Fleet Phospho-soda ACCU-PREP (Fleet)

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DESCRIPTION

COMPOSITION OF FLEET® PHOSPHO-SODA® ACCU-PREP® BOWEL CLEANSING SYSTEM

Fleet® Phospho-soda® ACCU-PREP® contains:

1. Six 15-mL (1/2 fl. oz.) units of Fleet® Phospho-soda® oral saline laxative, net contents 3 fl. oz. (90 mL).
   Active Ingredients: Each Unit (15-mL) contains monobasic sodium phosphate monohydrate 7.2g/dibasic sodium phosphate heptahydrate 2.7g.
2. Four Fleet® Relief® Pre-Moistened Anorectal Wipes.
   Active Ingredients: Each wipe is moistened with Pramoxine hydrochloride 1% and Glycerin 12%.
3. Patient mixing instructions.

Fleet® Phospho-soda®

COMPOSITION

Each 15-mL of Natural Ginger-lemon flavor Fleet® Phospho-soda® oral saline laxative contains 7.2 g monobasic sodium phosphate monohydrate and 2.7 g dibasic sodium phosphate heptahydrate in a stable, aqueous solution.

ELEMENTAL AND ELECTROLYTIC CONTENT:

ACTIONS

Fleet® Phospho-soda® is an oral saline laxative.

INDICATIONS AND USES

For use as part of a bowel cleansing regimen in preparing the colon for colonoscopy, other endoscopic and radiologic examinations and surgery. See DOSAGE AND ADMINISTRATION . This product generally produces a bowel movement in ½ to 6 hours.

PROFESSIONAL USE WARNINGS

Do not use in patients with clinically significant impairment of renal function, megacolon, gastrointestinal obstruction, ascites, congestive heart failure or in children under 5 years of age. Use with caution in patients with heart disease, acute myocardial infarction, unstable angina, pre-existing electrolyte disturbances, increased risk for electrolyte disturbances (e.g., dehydration, gastric retention, bowel perforation, colitis, ileus, inability to take adequate oral fluid, concomitant use of diuretics or other medications that affect electrolytes), with debilitated or elderly patients or with patients who are taking medications known to prolong the QT interval. In at-risk patients, including elderly patients, consider obtaining baseline and post-treatment sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values, and consider using the lower end of the dosage range. There is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium; consequently, hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis may occur.

Nephrocalcinosis associated with transient renal insufficiency and renal failure has been very rarely reported in patients using sodium phosphates for bowel cleansing.

Care should be taken to prescribe Fleet® Phospho-soda® oral saline laxative as a bowel cleanser by volumes, not "by the bottle" (see WARNINGS ), per recommendations with a particular attention to known contraindications and adequate hydration (see DOSAGE AND ADMINISTRATION and INFORMATION FOR PATIENT ). Additional fluids by mouth are recommended with all bowel cleansing dosages. Encourage patients to drink large amounts of clear liquids to prevent dehydration. Drinking large amounts of clear liquids also helps ensure that the patient's bowel will be clean for the procedure. No other sodium phosphate preparations should be given concomitantly.

OVERDOSAGE

Overdosage or retention may lead to severe electrolyte disturbances, including hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia, as well as dehydration and hypovolemia, with attendant signs and symptoms of these disturbances (such as metabolic acidosis, renal failure, and tetany). Certain severe electrolyte disturbances may lead to cardiac arrhythmia and death. The patient who has taken an overdose should be monitored carefully. Treatment of electrolyte imbalance may require immediate medical intervention with appropriate electrolyte and fluid replacement.

PRECAUTIONS

GENERAL

TAKING MORE THAN THE RECOMMENDED DOSE IN 24 HOURS CAN BE HARMFUL. IF THERE IS NO BOWEL MOVEMENT AFTER SIX HOURS, CONTACT A PHYSICIAN, AS DEHYDRATION COULD OCCUR. PRESCRIBE BY VOLUME. DO NOT PRESCRIBE "BY THE BOTTLE" AS SERIOUS SIDE EFFECTS FROM OVERDOSAGE MAY OCCUR.

INFORMATION FOR PATIENT

The patient should be instructed to open and read directions at least two days in advance of the examination.

Instruct the patient to contact a physician if there is no bowel movement after six hours as dehydration can occur.

DO NOT EXCEED RECOMMENDED DOSE UNLESS DIRECTED BY A PHYSICIAN. SERIOUS SIDE EFFECTS MAY OCCUR FROM EXCESS DOSAGE. IF THERE IS NO BOWEL MOVEMENT AFTER SIX HOURS, CONTACT A PHYSICIAN, AS DEHYDRATION AND CONSEQUENT SERIOUS SIDE EFFECTS COULD OCCUR.

During bowel preparation you will lose significant amounts of fluid. THIS IS NORMAL It is very important that you replace this fluid to prevent dehydration. Drink as much extra liquids as you can to help replace the fluids you are losing during bowel movements. Drinking large amounts of clear liquids also helps ensure that your bowel will be clean for the examination or procedure.

DO NOT USE if you have congestive heart failure, if you have serious kidney problems, or in children under 5 years of age.

