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MOVIPREP
Overview
What is MOVIPREP?
MoviPrep® consists of 4 separate pouches (2 of pouch A and 2 of pouch B)
containing white to yellow powder for reconstitution. Each pouch A contains 100
grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP,
2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP,
plus the following excipients: aspartame, NF (sweetener), acesulfame potassium,
NF (sweetener), and lemon flavoring. Each pouch B contains 4.7 grams of ascorbic
acid, USP and 5.9 grams of sodium ascorbate, USP. When 1 pouch A and 1 pouch B
are dissolved together in water to a volume of 1 liter, MoviPrep (PEG-3350,
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 200 grams of
PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams
of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium
ascorbate plus the following excipients: aspartame (sweetener), acesulfame
potassium (sweetener), and lemon flavoring.
What does MOVIPREP look like?
What are the available doses of MOVIPREP?
MoviPrep is available in a carton that contains 4 separate pouches (2 of pouch A
and 2 of pouch B). Each pouch A contains 100 grams of polyethylene glycol (PEG)
3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP,
and 1.015 grams of potassium chloride, USP, plus the following excipients:
aspartame, NF (sweetener), acesulfame potassium, NF (sweetener), and lemon
flavoring. Each pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams
of sodium ascorbate, USP.
What should I talk to my health care provider before I take MOVIPREP?
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.
Because many drugs are excreted in human milk, caution should be
exercised when MoviPrep is administered to a nursing woman.
The safety and effectiveness of MoviPrep in pediatric patients
has not been established.
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.
How should I use MOVIPREP?
MoviPrep® is indicated for cleansing of the colon as a preparation for
colonoscopy in adults 18 years of age or older.
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 in one of the following
ways:
Preparation of the MoviPrep
solution:
MoviPrep solution is prepared by emptying the contents of 1 pouch A and 1
pouch B into a suitable glass container (or the container provided) and adding
to the container 1 liter of lukewarm water. Mix the solution to ensure that the
ingredients are completely dissolved. If the patient prefers, the MoviPrep
solution can be refrigerated prior to drinking. The reconstituted solution
should be used within 24 hours.
After consumption of the first liter of MoviPrep solution, the above mixing
procedure should be repeated with the second pouch A and pouch B to reconstitute
the second liter of the MoviPrep solution.
What interacts with MOVIPREP?
Sorry No Records found
What are the warnings of MOVIPREP?
Sorry No Records found
What are the precautions of MOVIPREP?
Sorry No Records found
What are the side effects of MOVIPREP?
Sorry No records found
What should I look out for while using MOVIPREP?
MoviPrep is contraindicated in patients who have had a severe hypersensitivity
reaction to any of its components.
What might happen if I take too much MOVIPREP?
There have been no reported cases of overdose with MoviPrep. Purposeful or
gross accidental ingestion of more than the recommended dose of MoviPrep might
be expected to lead to severe electrolyte disturbances, including hyponatremia
and/or hypokalemia, as well as dehydration and hypovolemia, with signs and
symptoms of these disturbances. The patient who has taken an overdose should be
monitored carefully, and treated symptomatically for complications until stable.
How should I store and handle MOVIPREP?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.MoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).Rx onlySTORAGEMoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).Rx onlySTORAGEMoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).Rx onlySTORAGEMoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).Rx onlySTORAGEMoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).Rx onlySTORAGE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
MoviPrep produces a watery stool leading to cleansing of the
colon. The osmotic activity of polyethylene glycol 3350, sodium sulfate, sodium
chloride, potassium chloride, sodium ascorbate, and ascorbic acid, when taken
with 1 liter of additional clear fluid, usually results in no net absorption or
excretion of ions or water.
The pharmacokinetics of MoviPrep have not been studied in patients with renal
or hepatic insufficiency.
Non-Clinical Toxicology
MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction to any of its components.Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
Absorption of tetracycline is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Absorption of tetracycline is impaired by bismuth subsalicylate.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
MoviPrep should be used with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon
General
Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration of MoviPrep. If a patient experiences severe bloating, abdominal distention, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate tests should be performed to rule out these conditions before administration of MoviPrep®.
Phenylketonurics: MoviPrep contains phenylalanine – a maximum of 2.33 mg of phenylalanine per treatment.
No additional ingredients (e.g., flavorings) should be added to the MoviPrep solution.
Since MoviPrep contains sodium ascorbate and ascorbic acid, MoviPrep should be used with caution in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency especially G-6-PD deficiency patients with an active infection, with a history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions.
There have been rare reports of generalized tonic-clonic seizures associated with use of polyethylene glycol colon preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics or angiotensin converting enzyme (ACE)-inhibitors] or in patients with known or suspected hyponatremia. Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.
In the MoviPrep trials, abdominal distension, anal discomfort, thirst, nausea, and abdominal pain were some of the most common adverse reactions to MoviPrep administration. Since diarrhea was considered as a part of the efficacy of MoviPrep, diarrhea was not defined as an adverse reaction in the clinical studies. Tables 1 and 2 display the most common drug-related adverse reactions of MoviPrep and its comparator in the controlled MoviPrep trials.
Isolated cases of urticaria, rhinorrhea, dermatitis, and anaphylactic reaction have been reported with PEG-based products and may represent allergic reactions.
Published literature contains isolated reports of serious adverse events following the administration of PEG-based products in patients over 60 years of age. These adverse events included upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after aspirating the PEG-based preparation.
In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of MoviPrep. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to MoviPrep, or a combination of these factors.
General:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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