August 29, 2016
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Giazo

"An experimental oral lymphocyte trafficking agent, ozanimod (Receptos), showed modest activity against ulcerative colitis (UC) in a small, early-stage clinical trial.

In the double-blind, placebo-controlled phase 2 trial in adults wit"...

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Giazo

Indications
Dosage
How Supplied

INDICATIONS

GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.

Limitations Of Use

  • Effectiveness of GIAZO in the treatment of female patients was not demonstrated in clinical trials [see Clinical Trials].
  • Safety and effectiveness of GIAZO therapy beyond 8 weeks have not been established.

DOSAGE AND ADMINISTRATION

The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.

HOW SUPPLIED

Dosage Forms And Strengths

GIAZO is available as yellow, oval, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.

Storage And Handling

GIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.

Bottles of 180 Tablets NDC 65649-102-02

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LC Bridgewater, NJ 08807 USA. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/28/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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