Data from FDA - Curated by EPG Health - Last updated 02 June 2018

Indication(s)

1 INDICATIONS AND USAGE OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. OsmoPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS OsmoPrep Tablets are contraindicated in the following conditions: •Biopsy-proven acute phosphate nephropathy •Gastrointestinal (GI) obstruction •Gastric bypass or stapling surgery •Bowel perforation •Toxic colitis •Toxic megacolon Known allergy or hypersensitivity to sodium phosphate salts or any component of OsmoPrep [see Description (11)]. •Biopsy-proven acute phosphate nephropathy (4) •Gastrointestinal (GI) obstruction (4) •Gastric bypass or stapling surgery (4) •Bowel perforation (4) •Toxic colitis (4) •Toxic megacolon (4) •Hypersensitivity to any components of OsmoPrep (4)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥3%) are abdominal bloating, abdominal pain, nausea, and vomiting (6) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Abdominal bloating, nausea, abdominal pain, and vomiting were the most common adverse events reported with the use of OsmoPrep Tablets. Dizziness and headache were reported less frequently. Since diarrhea was considered as a part of the efficacy of OsmoPrep, diarrhea was not defined as an adverse event in the clinical studies. Table 1 shows the most common adverse events associated with the use of 48 grams of OsmoPrep, 60 grams of OsmoPrep, and 60 grams of Visicol in the colon preparation trials (n= 931). Table 1: Frequency of Adverse Events of Any Severity Occurring in Greater Than 3% of Patients in the OsmoPrep Trials OsmoPrep 32 tabs (48 g) N=272 OsmoPrep 40 tabs (60 g) N=265 Visicol® 40 tabs (60 g) N=268 Bloating 31% 39% 41% Nausea 26% 37% 30% Abdominal Pain 23% 24% 25% Vomiting 4% 10% 9% 6.2 Postmarketing Experience In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of OsmoPrep. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to OsmoPrep, or a combination of these factors. Body as a Whole: Hypersensitivity reactions including anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, paresthesia and swelling of the lips and tongue, and facial swelling. Cardiovascular: Arrhythmias Nervous system: Seizures Renal: Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dose of OsmoPrep Tablets for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate) taken orally with a total of 2 quarts of clear liquids in the following manner: The evening before the colonoscopy: Take 4 OsmoPrep Tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets. On the day of the colonoscopy: Starting 3-5 hours before the procedure, take 4 OsmoPrep Tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets. Examples of clear liquids are water, flavored water, lemonade (no pulp), ginger ale or apple juice. Do not drink any liquids colored purple or red. Patients should be advised of the importance of taking the recommended fluid regimen. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep. Patients should not use OsmoPrep for colon cleansing within 7 days of previous administration. No additional enema or laxative is required, and patients should be advised NOT to take additional agents, particularly those containing sodium phosphate. •Evening before colonoscopy: Four tablets with 8 ounces of clear liquids every 15 minutes for a total of 20 tablets (2) •Next morning: Four tablets with 8 ounces of clear liquids every 15 minutes for a total of 12 tablets (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS •Pregnancy: No human or animal data. Use only if clearly needed. (8.1) •Use with caution in patients with renal disease (5.1) 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with OsmoPrep. It is also not known whether OsmoPrep can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. OsmoPrep should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OsmoPrep is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use In controlled colon preparation trials of OsmoPrep, 228 (24%) of 931 patients were 65 years of age or older. In addition, 49 (5%) of the 931 patients were 75 years of age or older. Of the 228 geriatric patients in the trials, 134 patients (59%) received at least 48 grams of OsmoPrep. Of the 49 patients 75 years old or older in the trials, 27 (55%) patients received at least 48 grams of OsmoPrep. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. However, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after OsmoPrep administration. The mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received 48 grams of OsmoPrep in the phase 3 study were 7.0, 7.3, and 8.0 mg/dL, respectively. In addition, in all three sodium phosphate treatment groups, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old in the phase 3 study were 7.4, 7.9, and 8.0 mg/dL, respectively, after sodium phosphate administration. Greater sensitivity of some older individuals cannot be ruled out; therefore, OsmoPrep Tablets should be used with caution in geriatric patients. Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Warnings and Precautions (5)]. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when OsmoPrep is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS •Some drugs increase risks due to fluid and electrolyte changes (7.1) •Oral medication taken within 1 hour of start of each dose might not be absorbed properly (7.2) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing OsmoPrep for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5)] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of each OsmoPrep dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

More information

Category Value
Authorisation number NDA021892
Agency product number 593YOG76RN
Orphan designation No
Product NDC 65649-701
Date Last Revised 01-07-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 603011
Marketing authorisation holder Salix Pharmaceuticals, Inc.
Warnings WARNING See full prescribing information for complete boxed warning. There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions (5)]. It is important to use the dose and dosing regimen as recommended (pm/am split dose)[see Dosage and Administration (2)]. WARNING See full prescribing information for complete boxed warning. There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions (5)]. It is important to use the dose and dosing regimen as recommended (pm/am split dose)[see Dosage and Administration (2)].