Amynil
Generic Name
Nortriptyline Hydrochloride
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amynil 2 mg tablet | ৳ 12.90 | N/A |
Description
Overview of the medicine
Amynil 2 mg Tablet contains Nortriptyline Hydrochloride, a tricyclic antidepressant primarily used to treat depression. It is also utilized in the management of neuropathic pain and chronic pain syndromes.
Uses & Indications
Dosage
Adults
For depression: Typically initiated at 25 mg three or four times daily, or 50-150 mg once daily at bedtime. The 2 mg tablet may be used for titration or specific low-dose indications, e.g., for neuropathic pain, starting with 10-25 mg daily and titrating up. Maximum recommended dose is 150 mg/day.
Elderly
Lower doses are recommended, e.g., 10-25 mg once daily, with gradual titration based on response and tolerability.
Renal_impairment
No specific dose adjustment is generally required, but use with caution due to potential accumulation of active metabolites in severe impairment.
How to Take
Amynil tablets should be taken orally, with or without food. It can be taken as a single dose at bedtime due to its sedative effects, or in divided doses.
Mechanism of Action
Nortriptyline primarily works by inhibiting the reuptake of norepinephrine and to a lesser extent serotonin in the central nervous system, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. This leads to an antidepressant effect. It also possesses anticholinergic, antihistaminic, and alpha-adrenergic blocking properties.
Pharmacokinetics
Onset
Therapeutic effects for depression usually take 2-4 weeks to become evident. Pain relief may start earlier.
Excretion
Mainly excreted in the urine as metabolites, with a small amount excreted in feces.
Half life
Highly variable, ranging from 16 to 90 hours, with an average of approximately 30-40 hours.
Absorption
Well absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached within 2-4 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6, to active (10-hydroxynortriptyline) and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to nortriptyline or any other tricyclic antidepressant
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
- Acute recovery phase after myocardial infarction
- Uncontrolled narrow-angle glaucoma
Drug Interactions
Cimetidine
Can increase plasma concentrations of nortriptyline by inhibiting its metabolism.
Monoamine Oxidase Inhibitors (MAOIs)
Concurrent use may lead to serotonin syndrome, characterized by hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes. Should not be used within 14 days of MAOI use.
Sympathomimetics (e.g., adrenaline, noradrenaline)
Nortriptyline may potentiate the pressor effects of these agents.
CNS Depressants (e.g., alcohol, sedatives, hypnotics)
May enhance the sedative effects of nortriptyline.
Anticholinergic Drugs (e.g., atropine, antihistamines)
Additive anticholinergic effects, increasing the risk of side effects like dry mouth, constipation, and urinary retention.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe drowsiness, confusion, agitation, hallucinations, seizures, cardiac arrhythmias (tachycardia, QT prolongation, ventricular fibrillation), severe hypotension, and coma. Management involves supportive care, gastric lavage, activated charcoal, maintaining airway, cardiac monitoring, and symptomatic treatment. Physostigmine may be used for severe anticholinergic symptoms.
Pregnancy & Lactation
Pregnancy Category C. Nortriptyline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when Amynil is administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to nortriptyline or any other tricyclic antidepressant
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
- Acute recovery phase after myocardial infarction
- Uncontrolled narrow-angle glaucoma
Drug Interactions
Cimetidine
Can increase plasma concentrations of nortriptyline by inhibiting its metabolism.
Monoamine Oxidase Inhibitors (MAOIs)
Concurrent use may lead to serotonin syndrome, characterized by hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes. Should not be used within 14 days of MAOI use.
Sympathomimetics (e.g., adrenaline, noradrenaline)
Nortriptyline may potentiate the pressor effects of these agents.
CNS Depressants (e.g., alcohol, sedatives, hypnotics)
May enhance the sedative effects of nortriptyline.
Anticholinergic Drugs (e.g., atropine, antihistamines)
Additive anticholinergic effects, increasing the risk of side effects like dry mouth, constipation, and urinary retention.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe drowsiness, confusion, agitation, hallucinations, seizures, cardiac arrhythmias (tachycardia, QT prolongation, ventricular fibrillation), severe hypotension, and coma. Management involves supportive care, gastric lavage, activated charcoal, maintaining airway, cardiac monitoring, and symptomatic treatment. Physostigmine may be used for severe anticholinergic symptoms.
Pregnancy & Lactation
Pregnancy Category C. Nortriptyline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when Amynil is administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the packaging for the exact expiry date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by national drug authorities
Patent Status
Off-patent, generic available
WHO Essential Medicine
YesClinical Trials
Nortriptyline has been extensively studied in clinical trials since its introduction, demonstrating efficacy in major depressive disorder and various chronic pain conditions. Ongoing research explores its role in other neurological and psychiatric disorders.
Lab Monitoring
- Baseline and periodic Electrocardiogram (ECG) for cardiac effects, especially in patients with pre-existing heart conditions.
- Plasma drug levels (if therapeutic drug monitoring is indicated, e.g., in cases of non-response or suspected toxicity).
- Liver function tests (LFTs) periodically, especially in patients with hepatic impairment.
- Complete Blood Count (CBC) with differential, particularly if fever or sore throat develops.
Doctor Notes
- Assess for cardiac history, suicidal ideation, and seizure risk before initiating nortriptyline.
- Monitor for anticholinergic side effects, particularly in elderly patients.
- Consider therapeutic drug monitoring if there is no response at standard doses or if toxicity is suspected.
- Educate patients on potential drug and food interactions, especially with MAOIs and alcohol.
Patient Guidelines
- Do not stop taking Amynil abruptly; withdrawal symptoms can occur. Consult your doctor for gradual dosage reduction.
- Avoid alcohol while on this medication, as it can worsen drowsiness and other side effects.
- Report any suicidal thoughts or unusual changes in mood or behavior to your doctor immediately.
- Be aware of anticholinergic side effects like dry mouth, constipation, and blurred vision.
- This medication may cause drowsiness; avoid driving or operating heavy machinery until you know how it affects you.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Amynil may cause drowsiness, dizziness, or blurred vision. Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how the drug affects them.
Lifestyle Advice
- To manage dry mouth, chew sugar-free gum, suck on sugar-free candies, or use artificial saliva products.
- Increase fluid intake and dietary fiber to help with constipation.
- Rise slowly from a sitting or lying position to minimize dizziness due to orthostatic hypotension.
- Protect yourself from the sun as some TCAs can cause photosensitivity.
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