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Visicol

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Visicol

Visicol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous) 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. It contains forms of phosphorus. Common side effects include nausea, vomiting, stomach/abdominal pain or bloating, dizziness, and headache.

The recommended dose of Visicol Tablets for colon cleansing for adult patients is a total of 40 tablets (60 grams of sodium phosphate) taken orally over the course of 2 days, with a total of 3.6 quarts of clear liquids, following doctor's instructions. Visicol 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, medicines to prevent or treat nausea and vomiting, heart or blood pressure medications, or heart rhythm medicines. Tell your doctor all medications and supplements you use. During pregnancy, Visicol should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Visicol (sodium phosphate monobasic monohydrate, 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.

Visicol 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 Visicol (Sodium Phosphate Monobasic Monohydrate, Sodium Phosphate Dibasic Anhydrous) »

What is Patient Information Overview?

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

Visicol Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your 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 Visicol (Sodium Phosphate Monobasic Monohydrate, Sodium Phosphate Dibasic Anhydrous)»

What is Prescribing information?

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

Visicol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In the phase 3 Visicol trials, bloating, nausea, abdominal pain, and vomiting were the most common drug-related adverse events reported with the use of Visicol (see Table 2). Since diarrhea was considered as a part of the efficacy of Visicol diarrhea was not defined as an adverse event in the clinical trials. Small superficial mucosal ulcerations, typical of those previously reported from the use of liquid preparations of sodium phosphate, and instances of mucosal bleeding have been observed on colonoscopy.

No patient in the clinical studies developed predefined postural changes in vital signs with concomitant symptoms of lightheadedness or syncope.

Table 2: Frequency of Drug-related* Adverse Events ( ≥ 2%) of Patients in the Phase 3 Visicol Trials (Studies A and B)

  Visicol
%=n/N
N=427
NuLYTELY®
%=n/N
N=432
Bloating
47%
61%
Nausea
35%
54%
Abdominal Pain
30%
36%
Vomiting
7%
18%
* Drug-related were adverse events possibly or probably drug-related

Electrolyte Changes

In Visicol trials, changes in serum electrolytes (including phosphate, calcium, potassium, and sodium) have been observed in patients taking Visicol Tablets.

In the Visicol phase 3 trials, 96% and < 1% of patients who took Visicol (60 grams) and NuLYTELY (up to 4 liters), respectively, developed hyperphosphatemia (defined as phosphate level > 4.7 mg/dL) on the day of the colonoscopy. In these trials, patients who took Visicol and NuLYTELY had baseline mean phosphate levels of 3.3 and 3.4 mg/dL and subsequently developed on the day of the colonoscopy mean phosphate levels of 7.1, and 3.3 mg/dL, respectively.

Two to three days after colonoscopy, 34%, 66%, and 0% of patients who received Visicol had (reactive) hypophosphatemia (defined as phosphate level < 2.4 mg/dL), normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, 3%, 96%, and 1% of patients who received NuLYTELY had (reactive) hypophosphatemia normal phosphate levels, and hyperphosphatemia, respectively. Two to three days after colonoscopy, patients who took Visicol and NuLYTELY had mean phosphate levels of 2.6 and 3.3 mg/dL, respectively.

In the Visicol phase 3 trials, 47% and 9% of patients who took Visicol and NuLYTELY, respectively, developed hypocalcemia (defined as calcium level < 8.6 mg/dL) on the day of the colonoscopy. The mean changes in calcium levels (from baseline) for the Visicol and NuLYTELY patients were -0.6 and -0.1 mg/dL, respectively. Furthermore, in these trials, 28% and 3% of patients who took Visicol and NuLYTELY, respectively, developed hypokalemia (defined as potassium level < 3.5 mEq/L) on the day of the colonoscopy. The mean changes in potassium levels (from baseline) for the Visicol and NuLYTELY patients were -0.5 and -0.1 mEq/L, respectively. None of the patients who developed hypocalcemia or hypokalemia in the trials required treatment.

Postmarketing 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.

The following adverse events have been identified during post-approval use of Visicol. 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 Visicol, 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

Read the entire FDA prescribing information for Visicol (Sodium Phosphate Monobasic Monohydrate, Sodium Phosphate Dibasic Anhydrous) »

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Visicol - User Reviews

Visicol 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 Visicol 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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