POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES (Page 2 of 4)

6 ADVERSE REACTIONS

The following adverse reactions have been identified during post-approval use of PEG-3350 and electrolytes for oral solution. 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.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350 and electrolytes for oral solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

7 DRUG INTERACTIONS

7.1 Drugs that May Lead to Fluid and Electrolyte Abnormalities

Use caution when prescribing PEG-3350 and electrolytes for oral solution for patients who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.4)] in patients taking these concomitant medications.

7.2 Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of PEG-3350 and electrolytes for oral solution may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

7.3 Stimulant Laxatives

Concurrent use of stimulant laxatives and PEG-3350 and electrolytes 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 and electrolytes for oral solution.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with PEG-3350 and electrolytes for oral solution. It is also not known whether PEG-3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and electrolytes for oral solution should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PEG-3350 and electrolytes for oral solution is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of PEG-3350 and electrolytes for oral solution in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of PEG-3350 and electrolytes for oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

11 DESCRIPTION

For oral solution: Each 4 liter (4L) PEG-3350 and electrolytes for oral solution jug contains a white powder for reconstitution. PEG-3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.

Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.

Polyethylene Glycol 3350, NF

a

Sodium Sulfate, USP

The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:

b

Sodium Bicarbonate, USP

The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:

c

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na+ Cl-

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

12.2 Pharmacodynamics

PEG-3350 and electrolytes for oral solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3 Pharmacokinetics

The pharmacokinetics of PEG3350 following administration of PEG-3350 and electrolytes for oral solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate carcinogenic potential of PEG-3350 and electrolytes for oral solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of PEG-3350 and electrolytes for oral solution have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

In powdered form, for oral administration as a solution following reconstitution. PEG-3350 and electrolytes for oral solution, USP is available in a disposable jug in powdered form containing:

Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Storage:

Store in sealed container at 59º to 86°F (15ºC to 30°C). When reconstituted, keep solution

refrigerated. Use within 48 hours, Discard unused portion. Keep out of reach of children.

PEG-3350 and electrolytes for oral solution NDC 40032-090-19

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Medication Guide). Instruct patients:

  • To let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
  • Not to take other laxatives while they are taking PEG-3350 and electrolytes for oral solution.
  • To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
  • That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
  • That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician.
  • To contact their healthcare provider if they develop signs and symptoms of dehydration. [see Warnings and Precautions (5.1)].
  • That oral medication administered within one hour of the start of administration of PEG-3350 and electrolytes for oral solution solution may be flushed from the GI tract and the medication may not be absorbed completely.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

NLB-090-4L-02

Rev: 09/2015

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