Ask a doctor before use if you are under a doctor's care for any medical condition, are on a low salt diet or are pregnant or nursing a baby. Ask a doctor or pharmacist before use if you are taking any other medicines. Ask a doctor before using any laxative if you have abdominal (belly) pain, nausea, or vomiting, have a change in your daily bowel movements that lasts more than 2 weeks, or have already used another laxative for constipation for more than 1 week. Stop using this product and consult a doctor if you have any rectal bleeding, do not have a bowel movement within 6 hours of taking Phospho-soda ^® or have any symptoms that your body is losing more fluids than you are drinking. This is called dehydration. Early symptoms of dehydration include vomiting, dizziness or urinating less often than normal. These symptoms may be signs of serious problems.

Keep this and all drugs out of the reach of children. In case of overdose or accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

Each of the two doses consists of 2-3 pre-measured 15-mL (1/2 fl. oz.) units of Fleet® Phospho-soda® oral saline laxative. Dilute each pre-measured 15-mL (1/2 fl. oz.) unit in an 8 fl. oz. glass of clear liquid. Repeat for each pre-measured unit (2-3 units according to the doctor's instructions) at the prescribed times. The doses should be separated by 10-12 hours. Drink at least 3 additional 8 fl. oz. glasses of clear liquid after the first dose.

HYDRATION AND DIET

Encourage patients to drink large amounts of clear liquids to prevent dehydration. Drinking large amounts of clear liquids also helps ensure that the patient's bowel will be clean for the procedure. (See "Clear Liquids Diet List" below).

During bowel preparation you will lose significant amounts of fluid. THIS IS NORMAL. It is very important that you replace this fluid to prevent dehydration.

Day before the exam - eat a regular breakfast.

DO NOT DRINK OR EAT ANYTHING COLORED RED OR PURPLE.

Low residue lunch (must be eaten before 2 PM). Do not eat anything that is not on this diet. Do not eat more than the allowed portions. Lunch may include any of the following items:

• Main entrée - choose one of the following:
  
  • 3 oz. of skinless chicken, turkey, fish or seafood
  • 1 large or 2 medium eggs
  • 1 can of chicken noodle soup without vegetables
• Vegetable/Fruit - choose one of the following
  
  • ½ cup applesauce
  • ½ cup of cooked or canned vegetables without seeds. No corn .
• Bread - choose one of the following:
  
  • 1 white potato roll
  • 2 slices of white bread
  • 1 cup of cooked white rice or 1 cup of cooked pasta
  • 1 small skinless potato
• Condiments - choose one of the following:
  
  • 2 tsp. of soft tub margarine
  • 1 tsp. mustard or mayonnaise
• Dessert - choose one of the following:
  
  • 4 vanilla wafers
  • ¼ cup pretzels
  • ½ cup sherbet
• Any items from the "Clear Liquids Diet List" below:

CLEAR LIQUIDS DIET LIST:

BEVERAGES:

• Water, tea or coffee (no milk or non-dairy creamer); sweeteners are okay to use
• Soft drinks (orange, ginger ale, cola, Sprite®, 7-Up®, etc.), Gatorade®, Kool-Aid®
• Strained fruit juices without pulp (apple, white grape, orange, lemonade, etc.)

Fleet® Relief® Pre-Moistened Anorectal Wipes

COMPOSITION

Each wipe is moistened with Pramoxine hydrochloride 1%; Glycerin 12%.

ACTIONS

Fleet® Relief® Pre-Moistened Anorectal Wipes act as a local anesthetic and protectant for temporary relief of pain, soreness or burning.

INDICATIONS AND USES

For the temporary relief of local itching and discomfort associated with hemorrhoids. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues and temporarily provides a coating for relief of anorectal discomfort.

WARNINGS

FOR EXTERNAL USE ONLY

INFORMATION FOR THE PATIENT

Do not exceed the recommended daily dosage. Consult a doctor promptly in case of bleeding. Do not put the product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if the condition worsens or does not improve within 7 days; or if redness, irritation, swelling, pain or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.

DIRECTIONS

Adults & children 12 years & over: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth. Open the sealed pouch and remove one Fleet® Relief® Wipe and gently apply to the affected area. Apply after each bowel movement, up to 5 times daily. Discard the wipe after use. There are four Fleet® Relief® Wipes. They can be used after a bowel movement or whenever anorectal discomfort is felt.

HOW SUPPLIED

This complete, simple, convenient bowel cleansing kit includes six 15-mL units of Fleet® Phospho-soda® (Natural ginger-lemon flavor) and four Fleet® Relief® Pre-Moistened Anorectal Wipes. Fleet® Phospho-soda® ACCU-PREP® is available in 12 units per case.

Fleet® Phospho-soda® ACCU-PREP® should not be confused with Fleet® Enema, a sodium phosphates disposable ready-to-use enema. Fleet® Enemas, Adult and Children size, ARE NOT INTENDED FOR ORAL CONSUMPTION in any dosage size.

IS THIS PRODUCT OTC?

Yes. Fleet® Phospho-soda® ACCU-PREP® is an OTC product, but it may be stocked behind the pharmacy counter. Patients should be directed to ask their pharmacists for Fleet® Phospho-soda® ACCU-PREP®.

Questions, call 1-888-999-9711 or visit

www.phosphosoda.com

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