REALFATE-O

REALFATE-O Suspension
Sucralfate 500 mg + Oxetacaine 20 mg

Sucralfate is a unique oral drug. Chemically, it is a complex of the disaccharide sugar, sucrose, combined with
sulfate and aluminum. It is minimally absorbed into the body, and its actions are entirely on the ,:ning of the
stomach and duodenum.The following actions are thought to be important for its beneficial effects:

1. sucralfate binds to the surface of ulcers (attaching to exposed proteins) and coats the ulcer, thus protecting
the ulcer surface to some extent from further injury by acid and pepsin;
2. sucralfate directly inhibits pepsin (an enzyme that breaks apart proteins) in the presence of stomach acid;
3. sucralfate binds bile salts coming from the liver via the bile thus protecting the stomach lining from injury
caused by the bile acids;
4. Sucralfate may increase prostaglandin production, and prostaglandins are known to protect the lining of
the stomach.

Oxetacaine is a local anesthetic. In contrast to almost all other local anesthetics, oxetacaine ionizes only to a
very small extent at a low ph such as that of gastric acid. Since the anesthetic effect is due to the nonionized
molecules, which are lipid soluble and can penetrate nerve membranes, oxetacaine maintains its activity
even at a low ph. Oxetacaine relieves pain, bloating, discomfort, and fullness. Normally oxetacaine when
administered alone is absorbed into the blood, metabolized in the liver and excreted in the urine.

INDICATIONS:

Realfate-o (sucralfate) is indicated in:
-> Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur
during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been
demonstrated by x-ray or endoscopic examination.
-> Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer

The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or
after sucralfate. While healing with sucralfate may occur during the first week or two, treatment should be
continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Maintenance Therapy:

The recommended adult oral dosage is 1 g twice a day. Elderly: In general, dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy.