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Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid

FDA Drug Information • Also known as: Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid

Brand Names
Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid
Dosage Form
KIT
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative consisting of 6 pouches (2 of Pouch A, 2 of Pouch B and 2 of Lemon Flavor Pack) containing white to yellow free flowing powder with odor of lemon for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP. Pouch A contains 111.2 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP. Pouch B contains 10.6 g of powder for oral solution. Each Lemon Flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. When 1 Pouch A, 1 Pouch B and 1 Lemon Flavor pack are dissolved together in water to a volume of 1 liter, PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution colon preparation contains 200 grams of PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: sodium saccharin, USP, maltodextrin, NF, and lemon flavoring. A mixing container for reconstitution is enclosed.

What Is Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid Used For?

1 INDICATIONS AND USAGE PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Preparation and Administration: Two doses of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution are required for a complete preparation for colonoscopy, using a "Two-Day" preferred method or "One-Day" alternative method dosing regimen. ( 2.1 ) PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution must be reconstituted in water prior to ingestion. ( 2.1 ) Additional clear liquids must be consumed after each dose of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution in both dosing regiments. ( 2.1 , 5.1 ) Do not take other laxatives while taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. ( 2.1 , 5.5 ) Do not take oral medications within 1 hour of starting each dose. ( 2.1 ) Dosing Regimen: Two-Day (Split-Dose) (Preferred Method) : Dose 1 the evening before the colonoscopy, and Dose 2 the morning of the colonoscopy (approximately 12 hours after the start of Dose 1, and at least 3 ½ hours prior to the colonoscopy). ( 2.2 ) One-Day (Evening Only) (Alternative Method) : Dose 1 at least 3 ½ hours prior to bedtime the evening before the colonoscopy and Dose 2 approximately 1 ½ hours after starting Dose 1 the evening before the colonoscopy. ( 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution [ see Warnings and Precautions (5.1) ]. Two doses of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 "Split-Dose" is the preferred method and 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 "Evening Only" is the alternative method and consists of two separate doses: both doses are taken in the evening before the day of the colonoscopy, with a minimum of 1.5 hours between the start of the first dose and the start of the second dose [ see Dosage and Administration (2.3) ]. Both PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution dosing regimens require administration of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,...

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) ] Hypersensitivity Reactions [ see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 5%) are: Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. ( 6.1 ) One-Day (Evening-Only): abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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 clinical practice. The safety of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies (14)] . The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, 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 Reactions1 in Patients Undergoing Colonoscopy in Study 11 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution Two-Day Split Dosing Regimen (N=180) 4 Liter PEG + Electrolytes Solution (N=179) Malaise 19% 18% Nausea 14% 20% Abdominal pain 13% 15% Vomiting 8% 13% Upper abdominal pain 6% 6% Dyspepsia 3% 1% 1 Reported in at least 2% of patients in either treatment group Table 2: Common Adverse Reactions1,2 in Patients Undergoing Colonoscopy in Study 22 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution One-Day Evening Only Dosing Regimen(N=169) 90 mL Oral Sodium Phosphate Solution (N=171) Abdominal distension 60% 41% Anal discomfort 51% 52% Thirst 47% 65% Nausea 47% 47% Abdominal pain 39% 32% Sleep disorder 35% 29% Rigors 34% 30% Hunger 30% 71% Malaise 27% 53% Vomiting 7% 8% Dizziness 7% 18% Headache 2% 5% Hypokalemia 0% 6% Hyperphosphatemia 0% 6% 1 Reported in at least 5% of patients in either treatment group 2 Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PEG-3350, Sodium...

Drug Interactions

7 DRUG INTERACTIONS Drugs that increase risk for fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution for patients with conditions and/or who are using medications that increase the risk for 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution [ see Dosage and Administration (2.1) ] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution [see Warnings and Precautions ( 5.5 , 5.6 )] .

Contraindications

4 CONTRAINDICATIONS PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 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 colitis or toxic megacolon Hypersensitivity to any ingredient in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution [ see Warnings and Precautions (5.10) ] Gastrointestinal (GI) obstruction (4, 5.6 ) Bowel perforation (4, 4.6) Gastric retention (4) Ileus (4) Toxic colitis or toxic megacolon (4) Hypersensitivity to any ingredient in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution (4, 5.10 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution may lead to severe electrolyte disturbances, including hyponatremia and/or hypokalemia, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. Certain severe electrolyte disturbances may lead to cardiac arrhythmias, seizures, and renal failure [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is supplied as a white to yellow free flowing powder with odor of lemon for reconstitution. Pouch A contains 100 grams of PEG 3350, NF; 7.5 grams of sodium sulfate, NF; 2.691 grams of sodium chloride, USP/NF; and 1.015 gram of potassium chloride, USP/NF: NDC 0093-9044-19. Pouch B contains 4.7 grams of Ascorbic acid; 5.9 grams of sodium ascorbate, USP/NF: NDC 0093-9043-19. Lemon flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, mixing container: NDC 0093-9045-19 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, single-use inner carton: The inner carton contains three pouches labeled Pouch A, Pouch B and lemon flavor pack: NDC 0093-3560-19. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, single-use outer carton: Each outer carton contains 2 inner cartons, prescribing information and patient information and a mixing container with lid for reconstitution of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution: NDC 0093-3560-26 Storage Store carton/container at room temperature, between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).When reconstituted, store upright and keep solution refrigerated. Use within 24 hours [see Dosage and Administration (2.1)] .

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.