Fleet Prep Kits (Fleet)

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COMPOSITION

FLEET® Prep Kit 1 contains:

1. FLEET® Phospho-soda® Oral Saline Laxative--1.5 fl. oz. (45 mL). Active Ingredients: Each Tablespoon (15 mL) contains monobasic sodium phosphate monohydrate 7.2 g and dibasic sodium phosphate heptahydrate 2.7 g. Natural ginger-lemon flavoring.
2. FLEET® Bisacodyl Tablets--4 laxative tablets. Active Ingredient: Each enteric-coated tablet contains 5 mg bis-acodyl USP.
3. FLEET® Bisacodyl Suppository--1 laxative suppository. Active Ingredient: Each suppository contains 10 mg bisacodyl USP.
4. 1 Patient Instruction Sheet.

FLEET® Prep Kit 2 contains:

1. FLEET® Phospho-soda® Oral Saline Laxative--1.5 fl. oz. (45 mL).
2. FLEET® Bisacodyl Tablets--4 laxative tablets.
3. FLEET® Bagenema--1.
4. 1 Patient Instruction Sheet.

FLEET® Prep Kit 3 contains:

1. FLEET® Phospho-soda® Oral Saline Laxative--1.5 fl. oz. (45 mL).
2. FLEET® Bisacodyl Tablets--4 laxative tablets.
3. FLEET® Bisacodyl Enema 1.25 fl. oz. (37 mL)--1 laxative enema. Active Ingredient: Each 30-mL delivered dose contains 10 mg bisacodyl USP.
4. 1 Patient Instruction Sheet.

FLEET® PrepKit 3 should not be used in children under 12 years.

Each recommended dose (1.5 fl. oz.) (45 mL) of FLEET® Phospho-soda® oral saline laxative contains 5004 mg sodium.

ACTIONS AND USES

Bowel Cleansing System

INDICATIONS

For use as part of a bowel cleansing regimen in preparing the colon for surgery, x-ray or endoscopic examination.

PRECAUTIONS

GENERAL

Bisacodyl products may cause abdominal discomfort, faintness, and cramps. FLEET® Bisacodyl Tablets should be swallowed whole. Do not prescribe to patients who cannot swallow without chewing unless directed by a physician.

Store at temperatures not above 86°F (30°C)

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. 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® 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 your patients to drink large amounts of clear liquids to prevent dehydration. Drinking large amounts of clear liquids also helps ensure that your patient's bowel will be clean for the procedure. No other sodium phosphate preparations should be given concomitantly.

See individual listings for FLEET® Phospho-soda® Oral Saline Laxative, and FLEET® Bisacodyl Laxatives for additional warnings.

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.

INFORMATION FOR PATIENT

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.

Swallow Fleet® Bisacodyl Tablets whole; do not chew tablets unless directed by a physician. Do not take tablets within one hour after taking antacids, milk, or milk products.

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 accidental overdose or ingestion, seek professional assistance or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

SEE PATIENT INSTRUCTION SHEET FOR 18-, AND 24-HOUR PREPARATION SCHEDULE IN EACH KIT. The patient should open and read the enclosed directions and labels at least 48 hours in advance of examination.

HOW SUPPLIED

See "Description" for contents of each kit.

Shipping Unit:   48 FLEET® Prep Kits per case.

For full prescribing information on specific products, see individual listings (FLEET® Phospho-soda®, FLEET® Bisacodyl Laxatives).

IS THIS PRODUCT OTC?

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

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