Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
Teva Pharmaceuticals USA, Inc.
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE 50 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)]. 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://wome
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 100 tablets (50111-560-01), 500 tablets (NDC 50111-560-02) and 1000 tablets (50111-560-03). 100 mg: White, round, compressed tablet, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 100 tablets (50111-561-01), 500 tablets (NDC 50111-561-02) and 1000 tablets (NDC 50111-561-03). 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. Available in bottles of 100 tablets (NDC 50111-450-01) and 500 tablets (50111-450-02). 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.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.tevausa.com/medguides 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, Citiți documentul complet
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET TEVA PHARMACEUTICALS USA, INC. ---------- 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) Orthostatic Hypoten Citiți documentul complet