Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous

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.

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.

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

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 entire FDA prescribing information for OsmoPrep (Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous)

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© OsmoPrep Patient Information is supplied by Cerner Multum, Inc. and OsmoPrep Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.