Polyethylene Glycol-3350 And Electrolytes

Description

11 DESCRIPTION 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 supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white to off-white powder. Sodium Sulfate, USP The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USP The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is: 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 a b c

What Is Polyethylene Glycol-3350 And Electrolytes Used For?

1 INDICATIONS AND USAGE PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 ) PEG-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Preparation and Administration (2.1): Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution. Reconstitute PEG-3350 and electrolytes for oral solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of PEG-3350 and electrolytes for oral solution. (2.1) Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy. Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. Adult Dosing Regimen (2.2): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regimen for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2) 2.1 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution [see Warnings and Precautions (5.1)]. Reconstitute PEG-3350 and electrolytes for oral solutionwith water prior to ingestion, do not take undissolved PEG-3350 and electrolytes for oral solution [see Dosage and Administration (2.2)]. Do not take oral medications within 1 hour before the start of or during administration of PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.2)]. Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.3)]. Consume only clear liquids, avoid red and purple liquids. Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue PEG-3350 and electrolytes for oral solution until the symptoms abate. 2.2 Dosage Regimen Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regiment for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy. Instruct...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating abdominal cramps, vomiting and anal irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations and ischemic 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 )] The following adverse reactions associated with the use of PEG-3350 and electrolytes for oral solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )]. Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications (4), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].

Drug Interactions

7 DRUG INTERACTIONS Some drugs 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 PEG-3350 and electrolytes 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, seizure, arrhythmias, and prolonged QT 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 and electrolytes for oral solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of PEG-3350 and electrolytes for oral solution [see Dosage and Administration ( 2.1 )] . 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 [see Warnings and Precautions ( 5.5 )].

Contraindications

4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 ) Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 4 , 5.8 ) PEG-3350 and electrolytes for oral solution is contraindicated in the following conditions: Gastrointestinal (GI) obstruction ( 5.6 ) Bowel perforation ( 5.6 ) Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 5.8 )

Pregnancy and Breastfeeding

8.1 Pregnancy 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.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Polyethylene glycol 3350 and electrolytes for oral solution is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white to off white powder. $$UnOrderedlist