Prescription Drug Information: MoviPrep

MOVIPREP- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid, sodium ascorbate
Salix Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Important Preparation and Administration Instructions

Correct fluid and electrolyte abnormalities before treatment with MoviPrep [see Warnings and Precautions (5.1)].
Two doses of MoviPrep are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure. [see Dosage and Administration (2.2, 2.3)].
The “Split-Dose” is the preferred method and consists of two separate doses: the first dose is taken the evening before the colonoscopy, and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration (2.2)].
The “Evening Only” is the alternative method and consists of two separate doses: both doses are taken in the evening before the day of the colonoscopy, with a minimum of 1.5 hours between the start of the first dose and the start of the second dose [see Dosage and Administration (2.3)].
Both MoviPrep dosing regimens require administration of MoviPrep using the mixing container provided to reconstitute the contents of Pouch A and B with water to the Fill Line. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
Additional clear liquids (including water) must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].
Consume only clear liquids (no solid food) from the start of MoviPrep treatment until after the colonoscopy.
Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
Do not take other laxatives while taking MoviPrep [see Drug Interactions (7.3)].
Do not take oral medications within 1 hour before or after starting each dose of MoviPrep [see Drug Interactions (7.2)].
Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy.
Storage: After reconstitution, store MoviPrep solution in an upright position and keep refrigerated. Use within 24 hours after it is mixed in water.

2.2 Two-Day Split-Dosing Regimen (Preferred Method)

The Two-Day Split-Dosing regimen is the preferred dosing method.

Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first MoviPrep dose.

Instruct adult patients to take two separate doses in conjunction with fluids as follows:

Dose 1 – In the evening before the colonoscopy, approximately 10 to 12 hours before Dose 2:

1.
Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
2.
Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
3.
Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
4.
Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution.
5.
Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid before going to bed.

Dose 2 – Take next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 and at least 3 ½ hours prior to colonoscopy:

1.
Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
2.
Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
3.
Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
4.
Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution.
5.
Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid at least 2 hours before the colonoscopy.
6.
Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.
Stop drinking MoviPrep temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

2.3 One-Day Evening Only Dosing Regimen (Alternative Method)

The One-Day Evening Only regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate.

Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first MoviPrep dose.

Instruct adult patients to take two separate doses in conjunction with fluids as follows:

Dose 1 – At least 3 ½ hours before bedtime the evening before the colonoscopy:

1.
Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
2.
Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
3.
Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
4.
Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution.

Dose 2 – At least 1 ½ hours after starting Dose 1 on the evening before the colonoscopy:

1.
Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
2.
Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
3.
Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
4.
Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution.
5.
Refill the mixing container to the Fill Line (32 fluid ounces) with a clear liquid and drink all this liquid before going to bed.
6.
Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.
Stop drinking MoviPrep temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

3 DOSAGE FORMS AND STRENGTHS

MoviPrep is supplied as a white to yellow powder for reconstitution and is available in a carton that contains 2 pouches labeled Pouch A and 2 pouches labeled Pouch B.

Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride. Pouch A contains lemon flavoring [see Description (11)].
Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate.

4 CONTRAINDICATIONS

MoviPrep is contraindicated in the following conditions:

Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.6)]
Bowel perforation [see Warnings and Precautions (5.6)]
Gastric retention
Ileus
Toxic colitis or toxic megacolon
Hypersensitivity to any ingredient in MoviPrep [see Warnings and Precautions (5.10) and Description (11)]

5 WARNINGS AND PRECAUTIONS

5.1 Serious Fluid and Electrolyte Abnormalities

Advise patients to hydrate adequately before, during, and after the use of MoviPrep. If a patient develops significant vomiting or signs of dehydration after taking MoviPrep, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN).

Bowel preparations can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see Adverse Reactions (6.2)]. Correct fluid and electrolyte abnormalities before treatment with MoviPrep. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)] or in patients with known or suspected hyponatremia. Consider performing pre-dose and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients [see Drug Interactions (7.1)].

5.2 Cardiac Arrhythmias

There have been rare reports of serious arrhythmias (including atrial fibrillation) associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing MoviPrep for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, or electrolyte imbalance). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3 Seizures

There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing MoviPrep for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions (7.1)].

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