Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. 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 ). Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydro
Nortriptyline Hydrochloride Capsules USP, equivalent to 25 mg, base, are as follows: 25 mg: Opaque ivory cap and body, imprinted "TARO" on the cap and "NTP25" on the body. bottles of 20 NDC 68071-3211-2 bottles of 30 NDC 68071-3211-3 bottles of 45 NDC 68071-3211-5 bottles of 60 NDC 68071-3211-6 bottles of 90 NDC 68071-3211-9 bottles of 120 NDC 68071-3211-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.
Abbreviated New Drug Application
NORTRIPTYLINE HYDROCHLORIDE- nortriptyline hydrochloride capsule NuCare Pharmaceuticals, Inc. ---------- Medication Guide Nortriptyline Hydrochloride Capsules USP 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? • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. • 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. • 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 any of the following Lugege kogu dokumenti
NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE NUCARE PHARMACEUTICALS, INC. ---------- 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: Each capsule, for oral administration, contains nortriptyline hydrochloride equivalent to 10 mg, 25 mg, 50 mg, and 75 mg of nortriptyline hydrochloride USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, D&C Yellow #10 (aluminum lake), D&C Yellow #10, FD&C Blue #1 (aluminum lake), FD&C Blue #2 (aluminum lake), FD&C Green #3 (10, Lugege kogu dokumenti