Israel - English - Ministry of Health
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" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : רבמבונ 2011 .
“This leaflet format has been determined by the Ministryof Healthand thecontent thereof has been
checked and approved.” Dateof approval:November 2011.
Each tablet contains:
Sucralfate 1 g
Croscarmellose sodium, polyethylene glycol, magnesium stearate,microcrystalline
Sodiumcontent: 2.5-3.7 mgper tablet.
Ulsanic is a non-systemic anti-ulcer drug which actslocallyinthegastrointestinal
tract at the ulcer site.
Sucralfate is not an antacid; it has negligibleacid-neutralizingcapacityanditsanti-
ulcer effects cannot be attributed to neutralization of gastric acid.
Sucralfate forms a protective barrier at the ulcer site. It reacts withproteinaceous
exudates such as albumin and fibrinogen present in the ulcer crater, toformastable
chemicalcomplex.This complex binds selectively to the damaged mucosa, creating a
barrier, which prevents further tissue damage. The coating, which forms at the crater,
blocks the passage of erosive substances such as gastric acid and pepsin to the ulcer
site, thus protecting the tissues and promoting healing.
Sucralfate has beenfoundin vitroto inhibit the aggressive action of pepsin to
absorb bile salts.
Sucralfate is virtually unabsorbed from thegastrointestinaltractandthisresultsin
no significant systemic adverse effects.
Ulsanic is indicated in the short-term treatment of duodenal ulcer and gastric ulcer.
Known hypersensitivity to any ingredient of the preparation.
Patients with severe renal dysfunction or patients receiving dialysis,sincelong-term
administration of this product may causealuminiumencephalopathyaluminium
osteomalacia and anemia.
The product should only be used with caution in patients with renal dysfunction,due
to the possibility of increased aluminium absorption.Theconcomitantuseofother
aluminium containing medications is not recommendedinviewoftheenhanced
potential for aluminium absorption and toxicity.
Bezoars(aninsolublemass formed within the gastric lumen) have been reported
occasionally in patients taking this product. The majority of these patients had
underlyingconditionsthatmaypredispose to bezoar formation such as delayed
gastric emptying, or were receiving concomitantenteralfeeding(seeunder
Bezoarshavebeenreportedafteradministration of Ulsanic to severely ill patients,
especially in premature infants in whomthe use of sucralfate is not recommended.
Mutagenicity studies were not conducted.
Chronicoraltoxicitystudies of 24 months' duration were conducted in mice and rats
at doses up to 1 g/kg (12 times the human dose). There was noevidenceofdrug-
Effect on Fertility and Reproduction
A reproduction study in rats at doses up to 38timesthehumandosedidnotreveal
any indication of fertility impairment. The effect ofsucralfateonhumanfertilityisnot
Use in Pregnancy
Teratogenicity studies have been performed in mice, ratsandrabbitsatdosesupto
50times the human dose and have revealed no evidence of harm to the fetus due to
sucralfate.Therearehowever, no adequate and well controlled studies in pregnant
women.Becauseanimalreproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly needed.
Use During Lactation
It is not known whether thisdrugisexcreted in human milk. Problems in humans
have not been documented; however, risk-benefit should be considered.
Use in Pediatrics
Safety and effectiveness in children have not been established.
Use in the Elderly
Sincetheelderly often have reduced physiological function, the dosage should be
adjusted with care.
Use in Renal Impairment and Chronic Renal Failure
Patientswithnormalrenal function receiving the recommended doses of sucralfate
andaluminium-containing products adequately excrete aluminium in the urine.
Patientswithchronic renal failure or those receiving dialysis have impaired excretion
ofabsorbed aluminium. In addition, aluminium does not cross dialysis membranes
becauseitis bound to albumin and transferrin plasma proteins. Aluminium
accumulation and toxicity (aluminum osteodystrophy, aluminiumosteomalacia,
anemia, and aluminium encephalopathy) have been described in patientswithrenal
impairment. Sucralfate should be used with caution in patientswithchronicrenal
failure,and the blood concentrations of aluminium, phosphate, calcium, alkaline
phosphatase should be periodically measured.
Use in Dialysis Patients
Adversereactionstosucralfatein clinical trials were minor, of low incidence, and
only rarely led to discontinuation of the drug.
Constipation was the most frequent complaint (2%). Other adverse effects, reported
in less than 0.5% of the patients, are listed below by body system:
Gastrointestinal: Diarrhea, nausea, vomiting, gastricdiscomfort,indigestion,
flatulence, dry mouth.
Thirst has also been reported.
Dermatological: Pruritus, rash, urticaria, edema.
Central Nervous System: Dizziness, drowsiness, headache, sleepiness, vertigo.
Postmarketingreports of hypersensitivity reactions, including anaphylactic reactions,
urticaria (hives), angioedema, respiratory difficulty, and rhinitis havebeenreceived.
However, a causal relationship has not been established.
