CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID 10 mg/175mL; 3.5 g/175mL; 12 g/175mL Liquid — NDC 55566-6800-1 (Billing 55566-6800-01)
This is a package of CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID 10 mg/175mL; 3.5 g/175mL; 12 g/175mL Liquid from Ferring Pharmaceuticals Inc., marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.5179 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 55566-6800-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 55566 labeler · 6800 product · 1 package
- Package marketed since
- Mar 29, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5556668001 3
- Medicaid fills, this package
- 12,916 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 1, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 084411
- GCN: 53714
- GPI-14 (Medi-Span): 46992003452030
- HICL (First Databank): 024291
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 2626364
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Contact laxatives class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It works two ways to flush out your colon. One ingredient stimulates your colon to contract and move things along, while another draws water into your gut to make everything softer...
- What exactly does this prep do to my body?
- Quite a lot, and it really matters. After each dose of Clenpiq, you need to drink at least five 8-ounce cups of clear liquids after the first bottle and at least four cups after th...
- How much should I be drinking during the prep?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.518 | $181.27 / 350 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.5222 | $182.77 / 350 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.5457 | $191.00 / 350 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 55566-6800-01 You're viewing this Main listing | 2 BOTTLE in 1 CARTON / 175 mL in 1 BOTTLE | $0.5179 / mL | $181.25 | 2023-03-29 | — | Active |
| 55566-6800-02 55566-6800-2 | 2 BOTTLE in 1 CARTON / 175 mL in 1 BOTTLE Sample | — | — | 2023-03-30 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID 10 mg/175mL; 3.5 g/175mL; 12 g/175mL Liquid?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clenpiq 10 mg/175mL; 3.5 g/175mL; 12 g/175mLthis 55566-6800-01 | Ferring | 2 bottles | $0.518 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9827231 ↗ | Method of use | U-2162 | Jun 26, 2034 |
| US 11191753 ↗ | Method of use | U-3261 | Jun 23, 2034 |
| US 12576072 ↗ | Method of use | U-3261 | Jun 23, 2034 |
| US 10624879 ↗ | Drug product | — | Jun 23, 2034 |
| US 12458634 ↗ | Drug product | — | Jan 27, 2038 |
Is there a generic version of CLENPIQ 175 ML SOLUTION?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Ferring Pharmaceuticals Inc. labeler code 55566
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- Cervidil Dinoprostone 10 mg/241mg Insert NDC 55566-2800-1
- Stimate desmopressin acetate 1.5 mg/mL Spray NDC 55566-3000-0
- ENDOMETRIN Progesterone 100 mg Insert NDC 55566-6500-3
- Menopur menotropins Kit NDC 55566-7501-2
- FIRMAGON Degarelix Kit NDC 55566-8303-1
- FIRMAGON Degarelix Kit NDC 55566-8403-1
- Rebyota Donor Human Stool 50000000000 [CFU]/150mL Suspension NDC 55566-9800-2
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 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 ▾
2 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 ( 2.2 ) First dose: administer during evening before the colonoscopy Second dose: administer the next day, during the morning prior to the colonoscopy.
2.1Important Administration Instructions Correct fluid and electrolyte abnormalities before administration of CLENPIQ [see Warnings and Precautions (5.1) ] . CLENPIQ is ready to drink. It is a clear solution with possible presence of visible particles and it does not need to be diluted prior to administration.
One bottle of CLENPIQ is equivalent to one dose. Two doses of CLENPIQ are required for a complete preparation for colonoscopy as a Split-Dose regimen. The Split-Dose method consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy [see Dosage and Administration (2.2) ] .
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 [see Dosage and Administration (2.2) ] . Consume a variety of clear liquids. Clear liquids should include balanced electrolyte solution [see Warnings and Precautions (5.1 , 5.5) ] .
Additional clear liquids, other than water, include black coffee or tea, plain jello, clear broth or bouillon, clear juices without pulp, ginger ale and other sodas, and frozen juice bars. Do not drink anything colored red or purple. Consume only clear liquids (no solid food) on the day before colonoscopy and until after the colonoscopy.
Do not eat solid food or dairy and do not drink anything colored red or purple. Do not drink alcohol. Stop consumption of all liquids at least 2 hours before the colonoscopy.
Do not take other laxatives while taking CLENPIQ. Administer oral medications at least one hour before starting each dose of CLENPIQ. 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.
