Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT)
Elite Laboratories, Inc.
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 or within 14 days of stopping treatment with trimipramine maleate is contraindicated because of an increased risk of serotonin syndrome. The use of trimipramine maleate within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting trimipramine maleate in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also co
Trimipramine Maleate Capsules equivalent to 25 mg of Trimipramine are #2 Capsules, light blue opaque cap, yellow opaque body, imprinted “A-293” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 64850-850-30) with a child-resistant closure. Trimipramine Maleate Capsules equivalent to 50 mg of Trimipramine are #2 Capsules, light blue opaque cap, medium orange opaque body, imprinted “A-294” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 64850-851-30) with a child-resistant closure. Trimipramine Maleate Capsules equivalent to 100 mg of Trimipramine are #2 Capsules, light blue opaque cap, white opaque body, imprinted “A-295” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 64850-852-30) with a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Preserve in tight container. Protect from excessive heat. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from Moisture. Keep this and all medication out of the reach of children. Keep tightly closed. Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647 Rev. 09/22 IN0523
Abbreviated New Drug Application
TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE Elite Laboratories, Inc. ---------- MEDICATION GUIDE TRIMIPRAMINE MALEATE 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. 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 any of the following symptoms, especially if th Přečtěte si celý dokument
TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE ELITE LABORATORIES, 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 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 IS 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 or 100 mg of trimipramine as the base. 20 26 2 4 4 4 Inactive Ingredients: Each capsule contains lactose monohydrate and magnesium stearate. The capsule shell contains the following ingredients: D&C Yellow 10 (25 mg and 50 mg), FD&C Blue #1 (25 mg, 50 mg and 100 mg), FD&C Red #40 (50 mg), gelatin, and titanium dioxide. The cap Přečtěte si celý dokument