MoviPrep

Last updated on RxList: 6/15/2021
MoviPrep Side Effects Center

What Is MoviPrep?

MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) is a bowel cleanser indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

What Are Side Effects of MoviPrep?

Common side effects of MoviPrep include:

Dosage for MoviPrep

The MoviPrep dose for colon cleansing for adult patients is 2 liters (approximately 64 ounces) of MoviPrep solution (with 1 additional liter of clear fluids) taken orally prior to the colonoscopy, as directed.

What Drugs, Substances, or Supplements Interact with MoviPrep?

MoviPrep may interact with oral medication administered within 1 hour of the start of administration of MoviPrep, as the medication may be flushed from the gastrointestinal tract and may not be absorbed. Tell your doctor all medications and supplements you use.

MoviPrep During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using MoviPrep. It is unknown if MoviPrep could affect a fetus. Consult your doctor before breastfeeding.

Additional Information

Our MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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MoviPrep Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • no bowel movement within 2 hours after use;
  • vomiting;
  • dizziness, feeling like you might pass out;
  • little or no urination;
  • a seizure; or
  • signs of an electrolyte imbalance--increased thirst or urination, dry mouth, confusion, constipation, muscle pain or weakness, leg cramps, irregular heartbeats, tingly feeling.

You may need to drink the liquid more slowly, or stop using it for a short time if you have certain side effects. Call your doctor for instructions if you have:

  • gagging, choking, severe stomach pain or bloating;
  • nausea, vomiting, headache, trouble drinking liquids, little or no urinating; or
  • fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements.

Common side effects may include:

  • vomiting, stomach pain, indigestion, bloating;
  • rectal pain or irritation;
  • hunger, thirst, mild nausea;
  • trouble sleeping; or
  • dizziness, chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid )

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MoviPrep Professional Information

SIDE EFFECTS

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

  • Serious Fluid and Electrolyte Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Cardiac Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Patients with Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see WARNINGS AND PRECAUTIONS]
  • Patients with Significant Gastrointestinal Disease [see WARNINGS AND PRECAUTIONS]
  • Aspiration [see WARNINGS AND PRECAUTIONS]
  • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of MoviPrep as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies]. The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients.

Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials.

Table 1: Common Adverse Reactions1 in Patients Undergoing Colonoscopy in Study 1

MoviPrep
Two-Day Split Dosing Regimen
(N=180)
4 Liter PEG + Electrolytes Solution
(N=179)
Malaise 19% 18%
Nausea 14% 20%
Abdominal pain 13% 15%
Vomiting 8% 13%
Upper abdominal pain 6% 6%
Dyspepsia 3% 1%
1 Reported in at least 2% of patients in either treatment group

Table 2: Common Adverse Reactions1,2 in Patients Undergoing Colonoscopy in Study 2

MoviPrep
One-Day Evening Only
Dosing Regimen (N=169)
90 mL Oral Sodium Phosphate Solution (N=171)
Abdominal distension 60% 41%
Anal discomfort 51% 52%
Thirst 47% 65%
Nausea 47% 47%
Abdominal pain 39% 32%
Sleep disorder 35% 29%
Rigors 34% 30%
Hunger 30% 71%
Malaise 27% 53%
Vomiting 7% 8%
Dizziness 7% 18%
Headache 2% 5%
Hypokalemia 0% 6%
Hyperphosphatemia 0% 6%
1 Reported in at least 5% of patients in either treatment group
2 Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MoviPrep or other PEG-based products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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)]

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

Nervous system: tremor, seizure.

Renal: renal impairment and/or failure.

DRUG INTERACTIONS

Drugs That May Increase Risks Due To Fluid And Electrolyte Abnormalities

Use caution when prescribing MoviPrep 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, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS]. Consider additional patient evaluations as appropriate.

Potential For Reduced Drug Absorption

MoviPrep can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of MoviPrep [see DOSAGE AND ADMINISTRATION].

Stimulant Laxatives

Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking MoviPrep [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid )

© MoviPrep Patient Information is supplied by Cerner Multum, Inc. and MoviPrep Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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