Duodenal ulcer is a chronic recurrent disease.Whileshort-termtreatmentwith
Ulsaniccanresultincompletehealingof the ulcer, a successful course of treatment
withUlsanicshouldnot be expected to alter the post-healing frequency or severity of
Cautionshouldbeexercised when administering sucralfate to patients with
phosphatedeficiencies, since the aluminium in the sucralfate molecule binds to
phosphate in the gastrointestinal tract and inhibits its absorption.
Caution should be exercised because long-term administration ofthisproductmay
cause symptoms such as aluminium encephalopathy, aluminiumosteomalacia,
anemia, and aluminium osteodystrophy.
Effects on abilityto drive and use machines
Do not drive if you feel dizzy or drowsy.
The amount of free aluminium ions liberated from sucralfate in the gastrointestinal
tract is insignificant. Nevertheless, it is prudent to recommend a lapseof2hours
between the ingestion of sucralfate and other oral medications, to preventpossible
reducedtherapeuticefficacydue to aluminium ion chelation. Special caution is
required when the patient is being treated with oral tetracyclines.
The same precaution also applies if milk or dairy products are to be ingested.
Concurrent use of sucralfate and aluminium-containingmedicationsinpatientswith
renal failure may cause aluminium toxicity.
Simultaneous administration of sucralfate and antacidsinnotrecommended,since
antacidsmayinterferewith binding of sucralfate to the mucosa. It is therefore
recommended not to take antacids within 1 hour before or after sucralfate.
Some studies have shown that simultaneous sucralfate administration in healthy
volunteers reduced the extent of absorption (bioavailability) of the following drugs:
cimetidine,ofloxacin, ciprofloxacin, digoxin, norfloxacin, phenytoin, ranitidine,
tetracycline, sulpiride, ketoconazole, warfarin, thyroxine,quinidine,H2-antagonists
andtheophylline.Themechanismof these interactions appears to be nonsystemic in
nature, presumably resulting from sucralfate binding to the concomitantagentinthe
gastrointestinal tract. The bioavailability of these agents may be restored by
separating the administration of these agents from Ulsanic by two hours. In allcases
studied to date (cimetidine, ciprofloxacin, digoxin, and ranitidine), dosing the
concomitant medication 2hours before sucralfateeliminatedtheinteraction.Because
of the potential of sucralfate to alter the absorption of some other drugs,sucralfate
should be administered separately from otherdrugswhenalterationsinbioavailability
are felt to be critical. In these cases, patients should be monitored appropriately.
The administration of Ulsanic Tablets and enteral feeds by nasogastrictubeshould
be separated by one hour in patients receivingUlsanicTabletsfortheprophylaxisof
stress ulceration. In rare cases bezoar formation has beenreportedwhenUlsanicand
enteral feeds have been given too closely together. Therefore patients shouldbe
carefully observed, and, if the development of bezoarissuspected,thedrugshould
be discontinued and appropriate measures must be taken.
Other Drug Interactions
Sucralfate/Citrate Preparations (e.g.potassiumcitrate, sodium citrate):
Coadministrationofthesedrugswith sucralfate may increase the blood
concentrationsofaluminium.Themechanism may be due to chelation of aluminium,
which is assumed to increase its absorption. Therefore combinations of sucralfateand
citrate preparations should not be coadmininstered.
Sucralfate/Ion-Exchange Resins (whichabsorb and thus decrease serum potassium,
calcium, and also aluminium levels suchas calcium polystyrene sulfonate, sodium
polystyrene sulfonate): Concomitant administration may lead toreductioninthe
capacity of the ion-exchange resins.
Sucralfate/Thyroid Hormone Preparations (e.g. Levothyroxine sodium)/Bile Acid
Preparations (e.g. Ursodeoxycholic acid, deoxycholic acid/:Sucralfate may inhibit or
delaythe absorption of these drugs upon concomitant administration (sucralfate
absorbsthese drugs in the gastrointestinal tract). Therefore it is recommended to
increase dosing intervals.
Dosage and Administration
The tablets should not be chewed or crushed. They can be divided.
The recommended adult oral dosage is 1 tablet 4 times a day on an empty stomach,
30 minutes before each meal and at bedtime.
Antacids may be prescribed as needed for relief ofpainbutshouldnotbetaken
within the time-span of 1 hour before or 1 hour after Ulsanic.
While healing with Ulsanic may occur during thefirstweekortwo,treatmentshould
be continued for 4-8 weeks unless X-rayorendoscopicexaminationhas
There is no experience in humans with overdosage. Oral toxicitystudiesconducted
inanimals,however, using doses up to 12g/kg bodyweight, could not establish a
lethal dose. Therefore, risks associated with overdosage are believed to be minimal.
Store in a dry place, below 25 C.
Teva Pharmaceutical Industries Ltd
P.O.Box 3190, Petach Tikva.
Under license from
Chugai Pharmaceutical Company Ltd., Tokyo, Japan