Generic Name: sodium phosphates (SOE-dee-um FOS-fates)
Brand Name: Examples include OsmoPrep and Visicol
There have been rare reports of serious kidney problems in patients using oral sodium phosphate medicines. This usually occurred within days after taking OsmoPrep; however, some cases occurred up to several months after use. Some patients developed permanent kidney problems, and some required long-term dialysis.
The risk of severe kidney problems may be increased in patients who:
- are elderly
- are constipated
- are dehydrated
- have kidney problems
- have heart failure
- have certain stomach or bowel problems. Examples include:
- slow-moving or blocked bowels
- severe stomach pain or bloating
- take medicines that may affect kidney function. Examples include:
- certain heart or blood pressure medicines
- nonsteroidal anti-inflammatory drugs (NSAIDs)
Some patients who did not have risk factors also developed severe kidney problems.
Follow the directions provided by your doctor for using OsmoPrep. Do not take any other laxatives or bowel cleansing medicines (especially those that contain sodium phosphate) while you use OsmoPrep. Discuss any questions or concerns with your doctor.
OsmoPrep is used for:
Cleansing the bowel before certain medical procedures in certain patients. It may also be used for other conditions as determined by your doctor.
OsmoPrep is a saline laxative. It works by pulling water from the body into the bowel, which helps to soften the stool and cause a bowel movement.
Do NOT use OsmoPrep if:
- you are allergic to any ingredient in OsmoPrep
- you have had a kidney biopsy that shows you have kidney problems caused by too much phosphate in the blood (acute phosphate nephropathy)
- you have certain uncorrected blood electrolyte problems (eg, high phosphate or sodium levels, low potassium or calcium levels)
- you have stomach or bowel blockage or certain other bowel problems (eg, perforation, toxic colitis, toxic megacolon)
- you have had stomach surgery involving stapling or bypass
- you are using other laxatives or bowel cleansing products
- you have taken OsmoPrep or another laxative with sodium phosphate in it within the past 7 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using OsmoPrep:
Some medical conditions may interact with OsmoPrep. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have decreased kidney function, other kidney problems (eg, kidney or bladder infection, kidney stones), or fluid or electrolyte problems, or if you are dehydrated or on a low-salt (sodium) diet
- if you have a history of kidney problems caused by too much phosphate in the blood (acute phosphate nephropathy)
- if you have a narrow esophagus; have problems with gastric reflux; have trouble swallowing or are at risk of aspiration (inhaling foreign matter into the airway or lungs); have nausea, vomiting, or stomach pain; have fluid buildup in the abdomen (ascites); or have a sudden change in bowel movements that lasts longer than 2 weeks
- if you have a history of stomach or bowel problems (eg, colitis, inflammatory bowel disease [IBD], chronic constipation, slow-moving or blocked bowels) or stomach or bowel surgery (eg, colostomy)
- if you have a history of seizures, high blood pressure, irregular heartbeat (eg, QT prolongation), chest pain (eg, angina) or other heart problems (eg, congestive heart failure, heart muscle problems, recent heart attack), or heart surgery (eg, cardiac bypass graft surgery)
- if you drink alcohol or you are having withdrawal symptoms from stopping alcohol or benzodiazepines (eg, diazepam)
- if you take any medicine that may increase the risk of seizures, irregular heartbeat, or kidney problems. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of these problems
Some MEDICINES MAY INTERACT with OsmoPrep. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), angiotensin receptor blockers (eg, losartan), diuretics (eg, furosemide, hydrochlorothiazide), or NSAIDs (eg, ibuprofen, naproxen) because the risk of kidney problems may be increased
- Tricyclic antidepressants (eg, amitriptyline) because the risk of seizures may be increased
- Other laxatives or bowel cleansing products (especially those containing sodium phosphate) because they may increase the risk of OsmoPrep's side effects
- Seizure medicines (eg, carbamazepine, phenytoin) because their effectiveness may be decreased by OsmoPrep
This may not be a complete list of all interactions that may occur. Ask your health care provider if OsmoPrep may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use OsmoPrep:
Use OsmoPrep as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- OsmoPrep comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get OsmoPrep refilled.
- Drink a full glass (8 oz [240 mL]) of water or other clear liquid (eg, flavored water, lemonade without pulp, ginger ale, apple juice) with each dose of OsmoPrep. Do not drink any purple or red liquids.
- Drinking extra fluids before, during, and after taking OsmoPrep is recommended. Check with your doctor for instructions.
- Do not repeat a course of OsmoPrep for at least 7 days after you use OsmoPrep.
- If you also take other medicines, they may not work as well while you are taking OsmoPrep. Check with your doctor to see how you should take your other medicines during treatment with OsmoPrep.
- If you miss a dose of OsmoPrep or are unable to complete the course of treatment, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use OsmoPrep.
Important safety information:
- OsmoPrep may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use OsmoPrep with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. This may cause serious side effects.
- You may notice undigested or partially digested tablets of OsmoPrep in your stool. This is normal and not a cause for concern.
- Do not use any other laxative products or enemas, especially those containing sodium phosphates, while you are using OsmoPrep.
- You will need to take care not to become dehydrated while you are using OsmoPrep. Contact your doctor for instructions. Tell your doctor if you experience severe or persistent vomiting or symptoms of dehydration (eg, dizziness, headache, sluggishness, unusually dry mouth or eyes, weakness) while you are using OsmoPrep or after you take it.
- OsmoPrep may increase the risk of severe kidney problems in certain patients. Discuss any questions or concerns with your doctor.
- Lab tests, including kidney function, heart function, and blood electrolyte levels, may be performed while you use OsmoPrep. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use OsmoPrep with caution in the ELDERLY; they may be more sensitive to its effects.
- OsmoPrep should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using OsmoPrep while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you are using OsmoPrep, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of OsmoPrep:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Mild stomach pain; nausea; stomach bloating; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling of the lips or tongue; fainting; irregular heartbeat; seizures; severe or persistent nausea or vomiting; severe or persistent stomach bloating, cramping, or pain; symptoms of dehydration (eg, dizziness, headache, sluggishness, unusually dry mouth or eyes, weakness); symptoms of kidney problems (eg, decreased urination; swelling of the ankles, feet, or legs); wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; symptoms of blood electrolyte problems (eg, irregular heartbeat; muscle aches, cramps, pain, spasms, or weakness; numbness or tingling of the lips, tongue, fingers, or feet; seizures) or symptoms of dehydration (eg, dizziness, headache, sluggishness, unusually dry mouth or eyes, weakness).Proper storage of OsmoPrep:
Store OsmoPrep at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Discard any unused medicine that remains after use. Keep OsmoPrep out of the reach of children and away from pets.
- If you have any questions about OsmoPrep, please talk with your doctor, pharmacist, or other health care provider.
- OsmoPrep is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take OsmoPrep or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about OsmoPrep. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to OsmoPrep. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using OsmoPrep.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.