2.2Split-Dose Dosage Regimen The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses in conjunction with liquids, as follows: Dose 1 – On the day before colonoscopy: Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Take the first dose (1 bottle) of CLENPIQ during the evening before the colonoscopy (e.g., 5:00 PM to 9:00 PM).
Consume at least five 8-ounce cups (cup provided) of clear liquids after the CLENPIQ dose over the next 5 hours. If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve. Dose 2 – Next morning on the day of colonoscopy (start approximately 5 hours prior to colonoscopy): Continue… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral solution: Each bottle contains 10 mg of sodium picosulfate, 3.5 grams of magnesium oxide, and 12 grams of anhydrous citric acid in 175 mL of colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ oral solution : Each bottle contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide, and 12 g of anhydrous citric acid in 175 mL of solution ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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) ].
Severe renal impairment (creatinine clearance less than 30 mL/minute) ( 4 , 5.3 , 8.6 ) Gastrointestinal (GI) obstruction or ileus ( 4 ) Bowel perforation ( 4 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any of the ingredients in CLENPIQ ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmia, seizures, and renal impairment : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1 , 5.2 , 5.3 , 5.4 , 7.1 ) Use in patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration, and consider testing. ( 4 , 5.3 , 7.1 ) Syncope : Resulted in serious outcomes including falls, head injuries, and fractures; encourage adequate hydration.
( 5.5 ) Mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.6 ) Suspected GI obstruction or perforation : Rule out diagnosis before administration. ( 4 , 5.7 ) Patients at risk for aspiration : Observe during administration.
( 5.8 )
5.1Serious Fluid and Electrolyte Abnormalities Advise patients to hydrate adequately before, during, and after the use of CLENPIQ. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking CLENPIQ, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly.
Approximately 20% of patients in both arms (sodium picosulfate, magnesium oxide, and anhydrous citric acid, or 2 L of PEG + E plus two × 5-mg bisacodyl tablets) of clinical trials of another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product had orthostatic changes in blood pressure and/or heart rate on the day of colonoscopy and up to seven days post colonoscopy. In a single study of patients 9 to 16 years of age, approximately 20% of patients who received another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid had orthostatic changes (changes in blood pressure and/or heart rate) compared with approximately 7% of those who received the comparator (PEG) [see Clinical Studies (14) ] .
These changes occurred up to five days post colonoscopy. Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias, seizures, renal impairment, and syncope [see Warnings and Precautions (5.5) ] . Correct fluid and electrolyte abnormalities before treatment with CLENPIQ.
Advise patients to consume a variety of clear liquids (e.g., balanced electrolyte solution), and not only water after each dose of CLENPIQ. In addition, use caution when prescribing CLENPIQ for patients who have conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or that may increase the risk of seizure, arrhythmia, and renal impairment [see Drug Interactions (7.1) ] .
5.2Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing CLENPIQ for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, patients with known or suspected hyponatremia [see Adverse Reactions (6.2) ] .
5.3Use in Patients with Renal Impairment CLENPIQ is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), accumulation of magnesium in plasma may occur. Use caution when prescribing CLENPIQ for patients with mild to moderate renal impairment or patients taking concomitant medications that may affect r… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Use in Patients with Renal Impairment [see Warnings and Precautions (5.3) ] Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Syncope [see Warnings and Precautions (5.5) ] Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions (5.6) ] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.7) ] Aspiration [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Adults (≥2%): nausea, headache, hypermagnesemia, abdominal pain and dehydration or dizziness.
( 6.1 ) Pediatrics 9 to 16 years (>5%): nausea, vomiting, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Adults Clinical Study of CLENPIQ - Study 1 Table 1 displays the most common adverse reactions in a randomized, multicenter, assessor-blinded, non-inferiority trial of CLENPIQ for colon cleansing in adults (Study 1). CLENPIQ was compared to another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product, both administered according to the Split-Dose dosage regimen [see Clinical Studies (14) ] .
Table 1: Common Adverse Reactions Observed in at Least 2% of Patients Undergoing Colon Cleansing in Study 1 Adverse Reaction Split-Dose Regimen CLENPIQ (N=448) % Sodium picosulfate, magnesium oxide, and anhydrous citric acid Powder for reconstitution (N=453) % Nausea 3 3 Headache 3 3 Hypermagnesemia Magnesium levels returned to normal within one week after colonoscopy in all patients in the CLENPIQ group. 2 5 Abdominal pain Abdominal pain included reports of abdominal pain, abdominal pain upper, and abdominal pain lower.
