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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/03 | Phase 4 | Recruiting | Institut Universitari D Investigacio En Atencion Primaria Jordi Gol | ||
2024/05/16 | Early Phase 1 | ENROLLING_BY_INVITATION | |||
2024/03/15 | Phase 2 | Recruiting | |||
2024/03/08 | Not Applicable | Not yet recruiting | Federico II University | ||
2024/02/07 | Not Applicable | Completed | Aalborg University | ||
2023/12/08 | Not Applicable | Not yet recruiting | Shalamar Institute of Health Sciences | ||
2023/06/26 | Phase 2 | Completed | |||
2023/06/05 | Not Applicable | Recruiting | |||
2023/05/22 | Phase 4 | Completed | |||
2023/03/08 | Phase 4 | ENROLLING_BY_INVITATION | Dr. Reaz Mahmud |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Contract Pharmacy Services-PA | 67046-035 | ORAL | 100 mg in 1 1 | 9/18/2017 | |
| Preferred Pharmaceuticals Inc. | 68788-8363 | ORAL | 50 mg in 1 1 | 1/29/2024 | |
| St. Mary's Medical Park Pharmacy | 60760-181 | ORAL | 75 mg in 1 1 | 12/22/2022 | |
| AvPAK | 50268-039 | ORAL | 50 mg in 1 1 | 6/6/2023 | |
| Proficient Rx LP | 63187-359 | ORAL | 50 mg in 1 1 | 10/1/2022 | |
| Proficient Rx LP | 63187-408 | ORAL | 25 mg in 1 1 | 9/1/2022 | |
| DIRECT RX | 61919-011 | ORAL | 10 mg in 1 1 | 10/29/2015 | |
| Mylan Pharmaceuticals Inc. | 0378-0042 | ORAL | 10 mg in 1 1 | 9/26/2019 | |
| Proficient Rx LP | 71205-466 | ORAL | 75 mg in 1 1 | 8/1/2022 | |
| H.J. Harkins Company, Inc. | 52959-008 | ORAL | 10 mg in 1 1 | 10/11/2011 |
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 |
|---|---|---|---|---|---|
| TRIPTA TABLET 10 mg | ATLANTIC LABORATORIES CORPN LTD | SIN00415P | TABLET, SUGAR COATED | 10 mg | 4/28/1988 |
| TRIPTA TABLET 25 mg | ATLANTIC LABORATORIES CORPN LTD | SIN00414P | TABLET, SUGAR COATED | 25 mg | 4/27/1988 |
| APO-AMITRIPTYLINE TABLET 25 mg | SIN00090P | TABLET, FILM COATED | 25 mg | 3/15/1988 | |
| APO-AMITRIPTYLINE TABLET 10 mg | SIN00089P | TABLET, FILM COATED | 10 mg | 3/15/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amitriptyline Hydrochloride Tablets | 国药准字H31021200 | 化学药品 | 片剂(糖衣) | 3/2/2020 | |
| Amitriptyline Hydrochloride Tablets | 国药准字H43020561 | 化学药品 | 片剂 | 4/25/2020 | |
| Amitriptyline Hydrochloride Tablets | 国药准字H32023764 | 化学药品 | 片剂 | 7/22/2020 |
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 |
|---|---|---|---|---|---|
| Endep 50 (hexagonal) tablet blister pack | 64425 | Medicine | A | 5/19/1998 | |
| AMICHLOR amitriptyline hydrochloride 50mg tablet bottle pack | 215384 | Medicine | A | 8/22/2014 | |
| PIP-AMITRIPTYLINE amitriptyline hydrochloride 50mg tablet blister pack | 215376 | Medicine | A | 8/22/2014 | |
| AMITRIPTYLINE GxP amitriptyline hydrochloride 10 mg tablets blister pack | 232128 | Medicine | A | 11/27/2015 | |
| AMITRIPTYLINE PN amitriptyline hydrochloride 10 mg tablets blister pack | 232146 | Medicine | A | 11/27/2015 | |
| Chlordiazepoxide & Amitriptyline 10/25 mg Tablets Bottle | 368272 | Medicine | A | 6/4/2021 | |
| AMITRIPTYLINE SANDOZ amitriptyline hydrohloride 25mg tablet blister pack | 432990 | Medicine | A | 5/8/2024 | |
| AMICHLOR amitriptyline hydrochloride 50mg tablet blister pack | 215391 | Medicine | A | 8/22/2014 | |
| AMICHLOR amitriptyline hydrochloride 25mg tablet bottle pack | 215386 | Medicine | A | 8/22/2014 | |
| PPA-AMITRIPTYLINE amitriptyline hydrochloride 50mg tablet bottle pack | 215406 | Medicine | A | 8/22/2014 |
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