OsmoPrep (Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous)
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OsmoPrep (Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous)

OsmoPrep®
(sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP)

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]

It is important to use the dose and dosing regimen as recommended (pm/am split dose). [see DOSAGE AND ADMINISTRATION]

DRUG DESCRIPTION

OsmoPrep (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is an osmotic laxative 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:

  • Sodium phosphate monobasic monohydrate, USP

Sodium phosphate monobasic monohydrate Structural Formula Illustration

Molecular Formula: NaH2PO4• H2O
Molecular Weight: 137.99

  • Sodium phosphate dibasic anhydrous, USP

Sodium phosphate dibasic anhydrous Structural Formula Illustration

Molecular Formula: Na2HPO4
Molecular Weight: 141.96

OsmoPrep Tablets are for oral administration only.

What are the possible side effects of sodium biphosphate and sodium phosphate (Fleet Enema, Fleet Enema for Children, OsmoPrep, Visicol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium biphosphate and sodium phosphate and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding;
  • no bowel movement after use;
  • sores or ulcers around your rectum;
  • seizure (black-out or convulsions);
  • fast, slow, or uneven heart rate;
  • urinating less than...

Read All Potential Side Effects and See Pictures of OsmoPrep »

What are the precautions when taking sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous (OsmoPrep)?

See also How to Use section.

Before taking sodium phosphate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart failure, irregular heartbeat, QT prolongation in the EKG, chest pain, heart attack or heart surgery within the last 3 months), stomach/abdominal problems (such as blockage, severe constipation), gastric bypass/stapling, irritable bowel disease/colitis, low blood minerals, severe loss of body water (dehydration), kidney problems, liver problems (such as...

Read All Potential Precautions of OsmoPrep »

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

INDICATIONS

OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

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 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.

HOW SUPPLIED

Dosage Forms And Strengths

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.

Storage And Handling

NDC 65649-701-41, multi-dose, child-resistant bottle containing 100 tablets.

Each bottle contains two silica desiccant packets, which should not be ingested.

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: WellSpring Pharmaceutical Canada Corp., Oakville, Ontario Canada L6H 1M5. for: Salix Pharmaceuticals, Inc. Raleigh, NC 27615. Revised: October/2012

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

SIDE EFFECTS

Clinical Studies 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%

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.

Read the OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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] in patients taking these concomitant medications.

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.

Drug Abuse And Dependence

Laxatives and purgatives (including OsmoPrep) have the potential for abuse by patients who frequently engage in binge eating and vomiting to lose weight.

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

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.

OVERDOSE

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.

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].

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

CLINICAL PHARMACOLOGY

Mechanism of Action

OsmoPrep Tablets, a dosing regimen containing 48 grams of sodium phosphate (32 tablets), induces diarrhea. 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.

Pharmacokinetics

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 Figure 1). 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

Mean (±standard deviation) serum phosphorus concentrations - Illustration

The upper (4.5 mg/dL) and lower (2.6 mg/dL) reference limits for serum phosphate are represented by solid bars.

Special Populations

Renal Insufficiency: The effect of renal dysfunction on the pharmacokinetics of OsmoPrep Tablets has not been studied. Since the inorganic form of phosphate in the circulating plasma is excreted almost entirely by the kidneys, patients with renal disease may have difficulty excreting a large phosphate load. Thus, OsmoPrep Tablets should be used with caution in patients with impaired renal function. [see WARNINGS AND PRECAUTIONS]

Hepatic Insufficiency: OsmoPrep Tablets have not been investigated in patients with hepatic failure.

Geriatric: In a single pharmacokinetic study of sodium phosphate tablets, which included 6 elderly volunteers, plasma half-life increased two-fold in subjects > 70 years of age compared to subjects < 50 years of age (3 subjects and 5 subjects, respectively).

Gender: No difference in serum phosphate AUC values were observed in the single pharmacokinetic study conducted with sodium phosphate tablets in 13 male and 10 female healthy volunteers.

Clinical Studies

The colon cleansing efficacy and safety of OsmoPrep 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 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 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 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 60 gram and 48 gram treatment groups demonstrated non-inferiority compared to Visicol. See Table 2 for the results.