2 2 Dehydration or dizziness 2 2 Clinical Study of Another Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Product - Study 2 In a randomized, multicenter, investigator-blinded, active-controlled clinical trial for colon cleansing in adults, another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product was compared with a regimen of two liters (2 L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets (Study 2). In this study the protocol specified that abdominal bloating, distention, pain/cramping, and watery diarrhea, which are known to occur in response to bowel preparation, were documented as adverse events only if they required medical intervention (such as a change in study drug or led to discontinuation, therapeutic or diagnostic procedures, met the criteria for serious adverse event) or showed clinically significant worsening during the study that was not in the frame of the usual clinical course, as determined by the investigator.
The most common adverse reactions in Study 2 are shown in Table 2. Table 2: Common Adverse Reactions abdominal bloating, distention, pain/cramping, and watery diarrhea not requiring an intervention were not collected Observed in at Least 1% of Patients Undergoing Colon Cleansing in Study 2 Adverse Reaction Split-Dose Regimen Sodium picosulfate, magnesium oxide, and anhydrous citric acid (N=305) % 2 L PEG + E 2 L PEG + E = two liters polyethylene glycol plus electrolytes solution with 2 × 5-mg bisacodyl tablets (N=298) % Nausea 3 4 Headache 2 2 Vomiting 1 3 Electrolyte Abnormalities In Study 1, rates of abnormal electrolyte shifts were generally sim… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. ( 7.1 )
7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing CLENPIQ for patients with conditions or who are taking other drugs, that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, syncope, arrhythmias or QT prolongation in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 , 5.5) ] .
7.2Potential for Reduced Drug Absorption CLENPIQ can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1) ] : Administer oral medications at least one hour before of the start of administration of CLENPIQ. Administer tetracycline and fluoroquinolone antibiotics [see Drug Interactions (7.3) ] , iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of CLENPIQ to avoid chelation with magnesium.
7.3Antibiotics Prior or concomitant use of antibiotics with CLENPIQ may reduce efficacy of CLENPIQ as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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 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. Data Animal Data Reproduction studies with sodium picosulfate, magnesium oxide, and anhydrous citric acid have been performed in pregnant rats following oral administration of up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis.
There was no evidence of harm to the fetus due to sodium picosulfate, magnesium oxide, and anhydrous citric acid. The reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses. A pre and postnatal development study with sodium picosulfate, magnesium oxide, and anhydrous citric acid in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area).
Published reproduction studies with sodium picosulfate in pregnant rats and rabbits during the period of organogenesis did not show evidence of harm to the fetus at doses up to 100 mg/kg (approximately 49 and 98 times, respectively, the recommended human dose of 10 mg sodium picosulfate based on body surface area).
8.2Lactation Risk Summary There are no data on the presence of magnesium oxide or anhydrous citric acid in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Published data on lactating women indicate that the active metabolite of sodium picosulfate, bis-( p -hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below the limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day. There are no data on the effects of sodium picosulfate on the breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CLENPIQ and any potential adverse effects on the breastfed infant from CLENPIQ or the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of CLENPIQ have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of CLENPIQ in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid [see Clinical Studies (14) ].
The safety profile in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1) ] . Monitor for possible hypoglycemia in pediatric patients, as CLENPIQ has no caloric substrate. The safety and effectiveness of CLENPIQ in pediatric patients less than 9 years of age have not been established.
8.5Geriatric Use Of the 448 adult patients in Study 1 who received CLENPIQ, 124 (28%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 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. Data Animal Data Reproduction studies with sodium picosulfate, magnesium oxide, and anhydrous citric acid have been performed in pregnant rats following oral administration of up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis.
There was no evidence of harm to the fetus due to sodium picosulfate, magnesium oxide, and anhydrous citric acid. The reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses. A pre and postnatal development study with sodium picosulfate, magnesium oxide, and anhydrous citric acid in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area).
Published reproduction studies with sodium picosulfate in pregnant rats and rabbits during the period of organogenesis did not show evidence of harm to the fetus at doses up to 100 mg/kg (approximately 49 and 98 times, respectively, the recommended human dose of 10 mg sodium picosulfate based on body surface area).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CLENPIQ have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of CLENPIQ in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid [see Clinical Studies (14) ].
