Medication Guide

OsmoPrep® (AhZ-MŌ-prěp) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets

Read the Medication Guide that comes with OsmoPrep before you take it and each time you take it. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about OsmoPrep, ask your doctor or pharmacist.

What is the most important information I should know about OsmoPrep?

OsmoPrep can cause serious side effects, including:

Serious kidney problems. Rare, but serious kidney problems can happen in people who take medicines made with sodium phosphate, including OsmoPrep, to clean your colon before colonoscopy. These kidney problems can sometimes lead to kidney failure or the need for dialysis for a long time. These problems often happen within a few days, but sometimes may happen several months after taking OsmoPrep.  

Conditions that can make you more at risk for having serious kidney problems with OsmoPrep include if you:

• lose too much body fluid (dehydration)
• have slow moving bowels
• have bowels blocked with stool (constipation)
• have severe stomach pain or bloating
• have any disease that causes bowel irritation (colitis)
• have kidney disease
• have heart failure
• take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

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

Before you start taking OsmoPrep tell your doctor if you:

• have kidney problems.
• take any medicines for blood pressure, heart disease, or kidney disease.

Severe fluid loss. People who take medicines that contain sodium phosphate can have severe loss of body fluid, with severe changes in body salts in the blood, and abnormal heart rhythms. These problems can lead to death.

Tell your doctor if you have any of these symptoms of loss of too much body fluid (dehydration) while taking OsmoPrep:

• vomiting
• dizziness
• urinating less often than normal
• headache

See “What are the possible side effects of OsmoPrep?” for more information about side effects.

What is OsmoPrep?

OsmoPrep is a prescription medicine used in adults 18 years and older, to clean your colon before a colonoscopy. OsmoPrep cleans your colon by causing you to have diarrhea.  Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.

It is not known if OsmoPrep is safe and works in children under age 18.

Who should not take OsmoPrep?
Do not take OsmoPrep if:

• you have had a kidney biopsy that shows you have kidney problems because of too much phosphate
• you are allergic to sodium phosphate salts or any of the ingredients in OsmoPrep. See the end of this Medication Guide for a list of ingredients in OsmoPrep.

What should I tell my doctor before taking OsmoPrep?
Before taking OsmoPrep, tell your doctor about all of your medical conditions, including if you have:

• any of the medical conditions listed in the section “What is the most important information I should know about OsmoPrep?"
• irritation of the bowel (colitis). OsmoPrep can cause symptoms of irritable bowel disease to flare-up.
• damage to your bowels
• problems with abnormal heart beat
• had a recent heart attack or have other heart problems
• symptoms of too much body fluid loss (dehydration) including vomiting, dizziness, urinating less often than normal, or headache)
• had stomach surgery
• a history of seizures
• if you drink alcohol
• are on a low salt diet
• are pregnant. It is not known if OsmoPrep will harm your unborn baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Any medicine that you take close to the time that you take OsmoPrep may not work as well. Especially tell your doctor if you take:

• water pills (diuretics)
• medicines for blood pressure or heart problems
• medicines for kidney damage
• medicines for pain, such as aspirin or a non-steroidal anti-inflammatory drug (NSAID)
• a medicine for seizures
• a laxative for constipation in the last 7 days. You should not take another medicine that contains sodium phosphate while you take OsmoPrep.

Ask your doctor if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor or pharmacist when you get a new prescription.

How should I take OsmoPrep?

• Take OsmoPrep exactly as prescribed by your doctor.
• It is important for you to drink clear liquids before, during, and after taking OsmoPrep. This may help prevent kidney damage. Examples of clear liquids are water, flavored water, lemonade (no pulp), ginger ale or apple juice. Do not drink any liquids colored purple or red.

You must read, understand, and follow these instructions to take OsmoPrep the right way:

On the evening before your colonoscopy you will take a total of 20 OsmoPrep tablets, as follows:   

1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
2. Wait 15 minutes.
3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
4. Repeat steps 2 and 3 above, three more times. Make sure you wait 15 minutes after each time.

On the day of your colonoscopy you will take a total of 12 OsmoPrep tablets, starting about 3 to 5 hours before your colonoscopy, as follows: 

1. Take 4 OsmoPrep tablets with 8 ounces of clear liquids.
2. Wait 15 minutes.
3. Take 4 more OsmoPrep tablets with 8 ounces of clear liquids.
4. Repeat steps 2 and 3 one more time.

Tell your doctor if you have any of these symptoms while taking OsmoPrep:

• vomiting, dizziness, or if you urinate less often than normal. These may be signs that you have lost too much fluid while taking OsmoPrep.
• trouble drinking clear fluids
• severe stomach cramping, bloating, nausea, or headache.

If you take too much OsmoPrep, call your doctor or get medical help right away.

What should I avoid while taking OsmoPrep?

• You should not take other laxatives or enemas made with sodium phosphate, while taking OsmoPrep.
• You should not use OsmoPrep if you have already used it in the last 7 days.

What are the possible side effects of OsmoPrep?

OsmoPrep can cause serious side effects, including:

 

• See “What is the most important information I should know about OsmoPrep?”
• Seizures or fainting (black-outs). People who take a medicine that contains sodium phosphate, such as OsmoPrep, can have seizures or faint (become unconscious) even if they have not had seizures before. Tell your doctor right away if you have a seizure or faint while taking OsmoPrep
• Abnormal heart beat (arrhythmias)
• changes in your blood levels of calcium, phosphate, potassium, sodium

The most common side effects of OsmoPrep are:

• bloating
• stomach area (abdominal) pain
• nausea
• vomiting

These are not all the possible side effects of OsmoPrep. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store OsmoPrep?

• Store OsmoPrep at room temperature, between 59° F to 86° F (15° C to 30° C).
• Throw away any OsmoPrep that is not needed.
• Keep OsmoPrep and all medicines out of the reach of children.

General information about OsmoPrep

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OsmoPrep for a condition for which it was not prescribed. Do not give OsmoPrep to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about OsmoPrep. If you would like more information about OsmoPrep, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for healthcare professionals. For more information, call 1-866-669-7597 (toll-free) or go to www.Salix.com.

What are the ingredients in OsmoPrep?

Active ingredients: sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous

Inactive ingredients: polyethylene glycol 8000 and magnesium stearate

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised March 2009

Salix Pharmaceuticals, Inc.
Morrisville, NC  27560, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

VENART-30-4/Mar 2009