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OsmoPrep

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OsmoPrep

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders

Renal Disease and Acute Phosphate Nephropathy

There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal antiinflammatory drugs (NSAIDs).

Use OsmoPrep with caution in patients with impaired renal function (creatinine clearance less than 30 mL/minute), patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OsmoPrep Tablets.

Electrolyte Disorders

Advise all patients to hydrate adequately before, during, and after the use of OsmoPrep. If a patient develops significant vomiting or signs of dehydration while or after taking OsmoPrep, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. [see DOSAGE AND ADMINISTRATION]

Patients with electrolyte abnormalities should have them corrected before treatment with OsmoPrep. In addition, 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 renal impairment. [see DRUG INTERACTIONS]

Patients should not administer additional laxative or purgative agents, particularly additional sodium phosphatebased purgative or enema products.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing OsmoPrep 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). QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. OsmoPrep Tablets should be used with caution in patients who are taking medications known to prolong the QT interval, since serious complications may occur. Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

Seizures

There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate osmotic laxative products, such as OsmoPrep, 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. OsmoPrep should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].

Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering OsmoPrep. Use with caution in patients with severe active ulcerative colitis.

Inflammatory Bowel Disease

Administration of OsmoPrep Tablets may induce colonic mucosal aphthous ulcerations. In the OsmoPrep clinical program, aphthous ulcers were observed in 3% of patients who took the 48 gram OsmoPrep dosing regimen. This colonoscopic finding should be considered in patients with known or suspected inflammatory bowel disease.

Because published data suggest that sodium phosphate absorption may be enhanced in patients experiencing an acute exacerbation of chronic inflammatory bowel disease, OsmoPrep Tablets should be used with caution in such patients.

Aspiration

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of OsmoPrep.

Patient Counseling Information

[See Medication Guide]

OsmoPrep can cause serious kidney problems and or severe fluid loss. Consider performing baseline and postcolonoscopy laboratory studies (phosphate, calcium, potassium, sodium, creatinine and BUN). It is important to:

  • Instruct patients to tell their healthcare provider if they have a history of kidney disease or take medications for blood pressure, heart disease, or kidney disease.
  • Advise patients of the importance of taking the recommended fluid regimen. Advise them to hydrate adequately before, during, and after the use of OsmoPrep.
  • Instruct patients to tell their healthcare provider if they experience symptoms of dehydration.
  • Instruct patients to contact a healthcare provider if they experience a worsening of bloating, abdominal pain, nausea, vomiting, or headache.
  • Instruct patients not to take OsmoPrep with other laxatives or enemas made with sodium phosphate, because it could lead to complications.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of OsmoPrep. Studies to evaluate the possible impairment of fertility or mutagenic potential of OsmoPrep have not been performed.

Use In Specific Populations

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.

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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]. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.

Last reviewed on RxList: 10/25/2012
This monograph has been modified to include the generic and brand name in many instances.

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