Table 2: Phase 3 Study – Overall Colon Content Cleansing Response Rates1

Treatment Arm (grams of sodium phosphate) No. of tablets taken at 6 PM on the day prior to colonoscopy No. of tablets taken the next day2 Excellent Good Fair Inadequate Overall Response Rate (Excellent or Good)
OsmoPrep 32 tabs (48 g) n=236 20 12 76% 19% 3% 2% 95%
OsmoPrep 40 tabs (60 g) n=233 20 20 73% 24% 2% 1% 97%
Visicol 40 tabs (60 g) n=235 20 20 51% 43% 6% 0% 94%
1 Colon-cleansing efficacy was based on response rate to treatment. A patient was considered to be a responder if overall colon leansing was rated as “excellent” or “good” on a 4-point scale based on the amount of retained “colonic contents”. Excellent was defined as > 90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good was defined as > 90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. Fair was defined as > 90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed. Inadequate was defined as < 90% of mucosa n, mixture of semisolid and solid stool which could not be suctioned or washed.
2 On the day of the colonoscopy, study medication was taken 3 to 5 hours before the start of the colonoscopy.

Electrolyte Changes

In the OsmoPrep clinical studies, expected serum electrolyte changes (including phosphate, calcium, potassium, and sodium levels) have been observed in patients taking OsmoPrep.

In the OsmoPrep phase 3 study, 96%, 96%, and 93% of patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hyperphosphatemia (defined as phosphate level > 5.1 mg/dL) on the day of the colonoscopy. In this study, patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep had baseline mean phosphate levels of 3.5, 3.5, and 3.6 mg/dL and subsequently developed mean phosphate levels of 7.6, 7.9, and 7.1 mg/dL, respectively, on the day of the colonoscopy.

In the OsmoPrep phase 3 study, 20%, 22%, and 18% of patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep, respectively, developed hypokalemia (defined as a potassium level < 3.4 mEq/L) on the day of the colonoscopy. In this study, patients who took 60 grams of Visicol, 60 grams of OsmoPrep, and 48 grams of OsmoPrep all had baseline potassium levels of about 4.3 mEq/L and then developed a mean potassium level of 3.7 mEq/L on the day of the colonoscopy. In the OsmoPrep phase 3 trial, several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.

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

PATIENT INFORMATION

Medication Guide

OsmoPrep®
(AhZ-MO-prep)
(sodium phosphate monobasic monohydrate, and sodium phosphate dibasic anhydrous,) Tablets

Read this Medication Guide before you start taking OsmoPrep each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about OsmoPrep?

OsmoPrep can cause serious side effects, including:

Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OsmoPrep, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking OsmoPrep.

Conditions that can make you more at risk for having serious kidney problems with OsmoPrep include if you:

  • lose too much body fluid (dehydration)
  • have slow moving bowels
  • have bowels blocked with stool (constipation)
  • have severe stomach pain or bloating
  • have any disease that causes bowel inflammation (colitis)
  • have kidney disease or kidney problems
  • have heart failure
  • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Your age may also affect your risk for having kidney problems with OsmoPrep.

Before you start taking OsmoPrep, tell your doctor if you:

  • have kidney problems
  • take any medicines for blood pressure, heart disease, or kidney disease.

Severe fluid loss and severe changes in body salts in the blood (electroytes). People who take medicines that contain sodium phosphate can have severe loss of body fluid, with severe changes in body salts in the blood. These changes can be serious and can cause:

  • abnormal heart rhythms
  • seizures
  • kidney problems

Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking OsmoPrep:

  • vomiting
  • dizziness
  • urinating less often than normal
  • headache

See “What are the possible side effects of OsmoPrep?” for more information about side effects.

What is OsmoPrep?

OsmoPrep is a prescription medicine used in adults 18 years and older to clean your colon before a colonoscopy. OsmoPrep cleans your colon by causing you to have diarrhea. Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.

It is not known if OsmoPrep is safe and effective in children under age 18.

Who should not take OsmoPrep?

Do not take OsmoPrep if:

  • you have had a kidney biopsy that shows you have kidney problems because of too much phosphate.
  • impairment of the bowels or bowel function
  • had stomach surgery involving stapling or bypass
  • significant irritation of the bowels such as toxic megacolon
  • you are allergic to sodium phosphate salts or any of the ingredients in OsmoPrep. See the end of this Medication Guide for a list of ingredients in OsmoPrep.

What should I tell my doctor before taking OsmoPrep?

