polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid (Rx)

>10%

Split-dose

• Malaise (18-27%)
• Nausea (14-47%)
• Abdominal pain (13-39%)
• Vomiting (17 -12%)

Full-dose

• Abdominal distension (59.8%)
• Anal discomfort (51.5%)
• Thirst, nausea (47.3%)
• Abdominal pain (39.1%)
• Sleep disorder (34.9%)
• Rigors (33.7%)
• Hunger (30.2%)
• Malaise (26.6%)

1-10%

Split-dose

• Vomiting (7.8%)
• Upper abdominal pain (5.6%)
• Dyspepsia (2.8%)

Full-dose

• Vomiting (7.1%)
• Dizziness (6.5%)
• Headache (1.8%)

Frequency Not Defined

Rhinorrhea

Dermatitis

Urticaria

Anaphylactic reaction

Bloating

Postmarketing Reports

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)]

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

Nervous system: Syncope, tremor, seizure

Renal: Renal impairment and/or failure

Contraindications

Hypersensitivity

GI obstruction

Bowel perforation

Gastric retention

Ileus

Toxic colitis

Toxic megacolon

Cautions

Use with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities

Use with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction

Product contains polyethylene glycol (PEG) and lemon flavoring (containing citral, lemon, and lime oil, maltodextrin, xanthan gum, and vitamin E) and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus; inform patients of signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur

Serious arrhythmias (including atrial fibrillation) associated with use of ionic osmotic laxative products for bowel preparation; these occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances; consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias

Use with caution and observe unconscious or semiconscious patients with impaired gag reflex or other swallowing abnormalities or those who are otherwise prone to regurgitation or aspiration during administration; observe these patients during administration, especially if it is administered via nasogastric tube

Do not combine product with starch-based thickeners; polyethylene glycol (PEG), a component of the mixture, when mixed with starch-thickened liquids, reduces viscosity of the starch-thickened liquid; when a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid and cases of choking and potential aspiration were reported

Since product contains sodium ascorbate and ascorbic acid, use with caution in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

Phenylketonurics can be harmful to patients with phenylketonuria (PKU); contains phenylalanine, a component of aspartame; before prescribing drug to patient with PKU, consider combined daily amount of phenylalanine from all sources, including this drug combination

If severe vomiting occurs, check serum electrolytes

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

Serious arrythmias reported

Drug interaction overview

• Use with caution in patients with renal impairment or patients taking concomitant medications that affect renal function (such as diuretics, ACE inhibitors, angiotensin receptor blockers, or nonsteroidal anti-inflammatory drugs; patients may be at risk for renal injury; advise patients of the importance of adequate hydration before, during, and after use and consider performing pre-dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients
• Therapy can reduce absorption of other co-administered drugs; administer oral medications at least 1 hour before start of administration of each dose
• Concurrent use of stimulant laxatives may increase risk of mucosal ulceration or ischemic colitis; avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking therapy

Pregnancy

There are no available data with in pregnant women to inform a drug-associated risk for adverse developmental outcomes

Animal reproduction studies have not been conducted

Lactation

No data are available to assess the presence in human milk, the effects on the breastfed child, or the effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Elicits osmotic laxative effect and replenishes electrolytes; induces catharsis through strong electrolyte and osmotic effects

Absorption

Onset: 1-2 hr

Oral Preparation and Administration

Consume only clear liquids (no solid food) from the start of treatment until after the colonoscopy

Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material

Do not take other laxatives while taking

Do not take oral medications within 1 hr before or after starting each dose

Meals on day before colonoscopy

• Two-day split dose regimen or evening full dose: May consume light breakfast and lunch, which must be completed at 3 hr before first PlenVu dose
• One-day morning dose regimen (Plenvu): May consume a light breakfast followed by a light lunch, and clear broth soup and/or plain yogurt for dinner, which should be completed by ~8 pm

MoviPrep

• Prepare solution by emptying contents of 1 pouch A and 1 pouch B into a suitable glass container (or the container provided) and adding to the container 1 L lukewarm water
• Mix the solution to ensure that the ingredients are completely dissolved
• Solution can be refrigerated prior to drinking
• Reconstituted solution should be used within 24 hours
• After consumption of the first liter of solution, the above mixing procedure should be repeated with the second pouch A and pouch B to reconstitute the second liter
• No additional ingredients (eg, flavorings) should be added to the solution

PlenVu

• Correct fluid and electrolyte abnormalities before treatment
• Two doses are required for a complete colonoscopy preparation; the time interval between the 2 doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure (see Adult Dosage)
• The 2-day split-dosing method consists of 2 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
• The 1-day morning dosing method consists of 2 separate doses; both doses are taken in the morning of the day of the colonoscopy, with a minimum of 2 hr between the start of the first dose and the start of the second dose
• Must be reconstituted in water prior to ingestion; it may take 2-3 minutes for complete dissolution
• Additional clear liquids (including water) must be consumed in both dosing regimens
• Ensure completion of dose 2, including all additional liquids, at least 2 hours before the colonoscopy