Protriptyline is a tricyclic antidepressant indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. It is available as tablets for oral use. MedsAcross supplies Protriptyline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
Source: US FDA prescribing information
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Usual Adult Dosage Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg. When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms. Minor adverse reactions require reduction in dosage.
Source: US FDA prescribing information
Protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with a monoamine oxidase inhibiting compound. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. Protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.
Source: US FDA prescribing information
Boxed Warning Suicidality and Antidepressant Drugs 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. Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
Source: US FDA prescribing information
Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when protriptyline is administered. Protriptyline is more likely to aggravate agitation and anxiety and produce cardiovascular reactions such as tachycardia and hypotension. Cardiovascular: Myocardial infarction, stroke, heart block, arrhythmias, hypotension, particularly orthostatic hypotension, hypertension, tachycardia, palpitation. Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation, hypomania, exacerbation of psychosis, insomnia, panic, and nightmares.
Source: US FDA prescribing information
When protriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required. Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather. Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side-effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen.
Source: US FDA prescribing information
Store at 20°-25°C (68°-77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Protriptyline, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Protriptyline 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Protriptyline 5 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 September 1967 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Protriptyline in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Protriptyline and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Protriptyline on 27 September 1967, according to Drugs@FDA.
No listed presentation of Protriptyline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Protriptyline is classified under ATC code N06AA11 (Protriptyline).
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