Sucralfate description, usages, side effects, indications, overdosage, supplying and lots more!

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Sucralfate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SUCRALFATE DESCRIPTION


Sucralfate





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.


CLINICAL TRIALS

Acute Duodenal Ulcer






Maintenance Therapy After Healing of Duodenal Ulcer


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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

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


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