MOVIPREP- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Verfügbar ab:

Salix Pharmaceuticals, Inc.

INN (Internationale Bezeichnung):

POLYETHYLENE GLYCOL 3350

Zusammensetzung:

POLYETHYLENE GLYCOL 3350 100 g in 1 L

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. MoviPrep is contraindicated in the following conditions: Risk Summary There are no available data on MoviPrep in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with MoviPrep. 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. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data available on the presence of MoviPrep in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk o

Produktbesonderheiten:

MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is supplied as a white to yellow powder for reconstitution and is lemon flavored. NDC 65649-201-75, MoviPrep, single-use outer carton: Storage

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

MOVIPREP- POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE,
POTASSIUM CHLORIDE,
ASCORBIC ACID, SODIUM ASCORBATE
Salix Pharmaceuticals, Inc.
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MEDICATION GUIDE
MoviPrep® (moo-vee-prěp)
(polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium
chloride, sodium ascorbate, and
ascorbic acid for oral solution)
Read this Medication Guide and Instructions for Use before your
colonoscopy and again before you start
taking MoviPrep.
What is the most important information I should know about MoviPrep?
MoviPrep 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:
o
abnormal heartbeats that can cause death.
o
seizures. This can happen even if you have never had a seizure.
o
kidney problems.
Your chance of having fluid loss and changes in body salts with
MoviPrep is higher if you:
•
have heart problems.
•
have kidney problems.
•
take water pills (diuretics), 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 serious loss of body fluid
(dehydration) while taking MoviPrep:
•
vomiting
•
urinating less often than normal
•
dizziness
•
headache
See “What are the possible side effects of MoviPrep?” for more
information about side effects.
What is MoviPrep?
MoviPrep is a prescription medicine used by adults to clean the colon
before a colonoscopy. MoviPrep
cleans your colon by causing you to have diarrhea (loose stools).
Cleaning your colon helps your
healthcare provider see the inside of your colon more clearly during
your colonoscopy.
It is not known if MoviPrep is safe and effective in children.
Who should not take MoviPrep?
Do not take MoviPrep 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).
•

Fachinformation

MOVIPREP- POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE,
POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE
SALIX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOVIPREP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOVIPREP.
MOVIPREP® (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE,
POTASSIUM
CHLORIDE, SODIUM ASCORBATE, AND ASCORBIC ACID FOR ORAL SOLUTION)
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
MoviPrep is an osmotic laxative indicated for cleansing of the colon
as a preparation for colonoscopy in
adults. (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration:
•
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•
Dosing Regimen:
•
•
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DOSAGE FORMS AND STRENGTHS
For Oral Solution: 2 pouches labeled Pouch A and 2 pouches labeled
Pouch B. (3)
•
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CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
•
•
•
Two doses of MoviPrep are required for a complete preparation for
colonoscopy, using a “Two-Day”
preferred method or “One-Day” alternative method dosing regimen.
(2.1)
MoviPrep must be reconstituted in water prior to ingestion. (2.1)
Additional clear liquids must be consumed after each dose of MoviPrep
in both dosing regimens. (2.1,
5.1)
Do not take other laxatives while taking MoviPrep. (2.1, 5.5)
Do not take oral medications within 1 hour of starting each dose.
(2.1)
_Two-Day (Split-Dose) (Preferred Method): _Dose 1 the evening before
the colonoscopy, and Dose 2
the morning of the colonoscopy (approximately 12 hours after the start
of Dose 1, and at least 3 ½
hours prior to the colonoscopy). (2.2)
_One-Day (Evening Only) (Alternative Method)_: Dose 1 at least 3 ½
hours prior to bedtime the evening
before the colonoscopy and Dose 2 approximately 1 ½ hours after
starting Dose 1 the evening before
the colonoscopy. (2.3)
For complete information on dosing, preparation and administration see
full prescribing information
(2.1, 2.2, 2.3)
Each Pouch A contains 100 grams