Dosing & Uses
Dosage Forms & Strengths
polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid
MoviPrep, oral powder for solution
- After reconstitution (of 4 packets/2L) contains Pouch A (100g PEG 3350, 7.5g sodium sulfate, 2.69g sodium chloride, 1.015g potassium chloride), and Pouch B (4.7g ascorbic acid, and 5.9g sodium ascorbate)
- Four separate pouches in kit (2 of pouch A and 2 of pouch B)
- 1 pouch A and 1 pouch B are dissolved together in water to a volume of 1 L for oral use; repeat dissolution with second set of pouches A and B as directed depending on full or split dose
PlenVu, oral powder for solution
- Dissolve each dose in 500mL water (ie, total volume of prep is 1 L, not counting additional clear fluids that must be taken with each dose)
- Dose 1 contains: 100g PEG 3350, 9g sodium sulfate, 2g sodium chloride, 1g potassium chloride
- Dose 2 contains: Pouch A (40g PEG 3350, 3.2g sodium chloride, 1.2g potassium chloride), and Pouch B (7.54g ascorbic acid and 48.11g sodium ascorbate)
Colonoscopy Bowel Preparation
Indicated for cleansing of the colon as preparation for colonoscopy in adults aged ≥18 yrs and older
PO prior to colonoscopy as either a split-dose or full-dose regimen
Also see Administration
MoviPrep 2-dose regimens
Split-dose
- Dose 1 in evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
- Follow with 0.5 L (480mL) clear fluid
- Dose 2 in morning of colonoscopy: At least 3.5 hr before colonoscopy, drink 1 L PO over 1 hr (240 mL q 15 min)
- Follow with 0.5 L (480mL) clear liquids until at least 1 hr prior to colonoscopy
Full-dose
- Dose 1 at ~6 PM the evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
- Dose 2 at ~1.5 hrs later, 1 L PO over 1 hr (240 mL q 15 min)
- Follow with 1 L additional clear liquids during the evening before colonoscopy
PlenVu 2-dose regimens
- Prep consists of 2 separate nonidentical ~500-mL doses
- At least 500 mL of additional clear fluid must be taken after drinking each dose
- May be taken according to 2-day or 1-day dosing schedules
- Complete doses and additional clear liquids up to 2 hr before colonoscopy, then stop drinking liquids until after the colonoscopy
2-day schedule
- Dose 1: At ~4-8 pm the evening before the colonoscopy, drink prepared dose 1 solution over 30 min, refill container and drink additional clear liquids over the next 30 minutes, THEN
- Dose 2: The next morning (day of colonoscopy) ~12 hr after the start of dose 1 (ie, ~4-8 am) drink prepared dose 2 solution over 30 min, refill container and drink additional clear liquids over the next 30 minutes
Morning only schedule
- Both doses consumed in the morning before the colonoscopy
- Dose 1: At ~3-7 AM drink prepared dose 1 solution over 30 minutes; refill container and drink additional 500 mL of clear liquid over the next 30 minutes
- Dose 2: A minimum of 2 hr after the start of dose 1, drink prepared dose 2 solution PO over 30 minutes; refill container and drink additional clear liquids over the next 30 minutes
Dosage Modifications
Renal impairment
- Pharmacokinetics have not been studied in patients with renal or hepatic insufficiency
Safety and efficacy not established in pediatrics
Adverse Effects
>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
Warnings
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 & Lactation
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.Pharmacology
Mechanism of Action
Elicits osmotic laxative effect and replenishes electrolytes; induces catharsis through strong electrolyte and osmotic effects
Absorption
Onset: 1-2 hr
Administration
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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Plenvu oral - | 140-9-5.2 gram powder | ![]() | |
peg3350-sodium sulf-sodium,potassium Cl-ascor sod-vit C oral - | 100-7.5-2.691 gram powder | ![]() | |
MoviPrep oral - | 100-7.5-2.691 gram powder | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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