MESALAMINE suppository

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Sandoz Inc

طريقة التعاطي:

RECTAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Mesalamine suppositories, 1000 mg are 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 [see 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

ملخص المنتج:

Mesalamine suppositories, 1000 mg for rectal administration are available as oblong shaped, grey to light brown colored suppositories individually plastic wrapped and supplied in boxes of 30: NDC 0781-7088-33, carton of 30 rectal suppositories Store below 25°C (77°F), may be refrigerated. Keep away from direct heat, light or humidity. Retain in the carton until time of use.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MESALAMINE- MESALAMINE SUPPOSITORY
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESALAMINE
SUPPOSITORIES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MESALAMINE
SUPPOSITORIES.
MESALAMINE SUPPOSITORIES, FOR RECTAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
INDICATIONS AND USAGE
Mesalamine suppositories are 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:_
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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
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ADVERSE REACTIONS
The most common adverse reactions (≥ 1%) are: dizziness, rectal
pain, fever, rash, acne and colitis. (6.1)
Severe Cutaneous Adverse Reactions (5.5) 11/2021
Evaluate renal function prior to initiation of mesalamine
suppositories 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 suppositories
away from these surfaces to prevent staining. (2)
_RENAL IMPAIRMENT:_ Evaluate the risks and benefits in patients with
known renal impairment or
taking nephrotoxic drugs; monitor renal function. (5.1, 7.1, 8.6)
_MESALAMINE-INDUCED ACUTE INTOLERANCE SYNDROME:_ Symptoms may be
difficult to distinguish
from an exacerbation of ulcer