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OsmoPrep
Overview
What is OsmoPrep?
OsmoPrep (sodium phosphate monobasic
monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative
used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a
highly soluble tablet binder and does not contain microcrystalline cellulose
(MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets,
debossed with “SLX” on one side of the bisect and “102” on the other side of the
bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic
monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for
a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include
polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is
gluten-free.
The structural and molecular formulae and molecular weights of the active
ingredients are shown below:
What does OsmoPrep look like?
What are the available doses of OsmoPrep?
Sorry No records found.
What should I talk to my health care provider before I take OsmoPrep?
Sorry No records found
How should I use OsmoPrep?
OsmoPrep Tablets are indicated for cleansing of the colon as a
preparation for colonoscopy in adults 18 years of age or older.
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:
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 seven 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.
What interacts with OsmoPrep?
OsmoPrep Tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy.
OsmoPrep Tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.
What are the warnings of OsmoPrep?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Administration of sodium phosphate products prior to colonoscopy
for colon cleansing has resulted in fatalities due to significant fluid shifts,
severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have
been observed in patients with renal insufficiency, in patients with bowel
perforation, and in patients who misused or overdosed sodium phosphate products.
It is recommended that patients receiving OsmoPrep be advised to adequately
hydrate before, during, and after the use of OsmoPrep.
Considerable caution should be advised before OsmoPrep Tablets are used in
patients with the following illnesses: severe renal insufficiency (creatinine
clearance less than 30 mL/minute), congestive heart failure, ascites, unstable
angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of
the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic
megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Consider performing baseline and post-colonoscopy labs (phosphate, calcium,
potassium, sodium, creatinine, and BUN) in patients who may be at increased risk
for serious adverse events, including those with history of renal insufficiency,
history of-or at greater risk of-acute phosphate nephropathy, known or suspected
electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT,
recent history of a MI and those with known or suspected hyperphosphatemia,
hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting
and/or signs of dehydration then measure post-colonoscopy labs (phosphate,
calcium, potassium, sodium, creatinine, and BUN).
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
anti-inflammatory drugs (NSAIDs).
Use OsmoPrep with caution in patients with impaired renal function, 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.
There have been rare reports of generalized tonic-clonic seizures
and/or loss of consciousness associated with use of sodium phosphate 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. 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].
There have been rare, but serious, reports of arrhythmias
associated with the use of sodium phosphate products. OsmoPrep should be used
with caution in patients with higher risk of arrhythmias (patients with a
history of cardiomyopathy, patients with prolonged QT, patients with a history
of uncontrolled arrhythmias, and patients with a recent history of a myocardial
infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients
with high risk of serious, cardiac arrhythmias.
What are the precautions of OsmoPrep?
Patients should be instructed to drink 8 ounces of clear liquids
with each 4-tablet dose of OsmoPrep Tablets. Patients should take a total of 2
quarts of clear liquids with OsmoPrep. Inadequate fluid intake, as with any
effective purgative, may lead to excessive fluid loss, hypovolemia, and
dehydration. Dehydration from purgation may be exacerbated by inadequate oral
fluid intake, vomiting, and/or use of diuretics.
Patients should be instructed not to administer additional laxative or
purgative agents, particularly additional sodium phosphate-based purgative or
enema products.
Prolongation of the QT interval has been observed in some patients who were
dosed with sodium phosphate colon preparations. 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 with known prolonged QT.
Administration of OsmoPrep Tablets may induce colonic mucosal aphthous
ulcerations, since this endoscopic finding was observed with other sodium
phosphate cathartic preparations. 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.
Medications administered in close proximity to OsmoPrep Tablets
may not be absorbed from the gastrointestinal tract due to the rapid intestinal
peristalsis and watery diarrhea induced by the purgative agent.
Long-term studies in animals have not been performed to evaluate
the carcinogenic potential of OsmoPrep. Studies to evaluate the effect of
OsmoPrep on fertility or its mutagenic potential have not been performed.
Animal reproduction studies have not been conducted with
OsmoPrep. It is not known whether OsmoPrep can cause fetal harm when
administered to a pregnant woman, or can affect reproduction capacity. OsmoPrep
Tablets should be given to a pregnant woman only if clearly needed.
The safety and efficacy of OsmoPrep Tablets have not been
demonstrated in patients less than 18 years of age.
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 ). It is
recommended that patients receiving OsmoPrep be advised to adequately hydrate
before, during, and after the use of OsmoPrep.
What are the side effects of OsmoPrep?
Abdominal bloating, abdominal pain, nausea, 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 2 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).
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.
