Pronunciation:

nor-TRIP-ti-leen

Brand Names:

• Aventyl
• Pamelor

Dosage Forms:

• Capsule
• Solution

Warnings:

Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders. This risk must be balanced with the clinical need, as nortriptyline is not approved for use in pediatric patients. Closely monitor patients of all ages for clinical worsening, suicidality, or unusual changes in behavior; not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Antidepressant, Tricyclic

Uses of This Medicine:

Nortriptyline is used to treat depression. It is thought to work by increasing the activity of serotonin in the brain. Nortriptyline is a tricyclic antidepressant.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nortriptyline in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nortriptyline in the elderly. However, elderly patients are more likely to have age-related heart or liver problems, which may require caution and an adjustment in the dose for patients receiving nortriptyline.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromopride
• Dronedarone
• Furazolidone
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Levomethadyl
• Linezolid
• Methylene Blue
• Metoclopramide
• Moclobemide
• Pargyline
• Phenelzine
• Potassium Citrate
• Procarbazine
• Ranolazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acecainide
• Aceclofenac
• Acemetacin
• Albuterol
• Alfentanil
• Alfuzosin
• Almotriptan
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Apomorphine
• Aprindine
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Benzhydrocodone
• Benzphetamine
• Bretylium
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Butorphanol
• Carisoprodol
• Celecoxib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clonidine
• Clonixin
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Darunavir
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diclofenac
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Droxicam
• Duloxetine
• Enflurane
• Epinephrine
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Formoterol
• Foscarnet
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Ibuprofen
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Iobenguane I 123
• Iobenguane I 131
• Isoflurane
• Isradipine
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Levalbuterol
• Levoketoconazole
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lopinavir
• Lorcainide
• Lorcaserin
• Lornoxicam
• Loxapine
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methotrexate
• Mifepristone
• Milnacipran
• Mirtazapine
• Moricizine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Naratriptan
• Nefopam
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norepinephrine
• Norfloxacin
• Octreotide
• Ofloxacin
• Ondansetron
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Ozanimod
• Paliperidone
• Palonosetron
• Parecoxib
• Paroxetine
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidine
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Remifentanil
• Revefenacin
• Risperidone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Sematilide
• Sertindole
• Sertraline
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulindac
• Sultopride
• Sumatriptan
• Sunitinib
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Tiotropium
• Tolfenamic Acid
• Tolmetin
• Toremifene
• Tramadol
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Valdecoxib
• Vardenafil
• Venlafaxine
• Vilanterol
• Vilazodone
• Voriconazole
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Arbutamine
• Atomoxetine
• Carbamazepine
• Cimetidine
• Dicumarol
• Phenprocoumon
• Rifapentine
• S-Adenosylmethionine
• Terbinafine
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Behavior or mood changes (eg, aggression, panic attacks) or
• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Brugada syndrome (heart disorder), or family history of or
• Glaucoma (angle-closure type) or
• Heart rhythm problems (eg, arrhythmia) or
• Psychosis (mental illness) or
• Schizophrenia (mental illness) or
• Seizures, history of or
• Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.

• Heart attack, recent—Should not be used in patients with this condition.

• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or solution):
  • For depression:
    • Adults—25 milligrams (mg) 3 to 4 times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
    • Teenagers and older adults—30 to 50 milligrams (mg) once a day or in divided doses during the day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow for changes in your dose. Blood tests may be needed to check for any unwanted effects.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not use nortriptyline with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start using nortriptyline during the 2 weeks after you stop a MAO inhibitor. Wait 2 weeks after stopping nortriptyline before you start using a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions (seizures).

Nortriptyline may cause a serious condition called serotonin syndrome if taken together with certain medicines. Do not use nortriptyline with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, sumatriptan, tramadol, Frova®, Maxalt®, Relpax®, Zomig®). Check with your doctor first before using any other medicines with nortriptyline.

This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

Make sure your doctor knows if you have a heart disorder called Brugada syndrome. Brugada syndrome can be life-threatening and requires immediate medical attention. Call your doctor or the emergency department right away if you have a fast, pounding, or uneven heartbeat, unexplained fainting, lightheadedness, or troubled breathing after using this medicine.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before using any of these medicines with nortriptyline.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking nortriptyline together with medicines used during surgery may increase the risk of side effects.

This medicine may cause some people to become drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Agitation

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

clay-colored stools

cold sweats

confusion about identity, place, and time false beliefs that cannot be changed by facts

continuing ringing or buzzing or other unexplained noise in the ears

decreased urination

deep or fast breathing with dizziness

depression

difficulty in passing urine (dribbling)

difficulty with speaking

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

feeling, seeing, or hearing things that are not there

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

general feeling of tiredness or weakness

hives or welts

hostility

inability to move the arms, legs, or facial muscles

inability to speak

irritability

labored breathing, especially at night

loss of balance control

loss of consciousness

lower back or side pain

mood or mental changes

muscle spasm, trembling, jerking, or stiffness

nightmares

numbness of the feet, hands, and around mouth

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

panic

perspiration

pinpoint red or purple spots on the skin

redness of the face, neck, arms, and occasionally, upper chest

restlessness

seizures

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

stiffness of the limbs

stomach pain

sweating

swelling of the face, ankles, legs, or hands

swollen, painful, or tender lymph glands on side of face or neck

talking, feeling, and acting with excitement

trouble sleeping

twisting movements of the body uncontrolled movements, especially of the face, neck, and back

unexplained fainting

weakness in the arms, hands, legs, or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Chest pain or tightness

clumsiness

cold, clammy skin

confusion

decreased awareness or responsiveness

decreased urine output

dilated neck veins

extreme tiredness or weakness

fainting

fast, slow, or irregular heartbeat

fast, weak pulse

increased or excessive unconscious or jerking movements

irregular breathing

lightheadedness

loss of consciousness

low body temperature

muscle stiffness, weakness, or tightness

restlessness

seeing things that are not there

seizures

severe sleepiness

shivering

swelling of the face, fingers, feet, or lower legs

troubled breathing

weak or feeble pulse

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bigger, dilated, or enlarged pupils (black part of the eye)

black tongue

decreased interest in sexual ability or desire

difficulty having a bowel movement

enlargement of the breast

hair loss or thinning of the hair

heartburn

increase in sexual ability or desire

increased sensitivity of the eyes or skin to light

pain or discomfort in the chest, upper stomach, or throat

peculiar taste

severe sunburn

small red or purple spots on the skin

swelling of the testicles

swelling or inflammation of the mouth

waking to urinate at night

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.