What are the primary uses of Pamelor. How does nortriptyline work for nerve pain and depression. What are the most common side effects of this medication. Who should avoid taking nortriptyline. How should Pamelor be taken for maximum effectiveness.

Understanding Pamelor: A Comprehensive Overview

Pamelor, also known by its generic name nortriptyline, is a versatile medication primarily used to treat nerve pain and depression. This tricyclic antidepressant has been a staple in the medical field for decades, offering relief to those suffering from various conditions. But what exactly is Pamelor, and how does it work?

What is Pamelor?

Pamelor is the brand name for nortriptyline, a medication belonging to the tricyclic antidepressant (TCA) class. It works by affecting the balance of certain neurotransmitters in the brain, primarily norepinephrine and serotonin. This rebalancing can help alleviate symptoms of depression and manage nerve pain.

Primary Uses of Pamelor

While Pamelor is primarily prescribed for nerve pain and depression, it has several other uses:

• Treatment of neuropathic pain
• Management of major depressive disorder
• Addressing bedwetting in children (nocturnal enuresis)
• Off-label use for migraine prevention
• Potential application in smoking cessation programs

The Mechanism of Action: How Does Pamelor Work?

Understanding how Pamelor works in the body is crucial for patients and healthcare providers alike. The medication’s effectiveness lies in its ability to influence neurotransmitter levels in the brain.

Neurotransmitter Modulation

Pamelor primarily works by inhibiting the reuptake of norepinephrine and, to a lesser extent, serotonin in the brain. This action increases the concentration of these neurotransmitters in the synaptic cleft, leading to improved mood regulation and pain perception.

Effects on Nerve Pain

For nerve pain, Pamelor’s mechanism involves:

1. Altering pain signal transmission in the spinal cord
2. Enhancing the body’s natural pain suppression systems
3. Potentially reducing inflammation in nerve tissues

Dosage and Administration: Getting It Right

Proper dosage and administration of Pamelor are crucial for its effectiveness and safety. How should patients take this medication?

Standard Dosing Guidelines

The dosage of Pamelor varies depending on the condition being treated:

• For nerve pain: Starting dose is typically 10mg daily, which can be increased gradually
• For depression in adults: Doses range from 75mg to 100mg daily, sometimes up to 150mg under specialist supervision
• For depression in teenagers: Usually 30mg to 50mg daily, with potential for higher doses if necessary

Administration Tips

To maximize the benefits of Pamelor:

• Take it once daily, preferably in the evening or before bedtime
• Swallow tablets whole with water
• Can be taken with or without food
• Avoid chewing the tablets as they have a bitter taste
• Maintain a consistent schedule for optimal results

Side Effects: What to Expect and When to Worry

Like all medications, Pamelor can cause side effects. While many are mild and temporary, some may require medical attention. What are the most common side effects of Pamelor?

Common Side Effects

Patients taking Pamelor may experience:

• Dry mouth
• Constipation
• Drowsiness or dizziness
• Blurred vision
• Mild headaches
• Weight gain
• Difficulty urinating

These side effects often subside as the body adjusts to the medication.

Serious Side Effects

While rare, some side effects require immediate medical attention:

• Irregular heartbeat
• Severe dizziness or fainting
• Seizures
• Signs of liver problems (e.g., yellowing of eyes/skin)
• Severe abdominal pain
• Unusual bleeding or bruising

Patients experiencing these symptoms should seek medical help promptly.

Contraindications and Precautions: Who Should Avoid Pamelor?

While Pamelor can be beneficial for many, it’s not suitable for everyone. Certain conditions and medications can interact negatively with nortriptyline, making it essential to understand who should avoid this medication.

Medical Conditions

Patients with the following conditions should exercise caution or avoid Pamelor:

• Heart conditions, especially recent heart attacks
• Liver or kidney disease
• Glaucoma
• History of seizures
• Bipolar disorder
• Urinary retention issues
• Hyperthyroidism

Drug Interactions

Pamelor can interact with various medications, including:

• Monoamine oxidase inhibitors (MAOIs)
• Other antidepressants, especially SSRIs
• Certain antiarrhythmic medications
• Some antihistamines
• Certain antipsychotic drugs

Always inform your healthcare provider about all medications you’re taking.

Special Populations: Considerations for Specific Groups

Certain populations require special consideration when it comes to Pamelor use. How does this medication affect different groups?

Elderly Patients

Older adults may be more sensitive to the side effects of Pamelor. Lower starting doses are often recommended, with careful monitoring for adverse reactions. The risk of falls due to dizziness or drowsiness is a particular concern in this population.

Pregnant and Breastfeeding Women

The use of Pamelor during pregnancy and breastfeeding requires careful consideration:

• Pregnancy: Limited data available; potential risks should be weighed against benefits
• Breastfeeding: Nortriptyline can pass into breast milk; alternative medications may be preferred

Consult with a healthcare provider to make an informed decision.

Children and Adolescents

While Pamelor can be used in children for certain conditions:

• It’s primarily used for bedwetting in children aged 6 and above
• Depression treatment is approved for adolescents 12 and older
• Close monitoring is essential due to increased risk of suicidal thoughts in young people taking antidepressants

Long-Term Use and Discontinuation: What You Need to Know

Understanding the implications of long-term Pamelor use and proper discontinuation is crucial for patients and healthcare providers. What should be considered for extended treatment and stopping the medication?

Long-Term Effects

Prolonged use of Pamelor may lead to:

• Tolerance development, requiring dose adjustments
• Potential for weight gain and metabolic changes
• Increased risk of dental problems due to dry mouth
• Possible cognitive effects in elderly patients

Regular check-ups and monitoring are essential for long-term users.

Discontinuation Process

Stopping Pamelor abruptly can lead to withdrawal symptoms. A proper discontinuation process involves:

1. Gradual dose reduction under medical supervision
2. Monitoring for withdrawal symptoms like nausea, headache, and irritability
3. Potential implementation of alternative treatments if necessary
4. Extended follow-up to ensure successful transition off the medication

Alternative Treatments: Exploring Other Options

While Pamelor is effective for many, it’s not the only option for treating nerve pain and depression. What alternatives are available for patients who cannot take or do not respond well to nortriptyline?

