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Uses
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.
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Other Information
Prepopik® (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution is available in 2 flavors, orange and cranberry flavor, and is provided in two packets. The contents of each is to be dissolved in 5 ounces of cold water and consumed.
Each packet for both flavors contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The product also contains the following inactive ingredients: potassium hydrogen carbonate, saccharine sodium and orange or cranberry flavors. The orange flavor contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole, and the cranberry flavor contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch. The following is a description of the three active ingredients:
Sodium picosulfate is a stimulant laxative.
Sodium picosulfate
- Chemical name: 4,4´-(2-pyridylmethylene) diphenyl bis(hydrogen sulfate) disodium salt, monohydrate
- Chemical formula: C18H13NNa2O8S2.H2O
- Molecular weight: 499.4
- Structural formula:
.H2O
- Sodium picosulfate
Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative.
Magnesium oxide
- Chemical name: Magnesium oxide
- Chemical formula: Mg O
- Molecular weight: 40.3
- Structural formula: Mg O
Anhydrous citric acid
- Chemical name: 2-hydroxypropane-1,2,3-tricarboxylic acid
- Chemical formula: C6H8O7
- Molecular weight: 192.1
- Structural formula:
Anhydrous citric acid
Sources
Atopalm Tolnaftate Antifungal Manufacturers
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Neopharm Co., Ltd.
Atopalm Tolnaftate Antifungal | Ferring Pharmaceuticals Inc.
2.1 Dosing OverviewPrepopik®, supplied as a powder, must be reconstituted with cold water right before its use [see Dosage and Administration (2.2)]. 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 Dosage and Administration (2.3)] The alternative method is the "DayBefore" 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 Dosage and Administration (2.4)].Additional fluids must be consumed after every dose in both dosing regimens [see Dosage and Administration (2.3, 2.4)]. 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.
2.2 Reconstitution of the Prepopik® Powder (a) Reconstitute the Prepopik ® powder right before each administration. Do not prepare the solution in advance. (b) 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. (c) Stir for 2 to 3 minutes. The reconstituted Prepopik ® solution may become slightly warm as the powder dissolves. 2.3 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 hours before the time of the colonoscopy. 2.4 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.
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