Prescribing information (package insert) - Polyethylene Glycol 3350
DESCRIPTION
A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder For Oral Solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatment of constipation.
CLINICAL PHARMACOLOGY
Pharmacology
Polyethylene Glycol 3350 NF is an osmotic agent which causes water to be retained with the stool. Essentially, complete recovery of Polyethylene Glycol 3350 NF was shown in normal subjects without constipation. Attempts at recovery of Polyethylene Glycol 3350 NF in constipated patients resulted in incomplete and highly variable recovery. In vitro study showed indirectly that Polyethylene Glycol 3350 NF was not fermented into hydrogen or methane by the colonic microflora in human feces. Polyethylene Glycol 3350 NF appears to have no effect on the active absorption or secretion of glucose or electrolytes. There is no evidence of tachyphylaxis.
CLINICAL TRIALS
In one study, patients with less than 3 bowel movements per week were randomized to Polyethylene Glycol 3350 NF, 17 grams, or placebo for 14 days. An increase in bowel movement frequency was observed for both treatment groups during the first week of treatment. Polyethylene Glycol 3350 NF was statistically superior to placebo during the second week of treatment. In another study, patients with 3 bowel movements or less per week and/or less than 300 grams of stool per week were randomized to 2 dose levels of Polyethylene Glycol 3350 NF or placebo for 10 days each. Success was defined by an increase in both bowel movement frequency and daily stool weight. For both parameters, superiority of the 17 gram dose of Polyethylene Glycol 3350 NF over placebo was demonstrated.
INDICATIONS AND USAGE
For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.
CONTRAINDICATIONS
Polyethylene Glycol 3350 NF is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.
WARNINGS
Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol 3350 NF therapy.
PRECAUTIONS
General
Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel habits.
Polyethylene Glycol 3350 NF should be administered after being dissolved in approximately 4 to 8 ounces of water, juice, soda, coffee or tea.
Information for Patients
Polyethylene Glycol 3350 NF softens the stool and increases the frequency of bowel movements by retaining water in the stool. It should always be taken by mouth after being dissolved in 4 to 8 ounces of water, juice, soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur, consult your physician.
Two to 4 days may be required to produce a bowel movement. This product should be used for 2 weeks or less or as directed by your physician. Prolonged, frequent or excessive use of Polyethylene Glycol 3350 NF may result in electrolyte imbalance and dependence on laxatives.
Laboratory Tests
No clinically significant effects on laboratory tests have been demonstrated.
Drug Interactions
No specific drug interactions have been demonstrated.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term carcinogenicity studies, genetic toxicity studies or reproductive toxicity studies in animals have not been performed with Polyethylene Glycol 3350 NF.
Pregnancy
Category C
Animal reproductive studies have not been performed with Polyethylene Glycol 3350 NF.
It is also not known whether Polyethylene Glycol 3350 NF can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Polyethylene Glycol 3350 NF should only be administered to a pregnant woman if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients has not been established.
Geriatric Use
There is no evidence for special considerations when Polyethylene Glycol 3350 NF is administered to elderly patients. In geriatric nursing home patients a higher incidence of diarrhea occurred at the recommended 17 g dose. If diarrhea occurs Polyethylene Glycol 3350 NF should be discontinued.
ADVERSE REACTIONS
Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.
OVERDOSAGE
There have been no reports of accidental overdosage. In the event of overdosage, diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered. The oral LD50 is > 50 gm/kg in mice, rats and rabbits.
DOSAGE AND ADMINISTRATION
The usual dose is 17 grams (about 1 heaping tablespoon) of powder per day (or as directed by physician) in 4 to 8 ounces of water, juice, soda, coffee, or tea. Each bottle of Polyethylene Glycol 3350 NF is supplied with a dosing cup marked to contain 17 grams of laxative powder when filled to the indicated line. Two to 4 days (48 to 96 hours) may be required to produce a bowel movement.
HOW SUPPLIED
Product: 17856-0457
NDC: 17856-0457-1 17 g in a CUP / 72 in a CASE
NDC: 17856-0457-2 17 g in a POUCH / 72 in a CASE
NDC: 17856-0457-3 4 g in a POUCH / 72 in a CASE
NDC: 17856-0457-4 4.25 g in a POUCH / 72 in a CASE
NDC: 17856-0457-5 8.5 g in a CUP / 72 in a CASE
NDC: 17856-0457-6 8.5 g in a POUCH / 72 in a CASE
Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Manufactured by:
Nexgen Pharma, Inc.
Irvine, CA 92614
6920, 6921 Rev 11/08