Before you take OsmoPrep, tell your doctor if you:

  • have kidney problems
  • have heart problems
  • have a history of seizures
  • have had stomach surgery
  • have stomach or bowel problems
  • have ulcerative colitis
  • have problems with swallowing or gastric reflux
  • drink alcohol or are withdrawing from alcohol use
  • have any other medical conditions
  • are on a low salt diet
  • are pregnant. It is not known if OsmoPrep will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breast-feed. It is not known if OsmoPrep passes into your breast milk. You and your doctor should decide if you will take OsmoPrep while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

OsmoPrep may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of OsmoPrep.

Especially tell your doctor if you take:

  • water pills (diuretics)
  • medicines for blood pressure or heart problems
  • medicines for kidney problems
  • medicines for pain, such as aspirin or a non-steroidal anti-inflammatory drug (NSAID)
  • medicine for seizures
  • a laxative for constipation in the last 7 days. You should not take another medicine that contains sodium phosphate while you take OsmoPrep.

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor or pharmacist when you get a new prescription.

How should I take OsmoPrep?

  • Take OsmoPrep exactly as prescribed by your doctor.
  • It is important for you to drink clear liquids before, during, and after taking OsmoPrep. This may help prevent kidney damage. 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.

You must read, understand, and follow these instructions to take OsmoPrep the right way:

On the evening before your colonoscopy, you will take a total of 20 OsmoPrep tablets, as follows:

  1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
  2. Wait 15 minutes.
  3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
  4. Repeat steps 2 and 3 above, three more times. Make sure you wait 15 minutes after each time.

On the day of your colonoscopy, you will take a total of 12 OsmoPrep tablets, starting about 3 to 5 hours before your colonoscopy, as follows:

  1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
  2. Wait 15 minutes.
  3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
  4. Repeat steps 2 and 3 one more time.

If you take too much OsmoPrep, call your doctor or get medical help right away.

What should I avoid while taking OsmoPrep?

  • You should not take other laxatives or enemas made with sodium phosphate, while taking OsmoPrep.
  • You should not use OsmoPrep if you have already used it in the last 7 days.

What are the possible side effects of OsmoPrep?

OsmoPrep can cause serious side effects, including:

  • See “What is the most important information I should know about OsmoPrep?”
  • Changes in your blood tests. Your doctor may do blood tests after you take OsmoPrep to check your levels of calcium, phosphate, potassium, sodium in your blood. Tell your doctor if you have any symptoms of too much fluid loss, including:
    • vomiting
    • nausea
  • Abnormal heart beat (arrhythmias)
  • Seizures or fainting (black-outs). People who take a medicine that contains sodium phosphate, such as OsmoPrep, can have seizures or faint (become unconscious) even if they have not had seizures before. Tell your doctor right away if you have a seizure or faint while taking OsmoPrep.
  • Inflammatory bowel disease.

The most common side effects of OsmoPrep are:

  • bloating
  • stomach (abdominal) pain
  • nausea
  • vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OsmoPrep. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store OsmoPrep?

  • Store OsmoPrep at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Throw away any OsmoPrep that is not needed.

Keep OsmoPrep and all medicines out of the reach of children.

General information about OsmoPrep.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OsmoPrep for a condition for which it was not prescribed. Do not give OsmoPrep to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about OsmoPrep. If you would like more information about OsmoPrep, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information, call 1-866-669-7597 (toll-free) or go to www.Salix.com.

What are the ingredients in OsmoPrep?

Active ingredients: sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous

Inactive ingredients: polyethylene glycol 8000 and magnesium stearate OsmoPrep is gluten-free.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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

>

PATIENT INFORMATION

Medication Guide

OsmoPrep®
(AhZ-MO-prep)
(sodium phosphate monobasic monohydrate, and sodium phosphate dibasic anhydrous,) Tablets

Read this Medication Guide before you start taking OsmoPrep each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about OsmoPrep?

OsmoPrep can cause serious side effects, including:

Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OsmoPrep, to clean the colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking OsmoPrep.

Conditions that can make you more at risk for having serious kidney problems with OsmoPrep include if you:

  • lose too much body fluid (dehydration)
  • have slow moving bowels
  • have bowels blocked with stool (constipation)
  • have severe stomach pain or bloating
  • have any disease that causes bowel inflammation (colitis)
  • have kidney disease or kidney problems
  • have heart failure
  • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Your age may also affect your risk for having kidney problems with OsmoPrep.

