TRIMIPRAMINE MALEATE capsule

Trimipramine Maleate by

Drug Labeling and Warnings

Trimipramine Maleate by is a Prescription medication manufactured, distributed, or labeled by Breckenridge Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Manifestations

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.

Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.

Management

General

Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Plasma drug levels may not reflect the severity of the poisoning. Therefore, monitoring of plasma drug levels alone should not guide management of the patient.

Gastrointestinal Decontamination

All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.

Cardiovascular

A maximal limb-lead QRS duration of ≥ 0.10 seconds has been associated with an increased incidence of seizures. A QRS duration of ≥ 0.16 seconds has been associated with an increased incidence of ventricular dysrhythmias. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO 2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

CNS

In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

Psychiatric Follow-up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

  • HOW SUPPLIED

    Trimipramine Maleate Capsules

    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.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Breckenridge Pharmaceutical, Inc.
    Berlin, CT 06037

    Manufactured by:
    Rivopharm SA
    6928, Manno, Switzerland

    To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    05.2019

  • 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

    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 they are new, worse, or worry you:

    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling very agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood

    Visual Problems

    • eye pain
    • changes in vision
    • swelling or redness in or around the eye

      Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

    Who should not take trimipramine maleate capsules?

    • Do not take trimipramine maleate capsules if you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • Do not take an MAOI within 2 weeks of stopping trimipramine maleate capsules unless directed to do so by your physician.
    • Do not start trimipramine maleate capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

    What else do I need to know about antidepressant medicines?

    • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
    • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
    • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
    • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
    • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Revised 05.2019

    Distributed by:
    Breckenridge Pharmaceutical, Inc.
    Berlin, CT 06037

    Manufactured by:
    Rivopharm SA
    6928, Manno, Switzerland

  • PRINCIPAL DISPLAY PANEL - 25 mg 100 Capsule Bottle Label

    25mg 100 capsule bottle label 05-2019

  • PRINCIPAL DISPLAY PANEL - 50 mg 100 Capsule Bottle Label

    50mg 100 capsule bottle label 05-2019

  • PRINCIPAL DISPLAY PANEL - 100 mg 100 Capsule Bottle Label

    100mg 100 capsule bottle label 05-2019

  • PRINCIPAL DISPLAY PANEL - 25 mg 30 Capsule Bottle Label

    25mg 30 capsule bottle label 05-2019

  • PRINCIPAL DISPLAY PANEL - 50 mg 30 Capsule Bottle Label

    50mg 30 capsule bottle label  05-2019

  • PRINCIPAL DISPLAY PANEL - 100 mg 30 Capsule Bottle Label

    100mg 30 capsule bottle label 05-2019

  • INGREDIENTS AND APPEARANCE
    TRIMIPRAMINE MALEATE 
    trimipramine maleate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 51991-944
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT) TRIMIPRAMINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Coloryellow, blueScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code TR25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 51991-944-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2017
    2NDC: 51991-944-3330 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20812704/05/2017
    TRIMIPRAMINE MALEATE 
    trimipramine maleate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 51991-945
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT) TRIMIPRAMINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Colororange, blueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code TR50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 51991-945-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2017
    2NDC: 51991-945-3330 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20812704/05/2017
    TRIMIPRAMINE MALEATE 
    trimipramine maleate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 51991-946
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT) TRIMIPRAMINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Colorblue (Light Blue) , whiteScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code TR100
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 51991-946-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2017
    2NDC: 51991-946-3330 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20812704/05/2017
    Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

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