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.
8.1 Pregnancy: Teratogenic Effects
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.
8.3 Nursing Mothers
Because many drugs are excreted in human milk, caution should be exercised when MoviPrep is administered to a nursing woman.
8.4 Pediatric Use
The safety and effectiveness of MoviPrep in pediatric patients
has not been established.
8.5 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.
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.
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.
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.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic potential have not been performed with MoviPrep®. Studies to evaluate potential for impairment of fertility or mutagenic potential have not been performed with MoviPrep®.
The colon cleansing efficacy and safety of MoviPrep was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded, phase 3 trials in patients scheduled to have an elective colonoscopy.
In the first study, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep with 1 additional liter of clear fluid split into two doses (during the evening before and the morning of the colonoscopy) and 2) 4 liters of polyethylene glycol plus electrolytes solution (4L PEG + E) split into two doses (during the evening before and the morning of the colonoscopy). Patients were allowed to have a morning breakfast, a light lunch, clear soup and/or plain yogurt for dinner. 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 308 adult patients who had an elective colonoscopy. Patients ranged in age from 18 to 88 years old (mean age about 59 years old) with 52% female and 48% male patients. Table 3 displays the results.
RespondersA* or B† (%)
|C‡ (%)||D§ (%)|
4L PEG + E¶(N=155)
* A: colon empty and clean or presence of clear liquid, but easily removed by suction
† B: brown liquid or semisolid remaining amounts of stool, fully removable by suction or displaceable, thus allowing a complete visualization of the gut mucosa
‡ C: semisolid amounts of stool, only partially removable with a risk of incomplete visualization of the gut mucosa
§ D: semisolid or solid amounts of stool; consequently colonoscopy incomplete or needed to be terminated. 4 L PEG+E’s responder rate was not significantly higher than MoviPrep’s responder rate.
¶ 4L PEG + E is 4 Liter Polyethylene Glycol plus Electrolytes Solution
In the second study, patients were randomized to one of the following two
colon preparation treatments: 1) 2 liters of MoviPrep with 1 additional liter
of clear fluid 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 fluid during the day and evening prior to the colonoscopy. Patients
randomized to MoviPrep therapy were allowed to have a morning breakfast; a light
lunch; and clear soup and/or plain yogurt for dinner. Dinner had to be
completed at least one hour prior to initiation of the colon preparation
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.
RespondersA* or B† (%)
|C‡ (%)||D§ (%)|
90 mL OSPS¶(N=143)
* A: empty and clean or clear liquid (transparent, yellow, or green)
† B: brown liquid or semisolid remaining small amounts of stool, fully removable by suction or displaceable allowing a complete visualization of the underlying mucosa
‡ C: semi solid only partially removable/displaceable stools; risk of incomplete examination of the underlying mucosa
§ D: heavy and hard stool making the segment examination uninterpretable and, consequently, the colonoscopy needed to be terminated
OSPS is Oral Sodium Phosphate Solution
MoviPrep’s responder rate was not significantly higher than OSPS’s responder rate.
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