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Amitriptyline

Generic Name
Amitriptyline
Brand Names
Elavil
Drug Type
Small Molecule
Chemical Formula
C20H23N
CAS Number
50-48-6
Unique Ingredient Identifier
1806D8D52K

Overview

Amitriptyline is a tricyclic antidepressant that has been used to treat depression for decades. ELAVIL, a previously approved branded product of amitriptyline, was first approved by the FDA in 1961. Amitriptyline has been investigated in the treatment of pain-related conditions, attributed to its analgesic properties.

Background

Amitriptyline is a tricyclic antidepressant that has been used to treat depression for decades. ELAVIL, a previously approved branded product of amitriptyline, was first approved by the FDA in 1961. Amitriptyline has been investigated in the treatment of pain-related conditions, attributed to its analgesic properties.

Indication

This drug in indicated for the following conditions : Major depressive disorder in adults Management of neuropathic pain in adults Prophylactic treatment of chronic tension-type headache (CTTH) in adults Prophylactic treatment of migraine in adults Treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products. This product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis Off-label uses: irritable bowel syndrome, sleep disorders, diabetic neuropathy, agitation, fibromyalgia, and insomnia

Associated Conditions

  • Anorexia Nervosa (AN)
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Bulimia Nervosa
  • Depression
  • Depression Acute
  • Diabetic Neuropathies
  • Insomnia
  • Irritable Bowel Syndrome (IBS)
  • Major Depressive Disorder (MDD)
  • Migraine
  • Moderate Depression
  • Neuropathic Pain
  • Nocturnal Enuresis
  • Severe Depression
  • Sleep disorders and disturbances
  • Tension Headache
  • Moderate Agitation
  • Moderate Anxiety
  • Severe Anxiety
  • Severe agitation

FDA Approved Products

Amitriptyline Hydrochloride
Manufacturer:Graviti Pharmaceuticals Private Limited
Route:ORAL
Strength:75 mg in 1 1
Approved: 2023/05/26
NDC:69844-061
Amitriptyline Hydrochloride
Manufacturer:Northstar RxLLC
Route:ORAL
Strength:50 mg in 1 1
Approved: 2020/08/13
NDC:16714-448
Amitriptyline Hydrochloride
Manufacturer:Northstar RxLLC
Route:ORAL
Strength:150 mg in 1 1
Approved: 2020/08/13
NDC:16714-451
Amitriptyline Hydrochloride
Manufacturer:Northstar RxLLC
Route:ORAL
Strength:10 mg in 1 1
Approved: 2020/08/13
NDC:16714-446
Amitriptyline Hydrochloride
Manufacturer:Northstar RxLLC
Route:ORAL
Strength:25 mg in 1 1
Approved: 2020/08/13
NDC:16714-447

Singapore Approved Products

TRIPTA TABLET 10 mg
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:TABLET, SUGAR COATED
Strength:10 mg
Online:Yes
Approved: 1988/04/28
Approval:SIN00415P
TRIPTA TABLET 25 mg
Manufacturer:ATLANTIC LABORATORIES CORPN LTD
Form:TABLET, SUGAR COATED
Strength:25 mg
Online:Yes
Approved: 1988/04/27
Approval:SIN00414P
APO-AMITRIPTYLINE TABLET 25 mg
Manufacturer:APOTEX INC
Form:TABLET, FILM COATED
Strength:25 mg
Online:Yes
Approved: 1988/03/15
Approval:SIN00090P
APO-AMITRIPTYLINE TABLET 10 mg
Manufacturer:APOTEX INC
Form:TABLET, FILM COATED
Strength:10 mg
Online:Yes
Approved: 1988/03/15
Approval:SIN00089P

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