Generic Name: polyethylene glycolsodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate Dosage Form: power for oral solution.

Medically reviewed by Drugs.

Last updated on May 1, Dose 1 — In the evening before the colonoscopy, approximately 10 to 12 hours before Dose The One-Day Evening Only regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate.

Advise patients to hydrate adequately before, during, and after the use of MoviPrep. If a patient develops significant vomiting or signs of dehydration after taking MoviPrep, consider performing post-colonoscopy lab tests electrolytes, creatinine, and BUN.

Bowel preparations can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see Adverse Reactions 6.

Correct fluid and electrolyte abnormalities before treatment with MoviPrep. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme ACE inhibitors or angiotensin receptor blockers ARBs ] or in patients with known or suspected hyponatremia.

There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxative products for bowel preparation.

These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances.

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Use caution when prescribing MoviPrep for patients at increased risk of arrhythmias e. Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

The seizure cases were associated with electrolyte abnormalities e. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing MoviPrep for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold e.

Use MoviPrep 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 [see Drug Interactions 7.

These patients may be at risk for renal injury.

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Advise these patients of the importance of adequate hydration before, during, and after use of MoviPrep, and consider performing pre-dose and post-colonoscopy laboratory tests electrolytes, creatinine, and BUN in these patients [see Use in Specific Populations 8.

Osmotic laxatives may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization.

Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis and is not recommended.

Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering MoviPrep [see Contraindications 4 ].

Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of MoviPrep.

Observe these patients during the administration of MoviPrep. Use with caution in these patients. Since MoviPrep contains sodium ascorbate and ascorbic acid, MoviPrep should be used with caution in patients with glucosephosphate dehydrogenase G6PD deficiency, especially G6PD deficiency patients with an active infection, with a history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions.

Phenylalanine can be harmful to patients with phenylketonuria PKU. MoviPrep contains phenylalanine, a component of aspartame.

Each MoviPrep treatment contains mg of phenylalanine after hydrolysis of the aspartame molecule in vivo to aspartic acid and phenylalanine.

Before prescribing MoviPrep to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including MoviPrep.

MoviPrep contains polyethylene glycol PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions 2 ].

Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:.

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 14 ].

Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials.

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 shockrash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills.

Consider additional patient evaluations as appropriate. 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 2.

Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis.

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Avoid use of stimulant laxatives e. There are no available data on MoviPrep in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Animal reproduction studies have not been conducted with MoviPrep. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. There are no data available on the presence of MoviPrep in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production.

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

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However, 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 [see Warnings and Precautions 5.

Use MoviPrep with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions 7.

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Advise these patients of the importance of adequate hydration before, during and after the use of MoviPrep, and consider performing baseline and post-colonoscopy laboratory tests electrolytes, creatinine, and BUN in these patients [see Warnings and Precautions 5.

Certain severe electrolyte disturbances may lead to cardiac arrhythmias, seizures, and renal failure [see Warnings and Precautions 5.

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Monitor for fluid and electrolyte disturbances and treat symptomatically. MoviPrep PEG, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution is an osmotic laxative consisting of 4 pouches 2 of Pouch A and 2 of Pouch B containing white to yellow powder for reconstitution.

Pouch A contains Each Pouch B contains 4. Pouch B contains When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, MoviPrep PEG, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid is an oral solution having a lemon taste.

The entire, reconstituted, 2-liter MoviPrep colon preparation contains grams of PEG, 15 grams of sodium sulfate, 5.

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The primary mode of action is osmotic action of polyethylene glycolsodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, which induce a laxative effect.

The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools. The colon cleansing efficacy and safety of MoviPrep was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded trials in adult patients scheduled to have an elective colonoscopy.

Dinner had to be completed at least one hour prior to initiation of the colon preparation administration. The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by blinded gastroenterologists on the basis of videotapes recorded during the colonoscopy.

The blinded gastroenterologists graded the colon cleansing twice during introduction and withdrawal of the colonoscope and the poorer of the two assessments was used in the primary efficacy analysis.

The efficacy analysis included adult patients who had an elective colonoscopy. Table 3 displays the results.

In Study 2, patients were randomized to one of the following two colon preparation treatments: 1 2 liters of MoviPrep with 1 additional liter of clear liquid in the evening prior to the colonoscopy and 2 90 mL of oral sodium phosphate solution 90 mL OSPS with at least 2 liters of additional clear liquid during the day and evening prior to the colonoscopy.

The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by the colonoscopist and one blinded gastroenterologist on the basis of videotapes recorded during the colonoscopy.

In case of a discrepancy between the colonoscopist and the blinded gastroenterologist, a second blinded gastroenterologist made the final efficacy determination.

Table 4 displays the results.

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MoviPrep polyethylene glycolsodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution is supplied as a white to yellow powder for reconstitution.

Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking MoviPrep.

What is the most important information I should know about MoviPrep? MoviPrep and other bowel preparations can cause serious side effects, including:.

Your chance of having fluid loss and changes in body salts with MoviPrep is higher if you:. Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid dehydration while taking MoviPrep:.

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MoviPrep is a prescription medicine used by adults to clean the colon before a colonoscopy. MoviPrep cleans your colon by causing you to have diarrhea loose stools.

Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. What should I tell my healthcare provider before taking MoviPrep?

Before taking MoviPrep, tell your healthcare provider about all of your medical conditions, including if you:. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

MoviPrep may affect how other medicines work. Do not take medicines by mouth 1 hour before or after the start of MoviPrep.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

06.02.2020 – As a result, pain and swelling will decrease. But Lexo never compromises with Travel Style! The blinded gastroenterologists graded the colon cleansing twice during introduction and withdrawal of the colonoscope and the poorer of the two assessments was used in the primary efficacy analysis. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, MoviPrep PEG, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid is an oral solution having a lemon taste.

You must read, understand, and follow these instructions to take MoviPrep the right way. Call your doctor for medical advice about side effects. General information about the safe and effective use of MoviPrep.