国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)
Quality Care Products, LLC
ORAL
PRESCRIPTION DRUG
Doxepin hydrochloride capsules are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin h
Doxepin Hydrochloride Capsules, USP are available containing Doxepin Hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of Doxepin. Doxepin Hydrochloride Capsules USP, 10 mg are buff colored size “4” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 10 on body. 55700-783-30 Doxepin Hydrochloride Capsules USP, 25 mg are ivory and white colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 25 on body. Doxepin Hydrochloride Capsules USP, 50 mg are ivory colored size “3” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 50 on body. Doxepin Hydrochloride Capsules USP, 75 mg are brite lite green colored size “2” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 75 on body. Doxepin Hydrochloride Capsules USP, 100 mg are brite lite green and white colored size “1” hard gelatin capsule filled with white to off-white granules and imprinted with DOX on cap and 100 on body. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: December 2018
Abbreviated New Drug Application
DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE Quality Care Products, LLC ---------- MEDICATION GUIDE Doxepin Hydrochloride Capsules USP (dox’ e pin hye” droe klor’ ide) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 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 particularly high 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 in myself or a family member? • 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 the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has 阅读完整的文件
DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CAPSULE QUALITY CARE PRODUCTS, LLC ---------- DOXEPIN HYDROCHLORIDE CAPSULES USP RX ONLY SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use) DESCRIPTION Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C H NO•HCl having a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and in methylene chloride. Its structural formula is: Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1- Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. Each 10 mg, 25 mg, 5 阅读完整的文件