Amitriptyline

Name: Amitriptyline

Before taking amitriptyline

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking amitriptyline it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have an overactive thyroid gland.
  • If you have a problem with the way your liver works.
  • If you have epilepsy.
  • If you have high blood sugar levels (diabetes mellitus).
  • If you have had problems with constipation.
  • If you have any difficulties passing urine, or if you have had prostate trouble.
  • If you have a heart disorder or blood vessel disease.
  • If you have ever had a mental health problem (in particular, bipolar disorder or psychosis).
  • If you have increased pressure in your eyes, a condition called glaucoma.
  • If you have been told you have a tumour on your adrenal gland, called phaeochromocytoma.
  • If you have a rare inherited blood disorder called porphyria.
  • If you are taking other medicines, including those available to buy without a prescription, as well as herbal and complementary medicines. This is especially important if you have recently taken a medicine for depression, known as a monoamine-oxidase inhibitor (MAOI).
  • If you have ever had an allergic reaction to a medicine.

Amitriptyline Overview

Amitriptyline is a prescription medication used to treat the symptoms of depression. Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCAs), which work by adjusting the levels of natural chemicals in the brain.

This medication comes in tablet form and may be taken once or multiple times a day, depending on your doctor’s instructions.

Common side effects of amitriptyline include nausea, vomiting, and weakness.

Amitriptyline can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how amitriptyline affects you.  Do not drink alcohol while taking amitriptyline.

Uses of Amitriptyline

Amitriptyline is a prescription medication used to treat symptoms of depression.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Amitriptyline Brand Names

Amitriptyline may be found in some form under the following brand names:

  • Elavil

  • Endep

  • Etrafon

  • Limbitrol

  • Triavil

  • Vanatrip

Amitriptyline Dosage

Take amitriptyline exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will prescribe the appropriate dose and schedule of amitriptyline depending on your condition, age, and response to the medication. Doses of amitriptyline may range from 10 to 150 mg a day. The maximum daily dose of amitriptyline in the hospital setting is 300 mg a day.

Other Requirements

Store amitriptyline at room temperature.

Keep in a tight, light-resistant container.

Keep this and all medicines out of the reach of children.

What are some things I need to know or do while I take Amitriptyline?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If amitriptyline is stopped, your doctor will tell you when to start taking this medicine again after your surgery or procedure.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how amitriptyline affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop amitriptyline, you will want to slowly stop it as ordered by your doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Some people may have a higher chance of eye problems with this medicine. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • If you are 65 or older, use amitriptyline with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

How is this medicine (Amitriptyline) best taken?

Use amitriptyline as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take at bedtime if it causes sleepiness.
  • Take with or without food. Take with food if it causes an upset stomach.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Amitriptyline Description

Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C20H23N ∙ HCl and its structural formula is:

Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water.

Each tablet, for oral administration, contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of Amitriptyline hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, polyethylene glycol, and titanium dioxide; 10 mg contains D&C Red No. 27 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 1 Aluminum Lake; 25 mg contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 50 mg contains FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake; 75 mg contains D&C Red No. 7 Lake, and FD&C Blue No. 1 Aluminum Lake; 100 mg and 150 mg contain D&C Red No. 30 Lake, and D&C Yellow No. 10 Aluminum Lake.

References

Ayd, F.J., Jr.: Amitriptyline therapy for depressive reactions, Psychosom. 1: 320–325, Nov.–Dec. 1960.

Diamond, S.: Human metabolization of Amitriptyline tagged with carbon 14, Curr. Therap. Res.7: 170–175, Mar. 1965.

Dorfman, W.: Clinical experiences with Amitriptyline (A preliminary report), Psychosom. 1: 153–155, May–June 1960.

Fallette, J.M.; Stasney, C.R.; Mintz, A.A.: Amitriptyline poisoning treated with physostigmine, S. Med. J. 63: 1492–1493, Dec. 1970 (in Soc. Proc.).

Hollister, L.E.; Overall, J.E.; Johnson, M.; Pennington, V.; Katz, G.; Shelton, J.: Controlled comparison of Amitriptyline, imipramine and placebo in hospitalized depressed patients, J. Nerv. and Ment. Dis. 139: 370–375, Oct. 1964.

