COLPREP KIT- sodium sulfate, potassium sulfate, and magnesium sulfate for oral solution powder, for 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 (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)

Available from:

KVK-Tech, Inc.

INN (International Name):

SODIUM SULFATE

Composition:

SODIUM SULFATE 17.5 g in 22.7 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ColPrep Kit 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 ColPrep Kit. It is also not known whether ColPrep Kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ColPrep Kit 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 ColPrep Kit is administered to a nursing woman. The safety and effectiveness of ColPrep Kit have not been established in pediatric patients. Of the 375 patients who received another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g)

Product summary:

How Supplied: Each ColPrep Kit contains: ColPrep Kit NDC 10702-283-23 Storage: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15ºC and 30°C (59ºFand 86°F). [See USP controlled room temperature] Keep out of reach of children.

Authorization status:

New Drug Application

Patient Information leaflet

COLPREP KIT- SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE
FOR ORAL
SOLUTION POWDER, FOR SOLUTION
KVK-Tech, Inc.
----------
MEDICATION GUIDE
COLPREP (KO-L PREP) KIT
(SODIUM SULFATE, POTASSIUM SULFATE, AND
MAGNESIUM SULFATE)
FOR ORAL SOLUTION
What is the most important information I should know about ColPrep
Kit?
ColPrep Kit 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 risk of having fluid loss and changes in body salts with ColPrep
Kit is higher if you:
•
have heart problems
•
have kidney problems
•
take water pills, high blood pressure medicine, 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 ColPrep Kit:
• vomiting • urinating less often than normal
• dizziness • headache
Tell your healthcare provider right away if you have a seizure or
faint (lose consciousness).
See "What are the possible side effects of ColPrep Kit?" for more
information about side effects.
What is ColPrep Kit?
ColPrep Kit is a prescription medicine used by adults to clean the
colon before a colonoscopy. ColPrep
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 ColPrep Kit is safe and effective in children.
Do not take ColPrep Kit if your healthcare provider has told you that
you have:
•
a blockage in your bowel (obstruction).
•
an opening in the wall of your stomach or intestine (bowel
perforation).
•
a problem with food and fluid emptying from your stomach (gastric
retention).
•
a problem with food moving too slowly through your intestines (ileus).
•
a very dilated intestine

Summary of Product characteristics

COLPREP KIT- SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE
FOR ORAL
SOLUTION POWDER, FOR SOLUTION
KVK-TECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLPREP KIT SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR COLPREP KIT.
COLPREP KIT (SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE)
FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
ColPrep Kit is an osmotic laxative indicated for cleansing of the
colon as a preparation for colonoscopy in adults. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of ColPrep Kit is a split-dose (2-Day) oral
regimen. (2.1):
o Dose 1: administered in the evening before colonoscopy, 10 to 12
hours before the second dose
o Dose 2: administered the morning of colonoscopy, at least 3 ½ hours
before colonoscopy
ColPrep Kit must be reconstituted and diluted in water prior to
ingestion. Direct ingestion of the undiluted reconstituted
solution may increase the risk of nausea, vomiting, and dehydration.
(2.2, 5.8)
Additional fluids must be consumed after each dose of ColPrep. (2.2,
2.4)
For complete information on dosing, instructions for use, preparation
and administration, see full prescribing
information. (2.1, 2.2, 2.3, 2.4).
Do not take oral medications within 1 hour of start of each dose.
(2.3, 7.2)
Complete preparation at least 2 hours before colonoscopy or as
directed by physician. (2.3)
DOSAGE FORMS AND STRENGTHS
For oral solution: Two bottles per ColPrep Kit. Each bottle contains
sodium sulfate 17.5 g, potassium sulfate 3.13 g, and
magnesium sulfate 1.6 g. (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