Download PDR Physicians` Desk Reference PROOF

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FLEET® BISACODYL LAXATIVES:
ENEMA AND TABLETS
Fleet
PDR Main
DATE OF RUN 06/25/2014
TIME OF RUN 17:0
PROCESSING SECTION 2880
SUB-PROCESSING SECTION 0133
SETID
ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99
PAGE 1 cont’d
Jun 25 2014 16:59:38
OTC
A STIMULANT LAXATIVE
COMPOSITION
FLEET® Bisacodyl Enema - 10 mg bisacodyl enema solution in a 37-mL ready-to-use squeeze bottle which is not
made with natural rubber latex, with a 2-inch, prelubricated Comfortip®. It is disposable after a single use.
FLEET® Stimulant Laxative Tablets - Enteric-coated 5 mg
bisacodyl each tablet.
ACTION AND USES
Bisacodyl is a stimulant laxative given either orally or rectally, acting directly on the colonic mucosa where it stimulates sensory nerve endings to produce parasympathetic reflexes resulting in increased peristaltic contractions of the
colon. The contact action of the drug is restricted to the colon, and motility in the small intestine is not appreciably
influenced. FLEET® Stimulant Laxative Tablets usually
work within 6-12 hours, and the FLEET® Bisacodyl Enema
produces a bowel movement within 5–20 minutes. Bisacodyl
is useful as a laxative for relief of occasional constipation
and in bowel cleansing in preparation for x-ray or endoscopic examination. Bisacodyl may be used as a laxative in
postoperative, antepartum, or postpartum care or in preparation for delivery under guidance of a healthcare professional.
Store at controlled room temperature 68-77°F (20-25°C).
WARNINGS: Do not administer Fleet® Bisacodyl Enema to
children under 12 years of age.
GENERAL LAXATIVE WARNINGS
INFORMATION FOR PATIENT
Ask a doctor before using any laxative if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits lasting more than 2
weeks
• already used a laxative for more than 1 week
Stop using this product and consult a doctor if you have
• rectal bleeding
• no bowel movement within 20 minutes of using the rectal
product
• if constipation continues after one week of use
These symtoms may be signs of a serious condition.
All bisacodyl products may cause
• abdominal discomfort
• faintness
• mild cramps
Rectal products may also cause rectal burning.
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 to prevent accidental ingestion. In case of accidental overdose or
ingestion, seek professional assistance or contact a Poison
Control Center right away.
001
Format
PDRT
Physicians’ Desk ReferenceT
Index
Electronic
PROOF
〈 For publisher use only 〉
Fleet
PDR Main
DATE OF RUN 06/25/2014
TIME OF RUN 17:0
PROCESSING SECTION 2880
SUB-PROCESSING SECTION 0133
SETID
ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99
PAGE 2 cont’d
Jun 25 2014 16:59:38
DOSAGE AND ADMINISTRATION
Enema
SHAKE BEFORE USING.
Dosage:
Adults and children 12 years of age and over: Use one
1.25 fl. oz. bottle (30-mL delivered dose) as a single daily
dose (per 24 hours).
Children under 12 years of age: DO NOT USE.
Positions for using this enema:
• Left-side position: Lie on left side with knee bent, and
arms resting comfortably.
• Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left
arm folded comfortably.
Fleet® Bisacodyl Enema should be used at room temperature.
How to use this enema:
• Shake bottle well before removing protective shield
• REMOVE ORANGE PROTECTIVE SHIELD FROM ENEMA
COMFORTIP® BEFORE INSERTING.
• With steady pressure, gently insert enema tip into rectum
with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving
enema bears down, as if having a bowel movement. This
helps relax the muscles around the anus.
• DO NOT FORCE THE ENEMA TIP INTO RECTUM AS THIS
CAN CAUSE INJURY.
• Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more
liquid than needed. A small amount of liquid will remain
in the bottle after squeezing.
• Remove Comfortip® from rectum and discard bottle.
• Maintain position until urge to evacuate is strong (usually
5 to 20 minutes). Do not retain enema solution for more
than 20 minutes.
• Stop using this product and consult a doctor if you don’t
have a bowel movement within 20 minutes of using this
product.
The diaphragm at the base of the nozzle prevents reflux and
assures controlled flow of the enema solution.
IMPORTANT: FLEET® Bisacodyl Enema IS NOT INTENDED FOR ORAL CONSUMPTION in any dosage size.
PROFESSIONAL ADMINISTRATION
FLEET® Bisacodyl Enema should not be used in children
under 12 years of age. Careful consideration of the use of
enemas in children in general is recommended. 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 the 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.
002
Format
PDRT
Physicians’ Desk ReferenceT
Index
Electronic
PROOF
〈 For publisher use only 〉
Fleet
PDR Main
DATE OF RUN 06/25/2014
TIME OF RUN 17:0
PROCESSING SECTION 2880
SUB-PROCESSING SECTION 0133
SETID
ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99
PAGE 3 end
Jun 25 2014 16:59:38
Tablets
Adults and children 12 years of age and over: Take 1 to 3
tablets (usually 2) in a single dose once daily (per 24 hours).
Children 6 to under 12 years of age: Take 1 tablet once daily
(per 24 hours).
Children under 6 years of age: Consult a physician.
Expect results in 6–12 hours if taken at bedtime or within 6
hours if taken before breakfast. Swallow tablets whole. Do
not chew or crush tablets. Do not administer tablets within
1 hour after taking an antacid, milk, or milk products.
HOW SUPPLIED
Enema
FLEET® Bisacodyl Enema is supplied in a 1.25 fl. oz. (37mL) ready-to-use squeeze bottle.
NDC code: 0132070336.
Tablets
FLEET® Stimulant Laxative Tablets are supplied in cartons of 25 tablets (5 mg bisacodyl in each tablet) wrapped in
a foil seal.
NDC code: 0132070402
IS THIS PRODUCT OTC? Yes.
QUESTIONS?
Call
1-866-255-6960
or
visit
www.fleetlabs.com
003
ESTIMATED LENGTH OF PRODUCT 28800133 IS 14.611 INCHES