MedPath

Amoxapine

Generic Name
Amoxapine
Drug Type
Small Molecule
Chemical Formula
C17H16ClN3O
CAS Number
14028-44-5
Unique Ingredient Identifier
R63VQ857OT

Overview

Amoxapine, the N-demethylated derivative of the antipsychotic agent loxapine, is a dibenzoxazepine-derivative tricyclic antidepressant (TCA). TCAs are structurally similar to phenothiazines. They contain a tricyclic ring system with an alkyl amine substituent on the central ring. In non-depressed individuals, amoxapine does not affect mood or arousal, but may cause sedation. In depressed individuals, amoxapine exerts a positive effect on mood. TCAs are potent inhibitors of serotonin and norepinephrine reuptake. In addition, TCAs down-regulate cerebral cortical β-adrenergic receptors and sensitize post-synaptic serotonergic receptors with chronic use. The antidepressant effects of TCAs are thought to be due to an overall increase in serotonergic neurotransmission. TCAs also block histamine H receptors, α-adrenergic receptors and muscarinic receptors, which accounts for their sedative, hypotensive and anticholinergic effects (e.g. blurred vision, dry mouth, constipation, urinary retention), respectively. See toxicity section below for a complete listing of side effects. Amoxapine may be used to treat neurotic and reactive depressive disorders, endogenous and psychotic depression, and mixed symptoms of depression and anxiety or agitation.

Indication

For the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. May also be used to treat depression accompanied by anxiety or agitation.

Associated Conditions

  • Agitation
  • Anxiety
  • Depression, Endogenous
  • Neurotic depression
  • Psychotic Depression
  • Reactive depression

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Actavis Pharma, Inc.
0591-5713
ORAL
25 mg in 1 1
2/28/2015
Chartwell RX, LLC
62135-703
ORAL
150 mg in 1 1
9/8/2023
Chartwell RX, LLC
62135-701
ORAL
50 mg in 1 1
9/8/2023
Actavis Pharma, Inc.
0591-5714
ORAL
50 mg in 1 1
2/28/2015
Physicians Total Care, Inc.
54868-2438
ORAL
50 mg in 1 1
5/16/2011
Actavis Pharma, Inc.
0591-5716
ORAL
150 mg in 1 1
2/28/2015
Actavis Pharma, Inc.
0591-5715
ORAL
100 mg in 1 1
2/28/2015
Chartwell RX, LLC
62135-700
ORAL
25 mg in 1 1
9/8/2023
Chartwell RX, LLC
62135-702
ORAL
100 mg in 1 1
9/8/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ASENDIN - TAB 25MG
wyeth-ayerst canada inc.
02169886
Tablet - Oral
25 MG / TAB
2/4/1997
ASENDIN TAB 50MG
lederle cyanamid canada inc.
00527092
Tablet - Oral
50 MG / TAB
12/31/1981
ASENDIN - TAB 100MG
wyeth-ayerst canada inc.
02169908
Tablet - Oral
100 MG
4/12/1999
ASENDIN TAB 25MG
lederle cyanamid canada inc.
00527084
Tablet - Oral
25 MG / TAB
12/31/1981
ASENDIN TAB 100MG
lederle cyanamid canada inc.
00527106
Tablet - Oral
100 MG / TAB
12/31/1981
ASENDIN - TAB 50MG
wyeth-ayerst canada inc.
02169894
Tablet - Oral
50 MG / TAB
4/29/1997

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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