(nor trip' ti leen)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
SUICIDALITY AND ANTIDEPRESSANT DRUGSAntidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of escitalopram or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients.
|Indication(s) & Dosage||Depression
Adult: 75-100 mg daily in 3-4 divided doses, increased gradually up to 150 mg daily in severe depression.
Child: Adolescent: 30-50 mg daily in divided doses.
Elderly: 30-50 mg daily in divided doses.
Child: 6-7 yr (20-25 kg): 10 mg; 8-11 yr (25-35kg): 10-20 mg; >11 yr (35-54 kg): 25-35 mg. All doses are given 30 minutes before bedtime and treatment should continue for not >3 mth.
|Administration||Immediate-release: Should be taken on an empty stomach. Take Â½ hr before meals.
Extended-release: Should be taken with food. Swallow whole, do not chew/crush/divide.
|Overdose||Symptoms include cardiac dysrhythmias, severe hypotension, shock, CHF, pulmonary oedema, convulsions, and CNS depression, including coma. Gastric lavage should be perfprmed, followed by activated charcoal. Emesis is contraindicated. Initiate cardiac monitoring and observe for signs of CNS, respiratory depression, hypotension, cardiac dysrhythmias and seizures.|
|Contraindications||Mania, recent MI, arrhythmias (particularly heart block); severe liver disease; children <6 yr.|
|Special Precautions||Elderly; hepatic or renal dysfunction; benign prostatic hypertrophy; angle closure glaucoma; phaeochromocytoma; CVS disease; epilepsy; history of bowel obstruction; withdraw gradually; monitor for suicidal tendencies during early treatment; DM; thyroid disease; psychoses (may aggravate psychotic symptoms); urinary retention. Pregnancy, lactation.|
|Adverse Drug Reaction(s)||Tachycardia, slows conduction and prolongation of PR interval, lowers seizure threshold, peripheral neuropathy, dry mouth, constipation, urinary hesitancy, confusion and blurred vision, nausea, sweating, tremor, rashes, hypersensitivity reactions, hypomania or mania, headache, hyponatraemia, abnormal LFT, endocrine disorders, movement disorders, taste disturbances.
Potentially Fatal: Rare, blood dyscrasias.
|Drug Interactions||May antagonise hypotensive effects of guanethidine and similar compounds, clonidine and rauwolfia alkaloids. May cause additive CNS depression with CNS depressants (e.g. opioids, alcohol, sedatives and hypnotics). Possible increased risk of seizure with tramadol. Nortriptyline concentrations may be increased by quinidine, phenothiazines, haloperidol, inhibitors of CYP3A4, cimetidine, methylphenidate. Concentrations may be decreased by inducers of CYP3A4. Increased toxicity with SSRIs (reduce concentration).
Potentially Fatal: Severe hyperpyretic reaction with MAOIs, should not be used concomitantly or within 2 wk of stopping MAOIs. Potentiates hypertensive effect of sympathomimetics and anticoagulant action of coumarins. Please consult detailed drug interactions before prescribing.
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Oral: Store at 20-25Â°C.|
|Pharmacology||Nortriptyline is the chief active metabolite of amitriptyline. It is a dibenzocycloheptadiene tricyclic antidepressant. It prevents the re-uptake of noradrenaline and serotonin at nerve terminals.
Absorption: Peak plasma concentrations within 7-8.5 hr.
Distribution: Distributed in milk.
Metabolism: Extensively hepatic; converted to 10-hydroxynortriptyline.
Excretion: Excreted in the urine (around a third) and faeces (small amounts) as metabolites.
|ATC Classification||N06AA10 - nortriptyline; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.|
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as nortriptyline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take nortriptyline, but in some cases, a doctor may decide that nortriptyline is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take nortriptyline or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking nortriptyline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nortriptyline. Read the information carefully and ask your doctor if you have any questions. You also can obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.
No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Why is this medication prescribed?
Nortriptyline is used to treat depression. Nortriptyline is in a group of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.
How should this medicine be used?
Nortriptyline comes as a capsule and an oral liquid to take by mouth. It is usually taken one to four times a day and may be taken with or without food. Take nortriptyline at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take nortriptyline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of nortriptyline and gradually increase your dose.
Continue to take nortriptyline even if you feel well. Do not stop taking nortriptyline without talking to your doctor. If you suddenly stop taking nortriptyline, you may experience withdrawal symptoms such as headache, nausea, and weakness. Your doctor will probably want to decrease your dose gradually.
Other uses for this medicine
Nortriptyline is also sometimes used to treat panic disorders and post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nortriptyline is also sometimes used to help people stop smoking. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses. Ask your doctor for more information
What special precautions should I follow?
Before taking nortriptyline,
- tell your doctor if you are allergic to nortriptyline and other tricyclic antidepressants such as desipramine, clomipramine (Anafranil), imipramine (Tofranil), trimipramine any other medications, or any of the ingredients in nortriptyline capsules or liquid.
- tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline and tranylcypromine or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take nortriptyline. If you stop taking nortriptyline, you should wait at least 14 days before you start to take an MAO inhibitor.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin; antihistamines; chlorpropamide; cimetidine; flecainide; guanethidine; lithium; medication for high blood pressure, seizures, Parkinson's disease, diabetes, asthma, nausea, mental illness, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; propafenone; quinidine; sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine (Paxil), and sertraline (Zoloft);sleeping pills; thyroid medication; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have recently had a heart attack. Your doctor may tell you not to take nortriptyline.
- tell your doctor if you have or have ever had glaucoma (an eye condition), an enlarged prostate (a male reproductive gland), difficulty urinating, diabetes, seizures, schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), an overactive thyroid gland, or liver, kidney, or heart disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nortriptyline, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nortriptyline.
- you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- talk to your doctor about the safe use of alcohol while you are taking this medication.
- plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Nortriptyline may make your skin sensitive to sunlight.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Nortriptyline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
weakness or tiredness
excitement or anxiety
changes in appetite or weight
changes in sex drive or ability
Some side effects may be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
jaw, neck, and back muscle spasms
slow or difficult speech
uncontrollable shaking of a part of the body
difficulty breathing or swallowing
yellowing of the skin or eyes
Nortriptyline may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include
coma (loss of consciousness for a period of time)
hallucination (seeing things that do not exist)
widened pupils (dark circles in the middle of the eyes)
low body temperature
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
| | Latest mph edition: 09 Dec 2013 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.