Sucralfate

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• SUCRALFATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• SUCRALFATE CONTRAINDICATIONS
• PRECAUTIONS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• SUCRALFATE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

SUCRALFATE DESCRIPTION

CLINICAL PHARMACOLOGY

• ●     Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.

• ●     In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.

• ●     In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.

• ●     In vitro, sucralfate adsorbs bile salts.

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INDICATIONS & USAGE

• ●     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.

SUCRALFATE CONTRAINDICATIONS

PRECAUTIONS

Special Populations: Chronic Renal Failure and Dialysis Patients

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

Teratogenic effects. Pregnancy Category B.

NURSING MOTHERS

PEDIATRIC USE

SUCRALFATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Sucralfate Sucralfate TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-408(NDC:0591-0780) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUCRALFATE SUCRALFATE 1 g Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE cellulose, microcrystalline FD&C BLUE NO. 1 STARCH, CORN Product Characteristics Color Size Imprint Code Shape blue 19 mm WATSON;780 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-408-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018333 2011-07-21