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

Brand and Other Names:MoviPrep
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid

oral powder for solution

  • After reconstitution (of 4 packets/2L) contains Pouch A (100g PEG 3350, 7.5 g sodium sulfate, 2.69g sodium chloride, 1.015 g potassium chloride), and Pouch B (4.7 g ascorbic acid, and 5.9 g 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

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Gastrointestinal Lavage

Cleansing of the colon as preparation for colonoscopy in 18 yrs and older: 2 L PO prior to colonoscopy

Split-dose regimen

  • Evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
  • Follow with 0.5 L (480mL) clear fluid
  • 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 fluid at least 1 hr prior to colonoscopy

Full-dose regimen

  • 6 PM the evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
  • Approximately 1.5 hrs later, 1 L PO over 1 hr (240 mL q 15 min)
  • Follow with 1 L additional clear liquid during the evening before colonoscopy

Renal Impairment

Pharmacokinetics have not been studied in patients with renal or hepatic insufficiency

Administration

PEG/electrolyte Solution Preparation

  • 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

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 Category: C

Lactation: Unknown whether distributed in breast milk, caution advised

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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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

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.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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