SUFLAVE polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution Kit, 1 kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Suflave is a bowel prep — a solution you drink before a colonoscopy to completely clear out your colon. It's not treating a disease; it just cleans out your bowel so your doctor ca...
- What exactly is Suflave and why did my doctor prescribe it?
- It's a two-dose process over two days. The evening before your colonoscopy, you mix one bottle with the flavor packet and water, then drink 8 ounces every 15 minutes until the bott...
- How do I actually take this? The instructions seem complicated.
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $61.646 | $61.65 / 1 kit |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $62.01 | $62.01 / 1 kit |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Suflave 52268-0550-01 | Braintree | 1 kit | $61.646 | — | Availability likely | — |
| Suflavethis 24338-0550-01 | Azurity | 1 kit | $61.646 | — | Availability likely | — |
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⏳ 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 12433914 ↗ | Method of use | U-4143 | Jun 14, 2044 |
| US 12239659 ↗ | Method of use | U-4143 | Jun 14, 2044 |
| US 12290529 ↗ | Drug product | — | Aug 2, 2044 |
| US 12594298 ↗ | Drug product | — | Jun 14, 2044 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Jun 15, 2026 |
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 24338-0550-01 You're viewing this | 1 KIT in 1 KIT (24338-550-01) | 2026-04-01 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SUFLAVE is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUFLAVE is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.1 ) Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet. Each bottle must be reconstituted with water before ingestion.
An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration ( 2.2 ) The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE: o Day 1, Dose 1: Evening before Colonoscopy: 1 bottle with flavor enhancing packet o Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): 1 bottle with flavor enhancing packet For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information.
( 2.1 , 2.2 )
2.1Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with SUFLAVE [see Warnings and Precautions ( 5.1 )] Two doses of SUFLAVE are required for a complete preparation for colonoscopy. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet. Reconstitute each bottle with water before ingestion.
Do not reconstitute SUFLAVE with liquids other than water and/or add starch-based thickeners to the mixing bottle [see Warnings and Precautions ( 5.7 )] . Must consume an additional 16 ounces of water after each dose of SUFLAVE. Consume a low residue breakfast on the day before colonoscopy.
After breakfast, only consume clear liquids up to 2 hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol.
Do not take other laxatives while taking SUFLAVE [see Drug Interactions ( 7.3 )]. Do not take oral medications within 1 hour of starting each dose of SUFLAVE [see Drug Interactions ( 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 each dose of SUFLAVE [see Drug Interactions ( 7.2 )] .
Stop consumption of all fluids at least 2 hours prior to the colonoscopy. If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish.
2.2Split-Dose (2-Day) Recommended Dosage The recommended Split-Dose (two-day) regimen consists of two doses of SUFLAVE: Day 1, Dose 1: Evening before Colonoscopy : 1 bottle with flavor enhancing packet Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1) : 1 bottle with flavor enhancing packet
2.3Preparation and Administration Instructions The Day Prior to Colonoscopy: A low residue breakfast may be consumed. Examples of low residue foods are white bread, biscuits, muffins (no wheat), cornflakes, eggs, cream of wheat, grits, yogurt, cottage cheese, coffee, tea, juice without pulp, fruit (no skin or seeds). After breakfast, only consume clear liquids until after the colonoscopy.
Examples of clear liquids are water, fruit juice (without pulp), lemonade, plain coffee, tea (no cream or non-dairy creamer), chicken broth, gelatin dessert (no fruit or topping). No red or purple liquids, no milk or alcoholic beverages. Day 1, Dose 1 - Early in the Evening Prior to Colonoscopy: Open 1 flavor enhancing packet and pour the contents into 1 bottle.
Fill the provided bottle with lukewarm water up to the fill line. After capping the bottle, gently shake the bottle until all powder has dissolved. For best taste, refrigerate the solution for an hour before drinking.
Do not freeze. Use within 24 hours. Drink 8 ounces of solution every 15 minutes until the bottle is empty.
Drink an additional 16 ounces of water during the…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SUFLAVE is supplied as a white powder for reconstitution and is available in a carton that contains two bottles and two flavor enhancing packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. The bottle contains lemon-lime flavoring.
When diluted as directed, the solution is slightly hazy to hazy. For Oral Solution: Two bottles and two flavor enhancing packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride.
The bottle also contains lemon-lime flavoring. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS SUFLAVE is contraindicated in the following conditions: 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 ingredient in SUFLAVE [see Warnings and Precautions ( 5.8 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient in SUFLAVE ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.
( 5.3 , 7.1 ) Colonic mucosal ulcerations : Consider potential for ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration.
( 4 , 5.6 ) Patients at risk for aspiration : Observe during administration ( 5.7 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur ( 5.8 )
5.1Serious Fluid and Electrolyte Abnormalities Advise all patients to hydrate adequately before, during, and after the use of SUFLAVE. If a patient develops significant vomiting or signs of dehydration after taking SUFLAVE, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Bowel preparation products can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see Adverse Reactions ( 6.2 )] .
Correct fluid and electrolyte abnormalities before treatment with SUFLAVE. Use SUFLAVE with caution in patients with conditions, or who are using medications [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)], that increase the risk for fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and renal impairment [see Drug Interactions ( 7.1 )] .
