Prescription Drug Information: PEG-3350, Electrolytes, and Ascorbate (Page 3 of 6)

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PEG-3350, Electrolytes, and Ascorbate for Oral Solution or other PEG-based products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration.

Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]

Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills.

Nervous system: tremor, seizure.

Renal: renal impairment and/or failure.

7 DRUG INTERACTIONS

7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities

Use caution when prescribing PEG-3350, Electrolytes, and Ascorbate 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, Electrolytes, and Ascorbate 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, Electrolytes, and Ascorbate for Oral Solution [see Dosage and Administration (2.1)].

7.3 Stimulant Laxatives

Concurrent use of stimulant laxatives and PEG-3350, Electrolytes, and Ascorbate 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, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions (5.5, 5.6)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on PEG-3350, Electrolytes, and Ascorbate 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, Electrolytes, and Ascorbate 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.

8.2 Lactation

Risk Summary

There are no data available on the presence of PEG-3350, Electrolytes, and Ascorbate for Oral Solution in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PEG-3350, Electrolytes, and Ascorbate for Oral Solution to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PEG-3350, Electrolytes, and Ascorbate for Oral Solution and any potential adverse effects on the breastfed child from PEG-3350, Electrolytes, and Ascorbate for Oral Solution or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of PEG-3350, Electrolytes, and Ascorbate for Oral Solution in pediatric patients have not been established.

8.5 Geriatric Use

Of the 413 patients in clinical trials receiving PEG-3350, Electrolytes, and Ascorbate for Oral Solution, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age. 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 geriatric patients and younger patients. However, 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)].

8.6 Renal Impairment

Use PEG-3350, Electrolytes, and Ascorbate for Oral Solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions (7.1)]. 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 PEG-3350, Electrolytes, and Ascorbate for Oral Solution, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)].

10 OVERDOSAGE

Overdosage of more than the recommended dose of PEG-3350, Electrolytes, and Ascorbate 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.

11 DESCRIPTION

PEG-3350, Electrolytes, and Ascorbate for Oral Solution (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution.

Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. Pouch A contains 111.9 g of powder for oral solution.

Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution.

When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, PEG-3350, Electrolytes, and Ascorbate for Oral Solution (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste.

The entire, reconstituted, 2-liter PEG-3350, Electrolytes, and Ascorbate 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: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring.

A mixing container for reconstitution is enclosed.

Phenylketonurics: Contains Phenylalanine 131 mg per treatment.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary mode of action is osmotic action of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

14 CLINICAL STUDIES

The colon cleansing efficacy and safety of PEG-3350, Electrolytes, and Ascorbate for Oral Solution was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded trials in adult patients scheduled to have an elective colonoscopy.

In Study 1, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of PEG-3350, Electrolytes, and Ascorbate for Oral Solution with 1 additional liter of clear liquid split into two doses (during the evening before and the morning of the colonoscopy) and 2) 4 liters of polyethylene glycol plus electrolytes solution (4L PEG + E) split into two doses (during the evening before and the morning of the colonoscopy). Patients were allowed to have a morning breakfast, a light lunch, clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by blinded gastroenterologists on the basis of videotapes recorded during the colonoscopy.

The blinded gastroenterologists graded the colon cleansing twice (during introduction and withdrawal of the colonoscope) and the poorer of the two assessments was used in the primary efficacy analysis.

The efficacy analysis included 308 adult patients who had an elective colonoscopy. Patients ranged in age from 18 to 88 years old (mean age about 59 years old) with 52% female and 48% male patients. Table 3 displays the results.

Table 3: Effectiveness of Overall Colon Cleansing of PEG-3350, Electrolytes, and Ascorbate for Oral Solution vs. 4 Liter Polyethylene Glycol plus Electrolytes Solution in Study 1
*
A: colon empty and clean or presence of clear liquid, but easily removed by suction
B: brown liquid or semisolid remaining amounts of stool, fully removable by suction or displaceable, thus allowing a complete visualization of the gut mucosa
C: semisolid amounts of stool, only partially removable with a risk of incomplete visualization of the gut mucosa
§
D: semisolid or solid amounts of stool; consequently colonoscopy incomplete or needed to be terminated.
4L PEG + E is 4 Liter Polyethylene Glycol plus Electrolytes Solution.

Responders

A * or B (%)

C (%)

D § (%)

PEG-3350, Electrolytes, and Ascorbate for Oral Solution

(N=153)

88.9

9.8

1.3

4L PEG + E

(N=155)

94.8

4.5

0.6

4L PEG+E’s responder rate was not significantly higher than PEG-3350, Electrolytes, and Ascorbate for Oral Solution’s responder rate.

In Study 2, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of PEG-3350, Electrolytes, and Ascorbate for Oral Solution with 1 additional liter of clear liquid in the evening prior to the colonoscopy and 2) 90 mL of oral sodium phosphate solution (90 mL OSPS) with at least 2 liters of additional clear liquid during the day and evening prior to the colonoscopy. Patients randomized to PEG-3350, Electrolytes, and Ascorbate for Oral Solution therapy were allowed to have a morning breakfast; a light lunch; and clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by the colonoscopist and one blinded gastroenterologist (on the basis of videotapes recorded during the colonoscopy). In case of a discrepancy between the colonoscopist and the blinded gastroenterologist, a second blinded gastroenterologist made the final efficacy determination.

The efficacy analysis included 280 adult patients who had an elective colonoscopy. Patients ranged in age from 21 to 76 years old (mean age about 53 years old) with 47% female and 53% male patients. Table 4 displays the results.

Table 4: Effectiveness of Overall Colon Cleansing of PEG-3350, Electrolytes, and Ascorbate for Oral Solution vs. 90 mL Oral Sodium Phosphate Solution in Study 2
*
A: empty and clean or clear liquid (transparent, yellow, or green)
B: brown liquid or semisolid remaining small amounts of stool, fully removable by suction or displaceable allowing a complete visualization of the underlying mucosa
C: semisolid only partially removable/displaceable stools; risk of incomplete examination of the underlying mucosa
§
D: heavy and hard stool making the segment examination uninterpretable and, consequently, the colonoscopy needed to be terminated.
OSPS is Oral Sodium Phosphate Solution.

Responders

A * or B (%)

C (%)

D § (%)

PEG-3350, Electrolytes, and Ascorbate for Oral Solution

(N=137)

73.0

23.4

3.6

90 mL OSPS

(N=143)

64.4

29.4

6.3

PEG-3350, Electrolytes, and Ascorbate for Oral Solution’s responder rate was not significantly higher than OSPS’s responder rate.

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