MoviPrep

>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

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.

Mechanism of Action

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

Absorption

Onset: 1-2 hr

• Salix Pharmaceuticals, Inc.

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02.

Last reviewed: February 12, 2014
Date modified: October 13, 2017

• It is used to clean out the GI (gastrointestinal) tract.

• If you have an allergy to polyethylene glycol or any other part of MoviPrep (polyethylene glycol-electrolyte solution).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bowel block, enlarged colon, hole in the GI (gastrointestinal) tract, or slow-moving GI (gastrointestinal) tract.
• If you have electrolyte (like sodium, potassium, phosphate) problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take MoviPrep with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take MoviPrep as your doctor has told you. Follow all instructions you have been given closely. This includes when to take this medicine, foods and drinks to avoid before the exam, and when to stop eating and drinking before the exam. Talk with your doctor if you have any questions.
• Do not take other drugs within 1 hour of starting MoviPrep. Talk with your doctor about how to take your other drugs with this medicine.
• Mix with water as told before you take MoviPrep (polyethylene glycol-electrolyte solution). Do not swallow the dry powder.
• Some products come with flavors that can be added to the solution. Only add flavors that come with the kit.
• Chill the solution to make it taste better. However, do not give chilled solution to an infant. Talk with your doctor.
• Shake well before use.
• Drink clear liquids before, during, and after taking this medicine. Do not drink any liquids that are purple or red.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Call your doctor if you are not able to finish MoviPrep before your exam.

• Store powder at room temperature.
• After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long this medicine may be used after mixing.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing MoviPrep for patients with conditions, or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities.  Consider additional patient evaluations as appropriate. [See Warnings and Precautions (5)]

Potential for Altered Drug Absorption

Oral medication administered within 1 hour of the start of administration of MoviPrep may be flushed from the gastrointestinal tract and the medication may not be absorbed.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been performed with MoviPrep.  It is also not known if MoviPrep can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. MoviPrep should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when MoviPrep is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of MoviPrep in pediatric patients have not been established.

Geriatric Use

Of the 413 patients in clinical studies receiving MoviPrep, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age.  No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Rx only

NDC 65649-201-75

MoviPrep®

(PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,
Sodium Ascorbate and Ascorbic Acid for Oral Solution)

100 g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g

Phenylketonurics:
contains phenylalanine - a maximum of 131 mg per treatment.

KEEP OUT OF THE REACH OF CHILDREN.

2 Pouches Labeled
Pouch A:

Sodium sulfate 7.5g

Sodium chloride 2.691 g

Potassium chloride 1.015 g

also contains aspartame

2 Pouches Labeled
Pouch B:

Ascorbic acid 4.7 g

Sodium ascorbate 5.9 g

Potassium chloride 1.015 g

also contains aspartame

On mixing in 1 liter of water, one
Pouch A and one Pouch B provide:

Salix
Pharmaceuticals