Other Medications

Alternative pharmacological options include:

• Selective Serotonin Reuptake Inhibitors (SSRIs) for depression
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) for both pain and depression
• Gabapentinoids for neuropathic pain
• Newer antidepressants with different mechanisms of action

Non-Pharmacological Approaches

Complementary treatments that may be considered:

• Cognitive Behavioral Therapy (CBT) for depression and pain management
• Mindfulness and meditation techniques
• Physical therapy and exercise programs for pain
• Acupuncture and other alternative medicine practices
• Lifestyle modifications, including diet and sleep hygiene improvements

Pamelor (nortriptyline) remains a valuable tool in the treatment of nerve pain and depression. Its versatility and long-standing use in medical practice make it a reliable option for many patients. However, like all medications, it requires careful consideration of individual patient factors, potential side effects, and alternative treatments. By understanding the nuances of Pamelor use, patients and healthcare providers can make informed decisions to optimize treatment outcomes and improve quality of life.

Nortriptyline: a medicine used to treat nerve pain and depression

1. About nortriptyline

Nortriptyline is a medicine used for treating nerve pain.

Occasionally, it’s also used to treat depression and bedwetting in children (nocturnal enuresis) .

Nortriptyline is available on prescription. It comes as tablets.

2. Key facts

• If you take nortriptyline to treat nerve pain, it usually takes a week or so for pain to begin to wear off.
• If you take it for depression, it can take 4 to 6 weeks until it reaches full effect.
• Common side effects include a dry mouth and constipation. They’re usually mild and go away after a couple of weeks.
• Nortriptyline can make you feel sleepy so it’s best to take it in the evening or before you go to bed.
• If your doctor decides to take you off nortriptyline, they will reduce your dose gradually to help prevent withdrawal side effects such as muscle pain or feeling sick or tired.

3. Who can and cannot take nortriptyline

Most adults can take nortriptyline. Teenagers aged 12 to 17 years can take it for depression.

Children aged 6 to 17 years old can also take it for bedwetting but other medicines are used first which have less side effects.

Nortriptyline is not suitable for some people. Check with your doctor before starting to take nortriptyline if you:

• have ever had an allergic reaction to nortriptyline or any other medicine
• have a heart problem – nortriptyline can make some heart problems worse
• have liver or kidney problems
• have epilepsy or are having electroconvulsive treatment (ECT) – nortriptyline can increase your risk of seizures or fits
• have ever taken any medicines for depression – some antidepressants can affect the way nortriptyline works, even after you’ve stopped taking them
• are pregnant, trying to get pregnant or breastfeeding
• have glaucoma – nortriptyline can increase the pressure in your eye
• have thoughts about harming yourself or ending your life
• have type 1 or type 2 diabetes – if you have diabetes, nortriptyline may affect your blood sugar levels. If you usually test your blood sugar level, you may have to do this more often for the first few weeks of treatment. Talk to your diabetes nurse or doctor if the reading is high or low

4. How and when to take nortriptyline

You’ll usually take nortriptyline once a day. If you take it once a day, it’s best to take it before you go to bed as it can make you feel sleepy. If you find that it’s affecting your sleep, you could try taking it earlier in the evening.

This medicine does not usually upset your stomach. You can take it with or without food.

Swallow the tablets whole, with a drink of water. If you chew them, they taste bitter.

Dosage and strength

Nortriptyline tablets come in 3 different strengths, 10mg, 25mg or 50mg.

The usual dose to treat nerve pain in adults is 10mg a day. This can be increased if necessary. The maximum dose of nortriptyline for treating pain is 75mg a day, but this is only under the supervision of a pain specialist.

For depression in adults, the dose is increased gradually to between 75mg and 100mg a day. It can be increased to a maximum dose of 150mg a day if a specialist prescribes it.

For depression in teenagers (12 to 17 years), the dose is usually increased gradually to 30mg to 50mg a day, but higher doses may be needed.

What if I forget to take it?

If you forget a dose, take it as soon as you remember, unless it’s nearly time for your next dose. In this case, just leave out the missed dose and take your next dose at the usual time.

Never take 2 doses at the same time to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Urgent advice: Contact 111 for advice now if:

• you take more than your usual dose of nortriptyline

Go to 111.nhs.uk or call 111

Taking too much nortriptyline can cause serious side effects such as a change in your heartbeat, or you may have a seizure or fit.

5. Side effects

Like all medicines, nortriptyline can cause side effects in some people, but many people have no side effects or only minor ones.

Some of the common side effects of nortriptyline will gradually improve as your body gets used to the medicine.

Common side effects

Doses of nortriptyline for pain are lower than the doses for depression. This means the common side effects tend to be milder and go away within a few days.

Keep taking the medicine but talk to your doctor or pharmacist if these side effects bother you or do not go away:

• constipation
• feeling dizzy
• dry mouth
• feeling sleepy
• difficulty peeing
• headaches

Serious side effects

It happens rarely, but some people have a serious side effect after taking nortriptyline.

Contact a doctor if:

• your heartbeat becomes fast and irregular
• the whites of your eyes turn yellow, or your skin turns yellow, although this may be less obvious on brown or black skin – these can be signs of a liver problem
• you have a headache that does not get better, feel confused or weak and have muscle cramps – together these can be signs of low sodium levels in your blood
• you have thoughts about harming yourself or ending your life
• you have eye pain, a change in your eyesight, or swelling or redness in or around the eye
• you have constipation that lasts a long time or problems peeing which are causing stomach ache

Immediate action required: Call 999 or go to A&E if:

• you have weakness on one side of your face or body, trouble speaking or thinking, loss of balance or blurred eyesight – these can be signs of a stroke
• you have a seizure or fit
• you get severe chest pain – this can be a sign of a heart attack

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to nortriptyline.

Immediate action required: Call 999 or go to A&E now if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you’re wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of nortriptyline. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

6. How to cope with side effects of nortriptyline

What to do about:

• constipation – get more fibre into your diet such as fresh fruit, vegetables and cereals. Try to drink several glasses of water or squash every day. If you can, it may also help to increase your level of exercise.
• feeling dizzy – this is probably due to low blood pressure. Drink plenty of water or squash. Do not stand up too quickly after you’ve been sitting or lying down. Do not drive, cycle or use tools or machinery until this feeling passes. It’s best not to drink alcohol until you see how the medicine affects you.
• dry mouth – chew sugar-free gum or have some sugar-free sweets.
• feeling sleepy – take nortriptyline in the evening. It’s best not to drink alcohol until you see how the medicine affects you. Do not drive, cycle or use tools or machinery while you’re feeling sleepy.
• difficulty peeing – try to relax when you pee. Do not try to force the flow of urine. If it does not happen, try again later. Talk to your doctor urgently if you cannot pee at all.
• headaches – make sure you rest and drink plenty of fluids. It’s best not to drink alcohol until you see how the medicine affects you. Try taking paracetamol or ibuprofen if you need pain relief. Talk to your doctor if the headaches last longer than a few days or are severe.

