EzyColon Powder
Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate
12 gm + 3.5 gm + 10 mg
Pharmasia Ltd.
| Pack size | 2's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 280.00 AED |
Indications
EzyColon Powder is used for:
Bowel Preparation
Adult Dose
Bowel Preparation
Indicated for colon cleansing as a preparation for colonoscopy in adults
Two doses are required to complete the colonoscopy preparation by either a split dose regimen or a day before regimen
1 dose is provided by 1 bottle (160 mL) ready-to-drink solution
Split dose
Preferred dosing method
First dose: Take during the evening before the colonoscopy (eg, 5:00 to 9:00 PM) followed by five 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr
Second dose: Take the next day ~5 hr before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy; consume clear liquids within 5 hr up until 2 hr before the time of the colonoscopy
Day before dose
Alternate method
First dose: Take in the afternoon or early evening (eg, 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks of clear liquids before the next dose; consume clear liquids within 5 hr
Second dose: Take ~6 hr later in the late evening (eg, 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 hr
Child Dose
Bowel Preparation
Indicated for cleansing of the colon as a preparation for colonoscopy in patients aged ?9 years
<9 years: Safety and efficacy not established
>9 years
Two doses are required to complete the colonoscopy preparation by either a split dose regimen or a day before regimen
1 dose is provided by 1 bottle (160 mL) ready-to-drink solution
Split dose
Preferred dosing method
First dose: Take during the evening before the colonoscopy (eg, 5:00 to 9:00 PM) followed by five 8-ounce drinks of clear liquids before bed; consume clear liquids within 5 hr
Second dose: Take the next day ~5 hr before the colonoscopy followed by at least three 8-ounce drinks of clear liquids before the colonoscopy; consume clear liquids within 5 hr up until 2 hr before the time of the colonoscopy
Day before dose
Alternate method
First dose: Take in the afternoon or early evening (eg, 4:00 to 6:00 PM) before the colonoscopy followed by five 8-ounce drinks of clear liquids before the next dose; consume clear liquids within 5 hr
Second dose: Take ~6 hr later in the late evening (eg, 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 hr
Renal Dose
Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as accumulation of magnesium in plasma may occur. Patients with mild to moderate renal impairment or patients taking concomitant medications that may affect renal function may be at increased risk for renal injury.
Advise these patients of the importance of adequate hydration before, during and after the use of Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.
Administration
Oral Administration
Take with additional clear liquids after each dose according to either split-dose or day-before dose directions (see Adult Dosing)
Do not take oral medications within 1 hr of start of each dose
If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hr before and not less than 6 hr after administering prep
Do not take with other laxatives
Instruct patients to only drink clear liquids all day the day before the colonoscopy, and the next day until 2 hours before the colonoscopy; stop drinking all fluids at least 2 hr before the colonoscopy
Do not eat solid food or dairy and do not drink anything colored red or purple
Do not drink alcohol
Contra Indications
Hypersensitivity
Severe renal impairment (ie, CrCl <30 mL/minute)
GI obstruction or ileus
Bowel perforation
Toxic colitis or toxic megacolon
Gastric retention
Precautions
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use.
Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk.
Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.
Patients with mild to moderate renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing.
Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Suspected GI obstruction or perforation: Rule out diagnosis before administration.
Patients at risk for aspiration: Observe during administration.
Risk of vomiting and other GI complications with ingestion of undissolved powder: Dissolve each packet in 5 ounces of cold water and administered at separate times according to the dosing regimen
Pregnancy-Lactation
Pregnancy
No data are available regarding use in pregnant women
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats when administered at doses 1.2 times the recommended human dose based on body surface area during organogenesis
Lactation
There are no data on presence of magnesium oxide or anhydrous citric acid in either human or animal milk, effects on breastfed infant, or on milk production; published data on lactating women indicate that active metabolite of sodium picosulfate, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day; there are no data on effects of sodium picosulfate on breastfed infant or on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this drug and any potential adverse effects on breastfed infant or underlying maternal condition
Interactions
Oral medications taken within 1 hour of each dosing may be flushed from GI tract and not properly absorbed
Administer drugs prone to chelation with magnesium (eg, tetracycline, iron, digoxin) at least 2 hr before or at least 6 hr after administration
Prior or concomitant antibiotics may reduce efficacy by decreasing colonic bacteria-mediated conversion of sodium picosulfate to the active metabolite (BHPM)
Adverse Effects
Side effects of Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate :
>10%
Decreased eGFR (10-13.1%)
Increased magnesium (8.7-11.6%)
1-10%
Increased serum creatinine (1.9-4.5%)
Vomiting (3-4%)
Decreased potassium (4.7-7.3%)
Decreased sodium (1-3.7%)
Decreased chloride (1-3.7%)
Nausea (2.6-3%)
Headache (1.6-2.7%)
Mechanism of Action
The stimulant laxative activity of sodium picosulfate together with the osmotic laxative activity of magnesium citrate produces a purgative effect which, when ingested with additional fluids, produces watery diarrhea
Sodium picosulfate: Hydrolyzed by colonic bacteria to form an active metabolite, bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM); BHPM acts directly on the colonic mucosa to stimulate colonic peristalsis
Magnesium oxide and anhydrous citric acid: These 2 ingredients react to create magnesium citrate in solution, an osmotic agent that causes water to be retained within the GI tract
Note
EzyColon 12 gm + 3.5 gm + 10 mg Powder manufactured by Pharmasia Ltd.. Its generic name is Citric Acid Anhydrous + Magnesium Oxide + Sodium Picosulfate. EzyColon is availble in Bangladesh.
Farmaco BD drug index information on EzyColon Powder is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.