Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate

FDA Drug Information • Also known as: Moviprep, Plenvu

Brand Names: Moviprep, Plenvu
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION The active ingredients contained in PLENVU are provided in Table 3. Table 3: Details of Active Ingredients contained in PLENVU Chemical Name Chemical Formula Average Molecular Weight (g/mol) Chemical Structure Polyethylene Glycol (PEG) 3350 H-(OCH 2 -CH 2 ) n -OH 3350 Table 3: Details of Active Ingredients contained in PLENVU Sodium Ascorbate C 6 H 7 NaO 6 198.1 Table 3: Details of Active Ingredients contained in PLENVU Sodium Sulfate Na 2 SO 4 142.0 Table 3: Details of Active Ingredients contained in PLENVU Ascorbic Acid C 6 H 8 O 6 176.1 Table 3: Details of Active Ingredients contained in PLENVU Sodium Chloride NaCl 58.4 Na + Cl - Potassium Chloride KCl 74.6 K + Cl + PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel...

What Is Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate Used For?

1 INDICATIONS AND USAGE PLENVU ® is indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Preparation and Administration:

Two doses of PLENVU are required for a complete preparation for colonoscopy, using a “Two-Day” or “One-Day” dosage regimen. ( 2.1 )

Reconstitute PLENVU in water prior to ingestion. ( 2.1 )

Consume additional clear liquids after each dose of PLENVU in both dosing regimens. ( 2.1 , 5.1 )

Administer oral medications at least 1 hour before starting each dose of PLENVU. ( 2.1 , 7.2 ) Recommended Dosage Regimens:

Two-Day Split Dosage : Dose 1 the evening before the colonoscopy (approximately 4 pm to 8 pm) and Dose 2 the next morning (approximately12 hours after the start of Dose 1). ( 2.1 , 2.2 )

One-Day Morning Dosage : Dose 1 the morning of the colonoscopy (approximately 3 am to 7 am) and Dose 2 a minimum of 2 hours after the start of Dose 1. ( 2.1 , 2.3 )

For complete information on dosing, preparation and administration, see full prescribing information. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Preparation and Administration Instructions

Correct fluid and electrolyte abnormalities before treatment with PLENVU [see Warnings and Precautions ( 5.1 )] .

Two doses of PLENVU are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure [see Dosage and Administration ( 2.2 , 2.3 )] .

The recommended “Two-Day Split Dosage” method consists of two separate doses: the first dose is taken the evening before the colonoscopy and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2 )].

The recommended “One-Day Morning Dosage” method consists of two separate doses: both doses are taken in the morning of the day of the colonoscopy, with a minimum of 2 hours between the start of the first dose and the start of the second dose [see Dosage and Administration ( 2.3 )].

Reconstitute each pouch of PLENVU in the mixing container with water prior to ingestion. It may take 2 to 3 minutes for complete dissolution. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )].

Consume additional clear liquids (including water) in both dosing regimens [see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )] .

Consume only clear liquids (no solid food) from the start of PLENVU treatment until after the colonoscopy.

Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.

Do not take other laxatives while taking PLENVU.

Administer oral medications at least 1 hour before starting each dose of PLENVU [see Drug Interactions ( 7.2 )].

Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy. 2.2 Recommended Two-Day Split Dosage Regimen The recommended Two-Day Split Dosage regimen commences in the evening of the day...

Side Effects (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 )]

Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )]

Seizures [see Warnings and Precautions ( 5.3 )]

Patients with Renal Impairment [see Warnings and Precautions ( 5.4 )]

Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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 )]

Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions ( 5.8 )]

Risks in Patients with Phenylketonuria [see Warnings and Precautions ( 5.9 )]

Hypersensitivity Reactions [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (>2%) are nausea, vomiting, dehydration and abdominal pain/discomfort. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PLENVU Two-Day Split Dosage and One-Day Morning Dosage regimens was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials (Two-Day Split Dosage in the NOCT and MORA trials and One-Day Morning Dosage in the MORA trial) in 1351 adult patients undergoing colonoscopy. The mean age of the study population was 56 years (range 18 to 86 years), 92% of patients were Caucasian and 51% were female. In the NOCT trial, 61% of patients had mild renal impairment. In the MORA trial, 67% had mild renal impairment and 5% had moderate renal impairment. Patients with severe renal impairment were not enrolled in the clinical trials of PLENVU [see Clinical Studies ( 14 )]. The most common adverse reactions (>2%) in the PLENVU treatment groups in both trials were: nausea, vomiting, dehydration and abdominal pain/discomfort. Table 1 and Table 2 display adverse reactions reported in at least 1% of patients in one or more treatment group(s) in the NOCT and MORA trials, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials. Table 1: Common Adverse Reactions* in Patients Undergoing Colonoscopy in the NOCT Trial by Treatment Group Preferred Term PLENVU Two-Day Split Dosage Regimen (N = 275) % Trisulfate Trisulfate: Two 6-ounce bottles of oral solution each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams Two-Day Split Dosage Regimen (N = 271) % Nausea 7 2 Vomiting 6 3 Dehydration Includes signs and symptoms of dehydration, including dizziness, dry mouth, orthostatic hypotension, pre-syncope, syncope, and thirst 4 2 Abdominal Pain/Discomfort Includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness 2 2 Decline in Glomerular Filtration Rate (GFR) Decreased or abnormal GFR 2 2 Electrolyte Abnormalities Includes increased anion gap, decreased blood bicarbonate, hypomagnesemia, hyperosmolarity, hypokalemia, hyperkalemia, hypercalcemia, hypernatremia, hyperosmolar state, hyperuricemia, hypocalcemia, and hypophosphatemia 2 1 Fatigue 2 1 Headache 2 1 Abdominal Distension 1 1 Gastritis 1 1 Hiatus Hernia 1 0 Nasopharyngitis 1 1 * Reported in at least 1% of patients in either treatment group N = Total number of patients in the treatment group Table 2: Common Adverse Reactions* in Patients Undergoing Colonoscopy in the MORA Trial by Treatment Group Preferred Term PLENVU One-Day Morning Dosage Regimen...

Drug Interactions

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. ( 7.1 ) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing PLENVU for patients with conditions and/or who are using medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )]. Consider additional patient evaluations as appropriate. 7.2 Potential for Reduced Drug Absorption PLENVU can reduce the absorption of other coadministered oral drugs . Administer oral medications at least 1 hour before starting each dose of PLENVU [see Dosage and Administration ( 2.1 )]. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and PLENVU may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PLENVU [see Warnings and Precautions ( 5.5 )] .

Contraindications

4 CONTRAINDICATIONS PLENVU is contraindicated in the following conditions:

Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )]

Bowel perforation [see Warnings and Precautions ( 5.6 )]

Gastric retention

Ileus

Toxic megacolon

Hypersensitivity to any ingredient in PLENVU [see Warnings and Precautions ( 5.10 )]

Gastrointestinal (GI) obstruction ( 4 , 5.6 )

Bowel perforation ( 4 , 5.6 )

Gastric retention ( 4 )

Ileus ( 4 )

Toxic megacolon ( 4 )

Hypersensitivity to any ingredient in PLENVU ( 4 , 5.10 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available data with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU. 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.

Overdosage

10 OVERDOSAGE Overdosage of more than the recommended dose of PLENVU 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.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride: NDC 65649-400-01. Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride: NDC 65649-400-01. Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid: NDC 65649-400-01. PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 65649-400-01. PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 65649-400-01. Storage Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.