COMPOSITION

FLEET® ENEMA: Each 118 mL (delivered dose) contains 19 g monobasic sodium phosphate monohydrate and 7 g dibasic sodium phosphate heptahydrate. The latex free FLEET® Enema unit, with a 2-inch, pre-lubricated Comfortip®, contains 4.5 fl. oz. (133 mL) of enema solution in a ready-to-use squeeze bottle. FLEET® ENEMA FOR CHILDREN: Each 59 mL (delivered dose) contains 9.5 g monobasic sodium phosphate monohydrate and 3.5 g dibasic sodium phosphate heptahydrate. The latex free FLEET® Enema for Children unit, with a 2-inch, pre-lubricated Comfortip® contains 2.25 fl. oz. (66 mL) of enema solution in a ready-to-use squeeze bottle. Designed for quick, convenient administration by nurse or patient according to instructions. Disposable after single use.

ELEMENTAL & ELECTROLYTIC CONTENT

mEq Phosphate (PO 4 ) per mL                      4.15
mEq Sodium (Na) per mL                             1.61
mmole Phosphorus (P) per mL                      1.38

ACTION AND USES

FLEET® Enema is useful as a laxative in the relief of occasional constipation, and as part of a bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for x-ray and endoscopic examination. Used as directed, FLEET® Enema provides thorough yet safe cleansing action and induces complete emptying of the left colon usually within 2 to 5 minutes without pain or spasm. Also used for general postoperative care and to help relieve fecal or barium impaction.

GENERAL LAXATIVE

Using more than one enema in 24 hours can be harmful.

Do not use laxative products when nausea, vomiting, or abdominal pain is present unless directed by a physician. If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult a physician. Laxative products should not be used longer than 1 week unless directed by a physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. 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 immediately.

PROFESSIONAL USE

Do not use in patients with congenital megacolon, bowel obstruction, imperforate anus or congestive heart failure.

Use with caution in patients with impaired renal function, pre-existing electrolyte disturbances or in patients on diuretics or other medications which may affect electrolyte levels--or where colostomy exists.

Since FLEET® Enema contains sodium phosphates, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium and consequently hypocalcemia, hyperphosphatemia, hypernatremia, and acidosis may occur. This is of particular concern in children with megacolon or any other condition where there is retention of enema solution.

Additional fluids by mouth are recommended with all bowel cleansing dosages.

SINCE FLEET® BRAND ENEMAS ARE AVAILABLE IN ADULT AND CHILDREN'S SIZES, PRESCRIBE CAREFULLY.

PRECAUTIONS

DO NOT ADMINISTER 4.5 OZ. ADULT SIZE TO CHILDREN UNDER 12 YEARS OF AGE. DO NOT ADMINISTER A FULL 2.25 OZ. CHILDREN'S SIZE TO CHILDREN UNDER 5 YEARS OF AGE. FOR CHILDREN 2 TO UNDER 5 YEARS, USE ONE-HALF BOTTLE (SEE DOSAGE AND ADMINISTRATION ). DO NOT USE WITH CHILDREN UNDER 2 YEARS OF AGE. IF AFTER THE ENEMA SOLUTION IS ADMINISTERED THERE IS NO RETURN OF LIQUID, CONTACT A PHYSICIAN IMMEDIATELY AS DEHYDRATION COULD OCCUR.

OVERDOSAGE

Overdosage or retention of FLEET® Enema may cause hypocalcemia, hyperphosphatemia, hypernatremia, hypernatremic dehydration and acidosis.

Calcium, phosphate, potassium and sodium levels should be carefully monitored. Immediate corrective action should be taken to restore electrolyte balance with appropriate fluid replacements. Prompt parenteral administration of fluids with lower concentrations of sodium and chloride than extracellular fluid (40-50 mEq/liter) and moderate concentration of potassium (20-30 mEq/liter) administered at a rate of 3,000 to 4,000 cc/sq. m of body surface during the first 12 to 24 hours is dependent on the severity of dehydration and the clinical response.

DOSAGE AND ADMINISTRATION

Dosage: FLEET® Enema for Adults :

Do not use more unless directed by a doctor. See .

Adults and Children 12 years and over
One Bottle
Children 2 to 11 years
Use Fleet® Enema for Children
Children under 2 years
DO NOT USE
Sodium Content--4.4 g (191 mEq) in each 118 mL.

REMOVE ORANGE PROTECTIVE SHIELD FROM TIP BEFORE INSERTING.

Preferred position :   Lie on left side with knee slightly bent and the right leg drawn up, or knee-chest position.

Diaphragm at base of tube prevents accidental leakage and assures controlled flow of the enema solution. May be used at room temperature.

Dosage: FLEET® Enema for Children :

Do not use more unless directed by a doctor. See .

Children 5 to 11 years
One Bottle or as directed by a doctor
Children 2 to under 5 years
One-Half Bottle (See Below)
Children under 2 years
DO NOT USE

One-half bottle preparation: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow DIRECTIONS on back of carton.

Sodium Content--2.2 g (95.5 mEq) in each 59 mL.

REMOVE ORANGE PROTECTIVE SHIELD FROM TIP BEFORE INSERTING .

Preferred position :   Lie on left side with knee slightly bent and the right leg drawn up, or knee-chest position.

Diaphragm at base of tube prevents accidental leakage and assures controlled flow of the enema solution. May be used at room temperature.

PROFESSIONAL DOSAGE AND ADMINISTRATION

FLEET® Enema for Adults should not be used in children under 12 years of age. In those cases where complications are reported, infants and young children are often involved. FLEET® Enema for Children should be used with caution in children of any age. Careful consideration of the use of enemas in general in children is recommended. See DOSAGE AND ADMINISTRATION for dosing detail.

Proper and safe use of FLEET® Enema also requires that the product be administered according to the Directions. Health care professionals should remember, when administering the product, to gently insert the enema into the rectum with the tip pointing toward the navel. Insertion may be made easier by having the patient bear down as they would in having a bowel movement. Care during insertion is necessary due to lack of sensory innervation of the rectum and due to possibility of bowel perforation. Once inserted, squeeze the bottle until nearly all the liquid is expelled. If resistance is encountered on insertion of the nozzle or in administering the solution, the procedure should be discontinued. Forcing the enema can result in perforation and/or abrasion of the rectum.

If an enema containing phosphate or sodium is not advised, use FLEET® Bisacodyl Enema.

HOW SUPPLIED

FLEET® Enema is supplied in a 4.5 fl. oz. (133 mL) ready-to-use squeeze bottle. Children's size, 2.25 fl. oz. (66 mL). IMPORTANT : FLEET® Enema, Adult and children size, ARE NOT INTENDED FOR ORAL CONSUMPTION in any dosage size.

IS THIS PRODUCT OTC?

Yes.