5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing SUFLAVE for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT interval, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy).
Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
5.3Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with 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 SUFLAVE for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )] .
5.4Use in Patients with Risk of Renal Injury Use SUFLAVE with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequat…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (>2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies 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. The safety of SUFLAVE was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 929 adult patients undergoing colonoscopy. The active comparators were polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution in Study 1 and sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in Study 2 [see Clinical Studies (14)].
Table 1 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 1. Table 1: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 1 b SUFLAVE (%) N=233 Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution (%) N= 243 Nausea 13 9 Abdominal distension 6 3 Vomiting 6 3 Abdominal pain c 3 4 Headache 3 2 a Reported in at least 2% of patients in either treatment group. b Study 1 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. c Abdominal pain is composed of several similar terms.
Table 2 shows the most common adverse reactions reported in at least 2% of patients in either treatment group in Study 2. Table 2: Common Adverse Reactions a by Treatment Group in Adult Patients Undergoing Colonoscopy in Study 2 b SUFLAVE (%) N=227 Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (%) N=226 Nausea 7 6 Vomiting 4 7 Headache 2 2 Abdominal pain c 3 1 Abdominal distension 1 1 a Reported in at least 2% of patients in any treatment group. b Study 2 was not designed to support comparative claims for SUFLAVE for the adverse reactions reported in this table. c Abdominal pain is composed of several similar items.
Laboratory Changes Electrolyte Abnormalities In patients with normal baseline values, the most common electrolyte abnormality following study drug, on the day of colonoscopy, was increased magnesium (Study 1: 11% in SUFLAVE-treated patients and 2% in patients treated with active comparator; Study 2: 12% in SUFLAVE-treated patients and 11% in patients treated with active comparator). These changes were transient and resolved without intervention. Renal Function Parameters In patients with normal baseline values, at 48 to 72 hours after bowel preparation, an increase in serum creatinine of > 0.3 mg/dL and/or a decrease in eGFR of > 25% were reported in 2% of SUFLAVE-treated patients and 0 patients treated with active comparator in Study 1 and 1% of SUFLAVE-treated patients and 3% of patients treated with active comparator in Study 2.
These changes were transient and resolved.
6.2 Postmarketing Experience The following adverse reactions…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 )
7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing SUFLAVE to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of seizure, arrhythmias, and prolonged QT interval in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )].
7.2Potential for Reduced Drug Absorption SUFLAVE can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] : Administer oral medications at least one hour before starting each dose of SUFLAVE. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUFLAVE to avoid chelation with magnesium.
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and SUFLAVE may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUFLAVE [see Warnings and Precautions ( 5.5 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on the use of SUFLAVE during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (SUFLAVE). 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.
8.2Lactation Risk Summary There are no available data on the presence of SUFLAVE in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUFLAVE and any potential adverse effects on the breastfed child from SUFLAVE or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of SUFLAVE in pediatric patients have not been established.
8.5Geriatric Use Of the 460 patients who received SUFLAVE in clinical trials, 125 (27%) were 65 years of age or older. No differences in effectiveness of SUFLAVE were observed between geriatric patients and younger adult patients. Among geriatric patients, decreases in blood pressure on the day of colonoscopy were reported more frequently with SUFLAVE than with the active comparator in Study 1 (6% in SUFLAVE-treated patients and 1% in patients treated with active comparator) in Study 2 (3% in SUFLAVE-treated patients and 0% treated with active comparator) [see Clinical Studies ( 14 )] .
Geriatric 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 )] . Advise geriatric patients to hydrate adequately before, during, and after the use of SUFLAVE.
8.6Renal Impairment Use SUFLAVE with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of SUFLAVE, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warning and Precautions ( 5.4 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of more than the recommended dose of SUFLAVE 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 , 5.2 , 5.3 )] . Monitor for fluid and electrolyte disturbances and treat symptomatically.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The primary mode of action is the osmotic effects of polyethylene glycol 3350, sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.
12.3Pharmacokinetics After administration of the first dose of SUFLAVE in 18 healthy subjects, the mean ± SD maximum plasma concentration (C max ) for polyethylene glycol 3350 of 3.4 ± 1.4 mcg/mL was reached at 4 hours, and the mean ± SD serum C max for sulfate of 27.0 ± 11.4 mcg/mL was reached at 6 hours. Following a second dose of SUFLAVE (approximately 12 hours later), the mean ± SD plasma C max for polyethylene glycol 3350 of 2.9 ± 0.97 mcg/mL was reached at 4 hours, and the mean ± SD serum C max for sulfate of 29.2 ± 11.0 mcg/mL was reached at 3 hours.
Sulfate concentrations were below the limit of quantitation (19.2 mcg/mL) for all subjects by follow-up Day 3. Polyethylene glycol 3350 concentrations were below the limit of quantitation (LOQ 0.01 mcg/mL) for 16 of 18 subjects by follow-up Day 7.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is supplied as a white powder for reconstitution and is lemon-lime flavored. Each carton of SUFLAVE (NDC 24338-550-01) contains: Two bottles, each bottle (NDC 24338-551-01), closed with child resistant closure, contains a white powder of 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride for reconstitution.