The safety profile in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1) ] . Monitor for possible hypoglycemia in pediatric patients, as CLENPIQ has no caloric substrate. The safety and effectiveness of CLENPIQ in pediatric patients less than 9 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 448 adult patients in Study 1 who received CLENPIQ, 124 (28%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1) ].
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of more than the recommended dose of CLENPIQ may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see Warnings and Precautions (5.1) ] . Monitor for fluid and electrolyte disturbances and treat symptomatically.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.
12.2Pharmacodynamics The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional liquids, produces watery diarrhea.
12.3Pharmacokinetics Absorption After administration of the first dose of another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product in 16 healthy subjects, the mean ± SD maximum plasma concentration (C max ) for picosulfate of 2.3 ± 1.4 ng/mL was reached at 2 hours. After administration of two doses separated by 6 hours, the mean ± SD plasma C max for picosulfate of 3.2 ± 2.6 ng/mL was reached at approximately 7 hours after the first dose administration. In the same study, the uncorrected plasma magnesium concentration reached a C max of approximately 1.9 mEq/L at 10 hours after the first dose administration, which represents an approximately 20% increase from baseline.
In patients scheduled to have an elective colonoscopy who received the Split-Dose dosage regimen of CLENPIQ, the mean ± SD plasma concentration for picosulfate was 1.05 ± 0.83 ng/mL at 15 minutes pre-second dose, 2.98 ± 1.27 ng/mL at 1-2 hours post-second dose, and 1.81 ± 0.86 ng/mL at 3-6 hours post-second dose. Metabolism and Elimination Metabolism and Excretion Plasma concentrations of the free BHPM were below the lower limit of quantification (0.1 ng/mL) in 13 out of 16 subjects studied. The fraction of the sodium picosulfate dose excreted unchanged in urine was 0.1%.
In urine, the majority of excreted BHPM was in the glucuronide-conjugated form. The terminal half-life of sodium picosulfate was 7.4 hours. Use in Specific Populations Pediatric Patients Pharmacokinetics of picosulfate was studied in pediatric patients aged from 9 to 16 years old.
The half-life of picosulfate was 7 hours. The picosulfate reached the mean ± SD C max of 3.5 ± 2.1 ng/mL at approximately 6 to 7 hours. The baseline uncorrected mean serum magnesium concentration was 2.02 mEq/L at 10 hours after the first dose of sodium picosulfate, magnesium oxide, and anhydrous citric acid and ranged from 1.7 to 2.46 mEq/L.
Drug Interaction Studies In an in vitro study using human liver microsomes, sodium picosulfate did not inhibit the major CYP enzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5) evaluated. Based on an in vitro study using freshly isolated hepatocyte culture, sodium picosulfate is not an inducer of CYP1A2, CYP2B6, or CYP3A4/5.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
📦 Storage and Handling ▾
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.
📋 Description ▾
11 DESCRIPTION CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton. Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP.
The product also contains the following inactive ingredients: acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch. The following is a description of the three active ingredients contained in CLENPIQ: Sodium picosulfate is a stimulant laxative.
Sodium Picosulfate Chemical name: 4,4´-(2-pyridylmethylene) diphenyl bis(hydrogen sulfate) disodium salt, monohydrate Chemical formula: C 18 H 13 NNa 2 O 8 S 2 ∙H 2 O Molecular weight: 499.4 Structural formula: Sodium picosulfate Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative. Chemical Structure Magnesium Oxide Chemical name: Magnesium oxide Chemical formula: Mg O Molecular weight:
40.3Structural formula: Mg O Anhydrous Citric Acid Chemical name: 2-hydroxypropane-1,2,3-tricarboxylic acid Chemical formula: C 6 H 8 O 7 Molecular weight: 192.1 Structural formula: Anhydrous citric acid Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients: CLENPIQ is ready to drink. It is a clear solution with possible presence of visible particles and it does not need to be diluted prior to administration.
One bottle of CLENPIQ is equivalent to one dose. Two doses of CLENPIQ are required for a complete preparation for colonoscopy as a Split-Dose regimen. See Instructions for Use .
