SUCRALFATE (Page 2 of 2)

ADVERSE REACTIONS

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). 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, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting.

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.

OVERDOSAGE

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommen-dations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer

The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. Sucralfate should be administered 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.

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. (See PRECAUTIONS Geriatric Use).

HOW SUPPLIED

Sucralfate Suspension 1 g/10 mL is a pink suspension.

NDC 54868-5299-1
Ten (10) 10 mL oral liquid unit dose cups per tray.
Ten (10) trays per shipper.

NDC 54868-5299-0
Ten (10) 10 mL oral liquid unit dose cups per tray.
Three (3) trays per shipper.

SHAKE WELL BEFORE USING

Store at controlled room temperature 20-25°C (68-77°F) [see USP]). Avoid freezing.

Distributed by:
Axcan Scandipharm Inc.
Birmingham, AL 35242 USA

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

LI 770Rev. 11/07

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

NDC 54868-5299-0

image of package label
(click image for full-size original)

SUCRALFATE
Suspension
1 g/10 mL

Delivers 10 mLShake Well

Store between 20°-25°C (68°-77°F)

SUCRALFATE sucralfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5299(NDC:58914-170)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCRALFATE (SUCRALFATE) SUCRALFATE 1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
GLYCERIN
CELLULOSE, MICROCRYSTALLINE
WATER
SORBITOL
Product Characteristics
Color PINK Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5299-0 3 TRAY (TRAY) in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE (CUP) in 1 TRAY This package is contained within the CASE (54868-5299-0) and contains a CUP, UNIT-DOSE
1 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (54868-5299-0)
2 NDC:54868-5299-1 10 TRAY (TRAY) in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE (CUP) in 1 TRAY This package is contained within the CASE (54868-5299-1) and contains a CUP, UNIT-DOSE
2 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (54868-5299-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019183 05/24/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, inc. 194123980 relabel

Revised: 11/2010 Physicians Total Care, Inc.

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