CLENPIQ- sodium picosulfate, magnesium oxide, and anhydrous citric acid liquid

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:

ASM Aerosol-Service AG

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults. CLENPIQ 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 (5.3)] - 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 CLENPIQ Risk Summary There are no data with CLENPIQ use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based on body surface area during organogenesis. The estimated background risk of major

Product summary:

How Supplied CLENPIQ is supplied in a carton containing two bottles, each holding 160 mL of cranberry-flavored, colorless to slightly yellow, clear oral solution, along with an eight-ounce cup for measuring fluids for hydration. Each bottle contains 10 mg sodium picosulfate, 3.5 g magnesium oxide, and 12 g anhydrous citric acid. CLENPIQ Cranberry flavor: NDC# 55566-6700-1. Storage Store CLENPIQ at 25°C (77°F). Excursions permitted at 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate or freeze.

Authorization status:

New Drug Application

Patient Information leaflet

ASM Aerosol-Service AG
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued: DATE
MEDICATION GUIDE
CLENPIQ™ (CLEN-pik)
(sodium picosulfate, magnesium oxide, and anhydrous citric acid)
oral solution
Read and understand these Medication Guide instructions at least 2
days before your colonoscopy and
again before you start taking CLENPIQ.
What is the most important information I should know about CLENPIQ?
CLENPIQ 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
CLENPIQ 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 CLENPIQ:
•
vomiting
•
urinating less often than normal
•
dizziness
•
headache
See "What are the possible side effects of CLENPIQ?" for more
information about side effects.
What is CLENPIQ?
CLENPIQ is a prescription medicine used by adults to clean the colon
before a colonoscopy. CLENPIQ
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 CLENPIQ is safe and effective in children.
Do not take CLENPIQ 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 dilated intestine (toxic megacolon).
•
problems with the emptying of food and fluid from your stomach
(gastric retention).
•
an

Summary of Product characteristics

CLENPIQ- SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC
ACID LIQUID
ASM AEROSOL-SERVICE AG
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLENPIQ™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CLENPIQ.
CLENPIQ™ (SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC
ACID) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
CLENPIQ™ 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. (1)
DOSAGE AND ADMINISTRATION
Administration:
CLENPIQ is ready to drink. It does not need to be diluted prior to
administration. One bottle of CLENPIQ is equivalent
to one dose. (2.1)
Two doses of CLENPIQ 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 CLENPIQ 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 CLENPIQ. (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
Second dose: administer the next day, during the morning prior to the
colonoscopy.
Day-Before Dosage Regimen (Alternative Method), if Split-Dosing is
inappropriate (2.3)
First dose: administer during afternoon or early evening before the
colonoscopy.
Second dose: administer 6 hours later during evening before
colonoscopy.
DOSAGE FORMS