Amitriptyline is a tricyclic antidepressant with sedative effects. Amitriptyline affects certain chemical messengers (neurotransmitters) that communicate between brain cells and help regulate mood.

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

Amitriptyline may also be used for purposes not listed in this medication guide.

You should not use amitriptyline 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.

You may have thoughts about suicide when you first start taking an antidepressant such as amitriptyline, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Before taking this medicine

You should not use this medicine if you are allergic to amitriptyline, or:

• if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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.

To make sure amitriptyline is safe for you, tell your doctor if you have ever had:

• bipolar disorder (manic-depression) or schizophrenia;

• mental illness or psychosis;

• liver disease;

• heart disease;

• a heart attack, stroke, or seizures;

• diabetes (amitriptyline may raise or lower blood sugar);

• glaucoma; or

• problems with urination.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

Amitriptyline is not approved for use by anyone younger than 12 years old.

Take amitriptyline exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you need surgery, tell your surgeon you currently use amitriptyline. You may need to stop for a short time.

Do not stop using amitriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using amitriptyline.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Depression:

OUTPATIENTS:
-Initial dose: 75 mg orally per day in divided doses; this may be increased to 150 mg/day (if needed)
-Maintenance dose: 40 to 100 mg orally per day
-Maximum dose: 150 mg/day

Alternate outpatient treatment regimen: 50 to 100 mg orally as a single dose at bedtime; this may be increased by 25 or 50 mg as needed at bedtime to a total of 150 mg/day

INPATIENTS:
-Initial dose: 100 mg orally per day
-Maintenance dose: 40 to 100 mg orally as a single dose at bedtime
-Maximum dose: 300 mg/day

Comments:
-Dose increases should preferably be made in the late afternoon or at bedtime due to the sedative effect.
-The full therapeutic effect may take as long as 30 days to develop.
-Maintenance doses should be reduced to the lowest amount that will maintain relief of symptoms when satisfactory improvement has been obtained.
-Maintenance therapy should be continued for 3 months or longer to lessen the possibility of relapse.

Use: Relief of symptoms of depression

Usual Geriatric Dose for Depression:

10 mg orally 3 times a day AND 20 mg orally once a day 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

Usual Pediatric Dose for Depression:

12 years or older: 10 mg orally 3 times a day AND 20 mg orally once a day at bedtime

Comments:
-The full therapeutic effect may take as long as 30 days to develop.
-Dose adjustments should be made according to clinical response.

Use: Relief of symptoms of depression

You should not use this medicine if you are allergic to amitriptyline, or:

• if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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.

To make sure amitriptyline is safe for you, tell your doctor if you have ever had:

• bipolar disorder (manic-depression) or schizophrenia;

• mental illness or psychosis;

• liver disease;

• heart disease;

• a heart attack, stroke, or seizures;

• diabetes (amitriptyline may raise or lower blood sugar);

• glaucoma; or

• problems with urination.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

Amitriptyline is not approved for use by anyone younger than 12 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline can be fatal.

Overdose symptoms may include irregular heart rhythm, feeling like you might pass out, seizures, or coma.

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

Avoid driving or hazardous activity until you know how amitriptyline will affect you. Your reactions could be impaired.

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.

Get emergency medical help if you have signs of an allergic reaction to amitriptyline: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg;

• unusual thoughts or behavior;

• a light-headed feeling, like you might pass out;

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• pounding heartbeats or fluttering in your chest;

• confusion, hallucinations;

• a seizure (convulsions);

• painful or difficult urination;

• severe constipation;

• easy bruising, unusual bleeding; or

• fever, chills, sore throat, mouth sores.

Common amitriptyline side effects may include:

• constipation, diarrhea;

• nausea, vomiting, upset stomach;

• mouth pain, unusual taste, black tongue;

• appetite or weight changes;

• urinating less than usual;

• itching or rash;

• breast swelling (in men or women); or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking amitriptyline 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other antidepressants;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• bronchodilator asthma medication.

This list is not complete. Other drugs may affect amitriptyline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to amitriptyline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

• Duo-Vil® (containing Amitriptyline, Perphenazine)
• Etrafon® (containing Amitriptyline, Perphenazine)
• Limbitrol® (containing Amitriptyline, Chlordiazepoxide)
• Triavil® (containing Amitriptyline, Perphenazine)