Generic Endep ( Amitriptyline )

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Endep is a tricyclic antidepressant used to treat depressive illness, including depression with anxiety or agitation. It is also widely prescribed at lower doses for nerve pain, chronic pain syndromes, and migraine prevention. The medication works by increasing the levels of serotonin and norepinephrine in the brain, which helps improve mood and dampen pain signals.
A note on availability: Endep is the brand name used in Australia and some other markets. In Canada, amitriptyline is sold under the brand name Elavil and as generics including Apo-Amitriptyline, Teva-Amitriptyline, and Pro-Amitriptyline. The dosing and safety information below reflects the product monographs and clinical data that apply to amitriptyline hydrochloride.
The usual starting dose for depression in adults is 25 mg three times daily, or a single dose of 75 mg at bedtime. Your doctor may increase the dose gradually to a maintenance range of 50 mg to 100 mg per day in divided doses. For nerve pain or migraine prevention, much lower doses are often used, typically 10 mg to 25 mg at bedtime. The maximum recommended dose is 300 mg per day, but doses above 150 mg per day are usually reserved for hospitalized patients under close supervision.
The administration form is film-coated tablets in 10 mg, 25 mg, 50 mg, and 75 mg strengths. The 10 mg tablet is blue and round, the 25 mg tablet is yellow and round, the 50 mg tablet is orange and round, and the 75 mg tablet is orange and round.
Endep does not work overnight. It may take several weeks of steady dosing before you notice the full benefit for depression. For nerve pain, the effect may take even longer to build. Do not stop taking it just because you do not feel better in the first few days.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that amitriptyline can cause, and it can increase the risk of serious side effects including low blood pressure and heart rhythm problems.
The most common side effects are dry mouth, constipation, blurred vision, drowsiness, and weight gain. Dizziness when standing up is also common, especially in older adults.
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Common Use Endep

Amitriptyline is a tricyclic antidepressant of the dibenzazepine group. It works by blocking the reuptake of serotonin and norepinephrine at nerve endings, which increases their availability in the synaptic cleft. This helps restore chemical balance in the brain and is thought to underlie its antidepressant effect. Amitriptyline also has significant anticholinergic and antihistamine properties, which contribute to its sedative and side effect profile. Health Canada has approved amitriptyline for the drug management of depressive illness, including depressive illness of psychotic or agitated types. It is also indicated for the treatment of nocturnal enuresis (bedwetting) in children over 6 years of age. Amitriptyline is commonly prescribed off-label at lower doses for neuropathic pain, fibromyalgia, chronic tension headache, and migraine prophylaxis. It is not approved for use in children under 6 years of age.

Basic Endep Information

• INN (International Nonproprietary Name): Amitriptyline hydrochloride
• Brand names available in Canada: Elavil® (AA Pharma Inc.); generics include Apo-Amitriptyline (Apotex Inc.), Teva-Amitriptyline (Teva Canada Limited), Pro-Amitriptyline (Pro Doc Limitée), Mar-Amitriptyline (Marcan Pharmaceuticals Inc.), and pms-Amitriptyline (Pharmascience Inc.). Endep is not marketed in Canada; it is a brand available in other countries.
• ATC Code: N06AA09
• Forms and dosages: Film-coated tablets – 10 mg, 25 mg, 50 mg, and 75 mg. A 100 mg strength is also available from some manufacturers. An oral solution is not commercially available in Canada.
• Manufacturers in Canada: AA Pharma Inc. (Elavil, DIN 00371009 for 25 mg), Apotex Inc. (Apo-Amitriptyline, DIN 02403137 for 10 mg, DIN 02403145 for 25 mg, DIN 02403153 for 50 mg), Teva Canada Limited (Teva-Amitriptyline, DIN 02326043 for 10 mg), Pro Doc Limitée (Pro-Amitriptyline, DIN 00371009 for 25 mg), and Marcan Pharmaceuticals Inc. (Mar-Amitriptyline). The original Elavil brand was marketed by Merck Frosst Canada.
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02462745 (Amitriptyline Hydrochloride Tablets USP, 25 mg, Strides Pharma Canada), 02462761 (75 mg, Strides Pharma Canada), 00371009 (Pro-Amitriptyline 25 mg, Pro Doc, marketed since 2026-08-20), 02403137 (Apo-Amitriptyline 10 mg, Apotex), 02403145 (Apo-Amitriptyline 25 mg, Apotex), 02403153 (Apo-Amitriptyline 50 mg, Apotex), and 02326043 (Teva-Amitriptyline 10 mg, Teva Canada). The Elavil product monograph is dated May 9, 2023.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Endep exactly as your doctor prescribes. The dose depends on what is being treated. For depression in adults, the usual starting dose is 25 mg three times daily, or a single dose of 75 mg at bedtime. Your doctor may increase the dose gradually. The maintenance dose is usually 50 mg to 100 mg per day in divided doses. Some patients may need up to 150 mg per day, and in hospitalized patients under close supervision, doses up to 300 mg per day have been used. For older adults and adolescents, the usual starting dose is 10 mg three times daily, with a maintenance range of 25 mg to 50 mg per day. For nerve pain, fibromyalgia, or migraine prevention, the dose is much lower, typically 10 mg to 25 mg taken at bedtime. The dose may be increased slowly as tolerated, but usually not above 50 mg to 75 mg per night. Take the tablet with or without food. If it upsets your stomach, take it with a meal. Many people take the entire daily dose at bedtime because the medication can cause drowsiness. If you take it during the day, be careful with driving and machinery until you know how it affects you. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Endep suddenly without talking to your doctor. Stopping abruptly can cause withdrawal symptoms such as nausea, headache, and malaise. Your doctor will taper the dose gradually over weeks or months.

