MOVIPREP

MOVIPREP — polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid
Physicians Total Care, Inc.

MoviPrep® is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

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:

  1. Split-dose MoviPrep regimen: The evening before the colonoscopy, take the first liter of MoviPrep solution over one hour (one 8 ounce glass every 15 minutes) and then drink 0.5 liters (approximately 16 ounces) of clear fluid. Then, on the morning of the colonoscopy, take the second liter of MoviPrep solution over one hour and then drink 0.5 liters of clear liquid at least one hour prior to the start of the colonoscopy; or
  2. Evening only (Full-dose) MoviPrep regimen: Around 6 PM in the evening before the colonoscopy, take the first liter of MoviPrep solution over one hour (one 8 ounce glass every 15 minutes) and then about 1.5 hours later take the second liter of MoviPrep solution over one hour. In addition, take 1 liter (approximately 32 ounces) of additional clear liquid during the evening before the colonoscopy.

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.

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction to any of its components.

5 WARNINGS AND PRECAUTIONS

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.

5.1 Seizures

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.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

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.

Table 1: The Most Common Drug-Related Adverse Reactions* (≥ 2%) in the Study of MoviPrep vs. 4 liter Polyethylene Glycol plus Electrolytes Solution

MoviPrep®

(split dose)

N=180

4L PEG + E

N=179
n (% = n/N)n (% = n/N)
Malaise35 (19.4)32 (17.9)
Nausea26 (14.4)36 (20.1)
Abdominal pain24 (13.3)27 (15.1)
Vomiting14 (7.8)23 (12.8)
Upper abdominal pain10 (5.6)11 (6.1)
Dyspepsia5 (2.8)2 (1.1)

† 4L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution
Table 2: The Most Common Drug-Related Adverse Reactions* (≥ 5%) in the Study of MoviPrep vs. 90 mL Oral Sodium Phosphate Solution
MoviPrep®(evening-only)(full dose)N=16990 mL OSPSN=171
n (% = n/N)n (% = n/N)
Abdominal distension101 (59.8)70 (40.9)
Anal discomfort87 (51.5)89 (52.0)
Thirst80 (47.3)112 (65.5)
Nausea80 (47.3)80 (46.8)
Abdominal paint66 (39.1)55 (32.2)
Sleep disorder59 (34.9)49 (28.7)
Rigors57 (33.7)51 (29.8)
Hunger51 (30.2)121 (70.8)
Malaise45 (26.6)90 (52.6)
Vomiting12 (7.1)14 (8.2)
Dizziness11 (6.5)31 (18.1)
Headache3 (1.8)9 (5.3)
Hypokalemia0 (0)10 (5.8)
Hyperphosphatemia0 (0)10 (5.8)

* Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug. In addition to the recording of spontaneous adverse events, patients were also 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.
† OSPS is Oral Sodium Phosphate Solution

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.

6.2 Postmarketing Experience

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: Hypersensitivity reactions including anaphylaxis, rash, urticaria, lip and facial swelling, dyspnea, chest tightness and throat tightness.

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