Oral route (Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients .


Commonly Used Brand Name(s): Elavil, Vanatrip

Therapeutic Classification: Antidepressant

Pharmacologic Classification: Antidepressant, Tricyclic

Amitriptyline is used to treat symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA).

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

Take this medicine only as directed by your doctor to benefit your condition as much as possible. 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 comes with a medication guide. Read and follow the instructions in the guide carefully. Ask your doctor if you have any questions.

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 (tablets):
    • For depression:
      • Adults—At first, 75 milligrams (mg) per day given in divided doses, or 50 to 100 mg at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
      • Teenagers and Older adults—10 milligrams (mg) three times a day, and 20 mg at bedtime. Your doctor may adjust your dose as needed.
      • Children younger than 12 years of age—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.

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amitriptyline in children below 12 years of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Drug Interactions

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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Furazolidone
  • Grepafloxacin
  • Iproniazid
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Procarbazine
  • Ranolazine
  • Selegiline
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Toloxatone
  • 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.

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.

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

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:

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Amitriptyline may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Do not take amitriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping amitriptyline. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take other medicines unless they have been discussed with your doctor. Using this medicine together with cisapride (Propulsid®), may increase the chance of having serious side effects.

Do not suddenly stop taking this medicine without first checking 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 CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

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

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert .

They need to know if you have any of these conditions:

Take this medicine by mouth with a drink of water. Follow the directions on the prescription label. You can take the tablets with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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