APRISO- mesalamine capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Salix Pharmaceuticals, Inc.

INN (nemzetközi neve):

MESALAMINE

Összetétel:

MESALAMINE 375 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

APRISO ® is indicated for the maintenance of remission of ulcerative colitis in adults. APRISO is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of APRISO capsules [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) . In animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 times, respectively, the maximum recommended human dose ( see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Reproduction studies with mesalamine during organogenesis have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. Risk Summary Data from published literature report the presence of mesalamine and its metabolite, N-acetyl 5-aminosalicylic acid in human milk in small amounts with relative infant doses (RID) of 2% or less ( see Data) . There are case reports of diarrhea in breastfed infants exposed to mesalamine (see Clinical Considerations) . There is no information on the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of APRISO to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for APRISO and any potential adverse effects on the breastfed child from APRISO or from the underlying maternal condition. Clinical Considerations Advise the caregiver to monitor the breastfed infant for diarrhea. Data In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. The average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/L. The average concentration of the N-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/L. Based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (RID 0 to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of N-acetyl-5-aminosalicylic acid. Safety and effectiveness of APRISO in pediatric patients have not been established. Clinical studies of APRISO did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine-containing products such as APRISO. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with APRISO. 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 APRISO [see Use in Specific Populations ( 8.6)]. Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on APRISO 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 APRISO if renal function deteriorates while on therapy [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Drug Interactions (7.2)].

Termék összefoglaló:

APRISO ® extended-release capsules are available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine in a light blue opaque gelatin capsule with the letters “G” and “M” imprinted on either side of a black band and are available in bottles of 120 capsules (NDC 65649-103-02). Storage : Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Engedélyezési státusz:

New Drug Application

Termékjellemzők

APRISO- MESALAMINE CAPSULE, EXTENDED RELEASE
SALIX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APRISO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APRISO.
APRISO
(MESALAMINE) EXTENDED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
APRISO is an aminosalicylate indicated for the maintenance of
remission of ulcerative colitis in adults. ( 1)
DOSAGE AND ADMINISTRATION
Dosage
The recommended dosage is 1.5 g (four 0.375 g capsules) once daily in
the morning. ( 2)
Administration Instructions
Evaluate renal function before initiating therapy with APRISO. ( 2)
Swallow the capsules whole. Do not cut, break, crush or chew the
capsules. ( 2)
Avoid co-administration with antacids. ( 2, 7.1)
Drink an adequate amount of fluids. ( 2, 5.7)
Take APRISO without regard to meals. ( 2)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 0.375 g ( 3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates, aminosalicylates,
or any component of APRISO
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 in patients with known
renal impairment or taking
nephrotoxic drugs; monitor renal function. Discontinue if renal
function deteriorates. ( 5.1, 7.2, 8.6)
Mesalamine-Induced Acute Intolerance Syndrome:Symptoms may be
difficult to distinguish from an
exacerbation of ulcerative colitis; monitor for worsening symptoms;
discontinue treatment if acute
intolerance syndrome is suspected. ( 5.2)
Hypersensitivity Reactions, including Myocarditis and
Pericarditis:Evaluate patients immediately and
discontinue if a hypersensitivity reaction is suspected. ( 5.3)
Hepatic Failure:Evaluate the risks and benefits in patients with known
liver impairment. ( 5.4)
Severe Cutaneous Adverse Reactions:Discontinue at the first signs or
symptoms of severe cutaneous
adverse reactions or other signs