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OsmoPrep

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OsmoPrep

OsmoPrep

OsmoPrep Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) is 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. It is a laxative. This medication is available in generic form. Common side effects include nausea, vomiting, stomach/abdominal pain or bloating, dizziness, and headache.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

OsmoPrep in Detail - Patient Information: Side Effects

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

OsmoPrep Overview - Patient Information: Side Effects

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.

Persistent diarrhea or vomiting may result in a serious loss of body water (dehydration) and minerals. This may cause serious side effects to the kidneys and heart. 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.

Tell your doctor right away if you have any serious side effects, including: severe or persistent stomach/abdominal pain, black/bloody stools, rectal bleeding, mental/mood changes (such as confusion, unusual drowsiness).

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, chest pain, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 entire patient information overview for OsmoPrep (Sodium Phosphate Monobasic Monohydrate and Sodium Phosphate Dibasic Anhydrous)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

OsmoPrep FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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OsmoPrep - User Reviews

OsmoPrep User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication OsmoPrep sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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