PREPOPIK- sodium picosulfate, magnesium oxide, and anhydrous citric acid powder, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PICOSULFATE (UNII: LR57574HN8) (DEACETYLBISACODYL - UNII:R09078E41Y), MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Available from:

Ferring Pharmaceuticals Inc.

INN (International Name):

SODIUM PICOSULFATE

Composition:

SODIUM PICOSULFATE 10 mg in 16.1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prepopik® is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. Prepopik is contraindicated in the following conditions: - Patients with severe renal impairment (creatinine clearance less than 30 mL/minute) which may result in accumulation of magnesium [see Warnings and Precautions (5.4)] - Gastrointestinal obstruction or ileus [see Warnings and Precautions (5.6)] - Bowel perforation [see Warnings and Precautions (5.6)] - Toxic colitis or toxic megacolon - Gastric retention - Hypersensitivity to any of the ingredients in Prepopik [see Adverse Reactions (6.2)] Risk Summary There are no data with Prepopik use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1

Product summary:

How Supplied Prepopik is supplied in a carton containing 2 packets, each holding 16.1 grams of powder in orange flavor or 16.2 grams of powder in cranberry flavor for oral solution, along with a pre-marked dosing cup. Each packet for both flavors contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The excipients for both flavors include potassium hydrogen carbonate, sodium saccharin, orange or cranberry flavor. The orange flavor contains acacia gum, lactose, ascorbic acid, and butylated hydroxyanisole, and the cranberry flavor contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch. Storage Store at room temperature between 20 to 25°C (68 to 77°F). Excursions permitted between 15° and 30°C (59° and 86° F) [see USP Controlled room temperature]. Orange flavor: NDC# 55566-9300-2 Kit, 2 packets and cup Cranberry flavor: NDC# 55566-9700-1- Kit, 2 packets and cup

Authorization status:

New Drug Application

Patient Information leaflet

Ferring Pharmaceuticals Inc.
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This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: August 2018
MEDICATION GUIDE
PREPOPIK® (prep-ō-pik)
(sodium picosulfate, magnesium oxide, and anhydrous citric acid)
for oral solution
Read and understand this Medication Guide and the Instructions for Use
that come with PREPOPIK at least
2 days before your colonoscopy and again before you start taking
Prepopik.
What is the most important information I should know about Prepopik?
Prepopik 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:
•
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 blood salts with
Prepopik 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 Prepopik:
•
vomiting
•
urinating less often than normal
•
dizziness
•
headache
See "What are the possible side effects of Prepopik?" for more
information about side effects.
What is Prepopik?
Prepopik is a prescription medicine used by adults and children 9
years of age and older, to clean the colon
before a colonoscopy. Prepopik 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 Prepopik is safe and effective in children under 9
years of age.
Do not take Prepopik if your healthcare provider has told you that you
have:
•
serious kidney problems.
•
a blockage in your intestine (bowel obstruction).
•
an opening in the wall of your stomach or intestines (bowel
perforation).
•
a very dilat

Summary of Product characteristics

PREPOPIK- SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC
ACID POWDER, METERED
FERRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREPOPIK SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREPOPIK
.
PREPOPIK (SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID) FOR
ORAL SOLUTION
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1)
08/2018
Dosage and Administration (2.3, 2.4)
08/2018
Warnings and Precautions (5.1)
08/2018
INDICATIONS AND USAGE
Prepopik is a combination of sodium picosulfate, a stimulant laxative,
and magnesium oxide and anhydrous citric acid which
form magnesium citrate, an osmotic laxative, indicated for cleansing
of the colon as a preparation for colonoscopy in adults
and pediatric patients ages 9 years and older. (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration
Each packet of Prepopik must be dissolved with water prior to
ingestion and administered according to the dosing
regimen. Direct ingestion of the undissolved powder may increase the
risk of nausea, vomiting and dehydration. (2.2,
5.8)
Two doses (one packet per dose) of Prepopik are required for a
complete preparation for colonoscopy. The preferred
method is the "Split-Dose" method. The alternative is the "Day Before"
method. (2.1)
Additional fluids must be consumed after every dose of Prepopik in
both dosing regimens. (2.1, 5.1)
Do not take oral medications within 1 hour of start of each dose.
(2.1, 7.2)
If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin,
chlorpromazine, or penicillamine, take these
medications at least 2 hours before and not less than 6 hours after
administration of Prepopik. (2.1, 7.3)
For complete information on preparation before colonoscopy and
administration of the dosage regimen, see full
prescribing information. (2.1, 2.2, 2.3)
Split-Dose Dosage Regimen (Preferred Method) (2.2)
First dose: administer during evening before the colonoscopy