MESALAMINE suppository

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:

RECTAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Mesalamine is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. MESALAMINE is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [ s ee Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 ), and Description ( 11 )] . Risk Summary Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal 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. Data Animal Data Reproduction studies have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and in rabbits at oral doses up to 495 mg/kg/day (about 5.4 times the recommended human intra-rectal dose of mesalamine, based on body surface area) following administration during the period of organogenesis, and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. Risk Summary Mesalamine and its N-acetyl metabolite are present in human milk in undetectable to small amounts ( see Data ) . There are limited reports of diarrhea in breastfed infants. 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 mesalamine to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine and any potential adverse effects on the breastfed child from mesalamine or from the underlying maternal conditions.   Clinical Considerations Monitor breastfed infants for diarrhea. Data 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 dosages 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 safety and effectiveness of mesalamine in pediatric patients for the treatment of mildly to moderately active ulcerative proctitis have not been established. Mesalamine was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age, which only included 14 patients with histologically-confirmed cases of ulcerative proctitis. However, efficacy was not demonstrated. Adverse reactions seen in pediatric patients in this trial (abdominal pain, headache, pyrexia, pharyngolaryngeal pain, diarrhea and vomiting) were similar to those seen in adult patients. Clinical trials of mesalamine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.   Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as mesalamine who were 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine. In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing mesalamine [see Use in Specific Populations ( 8.6 )] . Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on mesalamine 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 if renal function deteriorates while on therapy [see Warnings and Precautions ( 5.1 ), Adverse Reactions (6.2 ) , Drug Interactions ( 7.1 )] .

Ringkasan produk:

Mesalamine 1000 mg suppositories for rectal administration are available as bullet shaped, light tan to grey suppositories containing 1000 mg mesalamine supplied in boxes of 30 individually plastic wrapped suppositories (NDC 59762-0118-3). Store below 25ºC (77ºF), may be refrigerated. Keep away from direct heat, light or humidity.

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

MESALAMINE- MESALAMINE SUPPOSITORY
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESALAMINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MESALAMINE.
MESALAMINE SUPPOSITORIES, FOR RECTAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mesalamine is an aminosalicylate indicated in adults for the treatment
of mildly to moderately active
ulcerative proctitis. (1)
DOSAGE AND ADMINISTRATION
Dosage
The recommended adult dosage is 1000 mg administered rectally once
daily at bedtime for 3 to 6
weeks. Safety and effectiveness beyond 6 weeks have not been
established. (2)
Administration Instructions:
Evaluate renal function prior to initiation of Mesalamine and
periodically while on therapy. (2, 5.1)
Do not cut or break the suppository. (2)
Drink an adequate amount of fluids. (2, 5.7)
Retain the suppository for one to three hours or longer, if possible.
(2)
Mesalamine suppositories will cause staining of direct contact
surfaces, including but not limited to
fabrics, flooring, painted surfaces, marble, granite, vinyl, and
enamel. Keep Mesalamine away from
these surfaces to prevent staining. (2)
DOSAGE FORMS AND STRENGTHS
Suppository: 1000 mg (3)
CONTRAINDICATIONS
Known or suspected hypersensitivity to salicylates or aminosalicylates
or to any ingredients in the
formulation. (4, 5.3)
WARNINGS AND PRECAUTIONS
Renal Impairment: Evaluate the risks and benefits in patients with
known renal impairment or taking
nephrotoxic drugs; monitor renal function. Discontinue Mesalamine if
renal function deteriorates. (5.1,
7.1, 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 Fa