Follow the directions in the Instructions for Use , for the Split-Dose regimen, as prescribed. 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 [see Dosage and Administration (2.2) ] . Consume a variety of clear liquids after each dose of CLENPIQ.
Ensure inclusion of balanced electrolyte solution, along with other clear liquids [see Dosage and Administration (2.1) , Warnings and Precautions (5.1 , 5.5) ] . Consume only clear liquids (no solid food) on the day before colonoscopy and until after the colonoscopy. Do not eat solid food or dairy and do not drink anything colored red or purple.
Do not drink alcohol. Do not take other laxatives while taking CLENPIQ. Administer oral medications at least one hour before starting each dose of CLENPIQ.
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. Delay the second dose of CLENPIQ, if severe bloating, distention, or abdominal pain occurs following the first dose until the symptoms resolve. Tell their healthcare provider if they have a history of fainting [see Warnings and Precautions (5.5) ] .
Contact their healthcare provider if they develop significant vomiting or signs of dehydration during or after taking CLENPIQ or if they experience confusion, delirium, dizziness, lightheadedness, fainting, loss of consciousness, or seizures [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5) ] .
💬 Medication Guide ▾
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). a very dilated intestine (toxic megacolon). problems with the emptying of food and fluid from your stomach (gastric retention). an allergy to any of the ingredients in CLENPIQ. See the end of this leaflet for a complete list of ingredients in CLENPIQ. Before taking CLENPIQ, tell your healthcare provider about all of your medical conditions, including if you: have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). have a history of seizures or take medicines for seizures. history of fainting. are withdrawing from drinking alcohol or from taking benzodiazepines. have low blood salt (sodium) level. have kidney problems or take medicines for kidney problems. have heart problems. have stomach or bowel problems including ulcerative colitis. have problems with swallowing or gastric reflux. are pregnant.
It is not known if CLENPIQ will harm your unborn baby. Talk to your provider if you are pregnant. are breastfeeding or plan to breastfeed. It is not known if CLENPIQ passes into your breast milk.
You and your healthcare provider should decide if you will take CLENPIQ while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. CLENPIQ may affect how other medicines work.
Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of CLENPIQ. Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems. medicines for kidney problems. medicines for seizures. water pills (diuretics). nonsteroidal anti-inflammatory medicines (pain medicines). medicines for depression or mental health problems. laxatives. Do not take other laxatives while taking CLENPIQ.
The following medicines should be taken at least 2 hours before starting CLENPIQ and not less than 6 hours after taking CLENPIQ: tetracycline fluoroquinolone antibiotics iron digoxin (Lanoxin) chlorpromazine penicillamine (Cuprimine, Depen) Ask your healthcare provider or pharmacist for a list of these medic… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption After administration of the first dose of another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product in 16 healthy subjects, the mean ± SD maximum plasma concentration (C max ) for picosulfate of 2.3 ± 1.4 ng/mL was reached at 2 hours. After administration of two doses separated by 6 hours, the mean ± SD plasma C max for picosulfate of 3.2 ± 2.6 ng/mL was reached at approximately 7 hours after the first dose administration. In the same study, the uncorrected plasma magnesium concentration reached a C max of approximately 1.9 mEq/L at 10 hours after the first dose administration, which represents an approximately 20% increase from baseline.
In patients scheduled to have an elective colonoscopy who received the Split-Dose dosage regimen of CLENPIQ, the mean ± SD plasma concentration for picosulfate was 1.05 ± 0.83 ng/mL at 15 minutes pre-second dose, 2.98 ± 1.27 ng/mL at 1-2 hours post-second dose, and 1.81 ± 0.86 ng/mL at 3-6 hours post-second dose. Metabolism and Elimination Metabolism and Excretion Plasma concentrations of the free BHPM were below the lower limit of quantification (0.1 ng/mL) in 13 out of 16 subjects studied. The fraction of the sodium picosulfate dose excreted unchanged in urine was 0.1%.
In urine, the majority of excreted BHPM was in the glucuronide-conjugated form. The terminal half-life of sodium picosulfate was 7.4 hours. Use in Specific Populations Pediatric Patients Pharmacokinetics of picosulfate was studied in pediatric patients aged from 9 to 16 years old.
