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

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Sulfasalazine

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SULFASALAZINE DESCRIPTION



Therapeutic Classification:


Chemical Designation:


Structural Formula:
Sulfasalazine

Inactive ingredients:


CLINICAL PHARMACOLOGY


Pharmacodynamics


Pharmacokinetics


Absorption:



Distribution:


Metabolism:


Excretion:


Special Populations

Elderly:


Pediatric:


Acetylator Status:


Gender:


INDICATIONS & USAGE

Sulfasalazine tablets, USP are indicated:



SULFASALAZINE CONTRAINDICATIONS


  • ●     Patients with intestinal or urinary obstruction,
  • ●     Patients with porphyria as sulfonamides have been reported to precipitate an acute attack,
  • ●     Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.

WARNINGS

PRECAUTIONS, Laboratory Tests

PRECAUTIONS

General:


INFORMATION FOR PATIENTS



LABORATORY TESTS




DRUG INTERACTIONS



DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects:

Pregnancy Category B:




Nonteratogenic Effects:



NURSING MOTHERS



PEDIATRIC USE



SULFASALAZINE ADVERSE REACTIONS



Blood dyscrasias:
Hypersensitivity reactions:
Gastrointestinal reactions:
Central nervous system reactions:
Renal reactions:
Other reactions:

Postmarketing Reports
Gastrointestinal:

DRUG ABUSE AND DEPENDENCE



OVERDOSAGE




Instructions for overdosage:


DOSAGE & ADMINISTRATION



Initial Therapy:
Adults:

Children, six years of age and older:

Maintenance Therapy:
Adults:

Children, six years of age and older:



HOW SUPPLIED



STORAGE AND HANDLING



REFERENCES








PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Sulfasalazine

Sulfasalazine

Sulfasalazine

Sulfasalazine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-832(NDC:0603-5801)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFASALAZINE SULFASALAZINE 500 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30
talc

Product Characteristics

Color Size Imprint Code Shape
yellow 13 mm 5904;V ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-832-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040349 2011-12-01


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Be sure to consult your doctor before taking any medication!
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