Before you start taking OsmoPrep, tell your doctor if you:

  • have kidney problems
  • take any medicines for blood pressure, heart disease, or kidney disease.

Severe fluid loss and severe changes in body salts in the blood (electroytes). People who take medicines that contain sodium phosphate can have severe loss of body fluid, with severe changes in body salts in the blood. These changes can be serious and can cause:

  • abnormal heart rhythms
  • seizures
  • kidney problems

Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking OsmoPrep:

  • vomiting
  • dizziness
  • urinating less often than normal
  • headache

See “What are the possible side effects of OsmoPrep?” for more information about side effects.

What is OsmoPrep?

OsmoPrep is a prescription medicine used in adults 18 years and older to clean your colon before a colonoscopy. OsmoPrep cleans your colon by causing you to have diarrhea. Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.

It is not known if OsmoPrep is safe and effective in children under age 18.

Who should not take OsmoPrep?

Do not take OsmoPrep if:

  • you have had a kidney biopsy that shows you have kidney problems because of too much phosphate.
  • impairment of the bowels or bowel function
  • had stomach surgery involving stapling or bypass
  • significant irritation of the bowels such as toxic megacolon
  • you are allergic to sodium phosphate salts or any of the ingredients in OsmoPrep. See the end of this Medication Guide for a list of ingredients in OsmoPrep.

What should I tell my doctor before taking OsmoPrep?

Before you take OsmoPrep, tell your doctor if you:

  • have kidney problems
  • have heart problems
  • have a history of seizures
  • have had stomach surgery
  • have stomach or bowel problems
  • have ulcerative colitis
  • have problems with swallowing or gastric reflux
  • drink alcohol or are withdrawing from alcohol use
  • have any other medical conditions
  • are on a low salt diet
  • are pregnant. It is not known if OsmoPrep will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
  • are breastfeeding or plan to breast-feed. It is not known if OsmoPrep passes into your breast milk. You and your doctor should decide if you will take OsmoPrep while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

OsmoPrep may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of OsmoPrep.

Especially tell your doctor if you take:

  • water pills (diuretics)
  • medicines for blood pressure or heart problems
  • medicines for kidney problems
  • medicines for pain, such as aspirin or a non-steroidal anti-inflammatory drug (NSAID)
  • medicine for seizures
  • a laxative for constipation in the last 7 days. You should not take another medicine that contains sodium phosphate while you take OsmoPrep.

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor or pharmacist when you get a new prescription.

How should I take OsmoPrep?

  • Take OsmoPrep exactly as prescribed by your doctor.
  • It is important for you to drink clear liquids before, during, and after taking OsmoPrep. This may help prevent kidney damage. 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.

You must read, understand, and follow these instructions to take OsmoPrep the right way:

On the evening before your colonoscopy, you will take a total of 20 OsmoPrep tablets, as follows:

  1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
  2. Wait 15 minutes.
  3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
  4. Repeat steps 2 and 3 above, three more times. Make sure you wait 15 minutes after each time.

On the day of your colonoscopy, you will take a total of 12 OsmoPrep tablets, starting about 3 to 5 hours before your colonoscopy, as follows:

  1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
  2. Wait 15 minutes.
  3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
  4. Repeat steps 2 and 3 one more time.

If you take too much OsmoPrep, call your doctor or get medical help right away.

What should I avoid while taking OsmoPrep?

  • You should not take other laxatives or enemas made with sodium phosphate, while taking OsmoPrep.
  • You should not use OsmoPrep if you have already used it in the last 7 days.

What are the possible side effects of OsmoPrep?

OsmoPrep can cause serious side effects, including:

  • See “What is the most important information I should know about OsmoPrep?”
  • Changes in your blood tests. Your doctor may do blood tests after you take OsmoPrep to check your levels of calcium, phosphate, potassium, sodium in your blood. Tell your doctor if you have any symptoms of too much fluid loss, including:
    • vomiting
    • nausea
  • Abnormal heart beat (arrhythmias)
  • Seizures or fainting (black-outs). People who take a medicine that contains sodium phosphate, such as OsmoPrep, can have seizures or faint (become unconscious) even if they have not had seizures before. Tell your doctor right away if you have a seizure or faint while taking OsmoPrep.
  • Inflammatory bowel disease.

