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

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ALLOPURINOL

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ALLOPURINOL DESCRIPTION


ALLOPURINOL



CLINICAL PHARMACOLOGY



ALLOPURINOL






INDICATIONS AND USAGE).






INDICATIONS & USAGE


CLINICAL PHARMACOLOGY,CONTRAINDICATIONS,WARNINGSandPRECAUTIONS).




ALLOPURINOL CONTRAINDICATIONS


WARNINGS


CLINICAL PHARMACOLOGY).



PRECAUTIONS

General







Information for Patients



Laboratory Tests

WARNINGS).



Drug Interactions
CLINICAL PHARMACOLOGY).









Drug/Laboratory Test Interactions


Pregnancy




Nursing Mothers


Pediatric Use
INDICATIONS AND USAGEandDOSAGE AND ADMINISTRATION).

ALLOPURINOL ADVERSE REACTIONS

PRECAUTIONSandDOSAGE AND ADMINISTRATION).
WARNINGS). Some patients with the most severe reaction also had fever, chills, arthralgias, cholestatic jaundice, eosinophilia and mild leukocytosis or leukopenia. Among 55 patients with gout treated with allopurinol for 3 to 34 months (average greater than 1 year) and followed prospectively, Rundles observed that 3% of patients developed a type of drug reaction which was predominantly a pruritic maculopapular skin eruption, sometimes scaly or exfoliative. However, with current usage, skin reactions have been observed less frequently than 1%. The explanation for this decrease is not obvious. The incidence of skin rash may be increased in the presence of renal insufficiency. The frequency of skin rash among patients receiving ampicillin or amoxicillin concurrently with allopurinol has been reported to be increased (seePRECAUTIONS).

Most Common Reactions*
Probably Causally Related



ADVERSE REACTIONSintroduction,INDICATIONS AND USAGE,PRECAUTIONSandDOSAGE AND ADMINISTRATION).

Incidence Less Than 1%
Probably Causally Related









PRECAUTIONS)

Incidence Less Than 1%
Causal Relationship Unknown











OVERDOSAGE





DOSAGE & ADMINISTRATION











HOW SUPPLIED




STORAGE AND HANDLING


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














ALLOPURINOL

ALLOPURINOL

ALLOPURINOL TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-634(NDC:0591-5544)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ALLOPURINOL ALLOPURINOL 300 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
orange 11 mm DAN;DAN;5544 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-634-20 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018877 2013-01-11


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