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

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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)

Inapatikana kutoka:

Salix Pharmaceuticals, Inc

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU is contraindicated in the following conditions: Risk Summary There are no available data with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU. 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 to assess the presence of PLENVU in human milk, the effects on the breastfed child or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PLENVU to a child during lactation; therefore

Bidhaa muhtasari:

PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride: NDC 65649-400-01. Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride: NDC 65649-400-01. Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid: NDC 65649-400-01. PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 65649-400-01. PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 65649-400-01. Storage Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

SODIUM ASCORBATE
Salix Pharmaceuticals, Inc
----------
MEDICATION GUIDE
MEDICATION GUIDE
PLENVU® (plen-vu)
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic
acid, sodium chloride
and potassium chloride for oral solution)
Read this Medication Guide and Instructions for Use before your
colonoscopy and again before you start
taking PLENVU.
What is the most important information I should know about PLENVU?
PLENVU 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 PLENVU
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 PLENVU:
•
vomiting
•
dizziness
•
urinating less often than normal
•
headache
See “What are the possible side effects of PLENVU?” for more
information about side effects.
What is PLENVU?
PLENVU is a prescription medicine used by adults to clean the colon
before a colonoscopy. PLENVU
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 PLENVU is safe and effective in children.
Do not take PLENVU 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).
•
problems with food and fluid emptying from your stomach (gastric
retention).
•
a problem with food moving too slowly through your intestines (ileus)

Tabia za bidhaa

PLENVU- 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
PLENVU SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLENVU.
PLENVU (POLYETHYLENE GLYCOL 3350, SODIUM ASCORBATE, SODIUM SULFATE,
ASCORBIC ACID, SODIUM CHLORIDE AND POTASSIUM CHLORIDE FOR ORAL
SOLUTION)
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 9/2023
INDICATIONS AND USAGE
PLENVU is an osmotic laxative indicated for cleansing of the colon in
preparation for colonoscopy in adults.
(1)
DOSAGE AND ADMINISTRATION
Preparation and Administration:
•
•
•
•
Recommended Dosage Regimens:
•
•
•
DOSAGE FORMS AND STRENGTHS
For Oral Solution: First dose: one pouch labeled Dose 1; Second dose:
two pouches labeled Dose 2 Pouch
A and Dose 2 Pouch B.
•
•
•
CONTRAINDICATIONS
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
®
Two doses of PLENVU are required for a complete preparation for
colonoscopy, using a “Two-Day” or
“One-Day” dosage regimen. (2.1)
Reconstitute PLENVU in water prior to ingestion. (2.1)
Consume additional clear liquids after each dose of PLENVU in both
dosing regimens. (2.1, 5.1)
Administer oral medications at least 1 hour before starting each dose
of PLENVU. (2.1, 7.2)
_Two-Day Split Dosage_: Dose 1 the evening before the colonoscopy
(approximately 4 pm to 8 pm) and
Dose 2 the next morning (approximately12 hours after the start of Dose
1). (2.1, 2.2)
_One-Day Morning Dosage_: Dose 1 the morning of the colonoscopy
(approximately 3 am to 7 am) and
Dose 2 a minimum of 2 hours after the start of Dose 1. (2.1, 2.3)
For complete information on dosing, preparation and administration,
see full prescribing information.
(2.1, 2.2, 2.3)
Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, 9 grams
of sodium sulfate, 2 grams of
sodium chloride, and 1 gram of potassium