Trimipramine: Difference between revisions
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|adverseReactions=hypotension, tachycardia, constipation, xerostomia, dizziness, somnolence, blurred vision | |adverseReactions=hypotension, tachycardia, constipation, xerostomia, dizziness, somnolence, blurred vision | ||
|blackBoxWarningTitle=<b><span style="color:#FF0000;">Suicidality and Antidepressant Drugs</span></b> | |blackBoxWarningTitle=<b><span style="color:#FF0000;">Suicidality and Antidepressant Drugs</span></b> | ||
|blackBoxWarningBody=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. | |blackBoxWarningBody=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. | ||
|fdaLIADAdult=<b>Depression</b> | |fdaLIADAdult=<b>Depression</b> | ||
*75 mg PO (divided into 1-3 doses per day); | *75 mg PO (divided into 1-3 doses per day); | ||
| Line 23: | Line 23: | ||
|offLabelPedGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Trimipramine in pediatric patients. | |offLabelPedGuideSupport=There is limited information about <i>Off-Label Guideline-Supported Use</i> of Trimipramine in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Trimipramine in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information about <i>Off-Label Non–Guideline-Supported Use</i> of Trimipramine in pediatric patients. | ||
|drugBox={{Drugbox2 | |||
| verifiedrevid = 470616008 | |||
| IUPAC_name = (±)-3-(10,11-dihydro-5''H''-dibenzo[''b,f'']azepin-5-yl)-''N'',''N'',2-trimethylpropan-1-amine | |||
| image = Trimipramine2DACS.svg | |||
| width = 200 | |||
| image2 = Trimipramine3Dan.gif | |||
| width2 = 250 | |||
<!--Clinical data--> | |||
| tradename = Surmontil | |||
| Drugs.com = {{drugs.com|monograph|surmontil}} | |||
| MedlinePlus = a602010 | |||
| licence_US = Trimipramine | |||
| pregnancy_AU = C | |||
| pregnancy_US = C | |||
| legal_AU = S4 | |||
| legal_CA = Rx-only | |||
| legal_UK = POM | |||
| legal_US = Rx-only | |||
| routes_of_administration = [[oral administration|Oral]], [[Intramuscular|IM]], [[Intravenous|IV]] | |||
<!--Pharmacokinetic data--> | |||
| bioavailability = 41%<ref name = TGA>{{cite web|title=PRODUCT INFORMATION SURMONTIL® Tablets and Capsules|work=TGA eBusiness Services|publisher=Aspen Pharmacare Australia Pty Ltd|date=28 November 2012|accessdate=30 November 2013|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-06847-3|format=PDF}}</ref><ref name = DM>{{cite web|title=SURMONTIL (trimipramine maleate) capsule [Duramed Pharmaceuticals Inc]|work=DailyMed|publisher=Duramed Pharmaceuticals Inc|date=December 2012|accessdate=30 November 2013|url=http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0177d783-773c-41bf-9db9-eb7e5c64474a}}</ref><ref name = MSR>{{cite web|title=Surmontil, Trimip (trimipramine) dosing, indications, interactions, adverse effects, and more|accessdate=30 November 2013|url=http://reference.medscape.com/drug/surmontil-trimipramine-342947#showall|work=Medscape Reference|publisher=WebMD}}</ref><ref name = EMC>{{cite web|title=Trimipramine 50mg Capsules - Summary of Product Characteristics (SPC)|work=electronic Medicines Compendium|publisher=Zentiva|date=19 November 2012|url=http://www.medicines.org.uk/emc/medicine/27192/SPC/Trimipramine+50mg+Capsules/|accessdate=30 November 2013}}</ref> | |||
| protein_bound = 94.9%<ref name = TGA/><ref name = DM/><ref name = MSR/><ref name = EMC/> | |||
| metabolism = [[Hepatic]]<ref name = TGA/><ref name = DM/><ref name = MSR/><ref name = EMC/> | |||
| elimination_half-life = 23-24 hours<ref name = TGA/><ref name = DM/><ref name = MSR/><ref name = EMC/> | |||
| excretion = [[Renal]]<ref name = TGA/><ref name = DM/><ref name = MSR/><ref name = EMC/> | |||
<!--Identifiers--> | |||
| CASNo_Ref = {{cascite|correct|CAS}} | |||
| CAS_number_Ref = {{cascite|correct|??}} | |||
| CAS_number = 739-71-9 | |||
| ATC_prefix = N06 | |||
| ATC_suffix = AA10 | |||
| PubChem = 5584 | |||
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} | |||
| DrugBank = DB00726 | |||
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | |||
| ChemSpiderID = 5382 | |||
| UNII_Ref = {{fdacite|correct|FDA}} | |||
| UNII = 6S082C9NDT | |||
| KEGG_Ref = {{keggcite|correct|kegg}} | |||
| KEGG = D00394 | |||
| ChEBI_Ref = {{ebicite|correct|EBI}} | |||
| ChEBI = 9738 | |||
| ChEMBL_Ref = {{ebicite|correct|EBI}} | |||
| ChEMBL = 644 | |||
<!--Chemical data--> | |||
| C=20 | H=26 | N=2 | |||
| molecular_weight = 294.434 g/mol | |||
| smiles = c1cc3c(cc1)CCc2c(cccc2)N3CC(C)CN(C)C | |||
| InChI = 1/C20H26N2/c1-16(14-21(2)3)15-22-19-10-6-4-8-17(19)12-13-18-9-5-7-11-20(18)22/h4-11,16H,12-15H2,1-3H3 | |||
| InChIKey = ZSCDBOWYZJWBIY-UHFFFAOYAN | |||
| StdInChI_Ref = {{stdinchicite|correct|chemspider}} | |||
| StdInChI = 1S/C20H26N2/c1-16(14-21(2)3)15-22-19-10-6-4-8-17(19)12-13-18-9-5-7-11-20(18)22/h4-11,16H,12-15H2,1-3H3 | |||
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} | |||
| StdInChIKey = ZSCDBOWYZJWBIY-UHFFFAOYSA-N | |||
}} | |||
|mechAction=Trimipramine maleate is an antidepressant with an anxiety-reducing sedative component to its action. The mode of action of trimipramine maleate on the central nervous system is not known. However, unlike amphetamine-type compounds it does not act primarily by stimulation of the central nervous system. It does not act by inhibition of the monoamine oxidase system. | |||
The single-dose pharmacokinetics of trimipramine was evaluated in a comparative study of 24 elderly subjects and 24 younger subjects; no clinically relevant differences were demonstrated based on age or gender. | |||
|structure=Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10, 11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). | |||
Trimipramine maleate capsules contain trimipramine maleate equivalent to 25 mg, 50 mg or 100 mg of trimipramine as the base. | |||
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 capsules are imprinted in black ink that contains: alcohol, D&C yellow No.10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C blue No. 1/brilliant blue FCF aluminum lake, FD&C red No. 40/allura red AC aluminum lake, propylene glycol, iron oxide black and shellac glaze. | |||
Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140°-144°C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20°C. | |||
|alcohol=Alcohol-Trimipramine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Trimipramine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 16:03, 23 May 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]
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Black Box Warning
|
Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
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.
|
Overview
Trimipramine is a Tricyclic antidepressant that is FDA approved for the {{{indicationType}}} of depression. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, tachycardia, constipation, xerostomia, dizziness, somnolence, blurred vision.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Depression
- 75 mg PO (divided into 1-3 doses per day);
- Increase gradually over a few days to 150 mg/day (in divided doses); max dosage is 200 mg/day
- Maintenance, 50-150 mg/day PO at bedtime; therapy should be continued for about 3 months
- Inpatients, 100 mg PO (divided into 1-3 doses per day); increase gradually over a few days to 200 mg/day (in divided doses);
- If no improvement in 2-3 weeks may increase to a max of 250-300 mg/day
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Trimipramine in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Trimipramine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Depression
- Not FDA-approved for use in children
- Adolescents, 50 mg/day PO increase up to 100 mg/day;
- Maintenance therapy should be continued for about 3 months.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Trimipramine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Trimipramine in pediatric patients.
Contraindications
There is limited information regarding Trimipramine Contraindications in the drug label.
Warnings
|
Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
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.
|
There is limited information regarding Trimipramine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Trimipramine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Trimipramine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Trimipramine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trimipramine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trimipramine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trimipramine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trimipramine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Trimipramine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Trimipramine in geriatric settings.
Gender
There is no FDA guidance on the use of Trimipramine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trimipramine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trimipramine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trimipramine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trimipramine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trimipramine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Trimipramine Administration in the drug label.
Monitoring
There is limited information regarding Trimipramine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Trimipramine and IV administrations.
Overdosage
There is limited information regarding Trimipramine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Mechanism of Action
Trimipramine maleate is an antidepressant with an anxiety-reducing sedative component to its action. The mode of action of trimipramine maleate on the central nervous system is not known. However, unlike amphetamine-type compounds it does not act primarily by stimulation of the central nervous system. It does not act by inhibition of the monoamine oxidase system. The single-dose pharmacokinetics of trimipramine was evaluated in a comparative study of 24 elderly subjects and 24 younger subjects; no clinically relevant differences were demonstrated based on age or gender.
Structure
Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10, 11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form).
Trimipramine maleate capsules contain trimipramine maleate equivalent to 25 mg, 50 mg or 100 mg of trimipramine as the base. 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 capsules are imprinted in black ink that contains: alcohol, D&C yellow No.10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C blue No. 1/brilliant blue FCF aluminum lake, FD&C red No. 40/allura red AC aluminum lake, propylene glycol, iron oxide black and shellac glaze. Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140°-144°C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20°C.
Pharmacodynamics
There is limited information regarding Trimipramine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Trimipramine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Trimipramine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trimipramine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Trimipramine How Supplied in the drug label.
Storage
There is limited information regarding Trimipramine Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Trimipramine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Trimipramine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Trimipramine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Trimipramine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Trimipramine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Trimipramine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ 1.0 1.1 1.2 1.3 1.4 "PRODUCT INFORMATION SURMONTIL® Tablets and Capsules" (PDF). TGA eBusiness Services. Aspen Pharmacare Australia Pty Ltd. 28 November 2012. Retrieved 30 November 2013.
- ↑ 2.0 2.1 2.2 2.3 2.4 "SURMONTIL (trimipramine maleate) capsule [Duramed Pharmaceuticals Inc]". DailyMed. Duramed Pharmaceuticals Inc. December 2012. Retrieved 30 November 2013.
- ↑ 3.0 3.1 3.2 3.3 3.4 "Surmontil, Trimip (trimipramine) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 30 November 2013.
- ↑ 4.0 4.1 4.2 4.3 4.4 "Trimipramine 50mg Capsules - Summary of Product Characteristics (SPC)". electronic Medicines Compendium. Zentiva. 19 November 2012. Retrieved 30 November 2013.