7. Pregnancy and breastfeeding

Nortriptyline and pregnancy

You may be advised to continue taking nortriptyline during pregnancy, especially if you take it to treat depression.

Speak to your doctor if you become pregnant while taking nortriptyline. Do not stop taking your medicine unless your doctor tells you to.

Your doctor can explain the risks and benefits of taking nortriptyline and will help you choose the best treatment for you and your baby.

Nortriptyline and breastfeeding

If your doctor or health visitor says your baby is healthy, you can use nortriptyline while breastfeeding.

Notriptyline passes into breast milk in very small amounts so it’s unlikely to cause any harm to your baby.

If you are being treated for depression it’s important to continue taking nortriptyline to keep you well. Breastfeeding will also benefit both you and your baby.

If you notice that your baby is not feeding as well as usual, or seems unusually sleepy, or if you have any other concerns about your baby, then talk to your health visitor or doctor as soon as possible.

Non-urgent advice: Tell your doctor if you’re:

• trying to get pregnant
• pregnant
• breastfeeding

For more information about how nortriptyline can affect you and your baby during pregnancy, read this leaflet on the Best Use of Medicines in Pregnancy (BUMPs) website.

8. Cautions with other medicines

Many medicines taken with nortriptyline can affect each other and increase the chance of side effects.

Always check with your doctor or a pharmacist before starting any new medicine while you are taking nortriptyline.

Taking opioid-based medicines, like codeine, morphine or oxycodone, together with nortriptyline can increase your risk of becoming very drowsy and having breathing problems.

Tell your doctor if you have ever taken any medicines for depression. Some antidepressants can affect the way nortriptyline works and cause very high blood pressure. This can happen even after you have stopped taking them.

Mixing nortriptyline with herbal remedies and supplements

Do not take St John’s wort, the herbal remedy for depression, while you are being treated with nortriptyline. It will increase your risk of side effects.

There’s very little information about taking nortriptyline with other herbal remedies and supplements. They are not tested in the same way as medicines.

Important:
Medicine safety

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal medicines, vitamins or supplements.

9. Common questions about nortriptyline

How does nortriptyline work?

Nortriptyline is from a group of antidepressants called tricyclic antidepressants.

If you’re taking it for pain relief, it will change the way that your nerves receive pain signals so your pain goes away.

If you’re taking nortriptyline for depression, it’s thought to work by increasing a chemical called serotonin in the brain. This helps to improve your mood.

How long does it take to work?

If you take nortriptyline to treat nerve pain, it usually takes a week or so for pain to begin to wear off. You may start to sleep better at night.

If you take nortriptyline for depression, you may start to feel better after a couple of weeks. It can take 4 to 6 weeks until you feel the full benefits.

Do not stop taking nortriptyline after 1 to 2 weeks just because you feel it’s not helping your symptoms. Give it at least 6 weeks to work.

How will nortriptyline make me feel?

Although nortriptyline is an antidepressant, the doses are lower if you take it to help pain. Taking nortriptyline as a painkiller will not change your personality or make you feel any different.

If you’re taking nortriptyline for depression, it helps to lift your mood gradually so you feel better. You may get on with people more easily because you are less anxious.

Nortriptyline will not change your personality or give you a high of feeling happy. It will simply help you feel like yourself again.

Do not expect to feel better overnight though. Some people feel worse during the first few weeks of treatment before they begin to feel better.

What if I do not feel better?

When nortriptyline is taken for nerve pain, most people are able to sleep better within a few days and the pain starts to wear off after a week or so.

If your pain does not get better or you have side effects, talk to your doctor as there may be other treatments which work for you.

Talk to your doctor if you take nortriptyline for depression and you do not feel better after taking it for 6 weeks, or the side effects bother you.

How long will I take nortriptyline for?

If you take nortriptyline for pain, once your pain is under control, you’ll probably continue to take it for as long as it’s working for you. Some people take it for many months and even for years.

If you take nortriptyline for depression, it’s likely you’ll take it for several more months once you’re feeling better.

Most doctors recommend that you take antidepressants for 6 months to a year after you’ve stopped feeling depressed.

Stopping before then can make depression come back. Talk to your doctor about the risks and benefits of continuing to take nortriptyline for more than a few months.

Can I take nortriptyline long term?

For most people, nortriptyline is safe to take for a long time.

There do not seem to be any lasting harmful effects from taking nortriptyline for many months or years.

Is nortriptyline addictive?

Nortriptyline is not addictive but you can get withdrawal side effects if you stop taking it suddenly. You may have flu-like symptoms like feeling sick, muscle pain and feeling tired or restless.

To help prevent this happening, your doctor will probably recommend reducing your dose gradually over several weeks, or longer if you have been taking nortriptyline for a long time.

What will happen when I stop taking it?

You may get withdrawal side effects when you stop taking nortriptyline, especially if you stop taking it suddenly.

These side effects are a physical reaction as the medicine leaves your body. They can include sweating, being sick, feeling anxious, and difficulty falling asleep.

To help prevent them, your doctor will probably recommend reducing your dose gradually over several weeks, or longer if you have been taking nortriptyline for a long time.

Important

Do not stop taking nortriptyline suddenly, or without talking to your doctor.

Can I take nortriptyline with other painkillers?

Paracetamol and ibuprofen are safe to take with nortriptyline for a short time. Talk to your doctor if you need to take them for more than a few days.

Will it affect my sex life?

A few people have sex-related problems while they take nortriptyline. Both men and women may have changes in their sex drive.

Sexual side effects are not very common and should pass after the first couple of weeks. If they do not, and this is a problem for you, go back to your doctor to see if there’s another medicine you can try.

How is nortriptyline different to other medicines for nerve pain?

Nortriptyline is usually prescribed by your doctor if other painkillers, such as paracetamol and ibuprofen, have not worked.

Nortriptyline does not work any better or worse than other medicines for nerve pain.

How is it different to other antidepressants?

Nortriptyline does not work any better or worse than other antidepressants. However, sometimes people respond better to one antidepressant than another.

The best antidepressant for you depends on your symptoms and what medicines have worked for you in the past.

Talk to your doctor if you are not feeling any better after taking nortriptyline for 6 weeks or if the side effects still bother you.