General:
Cardiovascular:
Nervous system:
Renal:
| OsmoPrep 32 tabs (48 g)N=272 | OsmoPrep40 tabs (60 g)N=265 | Visicol40 tabs (60 g)N=268 | ||
|---|---|---|---|---|
| Bloating | 31% | 39% | 41% | |
| Nausea | 26% | 37% | 30% | |
| Abdominal Pain | 23% | 24% | 25% | |
| Vomiting | 4% | 10% | 9% |
What should I look out for while using OsmoPrep?
OsmoPrep Tablets are contraindicated in patients with
biopsy-proven acute phosphate nephropathy.
OsmoPrep Tablets are contraindicated in patients with a known allergy or
hypersensitivity to sodium phosphate salts or any of its ingredients.
Administration of sodium phosphate products prior to colonoscopy
for colon cleansing has resulted in fatalities due to significant fluid shifts,
severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have
been observed in patients with renal insufficiency, in patients with bowel
perforation, and in patients who misused or overdosed sodium phosphate products.
It is recommended that patients receiving OsmoPrep be advised to adequately
hydrate before, during, and after the use of OsmoPrep.
Considerable caution should be advised before OsmoPrep Tablets are used in
patients with the following illnesses: severe renal insufficiency (creatinine
clearance less than 30 mL/minute), congestive heart failure, ascites, unstable
angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of
the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic
megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Consider performing baseline and post-colonoscopy labs (phosphate, calcium,
potassium, sodium, creatinine, and BUN) in patients who may be at increased risk
for serious adverse events, including those with history of renal insufficiency,
history of-or at greater risk of-acute phosphate nephropathy, known or suspected
electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT,
recent history of a MI and those with known or suspected hyperphosphatemia,
hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting
and/or signs of dehydration then measure post-colonoscopy labs (phosphate,
calcium, potassium, sodium, creatinine, and BUN).
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
anti-inflammatory drugs (NSAIDs).
Use OsmoPrep with caution in patients with impaired renal function, 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.
There have been rare reports of generalized tonic-clonic seizures
and/or loss of consciousness associated with use of sodium phosphate 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. 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].
There have been rare, but serious, reports of arrhythmias
associated with the use of sodium phosphate products. OsmoPrep should be used
with caution in patients with higher risk of arrhythmias (patients with a
history of cardiomyopathy, patients with prolonged QT, patients with a history
of uncontrolled arrhythmias, and patients with a recent history of a myocardial
infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients
with high risk of serious, cardiac arrhythmias.
What might happen if I take too much OsmoPrep?
There have been no reported cases of overdosage with OsmoPrep Tablets.
Purposeful or accidental ingestion of more than the recommended dosage of
OsmoPrep Tablets might be expected to lead to severe electrolyte disturbances,
including hyperphosphatemia, hypocalcemia, hypernatremia, or hypokalemia, as
well as dehydration and hypovolemia, with attendant signs and symptoms of these
disturbances. Certain severe electrolyte disturbances resulting from overdose
may lead to cardiac arrhythmias, seizure, renal failure, and death. The patient
who has taken an overdosage should be monitored carefully, and treated
symptomatically for complications until stable.
How should I store and handle OsmoPrep?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:OsmoPrep Tablets are supplied in child-resistant bottles containing 32 tablets. Each tablet contains 1.102 g sodium phosphate monobasic monohydrate, USP and 0.398 g sodium phosphate dibasic anhydrous, USP for a total of 1.5 g of sodium phosphate per tablet.Rx only.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Discard any unused portion.Manufactured by:for:VENART-30-4/Mar. 2009Product protected by US Patent No. 5,616,346 and other pending applications.Relabeling and Repackaging by:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
OsmoPrep Tablets, a dosing regimen containing 48 grams of sodium
phosphate (32 tablets), induces diarrhea, which effectively cleanses the entire
colon. Each administration has a purgative effect for approximately 1 to 3
hours. The primary mode of action is thought to be through the osmotic effect of
sodium, causing large amounts of water to be drawn into the colon, promoting
evacuation.
Pharmacokinetic studies with OsmoPrep have not been conducted.
However, the following pharmacokinetic study was conducted with Visicol® tablets
which contain the same active ingredients (sodium phosphate) as OsmoPrep. In
addition, Visicol is administered at a dose that is 25% greater than the
OsmoPrep dose.
An open-label pharmacokinetic study of Visicol in healthy volunteers was
performed to determine the concentration-time profile of serum inorganic
phosphorus levels after Visicol administration. All subjects received the
approved Visicol dosing regimen (60 grams of sodium phosphate with a total
liquid volume of 3.6 quarts) for colon cleansing. A 30 gram dose (20 tablets
given as 3 tablets every 15 minutes with 8 ounces of clear liquids) was given
beginning at 6 PM in the evening. The 30 gram dose (20 tablets given as 3
tablets every 15 minutes with 8 ounces of clear liquids) was repeated the
following morning beginning at 6 AM.
