SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE- sodium sulfate, potassium sulfate, magnesium sulfate solution, concentr

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:

Affordable Pharmaceuticals, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Risk Summary There are no available data on Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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,

Produkt oppsummering:

Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution  (for adults) (NDC 10572-012-01) contains: Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution  (for pediatric patients 12 years of age and older) (NDC 10572-112-01) 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

SULFATE, MAGNESIUM SULFATE SOLUTION, CONCENTRATE
Affordable Pharmaceuticals, LLC
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MEDICATION GUIDE
Sodium Sulfate, Potassium Sulfate and Magnesium
Sulfate Oral Solution (so-DEE-um sul-fate, po-TASS
ee-um sul-fate and mag-NEE-see-um sul-fate)
Read and understand this Medication Guide instructions at least 2 days
before your colonoscopy and again
before you start taking Sodium Sulfate, Potassium Sulfate and
Magnesium Sulfate Oral Solution.
What is the most important information I should know about Sodium
Sulfate, Potassium Sulfate and
Magnesium Sulfate Oral Solution?
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution
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 Sodium
Sulfate, Potassium Sulfate and
Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and
Magnesium Sulfate Oral Solution:
o vomiting o urinating less often than normal
o dizziness o headache
See "What are the possible side effects of Sodium Sulfate, Potassium
Sulfate and Magnesium Sulfate Oral
Solution?" for more information about side effects.
What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
Solution?
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution
is a prescription medicine used by
adults and children 12 years of age and older to clean the colon
before a colonoscopy. Sodium Sulfate,
Potassium Sulfate and Magnesium Sulfate Oral Solution cleans your
colon by

Preparatomtale

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE- SODIUM
SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION, CONCENTRATE
AFFORDABLE PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM SULFATE,
POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR SODIUM SULFATE, POTASSIUM SULFATE AND
MAGNESIUM
SULFATE ORAL SOLUTION
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Indications and Usage ( 1)
8/2020
Dosage and Administration ( 2.1, 2.4)
8/2020
INDICATIONS AND USAGE
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution
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 Sodium Sulfate, Potassium Sulfate and
Magnesium Sulfate Oral
Solution 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 Sodium Sulfate,
Potassium Sulfate and
Magnesium Sulfate Oral Solution: 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
Oral Solution 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
Sodium Sulfa