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Fleet Phospho-soda (Fleet)

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  • Description
  • Indications and Usage
  • Clinical Pharmacology
  • Overdosage
  • Warnings
  • Dosage and Administration
  • How Supplied
  • References

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  • COMPOSITION

    Each Tablespoon (15 mL) of Unflavored or 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, buffered aqueous solution.

    ELEMENTAL AND ELECTROLYTIC CONTENT

    mEq Phosphate (PO 4 ) per mL 12.45

    mEq Sodium (Na) per mL 4.82

    mg Sodium (Na) per mL111

    mmole Phosphorus (P) per mL 4.15

    This product is sugar free and can be refrigerated to improve taste. Do not freeze.

    INDICATIONS

    As a laxative, for the relief of occasional constipation. For use as part of a bowel cleansing regimen in preparing the colon for colonoscopy, other endoscopic and radiologic examinations and surgery.

    ACTION AND USES

    Versatile in action as a laxative or purgative, according to dosage. This product produces a bowel movement in 1 / 2 to 6 hours, depending on dosage.

    PROFESSIONAL USE WARNINGS AND PRECAUTIONS.   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 hyperphosphatemia, hypernatremia, 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.

    WARNINGS

    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 a 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 immediately.

    DOSAGE AND ADMINISTRATION

    DOSAGE: Do not use more unless directed by a doctor. See Warnings. NEVER take more than 3 Tablespoons at one time. Each bottle contains 3 Tablespoons. Drink as much additional clear fluids as possible.

    Laxative use:
    Ages (years)
    Step 1
    Step 2
    12 & Older
    Mix 1 tablespoon in a full glass of cold liquid (8 fl.oz.). Drink.
    Drink at least one extra full glass of liquid (8 fl.oz.).
    10 & 11
    Mix 1 tablespoon in a full glass of cold liquid (8 fl.oz.). Drink.
    Drink at least one extra full glass of liquid (8 fl.oz.).
    5 to 9
    Mix 1/2 tablespoon in a full glass of cold liquid (8 fl.oz.). Drink.
    Drink at least one extra full glass of liquid (8 fl.oz.).
    Under 5
    DO NOT USE
    DO NOT USE

    Medical procedures use only when directed by a doctor:
    Ages (years)
    Medical Procedures Dose
    Additional Clear Fluids
    12 & Older
    Mix 2-3 tablespoons in a full glass of cold liquid (8 fl.oz.). Drink.
    Drink at least 3 extra full glasses of liquid (24 fl.oz.).
    10 & 11
    Ask Your Doctor
    Ask Your Doctor
    5 to 9
    Ask Your Doctor
    Ask Your Doctor
    Under 5
    DO NOT USE
    DO NOT USE
    * DO NOT TAKE MORE THAN THIS AMOUNT IN A 24-HOUR PERIOD.

    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.

    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. (See "Clear Liquids Diet List" below).

    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); sweetners 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.)

    Dosing:    Each of the two doses consists of 2 or 3 tablespoons of Fleet® Phospho-soda®, according to the doctor's prescription. The doctor should also prescribe the timing of the two doses of diluted Fleet® Phospho-soda® so the doses are separated by 10-12 hours. See References.

    Dilution Alternatives:

    1. Mix 2 or 3 Tablespoons (use measuring Tablespoon, not tableware) Fleet® Phospho-soda® with 8 fl.oz. of cold, clear liquid. Then follow with at least 24 fl.oz. of clear liquid.
                                                                                                              OR
        
    2. Mix 2 or 3 Tablespoons Fleet® Phospho-soda® oral saline laxative with two or three 8 fl. oz. glasses cold, clear liquid (one Tablespoon of Fleet® Phospho-soda® oral saline laxative per glass). Drink two glasses within 20 minutes or three glasses within 30 minutes. Then follow with at least 24 fl. oz. of clear liquid.

    The taste of Fleet® Phospho-soda® is improved by mixing it with ginger ale, apple juice, or lemon-lime type drinks.

    HOW SUPPLIED

    Unflavored or Natural Ginger-lemon flavor in 1.5 fl. oz. bottles. FLEET® Phospho-soda® oral saline laxative should not be confused with FLEET® Enema, a sodium phosphates disposable ready-to-use enema. FLEET® Enema and Fleet® Enema for Children ARE NOT INTENDED FOR ORAL CONSUMPTION in any dosage size.

    IS THIS PRODUCT OTC?

    Yes.Questions, call 1-888-999-9711 or visit www.phosphosoda.com

    REFERENCES

    1. Balaban, D.H. et al. Low Volume Bowel Preparation for Colonoscopy: Randomized, Endoscopist-Blinded Trial of Liquid Sodium Phosphate versus Tablet Sodium Phosphate. The American Journal of Gastroenterology, 2003; 98(4):827
    2. Cohen, S.M. et al. Prospective, Randomized, Endoscopic-Blinded Trial Comparing Precolonoscopy Bowel Cleansing Methods. Diseases of the Colon & Rectum. 1994; 37(7):689.
    3. Hookey, L.C. et al. The Safety Profile of Oral Sodium Phosphate for Colonic Cleansing before Colonoscopy in Adults. Gastrointestinal Endoscopy, 2002; 56(6):895
    4. Barclay, R.L. et al. Carbohydrate-electrolyte Rehydration Protects against Intravascular Volume Contraction during Colonic Cleansing with Orally Administered Sodium Phosphate. Gastrointestinal Endoscopy, 2002. 56(5):633
    5. Allaire, J. et al. A Quality Improvement Project Comparing Two Regimens of Medication for Colonoscopy Preparation. Gastroenterology Nursing, 2003. 27(1):3
    6. Oliveira, L. et al. Mechanical Bowel Preparation for Elective Colorectal Surgery. Diseases of the Colon & Rectum. 1997; 40(5):585.
    7. Vanner, S. J. et al. A Randomized Prospective Trial Comparing Oral Sodium Phosphate with Standard Polyethylene Glycol-Based Lavage Solution (Golytely) in the Preparation of Patients for Colonoscopy. The American Journal of Gastroenterology. 1990; 85(4):422.













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