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

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Pentasa

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PENTASA DESCRIPTION




Pentasa




CLINICAL PHARMACOLOGY



Human Pharmacokinetics and Metabolism
Absorption.


Elimination.
CLINICAL TRIALS





INDICATIONS & USAGE



PENTASA CONTRAINDICATIONS



PRECAUTIONS

General



Renal


DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY




NURSING MOTHERS





PEDIATRIC USE



PENTASA ADVERSE REACTIONS



Table 1. Adverse Events Occurring in More than 1% of Either Placebo or PENTASA Patients in Domestic Placebo-controlled Ulcerative Colitis Trials. (PENTASA Comparison to Placebo)

Gastrointestinal:
Dermatological:
Nervous System:
Cardiovascular:
Other:


Postmarketing Reports

Gastrointestinal:
Other:

OVERDOSAGE



Treatment of Overdosage.

DOSAGE & ADMINISTRATION



HOW SUPPLIED




STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Pentasa

Pentasa

Mesalamine CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-561(NDC:54092-191)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MESALAMINE MESALAMINE 500 mg

Inactive Ingredients

Ingredient Name Strength
castor oil
SILICON DIOXIDE
STEARIC ACID
talc
FD&C BLUE NO. 1
GELATIN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
blue 23 mm PENTASA;500;mg;S429;500;mg CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-561-21 120 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020049 2011-10-04


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