The most common side effects of OsmoPrep are:

  • bloating
  • stomach (abdominal) pain
  • nausea
  • vomiting

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OsmoPrep. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store OsmoPrep?

  • Store OsmoPrep at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Throw away any OsmoPrep that is not needed.

Keep OsmoPrep and all medicines out of the reach of children.

General information about OsmoPrep.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OsmoPrep for a condition for which it was not prescribed. Do not give OsmoPrep to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about OsmoPrep. If you would like more information about OsmoPrep, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information, call 1-866-669-7597 (toll-free) or go to www.Salix.com.

What are the ingredients in OsmoPrep?

Active ingredients: sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous

Inactive ingredients: polyethylene glycol 8000 and magnesium stearate OsmoPrep is gluten-free.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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

Disclaimer

OsmoPrep Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

SODIUM PHOSPHATE MONOBASIC/DIBASIC - ORAL

(SOE-dee-um FOS-fate MAW-no-BAY-sik/dye-BAY-sik)

COMMON BRAND NAME(S): OsmoPrep

WARNING: Rarely, serious kidney problems have occurred with the use of this product. Kidney disease, bowel problems such as colitis or obstruction, severe loss of body water (dehydration), or being older than 55 years can increase the risk. Taking certain medications that can affect the kidneys (see Drug Interactions section) can also increase the risk. If any of these cautions apply to you, talk with your doctor before using this drug. Drink plenty of clear fluids to help prevent dehydration.

USES: This medication is used to clean out the intestines before a colonoscopy. Sodium phosphate is a laxative that works by drawing large amounts of water into the colon, causing you to have watery bowel movements. This cleans out the intestines so that your doctor can clearly view them during your colonoscopy.

This medication should not be used for weight loss or constipation due to the possibility of severe side effects.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Your doctor should tell you how long before the procedure you should take this product. Follow your doctor's directions closely. If you are uncertain about any of the information, consult your doctor or pharmacist.

Follow any special dietary instructions given by your doctor. A period of not eating is usually recommended before you start taking this medication and lasting until after the colonoscopy. Only clear liquids are allowed during this time.

The evening before your colonoscopy, take 4 tablets with at least 8 ounces (240 milliliters) of clear liquid by mouth every 15 minutes or as directed by your doctor. Repeat this dose and the liquids every 15 minutes until you have taken 5 doses (20 tablets). The next day, start taking the medication 3-5 hours before the colonoscopy. Take 4 tablets every 15 minutes with liquids as directed until you have taken 3 doses (12 tablets).

Dosage is based on your medical condition, procedure, and response to treatment. Do not use a higher dose or more often than directed by your doctor.

Do not use any other laxative products (especially sodium phosphate) while taking this product or for 7 days after treatment is finished. Doing so may increase your risk for severe side effects.

Watery bowel movements usually begin 1 hour after you start to take the tablets. The bowel movements can be very large and watery. Drink as many clear liquids as you can before, during, and after taking this medication so that you do not lose too much body water (become dehydrated). Doing so will help prevent serious side effects (such as kidney problems). Consult your doctor or pharmacist for more information.

The watery bowel movements from sodium phosphate may decrease the absorption of your regular medicines. Consult your doctor or pharmacist about how to minimize this effect.

Contact your doctor if you do not have a bowel movement within 3 hours after taking this medication.

Disclaimer

OsmoPrep Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, stomach/abdominal pain or bloating, dizziness, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: black/bloody stools.

Seek immediate medical attention if any of these rare but serious side effects occur: fast/irregular heartbeat, chest pain, fainting, mental mood changes (such as confusion, unusual drowsiness), seizures.

Persistent diarrhea or vomiting may result in a serious loss of body water (dehydration) and minerals. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, muscle weakness/cramping, or pale/wrinkled skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also How to Use section.

Before taking sodium phosphate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart failure, irregular heartbeat, QT prolongation in the EKG, chest pain, heart attack or heart surgery within the last 3 months), stomach/abdominal problems (such as blockage, severe constipation), gastric bypass/stapling, irritable bowel disease/colitis, low blood minerals, severe loss of body water (dehydration), kidney problems, liver problems (such as cirrhosis, fluid build-up in the abdomen), salt restricted diet, daily alcohol or sedative use, seizure problem, swallowing problems (such as narrowing of the swallowing tube/ esophagus).

