TRAZODONE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Advanced Rx Pharmacy of Tennessee, LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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)]. 8.1 Pregnancy 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://womensmentalhealth.org/clinical-and-research programs/pregnancy registry/antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with Trazodone Hydrochloride Tablets use in pregnant women have

Ürün özeti:

Trazodone Hydrochloride Tablets, USP 150 mg are white to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘45’ on either side and having two partial trisect on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0302-01 Bottles of 60 Tablets NDC: 80425-0302-02 Bottles of 90 Tablets NDC: 80425-0302-03 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). Excursions are permitted between 15ºC and 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Trazodone Hydrochloride Tablets, USP
(traz’ oh done hye’’ droeklor’ ide)
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

Ürün özellikleri

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
TRAZODONE HCL 150MG TABLET
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors
in pediatric
and young adult patients in short-term studies. Closely monitor all
antidepressant-
treated patients for clinical worsening, and for emergence of suicidal
thoughts and
behaviors [see WARNINGS AND PRECAUTIONS (5.1)]. Trazodone
Hydrochloride
Tablets are not approved for use in pediatric patients [see USE IN
SPECIFIC
POPULATIONS (8.4)].
1. INDICATIONS AND USAGE
Trazodone Hydrochloride Tablets are indicated for the treatment of
major depressive
disorder (MDD) in adults.
2. DOSAGE AND ADMINISTRATION
2.1 Dose Selection
An initial dose of 150 mg/day in divided doses is suggested. The
dosage should be
initiated at a low-dose and increased gradually, noting the clinical
response and any
evidence of intolerance. Occurrence of drowsiness may require the
administration of a
major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum
dose for
outpatients usually should not exceed 400 mg/day in divided doses.
Inpatients (i.e., more severely depressed patients) may be given up to
but not in excess
of 600 mg/day in divided doses.
Once an adequate response has been achieved, dosage may be gradually
reduced, with
subsequent adjustment depending on therapeutic response.
2.2 Important Administration Instructions
Trazodone Hydrochloride Tablets can be swallowed whole or administered
as a half
tablet by breaking the tablet along the score line. Trazodone
Hydrochloride Tablets
should be taken shortly after a meal or light snack.
2.3 Screen for Bipolar Disorder Prior to Starting Trazodone
Hydrochloride Tablets
Prior to initiating treatment with Trazodone Hydrochloride Tablets or
another
antidepressant, screen patients for a personal or family history of
bipolar disorder,
mania, or hypomania [see WARNINGS AN