JAMP-AMITRIPTYLINE 25 MG

What is JAMP-AMITRIPTYLINE?

JAMP-AMITRIPTYLINE 25 MG contains AMITRIPTYLINE HYDROCHLORIDE : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02457695, held by JAMP PHARMA CORPORATION, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Jun-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is JAMP-AMITRIPTYLINE used for?

JAMP-Amitriptyline (amitriptyline hydrochloride) is indicated for: • Drug management of depressive illness. • Depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression. Endogenous depression is more likely to be alleviated than are other depressive states. JAMP-Amitriptyline, because of its sedative action, is also of value in alleviating the anxiety component of depression. As with other tricyclic antidepressants, JAMP-Amitriptyline may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Dosage should be initiated at a low level and increased gradually according to tolerance and clinical response. Cardiac: Prior to initiating treatment, a cardiac evaluation (blood pressure, ECG) should be performed, especially in patients with cardiovascular disorders. Electrolyte disturbances (e.g., hypokalemia) should be treated. Cardiac function and ECG should be periodically monitored during treatment, after dose increases, or when initiating interacting medicines. Drug interactions: Consider potential interactions with monoamine oxidase inhibitors, thyroid medications, QT-prolonging drugs, and CYP450 inhibitors/inducers. Monitor for agitation, suicidal tendencies: Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behavior is advised in all patients, especially during treatment initiation or dose changes. Discontinuation: Dosage should be tapered gradually. Outpatient Adults: Initial dose: 25 mg 3 times a day. May be gradually increased to a total of 150 mg a day. Increases preferably in late afternoon and/or bedtime doses. Antidepressant activity may take up to 30 days to develop. Hospitalized Patients: May require 100 mg a day initially, gradually increased to 200 mg a day if necessary. Some may need up to 300 mg a day. Pediatric Patients: Not authorized for pediatric use. Elderly Patients: Lower dosages are recommended. 50 mg daily may be satisfactory for those not tolerating higher doses. Dose may be divided or given as a single dose at bedtime. Monitor carefully and obtain quantitative serum levels as clinically appropriate. Adjust dosage based on clinical response, not plasma levels. Maintenance: Reduce dosage to the lowest amount that maintains relief of symptoms (usually 50 to 100 mg/day in divided doses or as a single dose at bedtime). Continue maintenance therapy throughout the active phase of depression and for the expected duration of the depressive episode to lessen relapse. Plasma Levels: Determination of plasma levels may be useful for identifying patients with toxic effects, high levels, or suspected non-compliance. Elderly patients generally have higher plasma levels for a given oral dose. Concomitant use with inhibitors or inducers of cytochrome P450 enzymes: Increased levels of amitriptyline observed with co-administration of P450 inhibitors. Monitor plasma levels and adjust dosage. Dosage adjustments may also be required with P450 inducers. Use in CYP2D6 or CYP2C19 poor metabolizers: Higher plasma concentrations may occur; dosage adjustment should be considered. Hepatic Insufficiency: Use caution in mild to moderate impairment; lower doses may be required. Contraindicated in severe hepatic impairment. Administration: Tablets should be swallowed whole with water, with or without food. Missed Dose: Take as soon as remembered. If almost time for next dose, skip missed dose and continue regular schedule.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature (15°C to 30°C). Keep in a tightly closed container. Keep out of reach and sight of children. JAMP-Amitriptyline should never be disposed of in household trash. Disposal via a pharmacy take back program is recommended.

How is it supplied?

JAMP-Amitriptyline 10 mg: Each blue, round, biconvex, film coated tablet, contains 10 mg of amitriptyline hydrochloride. Available in bottles of 100 and 1000 tablets. JAMP-Amitriptyline 25 mg: Each yellow, round, biconvex, film coated tablet, engraved '25' on one side contains 25 mg of amitriptyline hydrochloride. Available in bottles of 100 and 1000 tablets. JAMP-Amitriptyline 50 mg: Each beige, round, biconvex, film coated tablet, engraved '50' on one side contains 50 mg of amitriptyline hydrochloride. Available in bottles of 100 and 1000 tablets. JAMP-Amitriptyline 75 mg: Each orange, round, biconvex, film coated tablet, engraved '75' on one side contains 75 mg of amitriptyline hydrochloride. Available in bottles of 100 tablets.

Contraindications

JAMP-Amitriptyline (amitriptyline hydrochloride) is contraindicated in: • Patients who are hypersensitive to amitriptyline hydrochloride or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Cross-sensitivity with other dibenzazepine compounds is a possibility. • Patients with recent myocardial infarction or acute congestive heart failure. • Patients with severe liver impairment. • Combination with cisapride (no longer marketed in Canada) due to the increased risk for QT interval prolongation and arrhythmia. • Combination with a monoamine oxidase inhibitor (MAOI) due to the risk of serotonin toxicity (a combination of symptoms that may include agitation, confusion, tremor, myoclonus, and hyperthermia). Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving concomitant tricyclic antidepressants and MAOIs. Treatment with a MAOI should be discontinued at least 14 days before initiating treatment with amitriptyline. Similarly, amitriptyline treatment should be discontinued at least 14 days before starting a MAOI.

Warnings and precautions

Serious Warnings and Precautions: Extreme caution should be used when JAMP-Amitriptyline is given in the following situations: • Cases of QT interval prolongation, cardiac arrhythmia and severe hypotension have been reported. Unexpected death has occurred in patients with cardiovascular disorders. Myocardial infarction and stroke have been reported. Extreme caution is advised in patients with a history of cardiovascular disorders (e.g., significant bradycardia, myocardial infarction, congestive or uncompensated heart failure), conduction abnormalities or patients with risk factors for QT interval prolongation, such as the concomitant use of QT-prolonging drugs. • Unmasking of Brugada syndrome has been reported with tricyclic antidepressants. JAMP-Amitriptyline should be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome. • In patients with a history or urinary retention or prostatic hypertrophy, or in patients with increased intraocular pressure or narrow angle glaucoma, because of the anticholinergic properties of JAMP-Amitriptyline. • In patient with thyroid disease or those taking thyroid medication, because of the possibility of cardiovascular toxicity, including arrhythmias. • In patients with a history of a seizure disorder, because JAMP-Amitriptyline has been shown to lower the seizure threshold. • Clinical Worsening and Suicide Risk: Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressant use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors.

What can be used instead?

Other Canadian products sharing ATC code N06AA09 AMITRIPTYLINE. 15 of 83 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies AMITRIPTYLINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. AMITRIPTYLINE appears in 18 registered pack listings across 6 markets, published on 6 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.