Fleet Enema, Fleet Enema for Children (Fleet)

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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 EXTRA®: Each 197-mL delivered dose contains 19 g monobasic sodium phosphate monohydrate and 7 g dibasic sodium phosphate heptahydrate. The latex-free FLEET® enema EXTRA® unit, with a 2 inch, pre-lubricated Comfortip®, contains 7.8 fl.oz. (230 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. Fleet® Enemas are designed for quick, convenient administration by nurse or patient according to instructions. It is disposable after a single use.

ELEMENTAL AND ELECTROLYTIC CONTENT

ACTION AND USES

FLEET® Enema, FLEET® Enema EXTRA® and FLEET® Enema for Children are useful as a laxative in the relief of occasional constipation and as part of a bowel cleansing regimen in preparing the colon for surgery, x-ray or endoscopic examination. Used as directed, FLEET® Enema, FLEET® Enema EXTRA®, and FLEET® Enema for Children provide thorough yet safe cleansing action and induces complete emptying of the left colon, usually within 1 to 5 minutes, without pain or spasm.

GENERAL LAXATIVE WARNINGS

INFORMATION FOR PATIENT

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 healthcare 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 right away.

PROFESSIONAL USE WARNINGS

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

Use with caution in patients with impaired renal function or 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 hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia 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.

WARNINGS

DO NOT USE IN 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 AND CONSEQUENT SERIOUS SIDE EFFECTS COULD OCCUR.

DO NOT ADMINISTER THE 4.5 FL. OZ. ADULT SIZE OR THE 7.8 FL.OZ. EXTRA® SIZE TO CHILDREN UNDER 12 YEARS OF AGE.

DO NOT ADMINISTER A FULL 2.25 FL. 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 ).

PRECAUTIONS

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

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.

DOSAGE AND ADMINISTRATION

Dosage: FLEET® Enema (Adult size) and FLEET® Enema EXTRA®:

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

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 in knee-chest position.

The diaphragm at base of tube prevents reflux and assures controlled flow of the enema solution. FLEET® Enema should be used at room temperature.

Dosage: FLEET® Enema for Children :

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

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.

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 in knee-chest position.

The diaphragm at base of tube prevents reflux and assures controlled flow of the enema solution. FLEET® Enema for Children should be used at room temperature. IMPORTANT : FLEET® Enema (Adult size), FLEET® Enema EXTRA® and Fleet Enema for Children ARE NOT INTENDED FOR ORAL CONSUMPTION in any dosage size.

PROFESSIONAL DOSAGE AND ADMINISTRATION

FLEET® Enema (Adult size) and FLEET® Enema EXTRA® 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 children in general is recommended. See DOSAGE AND ADMINISTRATION for dosing detail.

Proper and safe use of FLEET® Enemas also requires that the products be administered according to the Directions. Healthcare 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 if 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, consider using FLEET® Bisacodyl Enema.

HOW SUPPLIED

FLEET® Enema is supplied in a 4.5 fl. oz. (133-mL) ready-to-use squeeze bottle. The EXTRA® size is supplied in a 7.8 fl. oz. (230-mL) ready-to-use squeeze bottle. The children's size is 2.25 fl. oz. (66 mL).

IS THIS PRODUCT OTC?

Yes.

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