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Prepopik

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Prepopik

INDICATIONS

PREPOPIK™ (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION

Dosing Overview

PREPOPIK, supplied as a powder, must be reconstituted with cold water right before its use [see Reconstitution of the PREPOPIK Powder]. There are two dosing regimens, each requires two separate dosing times:

  • The preferred method is the "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy [see Split-Dose Dosing Regimen]
  • The alternative method is the "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy) [see Day-Before Dosing Regimen].

Additional fluids must be consumed after every dose in both dosing regimens [see Split-Dose Dosing Regimen and Day-Before Dosing Regimen]. Instruct patients to consume only clear liquids (no solid food or milk) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Instruct patients that if they experience severe bloating, distention, or abdominal pain following the first dose, delay the second dose until their symptoms resolve.

Reconstitution of the PREPOPIK Powder

  1. Reconstitute the PREPOPIK powder right before each administration. Do not prepare the solution in advance.
  2. Fill the supplied dosing cup with cold water up to the lower (5-ounce) line on the cup and pour in the contents of one packet of PREPOPIK powder.
  3. Stir for 2 to 3 minutes. The reconstituted PREPOPIK solution may become slightly warm as the powder dissolves.

Split-Dose Dosing Regimen (Preferred Method)

The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:

  • Take the first dose during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM) followed by five 8-ounce drinks (upper line on the dosing cup) of clear liquids before bed. Consume clear liquids within 5 hours.
  • Take second dose, the next day approximately 5 hours before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy. Consume clear liquids within 5 hours up until 2 hour before the time of the colonoscopy.

Day-Before Dosing Regimen (Alternative Method)

The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. Instruct patients to take two separate doses in conjunction with fluids, as follows:

  • Take the first dose in the afternoon or early evening (e.g., 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks (upper line on the dosing cup) of clear liquids before the next dose. Consume clear liquids within 5 hours.
  • Take the second dose approximately 6 hours later in the late evening (e.g., 10:00 PM to 12:00 AM), the night before the colonoscopy followed by three 8-ounce drinks of clear liquids before bed. Consume clear liquids within 5 hours.

HOW SUPPLIED

Dosage Forms and Strengths

For oral solution: each of the two packets contains lOmgof sodium picosulfate, 3.5 grams of magnesium oxide, and 12.0gramsof anhydrous citric acid in 16.1 grams of powder

PREPOPIK is supplied in a carton containing 2 packets, each holding 16.1 grams of powder for oral solution, along with a pre-marked dosing cup. Each packet contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The excipients include potassium hydrogen carbonate, sodium saccharin, spray dried orange flavor which contains acacia gum, lactose, ascorbic acid, and butylated hydroxyanisole.

Storage

Store at 25°C (77°F). Excursions permitted at 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

NDC# 55566-9300-2 Kit, 2 packets and cup

Manufactured by: Ferring Pharmaceuticals (China) Co., Ltd. No. 6 HuiLing Lu (Ferring Road) National Health Technology Park Zhongshan City, Guangdong Province, CHINA. Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, N.J. 07054

Last reviewed on RxList: 7/27/2012
This monograph has been modified to include the generic and brand name in many instances.

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