Sodium phosphate dibasic and sodium phosphate monobasic (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 helps by cleaning your colon and making you have diarrhea. This allows your doctor to 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 for your doctor to check your progress after you take this medicine. This will help your doctor see if the medicine is working properly. You may need blood and urine tests and an electrocardiogram (ECG) to check for unwanted effects.

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

This medicine may cause serious kidney problems. These are more likely to happen if you are over 55 years old, dehydrated, have low blood volume, and are taking medicines that could harm 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 any of the following symptoms: confusion, decreased urination, dizziness, dry mouth, fainting, increased heart rate, rapid breathing, or unusual tiredness or weakness.

Contact your doctor right away if you experience any changes in 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 have 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 you have discussed them 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 need to consider the risks of taking it against the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, you should think about the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of OsmoPrep® tablets in children. Safety and effectiveness have not been proven.

Geriatric

Studies so far have not found any specific issues in older adults that would limit the use of OsmoPrep® tablets. However, older patients may be more sensitive to the effects of OsmoPrep® tablets compared to younger adults and are more likely to have kidney issues related to age, which may require caution when using this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

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

• 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 together, your doctor may change the dose or the frequency of use for one or both medicines.

• 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 using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or the frequency of use for one or both medicines.

• 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

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to inform your doctor of any other medical issues you have, especially:

• Acute phosphate nephropathy (serious kidney problem caused by too much phosphate), biopsy-proven or
• Stomach or bowel problems (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)—Should not be used in patients with these conditions.

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

• Arrhythmia (heart rhythm problem) 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
• Trouble swallowing or gastric reflux or
• Ulcerative colitis or
• Withdrawal from alcohol or benzodiazepines—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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 with 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 immediately if any of the following symptoms of overdose occur:

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 occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may 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.