milk. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L. The concentration of the N-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/L. Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MESALAMINE delayed-release capsules and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Caution should be exercised when MESALAMINE delayed-release capsules is administered to a nursing woman. The safety and effectiveness of MESALAMINE delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. Use of MESALAMINE delayed-release capsules in these pediatric age groups is supported by evidence from adequate and well controlled studies of mesalamine delayed-release 400 mg tablets in adults and a single 6-week study in 82 pediatric patients 5 to 17 years of age [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ) , Clinical Studies ( 14.1 )] .  The safety and effectiveness of MESALAMINE delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients below the age of 5 years have not been established. The safety and effectiveness of MESALAMINE delayed-release capsules in the maintenance of remission of ulcerative colitis in pediatric patients have not been established. Clinical studies of mesalamine delayed-release tablets did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Reports from uncontrolled clinical studies and postmarketing experience suggest a higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) in subjects receiving mesalamine delayed-release tablets who are 65 years or older compared to younger patients taking mesalamine-containing products such as MESALAMINE delayed-release capsules. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with MESALAMINE delayed-release capsules. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing MESALAMINE delayed-release capsules [see Use in Specific Populations ( 8.6 )] . Mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on MESALAMINE delayed-release capsules therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. Discontinue MESALAMINE delayed-release capsules if renal function deteriorates while on therapy  [see Warnings and Precautions ( 5.1 ) , Adverse Reactions ( 6.2 ) , Drug Interactions ( 7.1 ) ] .

Ringkasan produk:

MESALAMINE delayed-release capsules are available as clear capsules and imprinted with “WC 400mg” in black ink. Each capsule contains four reddish-brown coated 100 mg mesalamine tablets. NDC   59762-0117-1 Bottle of 180 capsules Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

MESALAMINE- MESALAMINE CAPSULE, DELAYED RELEASE
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESALAMINE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR MESALAMINE DELAYED-RELEASE CAPSULES.
MESALAMINE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
MESALAMINE delayed-release capsules is an aminosalicylate indicated
for:
Treatment of mildly to moderately active ulcerative colitis in
patients 5 years of age and older. (1.1)
Maintenance of remission of ulcerative colitis in adults. (1.2)
DOSAGE AND ADMINISTRATION
Important Administration Instructions:
Do not substitute two MESALAMINE delayed-release 400 mg capsules with
one mesalamine delayed-
release 800 mg tablet. (2.1)
Evaluate renal function prior to initiation of MESALAMINE
delayed-release capsules. (2.1, 5.1)
Take with or without food. (2.1)
Swallow the capsules whole; do not cut, break, crush or chew. (2.1)
For patients who are unable to swallow the capsules, the capsules can
be opened and the inner tablets
swallowed. (2.1)
Drink an adequate amount of fluids. (2.1, 5.7)
Treatment of Mildly to Moderately Active Ulcerative Colitis:
Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks
Pediatric Patients 5 years or older: See weight-based dosing table in
the full prescribing information;
twice daily dosing for 6 weeks. (2.2)
Maintenance of Remission of Ulcerative Colitis
Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided
doses. (2.3)
DOSAGE FORMS AND STRENGTHS
Delayed-release capsules (containing four 100 mg tablets): 400 mg (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates or aminosalicylates
or to any of the ingredients of
MESALAMINE delayed-release capsules. (4, 5.3)
WARNINGS AND PRECAUTIONS
Renal Impairment: Assess renal function at the beginning of treatment
and periodically during
treatment. Evaluate the risks and benefits of using MESALAMIN