Included as part of the PRECAUTIONS section.
Renal Disease, Acute Phosphate Nephropathy, And Electrolyte
Renal Disease And Acute Phosphate Nephropathy
been rare, but serious, reports of renal failure, acute phosphate nephropathy,
and nephrocalcinosis in patients who received oral sodium phosphate products,
including OsmoPrep, 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 anti-inflammatory drugs (NSAIDs) [see DRUG INTERACTIONS].
Bowel preparations, including OsmoPrep can cause fluid
and electrolyte disturbances, which can lead to serious adverse reactions
including cardiac arrhythmias, seizures and renal impairment [see ADVERSE
- OsmoPrep is contraindicated in patients with a history of
acute phosphate nephropathy [see CONTRAINDICATIONS]. Use OsmoPrep with
caution in patients with severe renal impairment (creatinine clearance less
than 30 mL/minute), with conditions, or who are taking medications, that
increase the risk for fluid and electrolyte disturbances or may increase the
risk of arrhythmias, seizures, or renal impairment. Consider performing
baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium,
creatinine, and BUN) in these patients [see DRUG INTERACTIONS].
- Correct electrolyte abnormalities such as hypernatremia,
hyperphosphatemia, hypokalemia, or hypocalcemia before treatment with OsmoPrep [see DOSAGE AND ADMINISTRATION].
- Avoid additional sodium phosphate-based purgative or
enema products [see DRUG INTERACTIONS].
- Advise all patients to hydrate adequately before, during,
and after the use of OsmoPrep [see DOSAGE AND ADMINISTRATION].
- If a patient develops significant vomiting or signs of
dehydration while or after taking OsmoPrep, consider performing
post-colonoscopy lab tests [electrolytes, creatinine, and blood urea nitrogen
There have been rare reports of serious arrhythmias
associated with the use of ionic osmotic laxative products for bowel
preparation. QT prolongation with sodium phosphate tablets has been associated
with electrolyte imbalances, such as hypokalemia and hypocalcemia.
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) and those taking medications known
to prolong the QT interval, since serious complications may occur. Consider pre-dose
and post-colonoscopy ECGs s in patients at increased risk of serious cardiac
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.
Use OsmoPrep with caution in patients with a history of
seizures and in patients at higher risk of seizure, such as patients taking
medications that lower the seizure threshold (such as tricyclic
antidepressants), patients withdrawing from alcohol or benzodiazepines, or
patients with known or suspected hyponatremia [see DRUG INTERACTIONS].
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 [see CONTRAINDICATIONS].
Use with caution in patients with severe active
Colonic Mucosal Ulceration And Inflammatory Bowel Disease
Osmotic laxatives, including OsmoPrep, may induce colonic
mucosal aphthous ulcerations. In the OsmoPrep clinical program, aphthous ulcers
were observed in 3% of patients who took the recommended OsmoPrep dosing
regimen. Consider the potential for mucosal ulcerations resulting from bowel
preparation when interpreting colonoscopic finding should in patients with
known or suspected inflammatory bowel disease.
Use OsmoPrep with caution in patients experiencing an
acute exacerbation of chronic inflammatory bowel disease as published data
suggest that sodium phosphate absorption may be enhanced in such patients.
Patients with impaired gag reflex or other swallowing
abnormalities are at risk for regurgitation or aspiration of OsmoPrep. Observed
these patients during administration of OsmoPrep.
OsmoPrep may cause serious hypersensitivity reactions
including anaphylaxis, angioedema, rash, urticaria, and throat tightness [see
ADVERSE REACTIONS]. Inform patients of the signs and symptoms of
anaphylaxis and instruct them to seek immediate medical care should signs and
Patient Counseling Information
Advise the patient to read the FDA-approved patient
labeling (Medication Guide).
- On the importance of taking the recommended fluid
regimen. Advise them to hydrate adequately with clear liquids before, during,
and after the use of OsmoPrep [see DOSAGE AND ADMINISTRATION, WARNINGS
AND PRECAUTIONS]. Examples of clear liquids can be found in the Medication
- Two doses of OsmoPrep are required for a complete
preparation for colonoscopy.
- Do not eat or drink alcohol, milk, anything colored red
or purple or any other foods containing pulp material.
- Not to take other laxatives or enemas made with sodium
phosphate while they are taking OsmoPrep [see DRUG INTERACTIONS].
- Not to take oral medications within one hour before or
after starting each dose of OsmoPrep [see DRUG INTERACTIONS].
- To contact their healthcare provider if they develop
significant vomiting or signs of dehydration after taking OsmoPrep or if they
experience cardiac arrhythmias or seizures [see WARNINGS AND PRECAUTIONS].
- To seek immediate medical care should signs and symptoms
of a hypersensitivity reaction occur [see WARNINGS AND PRECAUTIONS].
No Information provided
Use In Specific Populations
There are no available data on sodium phosphate use in
pregnant women to inform a drug-associated risk for adverse developmental
Animal reproduction studies have not been conducted with
The estimated background risk of major birth defects and
miscarriage for the indicated population is unknown. All pregnancies have a
background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,
There are no data available to assess the presence of
sodium phosphate in human milk, the effects of the drug on the breastfed
infant, or the effects of the drug on milk production.
The lack of clinical data during lactation precludes a
clear determination of the risk of OsmoPrep to a child during lactation;
therefore, the developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for OsmoPrep and any potential
adverse effects on the breastfed child from OsmoPrep or from the underlying
Safety and effectiveness in pediatric patients have not
Of the 599 patients in clinical trials receiving at least
48 grams of OsmoPrep, 134 (22%) were 65 years of age or older, while 27 (5%)
were 75 years of age or older.
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 the
recommended OsmoPrep dosage regimen in Study 1were 7.0, 7.3, and 8.0 mg/dL,
respectively. After OsmoPrep administration, the mean phosphate levels in
patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dL,
respectively. Greater sensitivity of some older individuals cannot be ruled
out; therefore, use OsmoPrep with caution in geriatric patients. Advise
geriatric patients to adequately hydrate before, during, and after the use of
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].
Sodium phosphate is substantially excreted by the kidney.
Use OsmoPrep with caution in patients with severe renal impairment (creatinine
clearance less than 30 mL/min) or patients taking concomitant medications that
may affect renal function. These patients may be at risk for renal injury. Advise
these patients of the importance of adequate hydration before, during and after
the use of OsmoPrep, and consider performing baseline and post-colonoscopy labs
(phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see
WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].