Precautions

Amitriptyline carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Close monitoring is required, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Amitriptyline can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when amitriptyline is taken with other serotonergic drugs, including MAO inhibitors, SSRIs, SNRIs, triptans, tramadol, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Amitriptyline can cause orthostatic hypotension, a drop in blood pressure when standing up, leading to dizziness and fainting. This is more common in older adults. Move slowly when getting up from a sitting or lying position. The medication can prolong the QT interval on an electrocardiogram, a change in heart rhythm that can lead to serious arrhythmias. Use with caution if you have heart disease or take other drugs that affect heart rhythm. Amitriptyline can cause anticholinergic effects, including dry mouth, blurred vision, constipation, urinary retention, and increased intraocular pressure. It should be used with caution in patients with narrow-angle glaucoma, a history of urinary retention, or an enlarged prostate. The medication can lower the seizure threshold. If you have epilepsy or a condition that increases seizure risk, tell your doctor. Long-term use of amitriptyline can cause dental cavities, so regular dental checkups matter. Amitriptyline is not recommended during pregnancy unless the benefit clearly outweighs the risk to the fetus. It passes into breast milk, so breastfeeding is not recommended without medical advice. Women who could become pregnant should discuss the risks and benefits with their doctor. Amitriptyline should not be used in children under 6 years of age. Older adults may be more sensitive to the side effects, especially orthostatic hypotension and confusion, and may need lower doses. Tell your doctor if you have liver or kidney problems, thyroid disease, diabetes, or a history of mania or bipolar disorder.

Contraindications

Do not take Endep if you have had an allergic reaction to amitriptyline, any of the excipients, or cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group. Endep is contraindicated during the acute recovery phase following myocardial infarction. It should not be used in patients with recent myocardial infarction, heart failure, conduction disorders, or a history of conduction disorders. Amitriptyline is contraindicated in patients with narrow-angle glaucoma, prostatic hyperplasia, pyloric stenosis, and other stenoses of the gastrointestinal and genitourinary systems. It should not be used in patients with severe liver disease. Endep should not be given in combination, or within 14 days before or after treatment, with a MAO inhibitor, because of the risk of severe symptoms such as hypertensive crisis, hyperpyrexia, myoclonus, agitation, seizures, delirium, and coma. Concomitant treatment with selective, reversible MAO-A inhibitors, such as moclobemide, is also contraindicated. Amitriptyline should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Do not take amitriptyline if you have mania or a history of mania. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 10% of people experience dry mouth, constipation, blurred vision, drowsiness, and weight gain. Dizziness when standing up is also common, especially in older adults. Other common side effects include urinary retention, increased sweating, confusion, and a rash. These effects are often most noticeable when starting treatment or increasing the dose. Serious side effects require immediate medical attention. Orthostatic hypotension can cause fainting and falls. QT prolongation can cause palpitations, fainting, or sudden collapse. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. Blood disorders, including agranulocytosis and thrombocytopenia, have been reported. Liver problems, including jaundice and altered liver function, can occur. If you develop any of these serious effects, stop the medication and seek medical help right away. Antidepressants, including Endep, may increase suicidal thoughts or behaviour, especially in young people. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Discontinuation syndrome can occur if the medication is stopped suddenly, causing nausea, headache, and malaise.

Drug Interaction

Amitriptyline interacts with a long list of medications. MAO inhibitors are strictly contraindicated and must not be used with amitriptyline. Do not give amitriptyline for at least 2 weeks after discontinuation of treatment with MAO inhibitors, and the same applies when giving a MAO inhibitor after previous treatment with amitriptyline. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, paroxetine, sertraline, and citalopram are potent CYP2D6 inhibitors. Fluvoxamine is a potent CYP1A2 inhibitor and a mid-level CYP2D6 inhibitor. The use of SSRIs together with amitriptyline may cause increased plasma concentration of amitriptyline, with corresponding adverse effects, and a dose adjustment may be necessary. Other serotonergic agents, including SNRIs, lithium, tramadol, pethidine, dextromethorphan, and buprenorphine, may cause additive effects and increase the risk of serotonin syndrome. Tricyclic antidepressants may potentiate the effects of alcohol and other central depressant substances, including barbiturates, benzodiazepines, and general anaesthetics. Neuroleptics may result in increased plasma levels of tricyclic antidepressants, a lowered convulsion threshold, and seizures. Combination with thioridazine may produce severe cardiac arrhythmias. Terbinafine is a potent CYP2D6 inhibitor and may cause an increase in amitriptyline and nortriptyline exposure and accumulation. Amitriptyline may diminish or abolish the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine, and alpha-methyldopa. Tricyclic antidepressants may potentiate the anticoagulant effect of coumarin drugs by inhibiting hepatic metabolism of these anticoagulants. Careful monitoring of prothrombin time is recommended. Amitriptyline can increase the plasma concentration of phenytoin. Drugs that can prolong the QTc interval, such as some antipsychotics and antibiotics, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de pointes) when used with amitriptyline. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Endep, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same times each day.

Overdose

Overdose with amitriptyline is a medical emergency. Symptoms include irregular heartbeat, severe drowsiness, confusion, agitation, hallucinations, seizures, coma, and breathing problems. The risk is higher in children than in adults. Ingestion of 750 mg or more by an adult can result in severe toxicity. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of heart rhythm. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Endep tablets at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush amitriptyline down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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