BALSALAZIDE DISODIUM capsule

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

BALSALAZIDE DISODIUM (UNII: 1XL6BJI034) (BALSALAZIDE - UNII:P80AL8J7ZP)

Fáanlegur frá:

Apotex Corp.

INN (Alþjóðlegt nafn):

BALSALAZIDE DISODIUM

Samsetning:

BALSALAZIDE DISODIUM 750 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide disodium capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [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, the active moiety of balsalazide, 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 adverse developmental effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (MRHD) (see Data).   The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 2,500 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, the active moiety of balsalazide, 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 were performed in rats and rabbits following administration of balsalazide during organogenesis at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the MRHD based on body surface area for the rat and rabbit, respectively, and revealed no adverse embryofetal developmental effects due to balsalazide disodium. 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 0.1% or less for mesalamine (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 balsalazide to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for balsalazide and any potential adverse effects on the breastfed child from balsalazide or from the underlying maternal condition.   Clinical Considerations Advise the caregiver to monitor breastfed infants for diarrhea.   Data In published lactation studies, maternal mesalamine doses from various oral and rectal mesalamine 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 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. The safety and effectiveness of balsalazide disodium has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric and adolescent patients 5 years to 17 years of age. Use of balsalazide disodium for this indication is supported by evidence from adequate and well-controlled clinical studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 5 years to 17 years [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)]. Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day [see Dosage and Administration (2.2)].   The safety and effectiveness of balsalazide disodium capsules in pediatric patients below the age of 5 years have not been established.  Clinical trials of balsalazide disodium did not include sufficient numbers of subjects aged 65 years and over 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., neutropenia and pancytopenia, in patients who were 65 years or older compared to younger patients taking mesalamine-containing products. Balsalazide disodium is converted into mesalamine in the colon. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with balsalazide disodium. 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 balsalazide disodium capsules [see Use in Specific Populations (8.6)]. Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to balsalazide disodium, which is converted to mesalamine, may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on balsalazide disodium 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 balsalazide disodium capsules if renal function deteriorates while on therapy [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Drug Interactions (7.1)].

Vörulýsing:

Balsalazide Disodium Capsules, USP are available as white, opaque capsules imprinted “APO B750” in red ink. Balsalazide Disodium Capsules, USP are supplied as follows: Bottles of 30 (NDC 60505-2575-3) Bottles of 280 (NDC 60505-2575-7) Bottles of 350 (NDC 60505-2575-4) Unit Dose Blister Packs of 10 strips of 10 capsules (NDC 60505-2575-0) Storage Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF). See USP Controlled Room Temperature.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BALSALAZIDE DISODIUM- BALSALAZIDE DISODIUM CAPSULE
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BALSALAZIDE DISODIUM
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BALSALAZIDE
DISODIUM CAPSULES.
BALSALAZIDE DISODIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Balsalazide is an aminosalicylate indicated for the treatment of
mildly to moderately active ulcerative
colitis in patients 5 years of age and older. (1)
Limitations of Use: Safety and effectiveness of balsalazide beyond 8
weeks in children (ages 5 to 17
years) and 12 weeks in adults have not been established. (1)
DOSAGE AND ADMINISTRATION
Administration Instructions
Evaluate renal function before initiating therapy with balsalazide
disodium capsules. (2.1)
Swallow capsules whole. Do not cut, break, crush or chew. (2.1)
For patients who cannot swallow intact capsules, the capsules may be
opened and sprinkled on
applesauce, then chewed and swallowed immediately. (2.1)
Teeth and/or tongue staining may occur when administered sprinkled on
applesauce. (2.1)
Drink an adequate amount of fluids. (2.1, 5.8)
Take balsalazide disodium capsules with or without food. (2.1)
Dosage
_Adults: _The recommended dosage is 2.25 g (three 750 mg capsules)
three times daily for 8 weeks.
Some adult patients required treatment for up to 12 weeks in clinical
trials. (2.2)
_Pediatric Patients 5 Years to 17 Years of Age: _The recommended
dosage is EITHER:
2.25 g (three 750 mg capsules) three times for up to 8 weeks.
OR:
750 mg (one capsule) three times daily for up to 8 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 750 mg (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates, aminosalicylates,
or any of the components of
balsalazide disodium capsules or balsalazide metabolites. (4, 5.3)
WARNINGS AND PRECAUTIONS
Renal Impairment: Assess renal function at the beginning of treatment
and periodically during
treatment. Evaluate the ris