Will I gain or lose weight?

Nortriptyline can change how hungry you feel. Some people feel more hungry when they’re taking it, and others feel less hungry. So your weight may change when you first start taking it.

If you start to have problems with your weight while taking nortriptyline, talk to your doctor or pharmacist.

Can I drink alcohol with it?

You can drink alcohol while taking nortriptyline but it may make you feel sleepy. It might be best to stop drinking alcohol until you see how the medicine makes you feel.

Are there foods and drinks I should avoid?

Apart from being extra careful with alcohol, you can eat and drink normally while taking nortriptyline.

Will it affect my contraception?

Nortriptyline does not affect any type of contraception including the combined pill and emergency contraception.

Will it affect my fertility?

There’s no clear evidence to suggest that nortriptyline affects fertility in either men or women.

However, speak to your doctor or a pharmacist before taking nortriptyline if you’re trying to get pregnant.

Can I drive or ride a bike?

Some people feel sleepy while they’re taking nortriptyline. It’s best to stop driving, cycling or operating machinery for the first few days and after each dose increase, until you know how this medicine makes you feel.

Will recreational drugs affect nortriptyline?

Cannabis with nortriptyline can make you feel very sleepy, especially if you’ve just started taking it. Cannabis can also give you a fast heartbeat.

It may be dangerous to take nortriptyline with:

• methadone
• stimulants like MDMA (ecstasy) or cocaine
• hallucinogens like LSD
• novel psychoactive substances (these used to be called “legal highs”) like mephedrone

Nortriptyline has not been properly tested with recreational drugs. Talk to your doctor if you think you might use recreational drugs while taking nortriptyline.

Nortriptyline – StatPearls – NCBI Bookshelf

Continuing Education Activity

Nortriptyline is indicated for use in the treatment of depression (FDA-approved). It can also be used off-label for conditions such as chronic pain, diabetic neuropathy, myofascial pain, orofacial pain, and postherpetic neuralgia. Nortriptyline has also shown to be useful in patients trying to quit smoking. Nortriptyline is not FDA approved for use in children. This activity covers nortryptyline’s indications, mechanism of action, pharmacology, administration, adverse event profiles, eligible patient populations, contraindications, and monitoring, and highlights the role of the interprofessional team in the management of depression and other diseases with nortriptyline therapy.

Objectives:

• Outline the mechanism of action of nortriptyline.

• Review the indications for using nortriptyline.

• Summarize the potential adverse effects associated with nortriptyline therapy.

• Describe the importance of improving care coordination among the interprofessional team to enhance the delivery of care for patients who can benefit from therapy with nortriptyline.

Access free multiple choice questions on this topic.

Indications

Nortriptyline is indicated for use in the treatment of depression (FDA-approved). Nortriptyline is not FDA approved for use in children.

Nortriptyline can also be used for the following off-label indications:

• Chronic pain[1] 

• Diabetic neuropathy[2]

• Persistent myofascial pain[3]

• Trigeminal neuralgia[4]

• Postherpetic neuralgia[5]

• Smoking cessation[6]

• Migraine prophylaxis[7]

• Neurogenic cough[8]

Mechanism of Action

Nortriptyline is an antidepressant that falls under the pharmacological category of tricyclics (secondary amine), more commonly known as TCAs.The consensus is that nortriptyline inhibits the reuptake of serotonin and norepinephrine by the presynaptic neuronal membrane, thereby increasing the concentration of those neurotransmitters in the synapse. Additionally, nortriptyline inhibits the activity of histamine, 5-hydroxytryptamine, and acetylcholine. Nortriptyline increases the pressor effect of norepinephrine but hinders the pressor response of phenethylamine. However, research has found additional receptor effects, including desensitization of adenylyl cyclase, down-regulation of beta-adrenergic receptors, and downregulation of serotonin receptors. 

The proposed mechanism of nortryptyline in neuropathic pain is an increase in noradrenaline levels acting within dorsal root ganglia on β2-adrenoceptors expressed by non-neuronal satellite cells. This stimulation of β2-adrenoreceptors reduces the neuropathy-induced production of TNFα, resulting in the relief of neuropathic pain.[9] Nortriptyline’s mechanism in smoking cessation is unclear, but the possible action may involve simulating the noradrenergic actions of nicotine.[10] A recent study suggests that nortriptyline can be used as a new antimicrobial drug against multidrug-resistant Candida Albicans infection by inhibiting biofilm and ability to kill cells in a mature biofilm efficiently; however, more research is needed.[11]

Pharmacokinetics

• Absorption: Peak plasma concentrations are 7 to 8. 5 hours after oral administration, although antidepressant action is obtained after a few weeks.[12]

• Distribution: Nortriptyline is distributed to the brain, heart, and liver. Nortriptyline and its metabolite are highly bound to plasma and tissue proteins. Nortriptyline crosses the placenta, and nortriptyline is present in breast milk.[13]

• Metabolism: Nortriptyline, when administered orally, undergoes first-pass metabolism in the liver by CYP2D6.[14]

• Excretion: The primary route of elimination is urinary excretion, approximately one-third of the dose as metabolites within 24 hours, but it is also excreted in feces via the bile.

Administration

Nortriptyline is usually taken orally as a capsule or an oral solution. Capsule form comes in 10 mg, 25 mg, 50 mg, and 75 mg strengths. The oral solution form is usually of the following composition 10 mg/5 mL (473 mL). The usual adult dose is 25 mg three or four times daily; it should begin at a low level and increase as needed. As an alternate regimen, the total daily dosage can be given once daily. When doses higher than 100 mg daily are administered, plasma levels of nortriptyline should be monitored. Doses higher than 150 mg daily are not recommended.

Use in Specific Patient Population

• Patients with Hepatic impairment: No information has been provided in the manufacturer’s product labeling. However, caution and dose reduction are advised in patients with hepatic impairment, given the drug’s primary metabolism is by liver enzymes.[14]

• Patients with Renal impairment: No information has been provided in the manufacturer’s product labeling. 

• Pregnancy Considerations: According to product labeling, preclinical studies during pregnancy have been inconclusive. Safe use of nortriptyline during pregnancy has not been established; therefore, when the drug is administered to pregnant patients or women of childbearing potential, clinicians must weigh the potential benefits against the possible hazard.

