Fleet Phospho-soda EZ-Prep (Oral)

Sodium phosphate dibasic and sodium phosphate monobasic combination is used to clean or empty your bowels before a colonoscopy, which is an imaging procedure. This medicine cleans your colon and causes you to have diarrhea. This helps your doctor see the inside of your colon more clearly during the colonoscopy.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress after taking this medicine. This will help your doctor see if the medicine is working properly. Blood and urine tests and an electrocardiogram (ECG) may be needed to check for unwanted effects.

Do not take this medicine together with other laxatives or enemas containing sodium phosphate. Doing so may lead to serious unwanted effects.

This medicine may cause serious kidney problems. These are more likely to occur if you are over 55 years of age, dehydrated, have low blood volume, and are taking medicines that could be hard on your kidneys (for example, diuretics or water pills, certain blood pressure medicines, NSAID pain or arthritis medicine). Check with your doctor right away if you have bloody urine, a decrease in the amount or frequency of urine, lower back or side pain, trouble breathing, weight gain, or swelling of the face, fingers, and lower legs.

Taking more than one dose of over-the-counter (OTC) sodium phosphate medicine in 24 hours may cause serious kidney and heart problems. Check with your doctor if you have the following symptoms: confusion, decreased urination, dizziness, dry mouth, fainting, increase in heart rate, rapid breathing, or unusual tiredness or weakness.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Call your doctor right away if you have any unusual symptoms that concern you, such as bloating, abdominal or stomach pain, seizures, nausea, vomiting, or headache.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will consider the risks and benefits. Here are important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of OsmoPrep® tablets in children. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies do not show specific problems in elderly patients that would limit the use of OsmoPrep® tablets. However, older adults may be more sensitive to the effects of OsmoPrep® tablets and are more likely to experience age-related kidney issues, which may require caution when using this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while nursing.

Interactions with Medicines

Some medicines should not be taken together at all, while others can be used together with caution. Your doctor may need to adjust the dose or take other precautions if you are prescribed any of the following medicines while using this medicine. The interactions listed here are significant but not exhaustive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of your other medications.

• Bepridil
• Burosumab-twza
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Erdafitinib
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Telavancin
• Telithromycin
• Tetrabenazine
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be necessary for your treatment. If both are prescribed, your doctor may alter the dose or frequency of one or both.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Acetate
• Calcium Carbonate
• Calcium Citrate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used during or around meal times, as interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect your use of this medicine. Make sure to inform your doctor about any other medical issues, especially:

• Acute phosphate nephropathy (serious kidney problem caused by too much phosphate), biopsy-proven or
• Stomach or bowel issues (e.g., blockage, perforation) or
• Stomach surgery (e.g., bypass, stapling) or
• Toxic colitis (inflammation of the colon) or
• Toxic megacolon (severe irritation of the colon)—This medicine should not be used in these cases.

• Angina (severe chest pain), unstable or
• Congestive heart failure or
• Recent heart attack or
• Heart disease (e.g., cardiomyopathy) or
• History of heart rhythm issues (e.g., prolonged QT interval, poorly-controlled arrhythmia)—May increase the risk of arrhythmia.

• Arrhythmia (heart rhythm issue) or
• Dehydration or
• Electrolyte imbalance (e.g., high or low calcium, phosphate, potassium, or sodium in the blood) or
• Hypovolemia (low blood volume) or
• History of inflammatory bowel disease or
• History of seizures or
• Difficulty swallowing or gastric reflux or
• Ulcerative colitis or
• Withdrawal from alcohol or benzodiazepines—Use with caution. This may worsen these conditions.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical attention.

Check with your doctor right away if you experience any of the following side effects:

More common

• Bloating
• Stomach pain

Incidence not known

• Agitation
• Bloody or cloudy urine
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Confusion
• Cough
• Decrease in the frequency or amount of urine
• Decreased awareness or responsiveness
• Depression
• Difficult or labored breathing
• Difficult or painful urination
• Difficulty swallowing
• Dizziness
• Fainting
• Fast, slow, or irregular heartbeat
• Headache
• Hives, itching, skin rash
• Hostility
• Increased blood pressure
• Increased thirst
• Irritability
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• Loss of consciousness
• Lower back or side pain
• Muscle twitching
• Nausea
• Noisy breathing
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Redness of the skin
• Seizures
• Severe sleepiness
• Sudden decrease in the amount of urine
• Swelling of the face, ankles, or hands
• Tightness in the chest
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Vomiting

Get emergency help right away if you notice any of the following symptoms of overdose:

Symptoms of overdose

• Blurred vision
• Chest pain or discomfort
• Decreased frequency of urine
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Increase in heart rate
• Increased thirst
• Lightheadedness
• Loss of appetite
• Lower back or side pain
• Muscle cramps in the hands, arms, feet, legs, or face
• Muscle pain
• Pounding or rapid pulse
• Rapid breathing
• Restlessness
• Stomach cramps
• Sunken eyes
• Sweating
• Tremor
• Weakness
• Weight gain
• Wrinkled skin

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Fleet Phospho-soda EZ-Prep
• OsmoPrep
• Phospho-Soda
• Visicol

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Laxative, Hyperosmotic

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take each dose (4 tablets) with 8 ounces of clear liquids. Examples of clear liquids include: water, flavored water, clear broth, herbal tea, black tea, coffee, clear soda, gelatin, popsicles, lemonade (no pulp), ginger ale, white grape juice, or apple juice. Do not eat or drink alcohol, milk, anything colored purple or red, or any foods that have pulp.

Eat or drink only clear liquids after 12:00 PM (noon) on the day before and until after your colonoscopy. Do not eat solid food.

Drink as much extra liquid as you can before, during, and after taking this medicine. This will help replace the fluids you are losing with your bowel movements. This will also keep your kidneys working well and help soften your bowel movements, making them easier to pass.

Do not take any oral medicines within 1 hour before or after each dose of OsmoPrep®.

Do not take this medicine if you have already used it in the last 7 days. Your doctor will tell you if you need to use this medicine again.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For cleansing of the colon: Adults— Evening before the colonoscopy: Four tablets with 8 ounces (oz.) of clear liquids every 15 minutes (for a total of 20 tablets). Day of colonoscopy (starting 3 to 5 hours before the procedure): Four tablets with 8 oz. of clear liquids every 15 minutes (for a total of 12 tablets). Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.