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Abdominal bloating, abdominal pain, nausea, and vomiting were the most common adverse events reported with the use of OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets. Dizziness and headache were reported less frequently. Since diarrhea was considered as a part of the efficacy of OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) , 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 monobasic monohydrate and sodium phosphate dibasic anhydrous) , 60 grams of OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) , and 60 grams of Visicol in the colon preparation trials (n= 931).

Table 2: Frequency of Adverse Events of Any Severity Occurring in Greater Than 3% of Patients in the OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) 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 (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) . 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 monobasic monohydrate and sodium phosphate dibasic anhydrous) , or a combination of these factors.

General

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.

Drug Abuse And Dependence

Laxatives and purgatives (including OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) ) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.

Medications administered in close proximity to OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets may not be absorbed from the gastrointestinal tract due to the rapid intestinal peristalsis and watery diarrhea induced by the purgative agent.

Last reviewed on RxList: 9/15/2009
This monograph has been modified to include the generic and brand name in many instances.