MOVIPREP Oral solution

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1. Description

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 ...

2. Clinical 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 ...

3. Indications and Usage

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

4. Contraindications

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

5. Warnings

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 ...

6.1. 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, ...

6.2. Information for Patients

MoviPrep produces a watery stool which cleanses the colon before colonoscopy. It is recommended that patients receiving MoviPrep be advised to adequately hydrate before, during, and after the use of MoviPrep. ...

6.4. Drug Interactions

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.

6.6. 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 ...

6.7. Pregnancy

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 ...

6.9. Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when MoviPrep is administered to a nursing woman.

6.10. Pediatric Use

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

6.11. 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 ...

7. Adverse Reactions

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 ...

9. Overdosage

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, ...

10. 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 ...

11. How Supplied

MoviPrep is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution. MoviPrep is available in the following presentations: <u>Carton:</u> The MoviPrep carton contains ...

12. Storage and Handling

Store carton/container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). When reconstituted, store upright and keep solution refrigerated. Use within 24 hours.

13. Clinical Studies

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. ...