SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG), MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838)

Available from:

Lupin Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - Gastrointestinal obstruction - Bowel perforation - Gastric retention - Ileus - Toxic colitis or toxic megacolon - Known allergies to components of the kit [see Description (11)] Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. It is also not known whether Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. Of the 375 patients who received Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was given as a one-day preparation.

Product summary:

Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains: • Two (2) 6 ounce bottles of oral solution. • One (1) 19 ounce mixing container with a 16 ounce fill line. 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. Keep out of reach of children. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Package NDC 43386-700-83

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE- SODIUM SULFATE,
POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION
Lupin Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Sodium Sulfate (soe' dee um sul' fate), Potassium Sulfate (poe tas' ee
um sul' fate) and Magnesium
Sulfate ( mag nee' zee um sul' fate) Oral Solution
Read this Medication Guide before you start taking Sodium Sulfate,
Potassium Sulfate and Magnesium
Sulfate oral solution. This information does not take the place of
talking with your healthcare provider
about your medical condition or your treatment.
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 osmotic 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:
•
vomiting that prevents you from keeping down the additional prescribed
amount of water listed in
the Instructions for Use in the Patient Instructions for Use Booklet
•
dizziness
•
urinating less often than normal
•
headache
See Section “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 Su

Summary of Product characteristics

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE- SODIUM
SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM SULFATE,
POTASSIUM SULFATE, MAGNESIUM SULFATE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE.
SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE (SODIUM SULFATE,
POTASSIUM
SULFATE, MAGNESIUM SULFATE) SOLUTION FOR ORAL USE.
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Dosage and Administration 11/2012
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 adults
(1)
DOSAGE AND ADMINISTRATION
Dilute the solution prior to use. See FULL PRESCRIBING INFORMATION for
complete dosing and
administration instructions (2)
Split Dose (2-Day) Regimen
Evening before colonoscopy: dilute one bottle with water to a total
volume of 16 ounces (up to the fill
line) and drink the entire amount.
Drink 32 ounces of water over the next hour.
Next morning: repeat both steps using the second bottle.
Complete preparation at least 2 hours before colonoscopy or as
directed by physician.
DOSAGE FORMS AND STRENGTHS
Two 6 ounce bottles of oral solution, each containing sodium sulfate
17.5 grams, potassium sulfate
3.13 grams, and magnesium sulfate 1.6 grams. (3)
CONTRAINDICATIONS
Gastrointestinal obstruction (4, 5.6)
Bowel perforation (4, 5.6)
Gastric retention (4)
Ileus (4)
Toxic colitis or toxic megacolon (4)
Known allergies to components of the kit (4, 11)
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and
renal impairment– assess
concurrent medications and consider testing in some patients (5.1,
5.2, 5.3)
Patients with renal insufficiency– use caution, ensure adequate
hydration and consider testing (5.4)
Suspected GI obstruction or