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially kidney problems, dehydration, and irregular heartbeat.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

OsmoPrep Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may affect the kidneys (including ACE inhibitors such as lisinopril, ARBs such as valsartan, diuretics/"water pills" such as furosemide/hydrochlorothiazide, NSAIDs such as ibuprofen/naproxen).

Sodium phosphate can rarely increase the risk of an abnormal heart rhythm (QT prolongation in the EKG) from certain medications. These drugs include amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. QT prolongation can infrequently result in a serious (rarely fatal) irregular heartbeat. Consult your doctor or pharmacist for more details and for instructions on how you may minimize the risk of this effect.

Also report the use of drugs which might increase seizure risk when combined with sodium phosphate such as isoniazid (INH), phenothiazines (such as thioridazine), and tricyclic antidepressants (such as amitriptyline), among others. Consult your doctor or pharmacist for details.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting sodium phosphate.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood mineral levels, EKG, kidney function) may be performed to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: This medication should be used as scheduled. If you miss a dose, contact your doctor or pharmacist for instructions. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

OsmoPrep Patient Information Including Side Effects

Brand Names: Fleet Enema, Fleet Enema for Children, OsmoPrep, Visicol

Generic Name: sodium biphosphate and sodium phosphate (Pronunciation: SOE dee um bye FOS foe nate and SOE dee um FOS fate)

What is sodium biphosphate and sodium phosphate (OsmoPrep)?

Sodium biphosphate and sodium phosphate are forms of phosphorus, which is a naturally occurring substance that is important in every cell in the body.

Sodium biphosphate and sodium phosphate is used to treat constipation and to clean the bowel before surgery, x-rays, endoscopy, or other intestinal procedures. Sodium biphosphate and sodium phosphate enemas are also used for general care after surgery and to help relieve impacted bowels.

Sodium biphosphate and sodium phosphate may also be used for purposes not listed in this medication guide.

What are the possible side effects of sodium biphosphate and sodium phosphate (OsmoPrep)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium biphosphate and sodium phosphate and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding;
  • no bowel movement after use;
  • sores or ulcers around your rectum;
  • seizure (black-out or convulsions);
  • fast, slow, or uneven heart rate;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; or
  • swelling, weight gain, feeling short of breath.

Less serious side effects may include:

  • bloating, stomach pain;
  • tightness in your throat;
  • dizziness; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about sodium biphosphate and sodium phosphate (OsmoPrep)?

You should not use this medication if you have used it within the past 7 days, or if you have kidney disease, dehydration, or an electrolyte imbalance (such as high or low levels of potassium, sodium, phosphorous, or magnesium in your blood).

If you have any these conditions, you could have dangerous or life-threatening side effects on your kidneys from taking sodium biphosphate and sodium phosphate.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before using sodium biphosphate and sodium phosphate, tell your doctor about all of your medical conditions, especially heart disease, liver disease, recent stomach surgery, a bowel perforation or obstruction, colitis or inflammatory bowel disease, seizures, if you are older than 56 years, if you are on a low-salt diet, or if you have recently had a heart attack or recovered from drug or alcohol addiction.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Never use the medication in larger amounts, or for longer than recommended.

When using this medication in a child, use only the forms that are specially made for children.

Side Effects Centers

OsmoPrep Patient Information including How Should I Take

What should I discuss with my healthcare provider before using sodium biphosphate and sodium phosphate (OsmoPrep)?

You should not use this medication if you have used it within the past 7 days, or if you have:

  • kidney disease (or if you are on dialysis);
  • dehydration; or
  • an electrolyte imbalance (such as high or low levels of potassium, sodium, phosphorous, or magnesium in your blood).

If you have any these conditions, you could have dangerous or life-threatening side effects on your kidneys from taking sodium biphosphate and sodium phosphate.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure you can safely use sodium biphosphate and sodium phosphate, tell your doctor if you have any of these other conditions:

  • congestive heart failure;
  • liver problems such as cirrhosis, or ascites (fluid around your liver);
  • unstable angina (chest pain);
  • a heart rhythm disorder (such as "Long-QT syndrome");
  • a history of recent heart attack, heart surgery, or bypass surgery;
  • a history of gastric bypass surgery or stomach stapling;
  • a bowel obstruction or severe constipation;
  • trouble swallowing;
  • a perforated bowel;
  • inflammatory bowel disease, colitis or toxic megacolon;
  • epilepsy or other seizure disorder;
  • a recent history of drug or alcohol addiction withdrawal.
  • if you have ongoing vomiting or diarrhea, or if you are sweating more than usual;
  • if you are older than 56 years; or
  • if you are on a low-salt diet.