• Breastfeeding Considerations: According to product labeling, the safe use of nortriptyline during lactation has not been established. However, nortriptyline’s concentration in breastmilk is low. Consequently, amounts ingested by the infant are small. However, the less active metabolites are often detectable in low levels in infant serum. Many reviewers consider nortriptyline preferred TCA during breastfeeding; however, drugs that have a better safety profile during lactation are paroxetine and sertraline.[13]

Adverse Effects

Nortriptyline has a black box warning for increased risk of suicide in adolescents, children, and young adults with major depressive disorder and multiple other psychiatric disorders.[16]

The most common adverse effects of nortriptyline include downiness, xerostomia, dizziness, constipation, blurred visions, palpitations, tachycardia, impaired coordination, increased appetite, nausea/vomiting, diaphoresis, weakness, disorientation, confusion, restlessness, insomnia, anxiety/agitation, urinary retention, urinary frequency, rash, urticaria, pruritus, weight gain, libido changes, impotence, gynecomastia, galactorrhea, tremor, hypo/hyperglycemia, paraesthesia, and photosensitivity. [17]

The most serious adverse effects include orthostatic hypotension, HTN, syncope, ventricular arrhythmias, AV block, MI, stroke, paralytic ileus, glaucoma, increased IOP, agranulocytosis, leukopenia, thrombocytopenia, hepatitis, angioedema.[18][19]

Neuropsychiatric adverse drug reactions include EPS symptoms, ataxia, tardive dyskinesia, hallucinations, psychosis exacerbation, hypomania/mania, exacerbation of depression, suicidality, serotonin syndrome, SIADH, hyperthermia, and seizures.[20][21][22]

Cardiotoxicity is the hallmark adverse drug reaction of tricyclic antidepressants, such as nortriptyline. In the case of TCA toxicity, fast cardiac sodium channels are inhibited, which can lead to cardiac arrhythmias. On electrocardiography. A widened QRS complex is often noted.[23]

A patient can also have withdrawal symptoms such as dizziness, gastrointestinal problems such as nausea and vomiting, anxiety, headaches, and restlessness if the patient discontinues nortriptyline abruptly. Clinicians can avoid these withdrawal symptoms by gradually decreasing the dose of nortriptyline over a period.[24]

Drug Interactions

Clinicians should avoid concurrent usage of cimetidine and tricyclic antidepressants such as nortriptyline as the drug interaction can increase the concentration of TCAs. Using nortriptyline, along with alcohol, can increase the effects of alcohol on patients. Cytochrome P450 2D6 metabolizes nortriptyline. All pharmacological drugs that inhibit 2D6 can produce an adverse reaction. Significant drug interactions that can inhibit cytochrome P450 2D6 include quinidine and cimetidine. Cimetidine increases bioavailability and decreases the clearance of this drug due to its inhibition of metabolic pathways of both demethylation and hydroxylation, as well as its ability to reduce hepatic extraction of nortriptyline. Other drugs are substrates for CYP2D6, such as other antidepressants, phenothiazines, and type-1C antiarrhythmics such as propafenone and flecainide. [25][26]

Concurrent usage of nortriptyline with drugs that can inhibit cytochrome CYP2D6 may require lower doses than usually prescribed for either nortriptyline or the other medication.

Many patients prescribed nortriptyline may already be taking SSRIs such as fluoxetine. If the benefit of switching from fluoxetine to nortriptyline is higher than the risk, the clinician should consider that fluoxetine has an active metabolite, norfluoxetine, with a long half-life. The risk of adverse effects and interactions may be high for several weeks after discontinuing fluoxetine. Therefore, usage of nortriptyline with SSRIs like fluoxetine can increase the risk for serotonin syndrome. Fluoxetine should be discontinued for up to six weeks before starting another medication that inhibits serotonin reuptake. If serotonin syndrome occurs, clinicians should promptly administer an antidote, i.e., cyproheptadine. Cyproheptadine is a 5-HT1A, 5-HT2A, and h2 receptor antagonist.[27]

Contraindications

Tricyclic antidepressants use along with a monoamine oxidase (MAO) inhibitor, linezolid, and IV methylene blue is contraindicated as they can lead to an increased risk of developing serotonin syndrome. Serotonin syndrome can be life-threatening as it can cause a change in mental status, autonomic instability, neuromuscular changes, seizures, and gastrointestinal symptoms. More importantly, concurrent use of both medications can cause convulsions, hyper-pyretic crises, and death. The patient must discontinue MAO inhibitors for at least 14 days before starting nortriptyline.[28] If nortriptyline must be used alongside serotonergic drugs such as triptans, other TCAs, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort, the benefits must outweigh the risks.

Postmarketing reports have shown a possible association between nortriptyline and the unmasking of Brugada syndrome. For this reason, patients with confirmed or suspected Brugada syndrome should avoid nortriptyline as it can result in EKG abnormalities, syncope, and even sudden cardiac death.[29] Nortriptyline can cause pupillary dilation, potentially resulting in an angle-closure attack in an individual with anatomically narrow angles. Finally, nortriptyline is contraindicated during the acute recovery period after myocardial infarction. The use of nortriptyline is also contraindicated in patients with hypersensitivity to nortriptyline or its components. Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility.

Monitoring

As an antidepressant, the therapeutic range for nortriptyline is between 50 to 150 ng/mL (190 to 570 nmol/L). According to APA guidelines, patients using nortriptyline need monitoring for suicidal ideation, especially at the start of therapy and when making dosage changes. Clinicians should frequently monitor cardiac parameters such as heart rate, EKG, and blood pressure in adults who already have existing cardiac disease and elderly patients.[28]

Monitor for improvement/worsening of depression using questionnaires such as PHQ-9 (Patient Health Questionnaire-9), which are patient-reported outcomes[30], and the Montgomery-Asberg Depression Rating Scale (MADRS), which is based on clinical judgment. [31] Integration of clinical decision support tools (CDS tools) in EHR can improve the administration of questionnaires and management of depression.[32]

Toxicity

Like many other TCAs, the toxicity of nortriptyline can be very harmful to the body. During an overdose, there is a blockade of the following receptors: sodium channels (fast) in the heart, muscarinic Ach receptors (central and peripheral), alpha-1 receptors in the periphery, and h2 and GABA-A in the central nervous system. Therefore, the most crucial initial step when assessing a patient with toxicity is ensuring the patient can adequately breathe. Intubation is usually mandatory for airway protection and proper ventilation. In addition, the clinician can administer IV fluids for hypotension.

