Suclear

Suclear Manufacturers

• Braintree Laboratories, Inc.
  

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  Suclear | Braintree Laboratories, Inc.

  

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  2.1 Dosing Overview

  There are two dosing regimens. Each requires two separate dosing times:

  Split-Dose (2-Day) [see Dosage and Administration (2.2)] Day-Before (1-Day) [see Dosage and Administration (2.3)].

  Both Suclear dosing regimens require administration of Suclear using one 6-oz bottle of oral solution (containing sodium sulfate, potassium sulfate, and magnesium sulfate) diluted with water to 16-oz, followed by a 2-L jug of powder (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) dissolved in water. Additional fluids must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3)]. Instruct patients to consume only clear liquids (no solid food or milk) and to avoid alcohol on the day before colonoscopy until after completion of the colonoscopy. [see Warnings and Precautions (5.1)].

  2.2 Split-Dose (2-Day) 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:

  Dose 1 - Evening before the colonoscopy (10 to 12 hours prior to Dose 2)

  Dilute the 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix Drink the entire solution in the container. It is best to complete drinking the solution within 20 minutes. Refill the container with 16 oz of water to the fill line and drink it over the next 2 hours. Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed.

  Dose 2 - Next morning on the day of the colonoscopy (start at least 3 ½ hours prior to colonoscopy)

  Dissolve the powder of Dose 2 by adding water to the fill line on the jug. Shake the jug until all the powder is dissolved. The solution can be used with or without the addition of a flavor pack. Flavor packs are available in Cherry, Lemon-Lime, Orange and Pineapple. When dissolved in water to a volume of 2 liters, the solution is clear and colorless. The solution may be refrigerated after adding water. The solution should be used within 48 hours of reconstitution. Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (this is four 16-oz containers over a period of one and a half hours). Complete drinking the solution at least 2 hours before the colonoscopy. Consume only clear liquids until 2 hours prior to colonoscopy. Thereafter, nothing should be consumed until the completion of colonoscopy. 2.3 Day-Before (1-Day) Regimen (Alternative Method)

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

  On the evening before the colonoscopy:

  Dose 1 (Begin at least 3 ½ hours prior to bedtime)

  Dilute the 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix. Drink the entire solution in the container. It is best to complete drinking the solution within 20 minutes. Refill the container with 16 oz of water to the fill line and drink it over the next 2 hours.

  Dose 2 (Approximately 2 hours after starting Dose 1)

  Dissolve the powder of Dose 2 by adding water to the fill line on the jug. Shake the jug until all the powder is dissolved. The solution can be used with or without the addition of a flavor pack. Flavor packs are available in Cherry, Lemon-Lime, Orange and Pineapple. When dissolved in water to a volume of 2 liters, the solution is clear and colorless. The solution may be refrigerated after adding water. The solution should be used within 48 hours of reconstitution. Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (This is four 16-oz containers over a period of one and a half hours). Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed. Consume only clear liquids until 2 hours prior to colonoscopy. Thereafter, nothing should be consumed until the completion of colonoscopy.

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