The half-life of picosulfate was 7 hours. The picosulfate reached the mean ± SD C max of 3.5 ± 2.1 ng/mL at approximately 6 to 7 hours. The baseline uncorrected mean serum magnesium concentration was 2.02 mEq/L at 10 hours after the first dose of sodium picosulfate, magnesium oxide, and anhydrous citric acid and ranged from 1.7 to 2.46 mEq/L.
Drug Interaction Studies In an in vitro study using human liver microsomes, sodium picosulfate did not inhibit the major CYP enzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5) evaluated. Based on an in vitro study using freshly isolated hepatocyte culture, sodium picosulfate is not an inducer of CYP1A2, CYP2B6, or CYP3A4/5.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional liquids, produces watery diarrhea.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Adults Clinical Study with CLENPIQ – Study 1 The colon-cleansing efficacy of CLENPIQ was evaluated in a randomized, investigator-blinded, active-controlled, multicenter non-inferiority trial in the US and Canada in adult patients scheduled to have an elective colonoscopy (NCT03017235). Patients were randomized to CLENPIQ or another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product. Both products were administered by the "Split-Dose" (evening before and day of) dosing, where the first dose was taken the evening before the colonoscopy (between 5:00 and 9:00 PM), followed by at least five (5) 8-ounce glasses of clear liquid, and the second dose was taken the morning of the colonoscopy (at least 5 hours prior to but no more than 9 hours prior to colonoscopy), followed by at least four (4) 8-ounce glasses of clear liquid.
Patients in both treatment groups were limited to a clear liquid diet on the day before the procedure (24 hours before). A total of 901 adult patients were included in the primary efficacy analysis. Patients ranged in age from 20 to 80 years (mean age 57 years); 56% were female and 44% male.
Self-identified race was approximately distributed as follows: 85% White, 10% Black, 2% Asian, and 3% other. Approximately 15% of patients self-identified their ethnicity as Hispanic or Latino. The primary efficacy endpoint was the proportion of patients with successful overall colon cleansing, as assessed by blinded colonoscopists using the Modified Aronchick Scale.
The Modified Aronchick Scale is a validated tool used to assess overall colon cleansing prior to suctioning or cleaning. Successful colon cleansing was defined as bowel preparations with >90% of the mucosa seen and mostly liquid stool that were graded excellent (minimal suctioning needed for adequate visualization) or good (significant suctioning needed for adequate visualization) by the colonoscopist. In the trial, CLENPIQ was non-inferior and also met the pre-specified criteria for superiority to the comparator for overall colon cleansing.
Efficacy results are provided in Table 4. Table 4: Proportion of Patients with Successful Colon Cleansing According to the Modified Aronchick Scale in Study 1 Using the Split-Dose Regimen CLENPIQ Sodium picosulfate, magnesium oxide, and anhydrous citric acid Powder for reconstitution Difference between treatment groups Difference and 95% CI are based on stratified difference in proportions, where the stratification weight is based on Cochran-Mantel-Haenszel weight. % (n/N) % (n/N) Difference 95% CI 87.7% (393/448) 81.5% (369/453) 6.3% (1.8%, 10.9%) Non-inferior and superior to sodium picosulfate, magnesium oxide, and anhydrous citric acid Clinical Study of Another Oral Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Product – Study 2 The colon cleansing efficacy of another oral sodium picosulfate, magnesium oxide, and anhydrous citric acid product was evaluated in a randomized, investigator-blinded, active-controlled, multicenter US non-inferiority trial in adult patients scheduled to have an elective colonoscopy (NCT01073930).
Patients were randomized to sodium picosulfate, magnesium oxide, and anhydrous citric acid group or polyethylene glycol plus electrolytes (PEG + E) and bisacodyl. Sodium picosulfate, magnesium oxide, and anhydrous citric acid was given by "Split-Dose" (evening before and day of) dosing, where the first dose was taken the evening before the colonoscopy (between 5:00 and 9:00 PM), followed by five (5) 8-ounce glasses of clear liquid, and the second dose was taken the morning of the colonoscopy (at least 5 hours prior to but no more than 9 hours prior to colonoscopy), followed by three (3) 8-ounce glasses of clear liquid.
