Surprising Benefits of Sodium Picosulfate Liquid You Wont Believe What Happens Next
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 and pediatric patients 9 years of age and older.
• Correct fluid and electrolyte abnormalities before administration of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution [see Warnings and Precautions ( 5.1)].
• Two doses (one packet per dose) of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution are required for a complete preparation for colonoscopy either as a Split-Dose (preferred) or Day-Before dosing regimen.
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• 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, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2)].
• 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 Dosage and Administration ( 2.3)].
• Each packet of sodium picosulfate, magnesium oxide and anhydrous citric acid must be dissolved in 5 ounces of cold water prior to ingestion and administered according to the dosing regimen. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration and electrolyte disturbances [see Warnings and Precautions ( 5.8)].
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• Additional fluids must be consumed after every dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in both dosing regimens [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.1)].
• Consume only clear fluids (no solid food) from the start of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution treatment until after the colonoscopy.
• Do not take oral medications within one hour before or after starting sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.
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• If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution [see Drug Interactions ( 7.2)].
1. Reconstitute the sodium picosulfate, magnesium oxide and anhydrous citric acid powder immediately 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 sodium picosulfate, magnesium oxide and anhydrous citric acid powder.
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3. Stir for 2 to 3 minutes. The reconstituted sodium picosulfate, magnesium oxide and anhydrous citric acid solution may become slightly warm as the powder dissolves.
The Split-Dose regimen is the preferred dosing method. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses (one packet per dose) in conjunction with fluids.
• Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy.
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• Take the first dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM).
• Follow sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution by drinking at least five 8-ounce cups of clear liquids (40 ounces total), using the upper line on the cup, within 5 hours and before bed.
• Following the sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose, drink at least three 8-ounce cups of clear liquids (24 ounces), using the upper line on the cup, at least 2 hours before the colonoscopy.
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The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses (one packet per dose) in conjunction with fluids
• Take the first dose of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in the afternoon or early evening before the colonoscopy (e.g., 4:00 to 6:00 PM).
• Following the sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose, drink at least five 8-ounce cups of clear liquids (40 ounces total), using the upper line on the cup, within 5 hours and before the next dose.
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• Following the sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose, drink at least three 8-ounce cups (24 ounces), using the upper line on the cup, of clear liquids within 5 hours and before bed.
Reconstitute immediately before use. Do not prepare the solution in advance or store the solution for later use. Do not refrigerate or add ice to the solution.
For oral solution: Each of the two packets contains 10 mg of sodium picosulfate, 3.5 g of magnesium oxide and 12 g of anhydrous citric acid in 16.1g of powder for orange flavor.
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• Patients with severe renal impairment (creatinine clearance less than 30 mL/minute) which may result in accumulation of magnesium [see Warnings and Precautions ( 5.4)]
• Hypersensitivity to any of the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution [see Adverse Reactions ( 6.2)]
Advise patients to hydrate adequately before, during, and after the use of sodium picosulfate, magnesium oxide and anhydrous citric acid. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking sodium picosulfate, magnesium oxide and anhydrous citric acid, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Approximately 20% of adult patients in both arms (sodium picosulfate, magnesium oxide and anhydrous citric acid, 2L of PEG + E plus two x 5 mg bisacodyl tablets) of clinical trials of sodium picosulfate, magnesium oxide and anhydrous citric acid had orthostatic changes (changes in blood pressure and/or heart rate) on the day of colonoscopy. In adult clinical trials orthostatic changes were documented up to seven days post colonoscopy. In a single study of patients 9 to 16 years of age, approximately 20% of patients in sodium picosulfate, magnesium oxide and anhydrous citric acid arms had orthostatic changes (changes in blood pressure and/or heart rate) compared with approximately 7% of those who received the comparator (PEG) [see Clinical Studies ( 14)]. These changes occurred up to five days post colonoscopy.
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Fluid and electrolyte disturbances can lead to serious adverse reactions including cardiac arrhythmias or seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with sodium picosulfate, magnesium oxide and anhydrous citric acid [see Dosage and Administration ( 2.1)] . In addition, use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients who have conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or that may increase the risk of adverse events of seizure, arrhythmia, and renal impairment [see Drug Interactions ( 7.1)].
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
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Use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Adverse Reactions ( 6.2)].
Sodium picosulfate, magnesium oxide and anhydrous citric acid is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), accumulation of magnesium in plasma may occur [see Contraindications ( 4)]. As with other magnesium containing bowel preparations, use caution when prescribing sodium picosulfate, magnesium oxide and anhydrous citric acid for patients with mild to moderate renal impairment or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory ) [see Drug Interactions ( 7.1)]. These patients may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of sodium picosulfate, magnesium oxide and anhydrous citric acid. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.
Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of
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