The bottle contains lemon-lime flavor. Two flavor enhancing packets (NDC 24338-552-01). Storage Store SUFLAVE at room temperature between 20ºC to 25°C (68ºF to 77°F), excursions permitted from 15ºC to 30°C (59ºF to 86°F).
See USP controlled room temperature.
📋 Description ▾
11 DESCRIPTION SUFLAVE (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative and is provided in two bottles and two flavor enhancing packets for oral solution. The active ingredients contained in SUFLAVE are provided in Table 3. Table 3: Active Ingredients in SUFLAVE Chemical Name Chemical Formula Average Molecular Weight (g/mol) Chemical Structure Polyethylene Glycol 3350, USP 3350 Sodium Sulfate, USP Na 2 SO 4 142.04 Magnesium Sulfate, USP MgSO 4 120.37 Potassium Chloride, USP KCl
74.55 Sodium Chloride, USP NaCl
58.44Na + Cl - Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride, plus the following excipients: advantame, lemon-lime flavor, and neotame. Each flavor enhancing packet contains anhydrous citric acid, colloidal silicon dioxide, malic acid, and sucralose. Each dose of reconstituted oral solution is one liter of slightly hazy to hazy liquid that contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride and the following excipients: advantame, anhydrous citric acid, colloidal silicon dioxide, lemon-lime flavor, malic acid, neotame, and sucralose. peg3350 peg3350 sod sulfate mg sulfate pot chlo
💬 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: Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Must reconstitute each bottle with water before ingestion.
Must consume an additional 16 ounces of water after each dose of SUFLAVE. To hydrate adequately with clear liquids before, during, and after the use of SUFLAVE to prevent dehydration [see Warnings and Precautions (5.1)] . Examples of clear liquids can be found in the Instructions for Use .
If nausea, bloating, or abdominal cramping occurs, pause or slow the rate of drinking the solution and additional water until symptoms diminish. Do not take other laxatives while taking SUFLAVE. Do not drink milk or eat or drink anything colored red or purple.
Do not drink alcohol. Do not take oral medications within one hour of starting each dose of SUFLAVE [see Drug Interactions ( 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 each dose of SUFLAVE [see Drug Interactions ( 7.2 )] .
Complete all SUFLAVE and required water at least two hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking SUFLAVE or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Seek immediate medical care if signs and symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.8 )] .
Manufactured for: Azurity Pharmaceuticals, Inc. Woburn, MA 01801 Please see www.azurity.com for patent information. © Azurity Pharmaceuticals, Inc.
💬 Medication Guide ▾
Medication Guide SUFLAVE ® (Soo-FLAVE) (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) Read and understand this Medication Guide and the Instructions for Use at least 2 days before your colonoscopy and again before you start taking SUFLAVE. What is the most important information I should know about SUFLAVE? SUFLAVE 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 body salts with SUFLAVE is higher if you: have heart problems. have kidney problems. take water pills (diuretics), high blood pressure medicine, 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 SUFLAVE: vomiting • urinating less often than normal dizziness • headache See “What are the possible side effects of SUFLAVE?” for more information about side effects. What is SUFLAVE? SUFLAVE is a prescription medicine used by adults to clean the colon before a colonoscopy.
SUFLAVE cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if SUFLAVE is safe and effective in children.
Do not take SUFLAVE if your healthcare provider has told you that you have : a blockage in your bowel (obstruction) or a problem with food moving too slowly through your intestines (ileus). an opening in the wall of your stomach or intestine (bowel perforation). a very dilated intestine (toxic colitis or toxic megacolon). problems with food and fluid emptying from your stomach (gastric retention). an allergy to any ingredient in SUFLAVE. See the end of this Medication Guide for a complete list of the ingredients in SUFLAVE.
Before taking SUFLAVE, 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 heart problems. have stomach or bowel problems including ulcerative colitis. have problems with swallowing, gastric reflux, or if you inhale food or fluid into your lungs when eating or drinking (aspirate). have a history of seizures. are withdrawing from drinking alcohol or from taking benzodiazepines. have a low blood salt (sodium) level. have kidney problems. are pregnant.
It is not known if SUFLAVE will harm your unborn baby. Talk to your healthcare provider if you are pregnant. are breastfeeding or plan to breastfeed. It is not known if SUFLAVE passes into your breast milk.
You and your healthcare provider should decide if you will take SUFLAVE while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SUFLAVE may affect how other medicines work.
Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of SUFLAVE. Especially tell your healthcare provider if you take: medicines to treat a blood salt (electrolyte) imbalance. medicines for blood pressure or heart problems. medicines for kidney problems. medicines for seizures. water pills (diuretics). non-steroidal anti-inflammatory drugs (NSAIDs). medicines for depression or other mental health problems. laxatives. Do not take other laxatives while taking SUFLAVE. starch-based thickeners.
For patients who have trouble swallowing, do not mix SUFLAVE with starch-based thickeners. The following medicines should be taken at least 2 hours before starting each dose of SUFLAVE and not less than 6 ho…