NULYTELY WITH FLAVOR PACKS- polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Tilgængelig fra:

Braintree Laboratories, Inc.

INN (International Name):

Polyethylene Glycol 3350

Sammensætning:

Polyethylene Glycol 3350 420 g in 4 L

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

NuLYTELY is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. NuLYTELY is contraindicated in the following conditions: - Gastrointestinal (GI) obstruction, ileus, or gastric retention - Bowel perforation - Toxic colitis or toxic megacolon - Known allergy or hypersensitivity to any component of NuLYTELY [ see How Supplied/Storage and Handling ( 16) ] Pregnancy Category C. Animal reproduction studies have not been conducted with NuLYTELY. It is also not known whether NuLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. NuLYTELY 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 NuLYTELY is administered to a nursing woman. Safety and effectiveness of NuLYTE

Produkt oversigt:

In powdered form, for oral administration as a solution following reconstitution. NuLYTELY is available in a disposable jug in powdered form containing: NuLYTELY with Flavor Packs: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Each jug has an attached package containing 4 flavor packs (optional); one each 2.0 g: Cherry, Lemon-Lime, Orange and Pineapple flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing. Lemon-Lime Flavor NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children. NuLYTELY with Flavor Packs          NDC 52268-400-01 Lemon-Lime Flavor NuLYTELY        NDC 52268-302-01

Autorisation status:

New Drug Application

Indlægsseddel

POTASSIUM CHLORIDE
Braintree Laboratories, Inc.
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Medication Guide
NuLYTELY ® (Noo-lite-ly)
(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
oral solution)
Read this Medication Guide before you start taking NuLYTELY. 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 NuLYTELY?
NuLYTELY 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
NuLYTELY 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 NuLYTELY:
•
vomiting that prevents you from keeping down the solution
•
dizziness
•
urinating less often than normal
•
headache
See Section “ What are the possible side effects of NuLYTELY” for
more information about side effects.
What is NuLYTELY?
NuLYTELY is a prescription medicine used by adults to clean the colon
before a colonoscopy.
NuLYTELY 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.
NuLYTELY is safe and effective for use in pediatric patients aged 6
months and older.
Who should not take NuLYTELY?
Do not take NuLYTELY if your heathcare 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)
•
problems with food and fluid emptying from your stomach (gastric

Produktets egenskaber

NULYTELY WITH FLAVOR PACKS- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE,
SODIUM
BICARBONATE AND POTASSIUM CHLORIDE
BRAINTREE LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NULYTELY SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NULYTELY.
NULYTELY (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM
BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL
SOLUTION)
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions ( 5) 9/2013
INDICATIONS AND USAGE
NuLYTELY is a combination of PEG 3350, an osmotic laxative, and
electrolytes indicated for cleansing of the colon in
preparation for colonoscopy in adults and pediatric patients aged 6
months or greater ( 1)
DOSAGE AND ADMINISTRATION
NuLYTELY, supplied as a powder, must be reconstituted with water
before its use ( 2.1, 5.8)
On day prior to colonoscopy, instruct patients to:
Eat a light breakfast or have clear liquids (avoid red and purple
liquids) ( 2.2).
If adding a NuLYTELY flavor pack, pour the contents of flavor powder
(i.e., cherry, lemon-lime, orange or
pineapple) into container prior to reconstitution ( 2.2).
Early in the evening prior to colonoscopy, fill container containing
NuLYTELY powder with lukewarm water to 4 liter
fill line ( 2.2).
After capping container, shake vigorously several times ( 2.2).
Instruct patients to consume water or clear liquids during and after
bowel preparation up until 2 hours before time of
colonoscopy ( 2.3).
ADULTS: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4
liters are consumed or rectal effluent is clear. For
nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3)
PEDIATRIC PATIENTS (AGED 6 MONTHS OR GREATER): Drink 25 mL/kg/hour
orally or administer by NGT. Continue
drinking until watery stool is clear and free of solid matter ( 2.3).
DOSAGE FORMS AND STRENGTHS
For oral solution: polyethylene glycol 3350 420 grams, sodium
bicarbonate 5.72 grams, sodium chloride 11.2 grams,
potassium chloride 1.48 g