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Asacol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ASACOL DESCRIPTION


Asacol

Inactive Ingredients:

CLINICAL PHARMACOLOGY




Pharmacokinetics:




Clinical Studies:

Mildly to moderately active ulcerative colitis:



Maintenance of remission of ulcerative colitis:



Study to assess the effect on male fertility:


INDICATIONS & USAGE



ASACOL CONTRAINDICATIONS



PRECAUTIONS


General:




Renal:
Therefore, caution should be exercised when using Asacol (or other compounds which contain or are converted to mesalamine or its metabolites) in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.

Use in Hepatic Impairment:


INFORMATION FOR PATIENTS




DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY






NURSING MOTHERS


PRECAUTIONS, Pregnancy

PEDIATRIC USE



GERIATRIC USE




ASACOL ADVERSE REACTIONS



Table 1




Table 1


Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Musculoskeletal:
Nervous:
Respiratory/Pulmonary:
Skin:
Special Senses:
Urogenital:Renal subsection in PRECAUTIONS
Laboratory Abnormalities:

DRUG ABUSE AND DEPENDENCE

Abuse:


Dependency:


OVERDOSAGE



DOSAGE & ADMINISTRATION

For the treatment of mildly to moderately active ulcerative colitis:
For the maintenance of remission of ulcerative colitis:


HOW SUPPLIED




STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Asacol

Asacol

Asacol

Asacol TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-951(NDC:0430-0752)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MESALAMINE MESALAMINE 400 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBUTYL PHTHALATE
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
MAGNESIUM STEARATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)
polyethylene glycol
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc

Product Characteristics

Color Size Imprint Code Shape
red 14 mm 0752;DR BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-951-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019651 2012-03-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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