מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
Advanced Rx Pharmacy of Tennessee, LLC
ORAL
PRESCRIPTION DRUG
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
Trazodone Hydrochloride Tablets, USP 100 mg are white to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘44’ on either side of scoreline (functional) on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0298-01 Bottles of 60 Tablets NDC: 80425-0298-02 Bottles of 90 Tablets NDC: 80425-0298-03 Store at 20°C to 25°C (68°F to 77°F). Excursions 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.
Abbreviated New Drug Application
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 קרא את המסמך השלם
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- TRAZODONE HCL 100MG 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 קרא את המסמך השלם