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OsmoPrep

Last reviewed on RxList: 1/4/2019
OsmoPrep Side Effects Center

Last reviewed on RxList 01/04/2019

OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) is a laxative used to treat constipation and to clean the bowel before surgery, x-rays, endoscopy, or other intestinal procedures. OsmoPrep enemas are also used for general care after surgery and to help relieve impacted bowels. OsmoPrep is available in generic form. Common side effects of OsmoPrep include:

  • nausea,
  • vomiting,
  • stomach/abdominal pain or bloating,
  • dizziness,
  • headache, or
  • tightness in your throat.

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 as directed by a physician. OsmoPrep may interact with arsenic trioxide, diuretics (water pills), droperidol, narcotics, antibiotics, antidepressants, anti-malaria medications, NSAIDs (nonsteroidal anti-inflammatory drugs), medicines to treat psychiatric disorders, medicine to prevent or treat nausea and vomiting, migraine headache medicines, heart or blood pressure medications, or heart rhythm medicines. Tell your doctor all medications you use. During pregnancy, OsmoPrep should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

OsmoPrep Consumer Information

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

Stop using this medicine and call your doctor at once if you have:

  • headache, dizziness, vomiting, little or no urinating;
  • fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements;
  • fast, slow, or uneven heart rate;
  • seizure (black-out or convulsions); or
  • no bowel movement after use.

Common side effects may include:

  • bloating, nausea, or mild stomach discomfort.

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 entire detailed patient monograph for OsmoPrep (Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous)

OsmoPrep Professional Information

SIDE EFFECTS

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

  • Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders [see WARNINGS AND PRECAUTIONS]
  • Cardiac Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Use in Patients with Significant Gastrointestinal Disease [see WARNINGS AND PRECAUTIONS]
  • Colonic Mucosal Ulceration and Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
  • Aspiration [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 practice.

The safety of OsmoPrep was evaluated in two randomized, investigator-blinded, active controlled trials in 931 adult patients undergoing elective colonoscopy. The mean age of the study population was 60 years (range 20 to 89 years), 88% of patients were Caucasian and 55% were female [see Clinical Studies].

Table 1 shows the most common adverse reactions reported in greater than 3% of patients by treatment group in Study 1 [see Clinical Studies]. Since diarrhea was considered as a part of the efficacy of OsmoPrep, diarrhea was not defined as an adverse event in this clinical trial.

Table 1: Common Adverse Reactions1 in Patients Undergoing Colonoscopy in Study 1

  OsmoPrep 32 tabs (48 g)
N=272
OsmoPrep 40 tabs (60 g)
N=265
Sodium Phosphate2 40 tabs (60 g)
N=268
Bloating 31% 39% 41%
Nausea 26% 37% 30%
Abdominal Pain 23% 24% 25%
Vomiting 4% 10% 9%
1 Reported in more than 3% of patients in at least one treatment group
2 Another oral formulation of sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous

Electrolyte Abnormalities In Study 1

Hyperphosphatemia

A total of, 96%, 96%, and 93% of patients who took 60 grams of oral sodium phosphate, 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 oral sodium phosphate, 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.

Hyperkalemia

A total of 20%, 22%, and 18% of patients who took 60 grams of oral sodium phosphate, 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 oral sodium phosphate, 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.

Several patients on all three sodium phosphate regimens developed hypocalcemia and hypernatremia that did not require treatment.

The OsmoPrep 60-gram dosage regimen was associated with an increased risk of adverse reactions compared to the 48gram dosage regimen and a similar overall response rate [see Clinical Studies]. Therefore, the OsmoPrep 60-gram dosage is not a recommended regimen [see DOSAGE AND ADMINISTRATION].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of OsmoPrep. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions: anaphylaxis, angioedema (swelling of the lips, tongue and face), rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea, pharyngeal edema, dysphagia, and paresthesia.

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)

Related Resources for OsmoPrep

Read the OsmoPrep User Reviews »

© 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.

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