Additionally, sodium bicarbonate is the recommended treatment for patients with prolonged QRS (greater than 100 milliseconds) or ventricular arrhythmia. The sodium bicarbonate dosage depends on the patient’s weight, usually 1 to 2 mEq/kg.  Arrhythmias not responding to sodium bicarbonate therapy may need lidocaine, phenytoin, or bretylium. TCAs can also cause seizures. These can have treatment with benzodiazepines such as lorazepam 2 mg or diazepam 5 mg, administered through the intravenous (IV) route. Treatment with activated charcoal for gastrointestinal decontamination is only indicated in patients who present within 2 hours of overdose (1 g/kg). Although there is a strong blockage of muscarinic acetylcholine receptors, physostigmine is contraindicated in the event of TCA toxicity as it can cause adverse cardiac effects such as cardiac arrest.[28] The principles of management of pediatric overdose are similar. However, It is recommended that the clinician contact the local poison control center for specific pediatric treatment.

Enhancing Healthcare Team Outcomes

Interprofessional healthcare team members, including clinicians, psychiatrists, nurse practitioners and physician assistants, nurses, and pharmacists, should be aware that nortriptyline is no longer a first-line choice for its indicated conditions. There are many better and safer antidepressants on the market. The drug has many side effects, which are often not well tolerated.[33] 

However, when a patient is taking nortriptyline, all interprofessional team members should contribute from their individual disciplines to ensure proper dosing, the absence of drug-drug interactions, and participate in patient monitoring and education, to drive optimal outcomes with minimal adverse events. Every team member is responsible for monitoring and counseling the patient and must be alert for signs of therapeutic failure, possible drug interactions, or adverse events, including toxicity. If they note an issue with the patient, they should report these to the other team members and document their observations in the patient’s medical record. A randomized controlled trial aimed at the clinical effectiveness of collaborative care in managing patients with moderate to severe depression showed optimistic results. Coordinated care between health care providers had continued promising results up to one year after initiation of the depression treatment and was preferred by patients. [34] [Level 2]

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Disclosure: Gagindip Merwar declares no relevant financial relationships with ineligible companies.

Disclosure: Jonathan Gibbons declares no relevant financial relationships with ineligible companies.

Disclosure: Seyed Alireza Hosseini declares no relevant financial relationships with ineligible companies.

Disclosure: Abdolreza Saadabadi declares no relevant financial relationships with ineligible companies.

Pillintrip
Your depression and/or it comes from suicidal thoughts and behavior (suicidality) or unusual changes
whether you are taking antidepressants or not, and this risk may persist as long as
significant remission occurs. Suicide is a known risk for depression and some other psychiatrists
Disorders, and these disorders themselves, are the strongest predictors of suicide. It became one
However, there has long been concern that antidepressants play a role in worsening
depression and the occurrence of suicidality in some patients in the early stages of treatment.
Pooled analyzes of short-term placebo-controlled trials with antidepressants (SSRIs and others)
showed that these drugs increase the risk of suicidal thoughts and behaviors (suicide) in children
Adolescents and young adults (18 to 24 years old) with major depressive disorder (MDD) and others
mental disorders. Short-term studies have not shown an increase in the risk of suicidality
Antidepressants versus placebo in adults over 24 years of age; there was a decrease with antidepressants
compared with placebo in adults aged 65 years and older.

Pooled analyzes of placebo-controlled studies in children and adolescents with DMD, obsessive
OCD or other psychiatric disorders included 24 short-term studies with 9
Antidepressants in more than 4400 patients. Pooled analyzes of placebo-controlled trials in adults
with MDD or other psychiatric disorders included a total of 295 short-term studies (mean duration 2
Months) of 11 antidepressants in more than 77,000 patients. There were significant fluctuations in risk
Suicidality among drugs, but trend towards younger patients for almost all drugs
studied. There were differences in the absolute risk of suicidality on various grounds with which
highest incidence in MDD. Risk differences (stroke vs. placebo) were relatively stable
in age groups and according to indications. These differences in risk (drug-placebo difference in the number of
Cases of suicidality per 1000 treated patients) are in Table 1 .max

There were no suicides in any of the pediatric studies. There have been suicides in the adult trials, but this
this number was not enough to draw a conclusion about the effect of drugs on suicide.

It is not known if the risk of suicidality extends to long-term use, D.H., beyond several months.
However, there is significant evidence from placebo-controlled studies of adult maintenance
depression that the use of antidepressants may delay the relapse of depression.

All patients receiving antidepressants for each indication should be monitored
adequately and carefully monitored for clinical deterioration, suicidality, and unusual changes
Behavior, especially during the first months of drug therapy or during a dose
changes, either increased or decreased.

The following symptoms, restlessness, restlessness, panic attacks, insomnia, irritability, hostility
Aggression, impulsivity, akathisia (psychomotor restlessness), hypomania and mania were
reported in adults and pediatric patients treated with antidepressants for major depressive disorder
and for other indications, both psychiatric and non-psychiatric. Although the causal relationship between
The formation of such symptoms and either worsening depression and/or development of suicidal
Impulses have not been identified, there are concerns that such symptoms may be precursors
emerging suicidality.

Change of regimen should be considered, including possibly stopping it
drug in patients whose depression is consistently worse, or who develops an emerging
Suicidality or symptoms that may be precursors to an exacerbation of depression or suicidality, especially if
these symptoms are severe, come on suddenly, or were not part of the symptoms the patient had.

Families and caregivers of patients treated with antidepressants for major depressants
Disorder or other indications, both psychiatric and non-psychiatric, must be
Patients should be monitored for restlessness, irritability, unusual behavioral changes
and other symptoms described above, as well as the development of suicidality and reporting
such symptoms immediately for healthcare professionals. Such monitoring should include daily
Surveillance by families and caregivers. Nortriptyline hydrochloride recipes must be
written for the least amount of capsules according to good patient management to reduce
risk of overdose.

Patient screening for bipolar disorder

Major depressive episode may be first presentation
bipolar disorder. It is generally believed (although not proven in controlled studies) that treatment
such an episode with one antidepressant may be a chance of precipitation
mixed/manic episode in patients at risk for bipolar disorder. Are any of the symptoms described
such a transformation is not known above. Before starting treatment with
Antidepressants, patients with depressive symptoms should be adequately evaluated to determine if you
are at risk for bipolar disorder; such screening should include a detailed mental health history, including one
Family history of suicide, bipolar disorder, and depression. It should be noted that nortriptyline
Hydrochloric acid is not approved for the treatment of bipolar depression.

