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RX ITEM-FEBUXOSTAT 40Mg Tab 30 By Alembic Pharma Generic Uloric

FEBUXOSTAT 40Mg Tab 30 By Alembic Pharma Generic Uloric. item No.:RX900928  900928  NDC No.62332-0190-30 62332-190-30 6233219030 62332019030 UPC No.:3-62332-19030-0 362332-190300 362332190300 MPN 1903FEBUXOSTAT 80Mg Tab 30 By Alembic Pharma Generic UloricNDC 64764-0918-30 UPC/GTIN No.3-64764-91830-9 Mfg.Part No.91830 FEBUXOSTAT ORAL TABLET 40BRAND: ULORIC NDC: 64764-0918-30,64764091830 UPC: 3-64764-91830-9,364764918309 Takeda Pharma USAOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-FEBUXOSTAT 40Mg Tab 30 By Alembic Pharma Generic Uloric

$371.29$99.99

item No.:RX900928 900928 NDC No.62332-0190-30 62332-190-30 6233219030 62332019030 UPC No.:3-62332-19030-0 362332-190300 362332190300 MPN 19030 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx854901 Uloric 40mg Tab 30 by Takeda Pharma Item No.3854901 NDC No.64764091830 6476491830 UPC No.364764918

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ULORIC- febuxostat tablet
Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE

ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose


For treatment of hyperuricemia in patients with gout, ULORIC is recommended at 40 mg or 80 mg once daily.

The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks with 40 mg, ULORIC 80 mg is recommended.

ULORIC can be taken without regard to food or antacid use
DESCRIPTION

ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38.
Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205�C to 208�C.

ULORIC tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide and magnesium stearate. ULORIC tablets are coated with Opadry II, green.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
ULORIC, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. ULORIC is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
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.

FEBUXOSTAT 40Mg Tab 30 By Alembic Pharma Generic Uloric. item No.:RX900928  900928  NDC No.62332-0190-30 62332-190-30 6233219030 62332019030 UPC No.:3-62332-19030-0 362332-190300 362332190300 MPN 1903
FEBUXOSTAT 40Mg Tab 30 By
FEBUXOSTAT 40Mg Tab 30 By Alembic Pharma Generic Uloric. item No.:RX900928 900928 NDC No.62332-0190-30 62332-190-30 6233219030 62332019030 UPC No.:3-62332-19030-0 362332-190300 362332190300 MPN 1903

FEBUXOSTAT 80Mg Tab 30 By Alembic Pharma Generic Uloric
FEBUXOSTAT 80Mg Tab 30 By Alem
FEBUXOSTAT 80Mg Tab 30 By Alembic Pharma Generic Uloric

NDC 64764-0918-30 UPC/GTIN No.3-64764-91830-9 Mfg.Part No.91830 FEBUXOSTAT ORAL TABLET 40
RX ITEM-Uloric 40Mg Tab 30 By Takeda Pha
NDC 64764-0918-30 UPC/GTIN No.3-64764-91830-9 Mfg.Part No.91830 FEBUXOSTAT ORAL TABLET 40

BRAND: ULORIC NDC: 64764-0918-30,64764091830 UPC: 3-64764-91830-9,364764918309 Takeda Pharma USA
Uloric 40Mg Tab 30 By Takeda Pharma
BRAND: ULORIC NDC: 64764-0918-30,64764091830 UPC: 3-64764-91830-9,364764918309 Takeda Pharma USA

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
FEBUXOSTAT ORAL TABLET 40
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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