Hordern, A.; Burt, C.G.; Holt, N.F.: Depressive states. A pharmacotherapeutic study, Springfield, Ill., Charles C. Thomas, 1965.

Jenike, M.A.: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy, J. Geriatr. Psychiatry 1989;22(1).77–112.

Klerman, G.L.; Cole, J.O.: Clinical pharmacology of imipramine and related antidepressant compounds, Int. J. Psychiat. 3: 267–304, Apr. 1976.

Liu, B.; Anderson, C.; Mittman, N. et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998; 351 (9112):1303–1307.

McConaghy, N.; Joffe, A.D.; Kingston, W.R.; Stevenson, H.G.; Atkinson, I.; Cole, E.; Fennessy, L.A.; Correlation of clinical features of depressed outpatients with response to Amitriptyline and protriptyline, Brit. J. Psychiat. 114: 103–106, Jan. 1968.

McDonald, I.M.; Perkins, M.; Marjerrison, G.; Podilsky, M.: A controlled comparison of Amitriptyline and electroconvulsive therapy in the treatment of depression, Amer. J. Psychiat. 122: 1427–1431. June 1966 (in Brief Communications).

Slovis, T.; Ott, J.; Teitelbaum, D.; Lipscomb, W.: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin. Toxicol. 4: 451–459, Sept. 1971.

Symposium on depression with special studies of a new antidepressant, Amitriptyline, Dis. Nerv. Syst. 22: 5–56, May 1961 (Sect. 2).

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 03, August 2016

MEDICATION GUIDE Amitriptyline Hydrochloride Tablets USP

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

Talk to your, or your family member's, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? 1. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. 2. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. 3. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.   Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: 4. thoughts about suicide or dying 5. attempts to commit suicide 6. new or worse depression 7. new or worse anxiety 8. feeling very agitated or restless 9. panic attacks 10. trouble sleeping (insomnia) 11. new or worse irritability 12. acting aggressive, being angry, or violent 13. acting on dangerous impulses 14. an extreme increase in activity and talking (mania) 15. other unusual changes in behavior or mood 16. Visual problems: eye pain, changes in vision, swelling or redness in or around the eye

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. • Visual problems: Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

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

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 02, March 2017

Pronunciation

(a mee TRIP ti leen)

Pharmacologic Category

  • Antidepressant, Tricyclic (Tertiary Amine)

Onset of Action

Individual responses may vary, however 4 to 8 weeks of treatment are needed before determining if a patient with depression is partially or non-responsive; similarly 8 to 12 weeks are required for an adequate migraine prophylaxis trial (APA, 2010; Prinsheim, 2012); desired therapeutic effect (for analgesia) may take as long as 1 to 3 weeks.

Time to Peak

Serum: ~2 to 5 hours (Schulz, 1985)

Half-Life Elimination

~13 to 36 hours (Schulz, 1985)

Protein Binding

>90%

Monitoring Parameters

Evaluate mental status, suicide ideation (especially at the beginning of therapy or when doses are increased or decreased); anxiety, social functioning, mania, panic attacks or other unusual changes in behavior; heart rate, blood pressure and ECG in older adults and patients with preexisting cardiac disease; blood glucose; weight and BMI; blood levels are useful for therapeutic monitoring (APA, 2010).

What should I avoid while taking amitriptyline?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with amitriptyline.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Amitriptyline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect amitriptyline?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking amitriptyline with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • other antidepressants;

  • cimetidine;

  • heart rhythm medicine such as flecainide, propafenone, quinidine, and others; or

  • medicine to treat mental illness.

This list is not complete. Other drugs may interact with amitriptyline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Usual Geriatric Dose for Depression

10 mg orally 3 times a day with 20 mg at bedtime

Comments:
-The full therapeutic effect may take as long as 30 days to develop.
-Elderly patients should be monitored carefully and serum levels obtained as clinically appropriate.
-Dose adjustments should be made according to clinical response.

Use: Relief of symptoms of depression

Dialysis

Data not available

Bottom Line

Amitriptyline is an effective antidepressant but may cause drowsiness initially and a withdrawal syndrome with abrupt discontinuation.

Important Information

You should not use this medicine if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 9.03.

Medical Disclaimer

(web3)