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MoviPrep

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MoviPrep

MoviPrep

SIDE EFFECTS

Clinical Studies Experience

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.

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 Reactions1 ( ≥ 2%) in the Study of MoviPrep vs. 4 Liter Polyethylene Glycol plus Electrolytes Solution

  MoviPrep (split dose)
N=180
4L PEG + E2
N=179
n (% = n/N) n (% = n/N)
Malaise 35 (19.4) 32 (17.9)
Nausea 26 (14.4) 36 (20.1)
Abdominal pain 24 (13.3) 27 (15.1)
Vomiting 14 (7.8) 23 (12.8)
Upper abdominal pain 10 (5.6) 11 (6.1)
Dyspepsia 5 (2.8) 2 (1.1)
1Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug.
24L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution

Table 2: The Most Common Drug-Related Adverse Reactions1 ( ≥ 5%) in the Study of MoviPrep vs. 90 mL Oral Sodium Phosphate Solutio

  MoviPrep (evening-only) (full dose)
N=169
90 mL OSPS2
N=171
n (% = n/N) n (% = n/N)
Abdominal distension 101 (59.8) 70 (40.9)
Anal discomfort 87 (51.5) 89 (52.0)
Thirst 80 (47.3) 112 (65.5)
Nausea 80 (47.3) 80 (46.8)
Abdominal pain 66 (39.1) 55 (32.2)
Sleep disorder 59 (34.9) 49 (28.7)
Rigors 57 (33.7) 51 (29.8)
Hunger 51 (30.2) 121 (70.8)
Malaise 45 (26.6) 90 (52.6)
Vomiting 12 (7.1) 14 (8.2)
Dizziness 11 (6.5) 31 (18.1)
Headache 3 (1.8) 9 (5.3)
Hypokalemia 0 (0) 10 (5.8)
Hyperphosphatemia 0 (0) 10 (5.8)
1Drug-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.
2OSPS 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 PEG-based preparation.

Postmarketing Experience

In addition to adverse reactions 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 uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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.

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.

Read the MoviPrep (peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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]

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.

Last reviewed on RxList: 1/24/2014
This monograph has been modified to include the generic and brand name in many instances.

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MoviPrep - User Reviews

MoviPrep User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication MoviPrep sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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