Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
St. Mary's Medical Park Pharmacy
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE 100 mg
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)]. 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)]. Teratogenic Effects Pregnancy Category C Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2 in adolescents. There was also an in
Trazodone hydrochloride tablets USP, 100 mg are white, film-coated, round, convex, scored tablets, debossed “61” bisect “61” on one side and debossed “V” on the reverse side. They are available as follows: NDC 60760-434-60 BOTTLES OF 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.
Abbreviated New Drug Application
St. Mary's Medical Park Pharmacy ---------- MEDICATION GUIDE 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 • An extreme increase in activity and talking (mania) • Other unusual changes in behavior Lestu allt skjalið
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED ST. MARY'S MEDICAL PARK PHARMACY ---------- 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._ • ANTIDEPRESANTS 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 HYDROCHLORIDE TABLETS ARE 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 ( 2.1). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2). Tablets should be swallowed whole or broken in half along the score line ( 2.2). When discontinued, gradual dose reduction is recommended ( 2.6). DOSAGE FORMS AND STRENGTHS Scored tablets: 50 mg, 100 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 Lestu allt skjalið