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Fleet Phospho-soda (Fleet)
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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.
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 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.
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.
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:
CLEAR LIQUIDS DIET LIST:
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.
The taste of Fleet® Phospho-soda® is improved by mixing it with ginger ale, apple juice, or lemon-lime type drinks.
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