The comparator was given as two liters of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, administered the day before the procedure. All patients in both treatment groups were limited to a… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with CLENPIQ. Sodium picosulfate was not mutagenic in the Ames test, the mouse lymphoma assay, and the mouse bone marrow micronucleus test. In an oral fertility study in rats, sodium picosulfate, magnesium oxide, and anhydrous citric acid did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with CLENPIQ. Sodium picosulfate was not mutagenic in the Ames test, the mouse lymphoma assay, and the mouse bone marrow micronucleus test. In an oral fertility study in rats, sodium picosulfate, magnesium oxide, and anhydrous citric acid did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area).
📖 Instructions for Use ▾
Instructions for Use CLENPIQ ® (CLEN-pik) (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution NOTE: Do not refrigerate or freeze CLENPIQ. CLENPIQ is ready to drink and does not need to be mixed with anything. CLENPIQ is a clear liquid that may have particles.
READ BEFORE Taking CLENPIQ If you have questions before you start CLENPIQ, talk to your healthcare provider. Take CLENPIQ using the Split-Dose method. This means you will take 2 separate doses.
Each bottle is 1 dose and has the same ingredients. You can drink either bottle first. Drink the first bottle the evening before your colonoscopy.
Drink the second bottle the morning of your colonoscopy. Start a clear-liquid diet the day before your colonoscopy. Do not eat any solid foods.
Drink a variety of clear liquids. Clear liquids should include balanced electrolyte solution such as sports drinks (see Table 1). Drink only clear liquids all day the day before your colonoscopy.
Drink only clear liquids the next day until 2 hours before your colonoscopy. Stop drinking all liquids at least 2 hours before your colonoscopy. You must drink enough clear liquids to keep hydrated.
Drink FIVE or more 8-ounce cups of clear liquids after the first dose. Drink FOUR or more 8-ounce cups of clear liquids after the second dose. IMPORTANT: You can drink the clear liquids in Table 1.
TABLE 1: List of liquids for the clear-liquid diet Water, plain or flavored. Do not drink only water. Black coffee or tea ( no milk, cream, soy, or nondairy creamer) Sports drinks ( not red or purple ) Plain jello ( not red or purple ) Clear broth or bouillon Clear juices without pulp (such as apple juice or white grape juice) Ginger ale and other sodas ( not red or purple ) Frozen juice bars ( not red or purple ) IMPORTANT: Do NOT eat or drink the items in Table 2 starting from the day before your colonoscopy.
TABLE 2: List of foods and drinks to avoid while you are on the clear-liquid diet no solid foods no alcohol no dairy or non-dairy types of milk or cream no soy milk or drinks no juices with pulp no red or purple drinks no red or purple jello no other liquids that you cannot see through SPLIT-DOSE INSTRUCTIONS DOSE 1 In the evening the day before your colonoscopy (sometime between 5:00 PM to 9:00 PM) Place the first bottle on a flat surface. Push down on the cap while twisting to the left (counterclockwise). Drink the entire first bottle of CLENPIQ.
Drink CLENPIQ right from the bottle. Use the cup provided to drink five or more 8-ounce (oz) cups of clear liquids over the next 5 hours. IMPORTANT: See Table 1 for a list of clear liquids you can drink.
If you have any bloating or upset stomach after drinking CLENPIQ, wait until your stomach feels better before taking your second dose. DOSE 2 In the morning of your colonoscopy (about 5 hours before your colonoscopy) Place the second bottle on a flat surface. Push down on the cap while twisting to the left (counterclockwise).
Drink the entire second bottle of CLENPIQ. Drink CLENPIQ right from the bottle. Use the cup provided to drink four or more 8 ounce (oz) cups of clear liquids.
You can continue to drink clear liquids up to 2 hours before the colonoscopy. Do not eat solid food. Drink only clear liquids.
Do not drink only plain water (see Table 1). IMPORTANT: See Table 1 for a list of clear liquids you can drink. Stop drinking clear liquids 2 hours before your colonoscopy, or as advised by your healthcare provider.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054, USA Revised 08/2023 2009010037 Figure Figure
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 175 mL Bottle Carton Cranberry Flavor NDC 55566-6800-1 CLENPIQ ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution 10 mg/3.5 g/12 g per 175 mL bottle CLENPIQ ® is a ready-to-drink oral solution that doesn't need to be diluted. Read the enclosed Instructions for Use and Medication Guide AT LEAST 2 DAYS BEFORE your colonoscopy and again right before taking CLENPIQ ® . Contains two (2) 175 mL bottles Do not refrigerate or freeze.
Rx only FERRING PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 175 mL Bottle Carton