Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting nortriptyline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is
Nortriptyline Hydrochloride Capsules, USP equivalent to 10 mg base, are available as follows: Nortriptyline Hydrochloride Capsules, USP 10 mg: #3 capsules with a white body and an orange cap, imprinted "TEVA" on the cap and "10mg"-"0810" on the body, in bottles of 30 (NDC 71205-770-30), bottles of 60 (NDC 71205-770-60) and bottles of 90 (NDC 71205-770-90). Store and Dispense Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. AA 9/2021
Abbreviated New Drug Application
Proficient Rx LP ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.tevausa.com/medguides Nortriptyline Hydrochloride (nor trip' ti leen hye'' droe klor' ide) Capsules 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. 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? o 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. o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o 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 any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suic Đọc toàn bộ tài liệu
NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE PROFICIENT RX LP ---------- NORTRIPTYLINE 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 NORTRIPTYLINE 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. NORTRIPTYLINE 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 Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5_H_- dibenzo[_a,d_]cyclohepten-5-ylidene)-_N_-methyl-, hydrochloride. The structural formula is as follows: C H N•HCl M.W. 299.84 Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg nortriptyline. In addition, each capsule contains the followi Đọc toàn bộ tài liệu