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

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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)

Saadav alates:

Ferring Pharmaceuticals Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. 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 [see Adverse Reactions (6.2)]. 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

Toote kokkuvõte:

How Supplied CLENPIQ is supplied in a carton containing two bottles, each holding 175 mL of cranberry-flavored, colorless to slightly yellow, clear oral solution with possible presence of visible particles. Each bottle contains 10 mg sodium picosulfate, 3.5 g magnesium oxide, and 12 g anhydrous citric acid. An eight-ounce cup for measuring liquids for hydration is also supplied. CLENPIQ Cranberry flavor: NDC# 55566-6800-1. 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.

Volitamisolek:

New Drug Application

Infovoldik

Ferring Pharmaceuticals Inc.
----------
MEDICATION GUIDE
CLENPIQ® (CLEN-PIK)
(SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID)
ORAL SOLUTION
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 08/2023
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.
•
fainting.
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 and children 9 years
of age and older 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 under 9
years of age.
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).
MEDICATION GUIDE
CLENPIQ® (CLEN-PIK)
(SODIUM PICOSULFATE, MA

Toote omadused

CLENPIQ- SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC
ACID LIQUID
FERRING PHARMACEUTICALS INC.
----------
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
RECENT MAJOR CHANGES
Dosage and Administration,
Important Administration Instructions (2.1)
8/2023
Split-Dose Dosage Regimen (2.2)
8/2023
Warnings and Precautions,
Serious Fluid and Electrolyte Abnormalities (5.1)
8/2023
Syncope (5.5)
8/2023
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 and pediatric
patients ages 9 years and older. (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 as a Split-Dose
regimen. (2.1)
Consume five or more 8-ounce cups of clear liquids after the first
dose and four or more 8-ounce cups
of clear liquids after the second dose. (2.2)
Consume a variety of clear liquids after each dose of CLENPIQ. Ensure
inclusion of balanced electrolyte
solution along with other clear liquids. (2.1, 5.1, 5.5)
Administer oral medications at least 1 hour before starting CLENPIQ.
(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)
Split-Dose Dosage Regimen