TRAZODONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

TRAZODONE HYDROCHLORIDE

Composition:

TRAZODONE HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are contraindicated in: - Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://wo

Product summary:

Trazodone Hydrochloride Tablets USP are available as follows: 50 mg: White, round, compressed tablet, debossed “PLIVA 433” on one side and scored on the other side. Available in blistercards of 15 tablets (0615-2578-05) and 30 tablets (0615-2578-39). 100 mg: White, round, compressed tablet, debossed “PLIVA 434” on one side and scored on the other side. Available in blistercards of 15 tablets (0615-2579-05) and 30 tablets (NDC 0615-2579-39). 150 mg: White, oval, flat-faced, beveled edge tablet, scored and debossed as “PLIVA” bisect “441” on one side and tri-scored and debossed as “50” in each section on the other side. Directions for using the correct score when breaking the tablet please refer to the following: - For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). - For 75 mg, break the score down the middle of the tablet (one-half of a tablet). - For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). - For 150 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NCS HealthCare of KY, LLC dba Vangard Labs
----------
MEDICATION GUIDE
Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets,
for oral use
What is the most important information I should know about trazodone
hydrochloride tablets?
Antidepressant medicines, depression or other serious mental
illnesses, and suicidal thoughts or actions:
Talk to your healthcare provider about:
•
All risks and benefits of treatment with antidepressant medicines
•
All treatment choices for depression or other serious mental illnesses
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 higher 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?
•
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 your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider
between visits as needed, especially if you are worried about
symptoms.
Call a healthcare provider right away if you have any of the following
symptoms, especially if they are new,
worse, or worry you:
•
Thoughts about suicide or dying
•
Attempts to commit suicide
•
New or worse depression
•
New or worse anxiety
•
Feeling very agitated or restless
•
Panic attacks
•
Trouble sleeping (insomnia)
•
New or worse irritability
•
Acting aggressive, being angry or violent
•
Acting on dangerous impulses
�

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRAZODONE HYDROCHLORIDE TABLETS.
TRAZODONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC
AND YOUNG ADULT PATIENTS (5.1)
CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND
BEHAVIORS (5.1)
TRAZODONE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4)
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are a selective serotonin reuptake
inhibitor indicated for the treatment of
major depressive disorder (MDD) (1).
DOSAGE AND ADMINISTRATION
Starting dose: 150 mg in divided doses daily. May be increased by 50
mg per day every three to four
days. Maximum dose: 400 mg per day in divided doses (2).
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack (2).
Tablets should be swallowed whole or broken in half along the score
line, and should not be chewed or
crushed (2).
When discontinued, gradual dose reduction is recommended (2).
DOSAGE FORMS AND STRENGTHS
Bisectable tablets of 50 mg, 100 mg and 150 mg (3).
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (4).
WARNINGS AND PRECAUTIONS
Serotonin Syndrome: Increased risk when co-administered with other
serotonergic agents (e.g., SSRI,
SNRI, triptans), but also when taken alone. If it occurs, discontinue
trazodone hydrochloride tablets and
initiate supportive treatment (5.2).
Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs
that also increase the QT interval
and in patients with risk factors for prolonged QT interval (5.3)
Orthos