TRAZODONE HYDROCHLORIDE- 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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

TRAZODONE HYDROCHLORIDE

Composition:

TRAZODONE HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trazodone Hydrochloride Tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Trazodone Hydrochloride Tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)]. None. Teratogenic Effects Pregnancy Category C Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human mi

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 bottles of 1000. NDC   42291-833-10 100 mg: White, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 1000. NDC   42291-834-10 150 mg: White, trapezoid, flat-face, beveled edge tablet, scored and debossed as “PLIVA” and “441” on one side and tri-scored and debossed as “50” in each section on the other side. Available in bottles of 500. NDC   42291-835-50 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. 300 mg: White, oval, flat-faced, beveled-edge tablet with one side scored with a full bisect and having two partial trisects. Debossed with stylized barr/733 on one side and 100 100 100 on the other side with the middle 100 perpendicular to the others. Available in bottles of 1000  NDC 42291-836-01 -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets
USP
Read the Medication Guide that comes with trazodone hydrochloride
tablets 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 to your healthcare provider about your medical condition or
treatment. Talk to your healthcare
provider or pharmacist if there is something you do not understand or
you want to learn about trazodone
hydrochloride tablets.
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 prov

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE - TRAZODONE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE HYDROCHLORIDE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAZODONE
HYDROCHLORIDE TABLETS USP.
TRAZODONE HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. TRAZODONE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.12) 06/2015
INDICATIONS AND USAGE
Trazodone hydrochloride tablets USP are indicated for the treatment of
major depressive disorder (1).
• Efficacy was established in trials of trazodone immediate release
formulation in patients with major depressive disorder
(14).
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, 150 mg, and 300 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
• Clinical Worsening/Suicide Risk: Monitor for clinical worsening
and suicidal thinking and behavior (5.1).
• Serotonin Syndrome or Neuroleptic Malignant Syndrome-Like
Reactions: Have been reported with antidepressants. Discontinue
trazodone hydrochloride tablets and initiate supportive
treatment (5.2, 7).
• Activation of Mania/Hypomania: