Trazodone Hydrochloride (Page 4 of 4)

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines

• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying • new or worse irritability
• attempts to commit suicide • acting aggressive, being angry, or violent
• new or worse depression • acting on dangerous impulses
• new or worse anxiety • an extreme increase in activity and talking (mania)
• feeling very agitated or restless • other unusual changes in behavior or mood
• panic attacks
• trouble sleeping (insomnia)

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Mfg by PLIVA® Hrvatska d.o.o., Zagreb Croatia for PLIVA®, Inc.
Pomona, NY 10970
Dist. by Barr Laboratories, Inc., Pomona, NY 10970

Revised January 2008

BR-433, 434, 441

Z21-0433

c/n.1

FLEXIDOSE® is a registered trademark of PLIVA®, Inc. for its tablets. The trapezoidal shaped tablet is a trademark and original design of PLIVA® Inc.

TRAZODONE 50MG PACKAGE LABEL

Label Image 1
(click image for full-size original)

TRAZODONE 100MG PACKAGE LABEL

Label Image 2
(click image for full-size original)

TRAZODONE 150MG PACKAGE LABEL

Label Image 3
(click image for full-size original)
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-231(NDC:50111-433)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trazodone Hydrochloride (Trazodone) Trazodone Hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code PLIVA;433
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-231-15 15 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-231-30 30 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-231-45 45 TABLET (TABLET) in 1 BOTTLE None
4 NDC:16590-231-60 60 TABLET (TABLET) in 1 BOTTLE None
5 NDC:16590-231-90 90 TABLET (TABLET) in 1 BOTTLE None
6 NDC:16590-231-82 180 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071523 12/11/1987
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-232(NDC:50111-434)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trazodone Hydrochloride (Trazodone) Trazodone Hydrochloride 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;434
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-232-15 15 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-232-28 28 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-232-30 30 TABLET (TABLET) in 1 BOTTLE None
4 NDC:16590-232-60 60 TABLET (TABLET) in 1 BOTTLE None
5 NDC:16590-232-90 90 TABLET (TABLET) in 1 BOTTLE None
6 NDC:16590-232-71 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071524 12/11/1987
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-585(NDC:50111-441)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trazodone Hydrochloride (Trazodone ) Trazodone Hydrochloride 150 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 3 pieces
Shape TRAPEZOID Size 19mm
Flavor Imprint Code PLIVA;441
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-585-28 28 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-585-30 30 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-585-60 60 TABLET (TABLET) in 1 BOTTLE None
4 NDC:16590-585-90 90 TABLET (TABLET) in 1 BOTTLE None
5 NDC:16590-585-71 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071525 03/09/1988
Labeler — STAT RX LLC USA (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX LLC USA 786036330 repack, relabel

Revised: 11/2010 STAT RX LLC USA

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