Twenty-three healthy subjects (mean age 57 years old; 57% male and 43%
female; and 65% Hispanic, 30% Caucasian, and 4% African-American) participated
in this pharmacokinetic study. The serum phosphorus level rose from a mean (±
standard deviation) baseline of 4.0 (± 0.7) mg/dL to 7.7 (± 1.6 mg/dL), at a
median of 3 hours after the administration of the first 30-gram dose of sodium
phosphate tablets (see ). The serum phosphorus level
rose to a mean of 8.4 (± 1.9) mg/dL, at a median of 4 hours after the
administration of the second 30-gram dose of sodium phosphate tablets. The serum
phosphorus level remained above baseline for a median of 24 hours after the
administration of the initial dose of sodium phosphate tablets (range 16 to 48
hours).
Figure 1. Mean (± standard deviation) serum phosphorus
concentrations
The upper (4.5 mg/dL) and lower (2.6 mg/dL) reference limits for serum
phosphate are represented by solid bars.
Renal Insufficiency:
Hepatic Insufficiency:
Geriatric:
Gender:
Non-Clinical Toxicology
OsmoPrep Tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy.OsmoPrep Tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.
Administration of sodium phosphate products prior to colonoscopy for colon cleansing has resulted in fatalities due to significant fluid shifts, severe electrolyte abnormalities, and cardiac arrhythmias. These fatalities have been observed in patients with renal insufficiency, in patients with bowel perforation, and in patients who misused or overdosed sodium phosphate products. It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Considerable caution should be advised before OsmoPrep Tablets are used in patients with the following illnesses: severe renal insufficiency (creatinine clearance less than 30 mL/minute), congestive heart failure, ascites, unstable angina, gastric retention, ileus, acute bowel obstruction, pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome.
Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in patients who may be at increased risk for serious adverse events, including those with history of renal insufficiency, history of-or at greater risk of-acute phosphate nephropathy, known or suspected electrolyte disorders, seizures, arrhythmias, cardiomyopathy, prolonged QT, recent history of a MI and those with known or suspected hyperphosphatemia, hypocalcemia, hypokalemia, and hypernatremia. Also if patients develop vomiting and/or signs of dehydration then measure post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN).
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 anti-inflammatory drugs (NSAIDs).
Use OsmoPrep with caution in patients with impaired renal function, 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.
There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate 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. 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].
There have been rare, but serious, reports of arrhythmias associated with the use of sodium phosphate products. OsmoPrep should be used with caution in patients with higher risk of arrhythmias (patients with a history of cardiomyopathy, patients with prolonged QT, patients with a history of uncontrolled arrhythmias, and patients with a recent history of a myocardial infarction). Pre-dose and post-colonoscopy ECGs should be considered in patients with high risk of serious, cardiac arrhythmias.
Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Patients should be instructed to drink 8 ounces of clear liquids with each 4-tablet dose of OsmoPrep Tablets. Patients should take a total of 2 quarts of clear liquids with OsmoPrep. Inadequate fluid intake, as with any effective purgative, may lead to excessive fluid loss, hypovolemia, and dehydration. Dehydration from purgation may be exacerbated by inadequate oral fluid intake, vomiting, and/or use of diuretics.
Patients should be instructed not to administer additional laxative or purgative agents, particularly additional sodium phosphate-based purgative or enema products.
Prolongation of the QT interval has been observed in some patients who were dosed with sodium phosphate colon preparations. 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 with known prolonged QT.
Administration of OsmoPrep Tablets may induce colonic mucosal aphthous ulcerations, since this endoscopic finding was observed with other sodium phosphate cathartic preparations. 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.
Medications administered in close proximity to OsmoPrep Tablets may not be absorbed from the gastrointestinal tract due to the rapid intestinal peristalsis and watery diarrhea induced by the purgative agent.
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of OsmoPrep. Studies to evaluate the effect of OsmoPrep on fertility or its mutagenic potential have not been performed.
Animal reproduction studies have not been conducted with OsmoPrep. It is not known whether OsmoPrep can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. OsmoPrep Tablets should be given to a pregnant woman only if clearly needed.
The safety and efficacy of OsmoPrep Tablets have not been demonstrated in patients less than 18 years of age.
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 ). It is recommended that patients receiving OsmoPrep be advised to adequately hydrate before, during, and after the use of OsmoPrep.
Abdominal bloating, abdominal pain, nausea, 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 2 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).
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.
General:
Cardiovascular:
Nervous system:
Renal:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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