For internal use only - not for distribution PillCam ® COLON 2 Regimen Guidelines The following PillCam COLON 2 regimen was used in MA-201, the European PillCam COLON 2 Multicenter Trial
PillCam COLON 2 Regimen DayTimeInstructionsComments Day -2At bedtime4 Senna tablets (12mg) Improves cleansing Day -1 All dayClear liquid diet Only clear liquids, no solid food 7 pm – 9 pm2L PEG The 2L+2L PEG split improves cleansing (versus 3L+1L split) Exam Day 7 am – 8:30 am2L PEG Wait min between morning PEG and capsule ingestion No drinking is allowed after morning PEG until 1st boost (with the exception of 1 cup with capsule ingestion) not to delay capsule exit from stomach 9:15 am (45-75 min. after PEG) Capsule Ingestion* Boost I Upon SB detection 30ml NaP diluted in ½ glass of water + 1L water First boost is given upon SB detection to reduce SB transit time Approx. 50% of capsules will be excreted after 1 st boost Drink the 1L water within 1 hour Boost II 3 hrs after Boost I 25ml NaP diluted in ½ glass of water + 1L water Suppository 2 hrs after Boost II 10mg Bisacodyl Suppository Approx 25% of patients require suppository In approx 50% of cases, capsule will be excreted after suppository (guaranteeing complete exam) [*] Use of Domperidone 20mg only if capsule is delayed in stomach >1h (approx. 30% of patients) For internal use only - not for distribution
Pre-treatment ExcretionCleansingComments Pre-treatment Methods High Carb Diet SameSame or better Only white pasta/noodles cooked in salt water with no sauce were evaluated Bisacodyl (day-1) -10%Same Not recommended Senna (day-2) SameSame or better Recommended Low Residue Diet Same % Not recommended Simethicone -10%-20% (high dose, with MgC) ?? Not recommended For internal use only - not for distribution
Alternative Boosts DoseExcretionCleansingComments Alternative Boosts (NaP Substitutes) PEG 1L PEG for 1st boost (drink within 30 min) and 0.5L PEG for 2nd boost (drink within 15 min) ??Same Up to a total of 5.5L PEG MoviPrep 2/3L MoviPrep (drink within 15 min) + 1L water for 1st boost and 1/3L MoviPrep (drink all at once) + 0.5L water for 2nd boost -10%Same Up to a total of 3L MoviPrep Mg-Citrate 200ml (12gr) Magnesium Citrate (drink all at once) + 1L water (complete within the next hour) for 1st and 2nd boost -10%?? Brand names: Citramag, Citroma Mg-Citrate -Sodium Picosulfate 1 sachet Mg-Citrate-Sodium- Picosulfate prepared according to instruction (drink all at once) + 1.5L water (complete within the next hour) for 1st and 2nd boost -10%Same Brand names: Citrafleet, Picolax, Piclax, Picoprep Alternative laxatives should be used for boost only if NaP is unavailable or contraindicated For internal use only - not for distribution