Cilostazol: Package Insert and Label Information (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied

Cilostazol Tablets USP are available as follows:

50 mg – round, white tablets debossed with MP 474 on the upper side, plain on the other side.

Bottles of 60 NDC 70436-050-06

100 mg – round, white tablets debossed with MP 454 on the upper side, plain on the other side.

Bottles of 60 NDC 70436-051-06

16.2 Storage and handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Advise the patient:

to take cilostazol at least one-half hour before or two hours after food.
to discuss with their doctor before taking any CYP3A4 or CYP2C19 inhibitors (e.g., omeprazole).
that the beneficial effects of cilostazol on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced. Discontinue cilostazol if symptoms do not improve after 3 months.

Manufactured By:

Frontida Biopharm, Inc.

Philadelphia, PA 19124

Distributed By:

Slate Run Pharmaceuticals, LLC

Columbus, OH 43215

10000098/01

Rev. 00, 10/2017

PATIENT INFORMATION

Cilostazol (sil-OS-tah-zol) Tablets USP, for oral use

Read this Patient Information leaflet before you start taking cilostazol tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about cilostazol tablets?

Cilostazol tablets can cause serious side effects:

Cilostazol stops a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure. Do not take cilostazol tablets if you have heart failure of any kind.

What are cilostazol tablets?

Cilostazol tablets are a prescription medicine used to reduce the symptoms of intermittent claudication and can increase your ability to walk further distances.

It is not known if cilostazol tablets are safe and effective for use in children.

How does cilostazol tablets work?

Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks.

Who should not take cilostazol tablets?

Do not take cilostazol tablets if you:

have heart problems (heart failure)
are allergic to cilostazol or any of the ingredients in cilostazol tablets. See the end of this leaflet for a complete list of ingredients in cilostazol tablets.

Tell your doctor before taking this medicine if you have any of these conditions.

What should I tell my doctor before taking cilostazol tablets?

Before you take cilostazol tablets, tell your doctor if you:

drink grapefruit juice. Taking cilostazol tablets and drinking grapefruit juice can increase the amount of cilostazol tablets causing side effects.
have any other medical conditions
are pregnant or planning to become pregnant. It is not known if cilostazol tablets will harm your unborn baby.
are breastfeeding or planning to breastfeed. It is not known if cilostazol tablets passes into your breast milk. You and your doctor should decide if you will take cilostazol tablets or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of medicines that interact with cilostazol tablets. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take cilostazol tablets?

Take cilostazol tablets exactly as your doctor tells you to take it.
Your doctor will tell you how much cilostazol tablets to take and when to take it.
Your doctor may change your dose if needed.
Take cilostazol tablets 30 minutes before you eat or 2 hours after you eat.

What are the possible side effects of cilostazol tablets?

Cilostazol tablets may cause serious side effects, including:

heart problems. Taking cilostazol tablets may cause you to have heart problems, including a fast heart beat, palpitations, irregular heartbeat, and low blood pressure.
See “What is the most important information I should know about cilostazol tablets?
severe allergic reactions (anaphylaxis, angioedema). Call your doctor or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:
hives
swelling of your face, lips, mouth, or tongue
trouble breathing or wheezing
dizziness
changes in your blood cell counts (thrombocytopenia or leukopenia). Your doctor should do blood tests to check your blood cell counts while you take cilostazol tablets.

The most common side effects of cilostazol tablets include:

headache
abnormal stools
diarrhea

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of cilostazol tablets. For more information, ask your doctor or pharmacist.

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

How should I store cilostazol tablets?

Store cilostazol tablets at 68°F to 77°F (20°C to 25°C).

Keep cilostazol tablets and all medicines out of the reach of children.

General information about the safe and effective use of cilostazol tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol tablets for a condition for which they were not prescribed. Do not give cilostazol tablet to other people, even if they have the same symptoms that you have. They may harm them.

This Patient Information summarizes the most important information about cilostazol tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol tablets that is written for health professionals.

For more information call 1-888-341-9214.

What are the ingredients in Cilostazol Tablets USP?

Active ingredient: cilostazol, USP

Inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, and povidone.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Slate Run Pharmaceuticals, LLC.

Manufactured By:

Frontida Biopharm, Inc.

Philadelphia, PA 19124

Distributed By:

Slate Run Pharmaceuticals, LLC

Columbus, OH 43215

10000098/01

Rev. 00, 10/2017

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

70436-050-06

70436-050-06
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

70436-051-06

70436-051-06
(click image for full-size original)
CILOSTAZOL
cilostazol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cilostazol (cilostazol) cilostazol 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
POVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code MP;474
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-050-06 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077208 01/01/2018
CILOSTAZOL
cilostazol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-051
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cilostazol (cilostazol) cilostazol 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MP;475
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-051-06 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077208 01/01/2018
Labeler — Slate Run Pharmaceuticals, LLC (039452765)
Registrant — Slate Run Pharmaceuticals, LLC (039452765)

Revised: 01/2020 Slate Run Pharmaceuticals, LLC

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