Patients with cardiovascular disease should only receive Pamelor under strict supervision because
the tendency of the drug to cause sinus tachycardia and prolong conduction time. Myocardium
Heart attack, arrhythmia and strokes occurred. The effect of guanethidine and lowering blood pressure
such agents may be blocked. Due to its anticholinergic activity, Pamelor should be used
great care in patients with a history of urinary retention. Patients with a history of seizures
the administration of Pamelor should be closely monitored as this drug is known to be
spastic threshold. Greater caution is required when Pamelor is given to hyperthyroid patients or such patients
Retention of thyroid medications because cardiac arrhythmias may develop.

Pamelor may interfere with the mental and/or physical abilities needed for exercise
Tasks such as operating machinery or driving a car; therefore, the patient must be warned accordingly.

Excessive alcohol consumption in combination with nortriptyline therapy may be potentiated
An effect that may lead to an increase in suicide attempts or overdose, especially in patients
with a history of emotional distress or thoughts of suicide.

Coadministration of quinidine and nortriptyline may result in significantly longer plasma
Half-life, higher AUC and lower clearance of nortriptyline.

Serotonin syndrome

Potentially life-threatening serotonin syndrome has been reported with SNRI
SSRIs, including Pamelor alone, but especially when other serotonin drugs are used concomitantly
(including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St.
St. John’s wort) and with drugs that affect serotonin metabolism (especially MAOIs, both of which
for the treatment of psychiatric disorders, as well as others such as linezolid and intravenous methylene
blue).

Symptoms of serotonin syndrome may include changes in psychological status (eg, restlessness, hallucinations
delirium and coma), autonomic instability (eg. tachycardia, unstable blood pressure, dizziness
Diaphoresis, flushing, hyperthermia), neuromuscular changes (eg, tremor, stiffness, myoclonus
hyperreflexia, incoordination), convulsions and/or gastrointestinal symptoms (eg. nausea, vomiting
Diarrhea). Patients should be tested for serotonin syndrome.

Simultaneous use of Pamelor with Maoist is contraindicated in the treatment of mental disorders.
Pamelor should also not be started in a patient who is using an MAOI such as linezolid or
intravenous methylene blue. All methylene blue reports, route information
administration included intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports
involves administration of methylene blue on other bases (such as oral tablets or topical tissues
injection) or at lower doses. There may be circumstances in which treatment should be initiated
MAOI such as linezolid or intravenous methylene blue in a patient taking Pamelor. Pamelor should be
stop before starting treatment with an MAOMI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION ).

When Pamelor is used concomitantly with other serotonergic drugs, including triptan, tricyclic
Antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s wort clinical
Patients should be aware of the potentially increased risk of serotonin syndrome
especially during treatment administration and dose escalation.

Treatment with Pamelor and concomitant serotonergic agents should be discontinued immediately if
the above events occur and supportive symptomatic treatment should be initiated.

Unmasking Brugada syndrome

There have been post-marketing reports of a possible association between treatment with Pamelor and
impact of Brugada syndrome. Brugada syndrome is a disorder characterized by fainting
abnormal electrocardiographic (EKG) results and risk of sudden death. Pamelor should be at all
avoid in patients with Brugada syndrome or in patients with Brugada syndrome.

Angle-closure glaucoma

Pupil dilation which can occur with many antidepressants, including Pamelor
induce an angle attack in an anatomically narrow patient who does not have a patent
iridectomy.

Use in pregnancy

Safe use of Pamelor during pregnancy and lactation has not been established; Therefore, if the drug
potential is given to pregnant patients, breastfeeding mothers or women of childbearing potential
the use must be weighed against the possible hazards. Animal studies have shown
inconclusive results.

PRECAUTIONS

Information for Patients

Medical educators or other healthcare professionals should inform patients, their families and carers
about the benefits and risks associated with treatment with nortriptyline hydrochloride and should
advise you on your correct use. Patient Medication guide on “antidepressants”
Depression and other severe mental illnesses and suicidal thoughts or actions” are available for
Nortriptyline hydrochloride. The prescribing doctor or healthcare professional must be your patient
Families and your caregivers read the Medication Guide and should help you understand it.
Content. Patients should be given the opportunity to change the content of the Medication Guide to discuss and
You will receive answers to all your questions. Full text of the Medication Guide reprinted
at the end of this document.

Patients should report the following problems and be asked to notify their prescriber if they occur
taking nortriptyline hydrochloride.

Clinical deterioration and risk of suicide

Patients, your families and your caregivers should
encouraged to be alert for fear, anxiety, panic attacks, insomnia, irritability
Hostility, aggressiveness, impulsivity, akathisia (psychomotor unrest), hypomania, mania and others
unusual behavioral changes, exacerbation of depression and suicidal thoughts, especially in the early stages
antidepressant and when the dose is adjusted up or down. Families and caregivers of patients
should be advised to look for the development of symptoms daily, such as changes
may be harsh. Such symptoms should be reported to the prescribing physician or healthcare provider of the patient.
especially if you are severe, cutting or were not part of the symptoms the patient had.
These symptoms may be associated with an increased risk of suicidal thoughts and behaviors and
point out the need for very precise monitoring and possibly changes in medications.

Pamelor use in patients with schizophrenia may or may worsen psychosis
activate latent schizophrenic symptoms. When the drug is administered to patients with excessive or agitated activity, it increases
Anxiety and restlessness may arise. In patients with manic depression, Pamelor may cause manic symptoms.
phase must occur.

Annoying hostility of the patient can be awakened using Pamelor. epileptiform seizures can
accompany his administration as it applies to other drugs in his class.

If important, the drug can be administered by electro-cream therapy, although this is dangerous
can be increased. If possible, stop taking your medication for a few days before your planned surgery.

The possibility of a depressed patient attempting suicide persists after starting treatment; V
therefore, it is important that the minimum possible number of drugs be dispensed at a given point in time.

Both increases and decreases in blood sugar have been reported.

Patients should be advised that Pamelor may cause mild pupillary dilation, which in turn will cause mild pupillary dilation
People can lead to an episode of angle-closure glaucoma. Existing glaucoma is almost always
Open-air glaucoma because angle-closure glaucoma can definitely be treated at the time of diagnosis
with iridectomy. Open-angle glaucoma is not a risk factor for narrow-angle glaucoma. Patients may
want to be examined to determine if you are prone to corner closure and have one
prophylactic procedure (eg iridectomy) if you are susceptible.

Monoamine oxidase inhibitor (MAOI)

(See CONTRAINDICATIONS , WARNINGS and DOSAGE AND ADMINISTRATION .)

