Osmoprep Information
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate)
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Description
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) (sodium phosphate monobasic
monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a
purgative used to clean the colon prior to colonoscopy. Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) is
manufactured with a highly soluble tablet binder and does not contain
microcrystalline cellulose (MCC). Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) is gluten-free.
The structural and molecular formulae and molecular weights of
the active ingredients are shown below:
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets are for oral administration only.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Clinical Pharmacology
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) have not been
conducted. However, the following pharmacokinetic study was
conducted with Visicol® tablets which contain the same
active ingredients (sodium phosphate) as Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) . In addition,
Visicol is administered at a dose that is 25% greater
than the Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Clinical Studies
The colon cleansing efficacy and safety of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) was evaluated
in 2 randomized, investigator-blinded, actively controlled, multicenter,
U.S. trials in patients scheduled to have an elective colonoscopy. The
trials consisted of a dose ranging and a confirmatory phase 3
study.
In the phase 3 trial, patients were randomized into one of the
following three sodium phosphate treatment groups: 1) Visicol containing
60 grams of sodium phosphate given in split doses (30 grams in the
evening before the colonoscopy and 30 grams on the next day) with at
least 3.6 quarts of clear liquids; 2) Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) containing 60 grams of
sodium phosphate given in split doses (30 grams in the evening before
the colonoscopy and 30 grams on the next day) with 2.5 quarts of clear
liquids; and 3) Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) containing 48 grams of sodium phosphate (30
grams in the evening before the colonoscopy and 18 grams on the next
day) with 2 quarts of clear liquids. Patients were instructed to eat a
light breakfast before noon on the day prior to the colonoscopy and then
were told to drink only clear liquids after noon on the day prior to the
colonoscopy.
The primary efficacy endpoint was the overall colon cleansing
response rate in the 4-point Colonic Contents Scale. Response was
defined as a rating of “excellent” or
“good” on the 4-point scale as determined by the
blinded colonoscopist. This phase 3 study was planned to assess the
non-inferiority of the two Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) groups compared to the Visicol
group.
The efficacy analysis included 704 adult patients who had an
elective colonoscopy. Patients ranged in age from 21 to 89 years old
(mean age 56 years old) with 55% female and 45% male
patients. Race was distributed as follows: 87% Caucasian,
10% African American, and 3% other race. The Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 60
gram and 48 gram treatment groups demonstrated non-inferiority compared
to Visicol. See Table 1 for the results.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Indications And Usage
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets are indicated for cleansing of the colon as a
preparation for colonoscopy in adults 18 years of age or
older.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Contraindications
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets are contraindicated in patients with
biopsy-proven acute phosphate nephropathy.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets are contraindicated in patients with a known
allergy or hypersensitivity to sodium phosphate salts or any of its
ingredients.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Warnings
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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) be advised to adequately hydrate before, during, and
after the use of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) .
Considerable caution should be advised before Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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).
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Precautions
Patients should be instructed to drink 8 ounces of clear
liquids with each 4-tablet dose of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets. Patients
should take a total of 2 quarts of clear liquids with Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) .
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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets may induce colonic
mucosal aphthous ulcerations, since this endoscopic finding was
observed with other sodium phosphate cathartic preparations. In
the Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) clinical program, aphthous ulcers were observed in
3% of patients who took the 48 gram Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate)
Tablets should be used with caution in such
patients.
In controlled colon preparation trials of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) . Of the 49
patients 75 years old or older in the trials, 27 (55%)
patients received at least 48 grams of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) . 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) administration. The mean colonoscopy-day phosphate
levels in patients 18-64, 65-74, and ≥ 75 years old
who received 48 grams of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) be advised to adequately
hydrate before, during, and after the use of
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) .
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Adverse Reactions
Abdominal bloating, abdominal pain, nausea, and vomiting were the
most common adverse events reported with the use of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets.
Dizziness and headache were reported less frequently. Since diarrhea was
considered as a part of the efficacy of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , 60 grams of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , and 60 grams of Visicol in the colon
preparation trials (n=931).
In addition to adverse events reported from clinical trials, the
following adverse events have been identified during post-approval use
of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) . 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , or a combination of these
factors.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Drug Abuse And Dependence
Laxatives and purgatives (including Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) ) have the potential
for abuse by bulimia nervosa patients who frequently have binge eating
and vomiting.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Overdosage
There have been no reported cases of overdosage with Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate)
Tablets. Purposeful or accidental ingestion of more than the recommended
dosage of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Dosage And Administration
The recommended dose of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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 (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) be advised to adequately hydrate before, during, and after the
use of Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) .
Patients should not use Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) 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.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) How Supplied
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Tablets are supplied in child-resistant bottles
containing 100 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.
Each bottle contains two silica desiccant packets, which should
not be ingested.
NDC 65649-701-41 (100 tablet bottle)
Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F) [See USP Controlled Room
Temperature]. Discard any unused portion.
VENART-30-4/Mar. 2009
Product protected by US Patent No. 5,616,346 and other pending
applications.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) Medication Guide
Read the Medication Guide that comes with Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) before you
take it and each time you take it. This Medication Guide does not take
the place of talking with your doctor about your medical condition or
your treatment. If you have any questions about Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate) , ask your
doctor or pharmacist.
Osmoprep (Sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate)
