SUTAB- sodium sulfate, magnesium sulfate, and potassium chloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

זמין מ:

Braintree Laboratories, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUTAB is contraindicated in the following conditions: - Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6) - Bowel Perforation [see Warnings and Precautions ( 5.6) - Toxic colitis or toxic megacolon - Gastric retention - Hypersensitivity to any ingredient in SUTAB  [see Warnings and Precautions ( 5.7) and Description ( 11)] Risk Summary There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). 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.

leaflet_short:

Each tablet of SUTAB contains 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side. Each carton of SUTAB (NDC 52268-201-01) contains: Note to Pharmacist : Inform the patient to remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2)] Storage Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature.

מצב אישור:

New Drug Application

עלון מידע

Braintree Laboratories, Inc.
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MEDICATION GUIDE
SUTAB ®(Sootab)
(sodium sulfate, potassium sulfate and potassium chloride)
tablets, for oral use
Read and understand these Medication Guide Instructions at least 2
days beforeyour colonoscopy and
again before you start taking SUTAB.
What is the most important information I should know about SUTAB?
SUTAB and other bowel preparations can cause serious side effects,
including:
Serious loss of body fluid (dehydration) and changes in body 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 SUTAB
is higher if you:
•
have heart problems.
•
have kidney problems.
•
take water pills (diuretics) 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 SUTAB:
•
vomiting • urinating less often than normal
•
dizziness • headache
See “What are the possible side effects of SUTAB?” for more
information about side effects.
What is SUTAB?
SUTAB is a prescription medicine used by adults to clean the colon
before a colonoscopy. SUTAB
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 SUTAB is safe and effective in children.
Do nottake SUTAB if your healthcare provider has told you that you
have:
•
a blockage in your bowel (obstruction) or a problem with food moving
too slowly through your
intestines (ileus).
•
an opening in the wall of your stomach or intestine (bowel
perforation).
•
a very dilated intestine (toxic colitis or toxic megacolon).
•
problems with food and fluid emptying from your stomach (gastric
retention).
•
allergies to any ingredient in SUTAB. See the end of this Medic

מאפייני מוצר

SUTAB- SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE
TABLET
BRAINTREE LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUTAB
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUTAB.
SUTAB (SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE)
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1, 2.2)
10/2023
Warnings and Precautions ( 5.8)
10/2023
INDICATIONS AND USAGE
SUTAB is an osmotic laxative indicated for cleansing of the colon in
preparation for colonoscopy in adults.
(1)
DOSAGE AND ADMINISTRATION
For complete information on preparation before colonoscopy and
administration of the dosage regimen,
see full prescribing information. ( 2.1, 2.2)
Preparation and Administration ( 2.1)
Administration of two doses (24 tablets) are required for a complete
preparation for colonoscopy.
SUTAB is supplied as two bottles each containing 12 tablets. Twelve
(12) tablets are equivalent to one
dose.
Each SUTAB bottle contains a desiccant. REMOVE AND DISCARD THE
DESICCANTfrom both bottles the
evening prior to the colonoscopy.
Must consume water with each dose and an additional 32 ounces of water
after each dose.
Do not take other laxatives.
Administer oral medications at least 1 hour before starting each dose
of SUTAB.
If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin,
chlorpromazine, or penicillamine, take
these medications at least 2 hours before and not less than 6 hours
after administration of each dose.
Recommended Split Dose (2-Day) Regimen ( 2.2)
_Day 1, Dose 1: On the Evening Prior to Colonoscopy_
1. Open 1 bottle of 12 tablets. REMOVE AND DISCARD THE DESICCANT.
REMOVE AND DISCARD THE
DESICCANTfrom the second bottle and close the bottle. Use the second
bottle for the second dose on
the morning of the colonoscopy.
2. Fill the provided container with 16 ounces of water (up to the fill
line). Swallow each tablet with a sip of
water and drink