FDA pregnancy category C. It is not known whether sodium biphosphate and sodium phosphate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sodium biphosphate and sodium phosphate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use sodium biphosphate and sodium phosphate (OsmoPrep)?

Use exactly as directed on the label, or as prescribed by your doctor. Never use this medication in larger or smaller amounts or for longer than recommended.

To keep from getting dehydrated, drink a full glass (8 ounces) of water or other clear liquid each time you use this medication. You may be instructed not to drink or eat anything before your medical test. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours after using this medicine.

If you take the tablet form of this medicine, you will most likely start taking it the evening before your colonoscopy, and finish taking it on the day of your colonoscopy.

For best results, take the oral liquid on an empty stomach when you first get out of bed, at least 30 minutes before eating. You may also take the medicine at bedtime. In most cases, it will work overnight.

Measure the oral liquid and mix it with one-half glass (4 oz) of cool water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

When using this medication in a child, use only the forms that are specially made for children.

  • Fleet Enema For Children can be used in children from 2 to 11 years old.
  • Never use an adult-strength sodium biphosphate and sodium phosphate enema in a child younger than 12 years old.
  • Do not use the enema to treat a child younger than 2 years of age without the advice of a doctor.
  • Fleet Phospho-Soda oral liquid can be given to children who are at least 5 years old.
  • Do not give the oral solution to a child younger than 5 years of age without the advice of a doctor.
  • Do not give the oral tablet (Visicol) to a child younger than 18 years old.

Do not take the rectal enema by mouth. It is for use only in your rectum.

To use the enema, lie down on your left side with your knees bent.

Remove the cap from the applicator tip and gently insert the tip into your rectum. Slowly squeeze the bottle to empty the contents into the rectum.

For best results, stay lying down until you feel the urge to have a bowel movement. This should occur within 2 to 15 minutes in most cases.

If you do not get any results after using sodium biphosphate and sodium phosphate, call your doctor before using another dose. Using too much of this medication in 24 hours can be harmful. Do not use sodium biphosphate and sodium phosphate for longer than 1 week unless your doctor has told you to.

Store at room temperature away from moisture and heat. Throw away any leftover medicine after your treatment ends.

To be sure this medication has not caused harmful effects, your doctor may want to test your blood and check your kidney function in the days after your colonoscopy. Do not miss any follow-up visits to your doctor.

Side Effects Centers

OsmoPrep Patient Information including If I Miss a Dose

What happens if I miss a dose (OsmoPrep)?

Call your doctor for instructions if you miss a dose or do not finish all doses required before your colonoscopy.

Do not use more than the recommended dose of this medication in any 24-hour period.

What happens if I overdose (OsmoPrep)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, or fainting.

What should I avoid while using sodium biphosphate and sodium phosphate (OsmoPrep)?

Do not use other laxatives while using this medication, unless your doctor has told you to.

What other drugs will affect sodium biphosphate and sodium phosphate (OsmoPrep)?

Tell your doctor about all other medications you use, especially:

  • arsenic trioxide (Trisenox);
  • a diuretic (water pill);
  • droperidol (Inapsine);
  • narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Vicodin), hydromorphone (Dilaudid), levomethadyl (Orlaam), methadone (Dolophine, Methadose) methadone (Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Percocet), propoxyphene (Darvocet, Darvon), and others;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);
  • anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
  • migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig);
  • heart or blood pressure medication such as benazepril (Lotensin), candesartan (Atacand), captopril (Capoten), eprosartan (Teveten), fosinopril (Monopril), enalapril (Vasotec), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar); quinapril (Accupril), telmisartan (Micardis), valsartan (Diovan), and others; or
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan, Pronestyl), quinidine (Cardioquin, Quinaglute), or sotalol (Betapace).

This list is not complete and other drugs may interact with sodium biphosphate and sodium phosphate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about sodium biphosphate and sodium phosphate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

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