Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT)
Breckenridge Pharmaceutical, Inc.
TRIMIPRAMINE MALEATE
TRIMIPRAMINE 25 mg
ORAL
PRESCRIPTION DRUG
Trimipramine maleate capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression. The use of MAOIs intended to treat psychiatric disorders with trimipramine maleate capsules or within 14 days of stopping treatment with trimipramine maleate capsules is contraindicated because of an increased risk of serotonin syndrome. The use of trimipramine maleate capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting trimipramine maleate capsules 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 trimipramine maleate capsules and other dibenzazepines is a possibility. The drug is contraindicated during the acute recovery period after a myocardial infarction.
25 mg — #3 Capsules, with a yellow opaque body and blue opaque cap in bottles of 100 (NDC 51991-944-01) and in bottles of 30 (NDC 51991-944-33). Capsules contain white or almost white powder. Printed with TR25 in black ink on the cap. 50 mg — #2 Capsules, with an orange opaque body and blue opaque cap in bottles of 100 (NDC 51991-945-01) and in bottles of 30 (NDC 51991-945-33) Capsules contain white or almost white powder. Printed with TR50 in black ink on the cap. 100 mg — #0 Capsules, with a white opaque body and light blue opaque cap in bottles of 100 (NDC 51991-946-01) and in bottles of 30 (NDC 51991-946-33). Capsules contain white or almost white powder. Printed with TR100 in black ink on the cap. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep bottles tightly closed. Dispense in a tight container. Dispense with Medication Guide available at: www.bpirx.com/products/patientinformation
Abbreviated New Drug Application
TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE Breckenridge Pharmaceutical, Inc. ---------- MEDICATION GUIDE Trimipramine Maleate (trye-MIP-ra-meen MAL-ee-ate) Capsules Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Dispense with Medication Guide available at: www.bpirx.com/products/patientinformation 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 sympto Lesen Sie das vollständige Dokument
TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE BRECKENRIDGE PHARMACEUTICAL, INC. ---------- TRIMIPRAMINE MALEATE CAPSULES 25 MG, 50 MG AND 100 MG 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 TRIMIPRAMINE MALEATE CAPSULES 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. TRIMIPRAMINE MALEATE CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS - CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS - INFORMATION FOR PATIENTS, AND PRECAUTIONS - PEDIATRIC USE) DESCRIPTION Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). MOLECULAR FORMULA: C H N ∙ C H O MOLECULAR WEIGHT: 410.5 Trimipramine maleate capsules contain trimipramine maleate equivalent to 25 mg, 50 mg, 20 26 2 4 4 4 or 100 mg of trimipramine as the base. The inactive ingredients present are lactose monohydrate and magnesium stearate. The capsule shell contains D&C Yellow 10 (25 mg), FD&C Blue 1 (25 mg, 50 mg and 100 mg), FD&C Yellow 6 (25 mg, 50 mg), D&C Red 28 (50 mg), FD&C Red 40 (50 mg), gelati Lesen Sie das vollständige Dokument