Ser otonergic drugs

(See CONTRAINDICATIONS , WARNINGS and DOSAGE AND ADMINISTRATION . )

Pediatric use

Safety and efficacy in the pediatric population have not been established (see BOX WARNING
and WARNINGS Clinical deterioration and suicide Risk j). If someone is considering using nortriptyline
treatment in a child or adolescent should balance potential risks with clinical needs.

Geriatric use

Clinical studies with Pamelor did not include sufficient numbers of subjects aged 65 years and older
determine if you react differently than young people. Other reported clinical events
indicates that, as with other tricyclic antidepressants, liver side effects (mainly characterized by
Jaundice and elevated liver enzymes) are very rarely seen in geriatric patients and death.
Cholestatic liver damage has been reported in isolated cases. Cardiovascular function
arrhythmias and fluctuations in blood pressure should be especially monitored. It was too
Reports of confusion after tricyclic antidepressant in the elderly. high
Plasma concentrations of the active metabolite of nortriptyline, 10-hydroxynortriptyline, were also
reported in the elderly. As with other tricyclic antidepressants, dose selection for the elderly patient
should generally be limited to the lowest effective total daily dose (see DOSAGE AND ADMINISTRATION ).

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ^® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Pamelor

Trade names: Canada

APO-Nortriptyline; Aventyl; TEVA-Northriptyline [DSC]

Warning

• Drugs like this have increased the likelihood of suicidal thoughts or actions in children and young people. This risk may be higher in people who have tried or had suicidal thoughts in the past. All people taking this drug must be closely monitored. If you develop or worsen disorders such as depression, nervousness, anxiety, grouchiness, panic attacks, and changes in mood or behavior, contact your doctor immediately. Contact your doctor immediately if you have suicidal thoughts or suicide attempts.
• This drug is not approved for use in children. Consult your doctor.

What is this drug used for?

• Used to treat depression.
• This drug may also be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
• If you have recently had a myocardial infarction.
• If you have a certain heart disorder called Brugada syndrome or have ever fainted for no reason.
• If you are taking any of the following drugs: linezolid or methylene blue.
• If you have taken medications for depression or Parkinson’s disease in the past 14 days. These include isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. An episode of very high blood pressure may occur.

This list of drugs and conditions that may interfere with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists. You may need to stop taking this drug before certain types of surgery, as told by your doctor. If you stop taking this drug, your doctor will tell you when you can start taking this drug again after your surgery or procedure.
• Avoid driving and other activities that require increased attention until you see how this drug affects you.
• To reduce the risk of dizziness or fainting, get up slowly from a lying or sitting position. Walking up and down stairs should be done with care.
• If you have high blood sugar (diabetes), you should check your blood sugar regularly.
• Talk to your doctor if you have signs of high or low blood sugar such as fruity breath, dizziness, rapid breathing, tachycardia, confusion, drowsiness, feeling weak, flushing, headache, unusual thirst or hunger, frequent urination, tremors or sweating.
• Check with your doctor before using alcohol, marijuana or other forms of cannabis, or prescription or over-the-counter drugs that can slow you down.
• If you have or have ever had seizures, talk to your doctor.
• You can get burned quickly. Avoid direct sunlight, sun lamps and tanning beds. Use sun umbrellas, wear long clothes and sunglasses.
• Caution should be exercised in hot weather and during vigorous activity. Drink plenty of fluids to prevent dehydration.
• Some patients may be at increased risk of eye problems when using this drug. Your doctor may order an eye examination to see if you are at increased risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, swelling or redness around the eye.
• Some people who take this drug have a certain heart disorder (Brugada syndrome). These people had the disorder before but were unaware of it. People with Brugada syndrome have abnormal heart rhythms and are at risk of sudden death. Consult your doctor.
• A severe and sometimes deadly complication called serotonin syndrome can occur. This risk may be increased if certain other drugs are taken at the same time. Call your doctor right away if you experience agitation, balance problems, confusion, hallucinations, high fever, tachycardia or abnormal heart rhythms, flushing, muscle twitching or stiffness, seizures, tremors or tremors, excessive sweating, severe diarrhea, nausea or vomiting , a very severe headache.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of high or low blood pressure, such as a very severe headache or dizziness, fainting, or changes in vision.
• Pain or pressure in the chest.
• Increased or abnormal heart rhythm.
• Weakness on 1 side of the body, difficulty speaking or thinking, problems with balance, sagging on one side of the face, or blurred vision.
• Confusion of consciousness.
• Hallucinations (a person sees or hears something that is not in reality).
• Nightmares.
• Unusual sensations of burning, numbness, or tingling.
• Shiver.
• With problems in controlling body movements.
• Tinnitus.
• Severe constipation or abdominal pain. These may be signs of a severe bowel disorder.
• Obstruction of the urinary tract.
• Seizures.
• fever, chills, sore throat; the appearance of bruising and bleeding for unexplained reasons; pronounced feeling of tiredness or weakness.
• Yellowness of the skin or eyes.
• Irritation or pain in the mouth.
• Changing the color of the tongue.
• Change in the frequency of urination.
• Hair loss.
• Enlarged chest.
• Discharge from the nipple.
• Change in sex drive.
• Inability to achieve or maintain an erection.
• Swelling of testicles.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Talk to your doctor or get medical help if these or any other side effects bother you or don’t go away:

• Dry mouth.
• Feeling dizzy, drowsy, tired or weak.
• Constipation, diarrhea, abdominal pain, nausea, vomiting, or decreased appetite.
• Headache.
• Change in the ability to perceive taste.
• Gastric colic.
• Sleep disorders.
• Weight gain or loss.
• Excessive sweating.
• Hyperemia (blush).

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All forms:

• When taken once a day, take this medication 30 minutes before bedtime.
• Keep taking this drug as instructed by your doctor or other health care professional, even if you feel well.
• Do not stop taking this drug abruptly without consulting your doctor. This can increase the risk of side effects. If necessary, taking this drug should be stopped gradually, in accordance with the recommendations of the doctor.

Fluid:

• Liquid doses should be measured with caution. Use the dispenser that comes with the medicine. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.

What if I miss a dose of a drug?

• Take the missed dose as soon as you can.
• If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.
• If you are taking the 1 daily dose at bedtime, do not take the missed dose the next morning.

How do I store and/or discard this drug?

• Store at room temperature.
• Store in a dry place. Do not store in the bathroom.
• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General drug information

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes summaries of diagnosis, treatment and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient.