Sodium Phosphate, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to cleanse the bowel before a colonoscopy. Take it exactly as directed.
• Stay close to the bathroom after you take this medicine.
• Rarely, this medicine may cause serious kidney problems, especially if you have certain health problems or are over age 65. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: bowel evacuant

Generic and brand names: sodium phosphate, oral; OsmoPrep

What is this medicine used for?

This medicine is taken by mouth to cleanse the bowel before a colonoscopy (using a flexible scope to examine the colon and bowel) in adults.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, bowel perforation, severe constipation, megacolon, or hypomotility (slow movement) syndrome
• Gastric bypass or stapling surgery
• Heart disease such as heart failure, irregular heartbeat, heart attack, or angina (chest pain)
• Imbalances of calcium, magnesium, potassium, phosphate, or sodium in your blood
• Kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Seizures
• Trouble swallowing

Tell your provider if you drink alcohol or have recently stopped drinking alcohol. Also tell your provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed without your healthcare provider's approval while taking this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine exactly as prescribed. If your healthcare provider has not given you specific instructions, follow the directions that come with the medicine package. Do not take more or take it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

You need to have a clear liquid diet for at least 12 hours before you take this medicine. Drink only clear liquids such as water, lemon-lime soda, clear soup (bouillon), ginger ale, apple juice, or Jell-O. Avoid any liquid that is red or purple in color because it might look like blood in the bowel movement.

Be sure to drink at least 8 ounces of clear liquid with each dose. You will need to take several tablets at a time. Swallow the tablets whole.

The evening before the colonoscopy, take the prescribed number of tablets with at least 8 ounces of water, apple juice, white grape juice, or colorless soda every 15 minutes until you have taken the total number of prescribed tablets that evening. The next day, at least 3 to 5 hours before the colonoscopy, take the prescribed number of tablets every 15 minutes with at least 8 ounces of clear liquid until you have taken them all.

This medicine will cause you to have several watery bowel movements until you have only clear movements. Stay close to the bathroom after you take this medicine.

Do not take other laxative products such as enemas (Fleet Enema) or liquid laxatives such as Fleet Phospho-Soda.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: weakness, dizziness, fast heartbeat, seizures.

What should I watch out for?

Rare, but serious kidney problems can happen in people who take this medicine. These problems may lead to kidney failure or the need for dialysis for a long time. These problems may happen within a few days, or several months after taking this medicine.

You are more at risk for having serious kidney problems with this medicine if you:

• Lose too much body fluid (from diarrhea, sweating, or vomiting)
• Have slow moving bowels or are constipated
• Have severe stomach pain or bloating
• Have any disease that causes bowel irritation (colitis)
• Have kidney disease
• Have heart failure
• Take water pills, certain blood pressure medicines such as ACE-inhibitors or angiotensin receptor blockers, or Nonsteroidal anti-inflammatory medicines (NSAIDs).

Your age may also affect your risk for having kidney problems with this medicine.

Be sure to drink at least 8 ounces of clear liquid with each dose. If you do not drink enough water, you may become dehydrated or not cleanse all the waste from your colon. If this happens, you may need a repeat exam.

You may see partially digested tablets in your bowel movement. This is not harmful.

You should not take more than one course of this medicine within 7 days.

Adults over the age of 65 may be at greater risk of side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Blood in bowel movement; severe vomiting; severe abdominal pain; chest pain; irregular heartbeat; severe dizziness or fainting; decreased or trouble urinating; seizures.

Other: Nausea, vomiting, abdominal bloating and discomfort, dizziness, headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), and moxifloxacin (Avelox)
• Antidepressants such as amitriptyline, imipramine (Tofranil), and nortriptyline (Pamelor)
• Antipsychotic medicines such as haloperidol (Haldol), pimozide (Orap), risperidone (Risperdal), and thioridazine
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), and quinidine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)

Tell your healthcare provider if you have recently stopped using alcohol or taking antianxiety medicines, such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), triazolam (Halcion), and lorazepam (Ativan).

Any other medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) taken close to the time that you take this medicine may not be properly absorbed. Ask your healthcare provider how and when to take any other medicines you may need.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.