AVENTYL 10 MG
NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) : 10 MG · DIN 00015229 · AA PHARMA INC
Health Canada status: MARKETED
What is AVENTYL?
AVENTYL 10 MG contains NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 00015229, held by AA PHARMA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Jan-2022. 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 AVENTYL used for?
AVENTYL (nortriptyline hydrochloride) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
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
| DIN | 00015229 |
|---|---|
| Brand name | AVENTYL |
| Generic / active ingredient | NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) : 10 MG |
| Manufacturer | AA PHARMA INC |
| Strength | 10 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N06AA10 NORTRIPTYLINE |
| AHFS class | 28:16.04.28 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Jan-2022 |
| Original market date | 1965-12-31 00:00:00 |
How is it administered?
Adults (≥ 18 years): The recommended dose of AVENTYL is 25 mg, taken orally 3 - 4 times daily. When initiating treatment with AVENTYL, dosage should begin at a low level and increase gradually, as required. Doses above 100 mg/day are not recommended. Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. The use of AVENTYL in children is not recommended. When considering the use of nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. Dosing in adolescents should be reduced to 30 to 50 mg/day, in divided doses. Geriatrics: Dosing for elderly patients should be limited to 30 to 50 mg/day, in divided doses. If a patient misses a dose of AVENTYL, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule. When discontinuing AVENTYL, the dosage should be tapered gradually.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature (15°C-30°C). Keep tightly closed. AVENTYL should never be disposed of in household trash. Disposal via a pharmacy take back program is recommended. Keep out of reach and sight of children.
How is it supplied?
Available in bottles of 100, 250, 500 and 1000 capsules.
Contraindications
AVENTYL is contraindicated: • in patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Cross-sensitivity between nortriptyline and other dibenzazepines is a possibility. • with concomitant use of a MAO inhibitor or use within 14 days of discontinuing treatment with a MAO inhibitor. • during the acute recovery period following myocardial infarction.
Warnings and precautions
Increased risk of self-harm, harm to others, suicidal thinking and behaviour with antidepressant use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors. Patients with cardiovascular disease should be given nortriptyline only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia and strokes have occurred. Great care is required if nortriptyline is administered to hyperthyroid patients or those receiving thyroid medication, because cardiac arrhythmias may develop. Abrupt cessation of treatment following prolonged therapy may produce withdrawal symptoms, including flu-like symptoms, dizziness, nausea, headache, agitation, malaise, and abdominal cramping. Nortriptyline may cause somnolence, dizziness, and confusion. Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Nortriptyline is known to lower convulsive threshold. Extreme caution should be exercised when using AVENTYL in patients with a history of seizures. Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition and has been reported with tricyclic antidepressants. If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. The use of nortriptyline in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic depressive patients, nortriptyline may cause symptoms of the manic phase to emerge. Inform the patient that their response to alcohol may be exaggerated. Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may increase the risk of suicidal thinking and behaviour and/or overdosage, especially in patients with a history of emotional disturbances or suicidal ideation. The possibility of a suicidal attempt by depressed patients remains even after initiation of treatment. It is important that the least possible quantity of drug be dispensed at any given time.
What can be used instead?
Other Canadian products sharing ATC code N06AA10 NORTRIPTYLINE. 2 of 24 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.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| AVENTYL | 25 MG | CAPSULE | AA PHARMA INC | MARKETED | DIN 00015237 |
| APO-NORTRIPTYLINE | 10 MG | CAPSULE | APOTEX INC | DORMANT | DIN 02223511 |
| APO-NORTRIPTYLINE | 25 MG | CAPSULE | APOTEX INC | DORMANT | DIN 02223538 |
| AVA-NORTRIPTYLINE | 10 MG | CAPSULE | AVANSTRA INC | CANCELLED POST MARKET | DIN 02364301 |
| AVA-NORTRIPTYLINE | 25 MG | CAPSULE | AVANSTRA INC | CANCELLED POST MARKET | DIN 02364328 |
| DOM-NORTRIPTYLINE 10MG CAPSULES | 10 MG | CAPSULE | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02178729 |
| DOM-NORTRIPTYLINE 25MG CAPSULES | 25 MG | CAPSULE | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02178737 |
| GEN-NORTRIPTYLINE CAPSULES 10MG | 10 MG | CAPSULE | GENPHARM ULC | CANCELLED POST MARKET | DIN 02231686 |
| GEN-NORTRIPTYLINE CAPSULES 25MG | 25 MG | CAPSULE | GENPHARM ULC | CANCELLED POST MARKET | DIN 02231687 |
| NORTRIPTYLINE | 10 MG | CAPSULE | APOTEX INC | APPROVED | DIN 02223139 |
Who else supplies NORTRIPTYLINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NORTRIPTYLINE appears in 12 registered pack listings across 4 markets, published on 3 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.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.