ULORIC (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

ULORIC 40 mg tablets are light green to green in color, round, debossed with “TAP” on one side and “40″ on the other side and supplied as:

NDC Number

Size

64764-918-11

Hospital Unit Dose Pack of 100 Tablets

64764-918-30

Bottle of 30 Tablets

64764-918-90

Bottle of 90 Tablets

64764-918-18

Bottle of 500 Tablets

NDC 69189-0918-1  single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information)

17.1 General Information

Patients should be advised of the potential benefits and risks of ULORIC. Patients should be informed about the potential for gout flares, elevated liver enzymes and adverse cardiovascular events after initiation of ULORIC therapy.

Concomitant prophylaxis with an NSAID or colchicine for gout flares should be considered.

Patients should be instructed to inform their healthcare professional if they develop a rash, chest pain, shortness of breath or neurologic symptoms suggesting a stroke. Patients should be instructed to inform their healthcare professional of any other medications they are currently taking with ULORIC, including over-the-counter medications.

Patient Information
ULORIC (Ū–’lor–ik)
(febuxostat) tablets

Read the Patient Information that comes with ULORIC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ULORIC?

ULORIC is a prescription medicine called a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels in adults with gout.

It is not known if ULORIC is safe and effective in children under 18 years of age.

Who should not take ULORIC?

Do not take ULORIC if you:

take azathioprine (Azasan, Imuran)
take mercaptopurine (Purinethol)

It is not known if ULORIC is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before taking ULORIC?

Before taking ULORIC tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems
have a history of heart disease or stroke
are pregnant or plan to become pregnant. It is not known if ULORIC will harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if ULORIC passes into your breast milk. You and your healthcare provider should decide if you should take ULORIC while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ULORIC may affect the way other medicines work, and other medicines may affect how ULORIC works.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ULORIC?

Take ULORIC exactly as your healthcare provider tells you to take it.
ULORIC can be taken with or without food.
ULORIC can be taken with antacids.
Your gout may flare up when you start taking ULORIC, do not stop taking your ULORIC even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.
Your healthcare provider may do certain tests while you take ULORIC.

What are the possible side effects of ULORIC?

Heart problems. A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

The most common side effects of ULORIC include:

liver problems
nausea
gout flares
joint pain
rash

Tell your healthcare provider if you develop a rash, have any side effect that bothers you, or that does not go away. These are not all of the possible side effects of ULORIC. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ULORIC?

Store ULORIC between 59°F and 86°F (15°C to 30°C).

Keep ULORIC out of the light.

Keep ULORIC and all medicines out of the reach of children.

General information about the safe and effective use of ULORIC.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use ULORIC for a condition for which it was not prescribed. Do not give ULORIC to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about ULORIC. If you would like more information about ULORIC talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ULORIC that is written for health professionals. For more information go to www.uloric.com, or call 1-877-825-3327.

What are the ingredients in ULORIC?

Active Ingredient: febuxostat

Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, magnesium stearate, and Opadry II, green

Distributed by:
Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015

Revised: March 2013

ULORIC is a registered trademark of Teijin Limited registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

©2009-2013 Takeda Pharmaceuticals America, Inc.

ULR015 R4

Febuxostat 40 mg tablet label
(click image for full-size original)
ULORIC febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0918(NDC:64764-918)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
febuxostat (febuxostat) febuxostat 40 mg
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
HYDROXYPROPYL CELLULOSE (TYPE H)
croscarmellose sodium
silicon dioxide
magnesium stearate
Product Characteristics
Color GREEN (light green to green) Score no score
Shape ROUND (round shaped) Size 9mm
Flavor Imprint Code TAP;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-0918-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 03/02/2015
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0918), repack (69189-0918)

Revised: 12/2015 Avera McKennan Hospital

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