SUPREP BOWEL PREP- sodium sulfate, potassium sulfate, magnesium sulfate solution, concentrate

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152), MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)

Tilgjengelig fra:

Braintree Laboratories, Inc.

INN (International Name):

sodium sulfate

Sammensetning:

sodium sulfate 17.5 g in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. SUPREP Bowel Prep Kit is contraindicated in the following conditions: - Gastrointestinal obstruction or ileus  [see Warnings and Precautions ( 5.6)] - Bowel perforation [see Warnings and Precaution ( 5.6)] - Toxic colitis or toxic megacolon - Gastric retention - Hypersensitivity to any of the ingredients in SUPREP Bowel Prep Kit Risk Summary There are no available data on SUPREP Bowel Prep Kit use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (SUPREP Bowel Prep Kit). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies

Produkt oppsummering:

Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for adults) (NDC 52268-012-01) contains: Each SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution (for pediatric patients 12 years of age and older) (NDC 52268-112-01) contains: Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Braintree Laboratories, Inc.
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MEDICATION GUIDE
SUPREP ® (Soo-prep) Bowel Prep Kit
(sodium sulfate, potassium sulfate and magnesium sulfate)
oral solution
Read and understand this Medication Guide instructions at least 2 days
before your colonoscopy and
again before you start taking SUPREP Bowel Prep Kit.
What is the most important information I should know about SUPREP
Bowel Prep Kit?
SUPREP Bowel Prep Kit and other bowel preparations can cause serious
side effects, including:
•
Serious loss of body fluid (dehydration) and changes in blood salts
(electrolytes) in your blood.
These changes can cause:
•
abnormal heartbeats that can cause death
seizures. This can happen even if you have never had a seizure.
kidney problems
Your chance of having fluid loss and changes in body salts with SUPREP
Bowel Prep Kit is higher if
you:
• have heart problems
• have kidney problems
• take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)
Tell your healthcare provider right away if you have any of these
symptoms of a loss of too much body
fluid (dehydration) while taking SUPREP Bowel Prep Kit:
o vomiting o urinating less often than normal
o dizziness o headache
See What are the possible side effects of SUPREP Bowel Prep Kit? for
more information about side
effects.
What is SUPREP Bowel Prep Kit?
SUPREP Bowel Prep Kit is a prescription medicine used by adults and
children 12 years of age and older
to clean the colon before a colonoscopy. SUPREP Bowel Prep Kit cleans
your colon by causing you to
have diarrhea. Cleaning your colon helps your healthcare provider see
the inside of your colon more
clearly during your colonoscopy.
It is not known if SUPREP Bowel Prep Kit is safe and effective in
children under 12 years of age.
Do not take SUPREP Bowel Prep Kit if your healthcare provider has told
you that you have:
• a blockage in your intestine (bowel obstruction)
• an opening in the wall of your stomach or intestine (bowel
perforation)
• a very dilated intestine (toxic megacolon)
• problems wit

Preparatomtale

SUPREP BOWEL PREP- SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM
SULFATE SOLUTION,
CONCENTRATE
BRAINTREE LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPREP BOWEL PREP KIT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPREP BOWEL PREP
KIT
SUPREP BOWEL PREP KIT (SODIUM SULFATE, POTASSIUM SULFATE, AND
MAGNESIUM SULFATE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 08/2010
RECENT MAJOR CHANGES
Indications and Usage ( 1)
8/2020
Dosage and Administration ( 2.1, 2.4)
8/2020
INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing
of the colon in preparation for colonoscopy in adult
and pediatric patients 12 years of age and older. ( 1)
DOSAGE AND ADMINISTRATION
Preparation and Administration ( 2.2)
Must dilute in water prior to ingestion.
Administration of two bottles of SUPREP Bowel Prep Kit is required for
a complete preparation for colonoscopy. One
bottle is equivalent to one
dose .
Must consume additional water after each dose.
Stop consumption of all fluids at least 2 hours before the
colonoscopy.
Recommended Dosage and Administration
Split-Dose (two-day) regimen consists of two doses of SUPREP Bowel
Prep Kit: first dose during the evening prior to
colonoscopy and second dose the next day, during the morning of
colonoscopy. ( 2.1, 2.3, 2.4)
Recommended SUPREP Bowel Prep Kit dosage is:
º ADULTS: Two 6-ounce doses. ( 2.3)
º PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER: Two 4.5-ounce doses.
( 2.4)
For complete information on preparation before colonoscopy and
administration of the dosage regimen, see full
prescribing Information. ( 2.1, 2.2, 2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
SUPREP Bowel Prep Kit (FOR ADULTS): Two bottles each containing 6
ounces of an oral solution of 17.5 grams sodium
sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium
sulfate. ( 3)
SUPREP Bowel Prep Kit (FOR PEDIATRIC PATIENTS 12 YEARS OF AGE AND
OLDER): Two bottles each containing 4.5-ounces
of an oral