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

Brand and Other Names:MoviPrep, Plenvu
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Dosing & Uses

AdultPediatric

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)
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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

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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

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

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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

Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration

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

If severe vomiting occurs, check serum electrolytes

Phenylketonurics: product contains phenylalanine

Serious arrythmias reported

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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.

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Pharmacology

Mechanism of Action

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

Absorption

Onset: 1-2 hr

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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
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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.