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    Generic Name: Amitriptyline (am-ee-TRIP-tih-leen)
    Brand Name: Elavil

    The RISK OF SUICIDAL THINKING AND BEHAVIOR was increased by antidepressants in short-term studies in children and adolescents with certain psychiatric disorders. Anyone considering the use of Amitriptyline or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation and communication with the prescriber. Results from several studies in children and adolescents with certain psychiatric disorders have revealed a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with antidepressants.


    Amitriptyline is used for:

    The relief of depression. It may also be used to treat chronic pain and other conditions as determined by your doctor.

    Amitriptyline is a tricyclic antidepressant. How tricyclic antidepressants improve depression symptoms is not fully understood. They are thought to increase the activity of certain chemicals in the brain (norepinephrine, serotonin), which help improve mood.

    Do NOT use Amitriptyline if:

    • you are allergic to any ingredient in Amitriptyline
    • you are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine, selegiline) within the last 14 days
    • you are taking antihistamines (eg, diphenhydramine), cisapride, dofetilide, droperidol, fluoroquinolones (eg, ciprofloxacin), ketolides (eg, telithromycin) macrolides (eg, erythromycin), mibefradil, or pimozide
    • you are recovering from a heart attack

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Amitriptyline :

    Some medical conditions may interact with Amitriptyline . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have a history of mental illness (eg, bipolar disorder, mania, manic-depression), or have considered or attempted suicide
    • if you have alcoholism or regularly consume 3 or more alcoholic beverages per day
    • if you have glaucoma, an irregular heartbeat, heart disease, chest pain, liver disease, prostate problems, thyroid disease, or are unable to urinate (urinary retention)
    • if you have a history of seizures, epilepsy, or porphyria

    Some MEDICINES MAY INTERACT with Amitriptyline . Tell your health care provider if you are taking any other medicines, especially any of the following:

    • MAO inhibitors (eg, phenelzine, selegiline) because they can cause serious, sometimes life-threatening, reactions. Do NOT take MAO inhibitors with, or within 2 weeks of taking, Amitriptyline
    • Anticholinergics (eg, scopolamine), bupropion, cimetidine, fluconazole, phenothiazines (eg, chlorpromazine), SSRIs (eg, fluoxetine), terbinafine, or valproic acid because side effects such as blurred vision, difficult urination, drowsiness or sedation, dry mouth, or lightheadedness may occur
    • Antihistamines (eg, diphenhydramine), cisapride, dofetilide, droperidol, fluoroquinolones (eg, ciprofloxacin), ketolides (eg, telithromycin), macrolides (eg, erythromycin), mibefradil, pimozide, or streptogramins (eg, quinupristin/dalfopristin) because serious side effects on the heart (eg, racing heartbeat, dizziness, fainting, life-threatening abnormal heartbeat leading to unconsciousness, and lack of heartbeat, may be increased by Amitriptyline
    • Carbamazepine, thyroid medicines (eg, levothyroxine), or stimulants (eg, albuterol, pseudoephedrine) because their side effects may be increased by Amitriptyline
    • Warfarin because side effects such as serious bleeding may be increased by Amitriptyline
    • Clonidine, guanethidine, or guanfacine because the effectiveness of these medicines may be decreased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Amitriptyline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Amitriptyline :

    Use Amitriptyline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Amitriptyline comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Amitriptyline refilled.
    • Amitriptyline may be taken with food or on an empty stomach.
    • Avoid eating or drinking grapefruit juice while taking Amitriptyline .
    • Amitriptyline may take up to 30 days to control symptoms of depression. Continue to use Amitriptyline even if you feel well. Do not miss any doses.
    • If you miss a dose of Amitriptyline , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Amitriptyline .

    Important safety information:

    • Amitriptyline may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Amitriptyline . Using Amitriptyline alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
    • Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Amitriptyline . Amitriptyline will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
    • Alcoholic beverages, hot weather, exercise, and fever can increase dizziness. To prevent dizziness or fainting, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness or weakness.
    • Involuntary and uncontrollable movements may develop in patients taking Amitriptyline . Occurrence is highest among the elderly, especially women. The risk of developing these involuntary movements and the likelihood they will become permanent are increased with long-term use and with high doses. However, it is possible to develop these symptoms after short-term use at low doses. Contact your health care provider at once if any of the following occur: involuntary movements of the tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs.
    • Amitriptyline may cause sensitivity to sunlight. Avoid prolonged exposure to the sun and other ultraviolet light (eg, tanning beds). Use sunscreens and wear protective clothing until tolerance is determined.
    • Do not become overheated in hot weather or during exercise or other activities since heatstroke may occur.
    • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Amitriptyline .
    • Use caution in the ELDERLY because they may be more sensitive to its effects, especially lightheadedness upon standing; rapid heartbeat; breathing problems; difficult urination; and constipation.
    • PREGNANCY and BREAST-FEEDING: Amitriptyline has been shown to cause harm to the human fetus. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Amitriptyline is excreted in the breast milk. Do not breast-feed while taking Amitriptyline .

    Possible side effects of Amitriptyline :

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Abnormal skin sensations; anxiety; bad taste in mouth; black tongue; blurred vision; clumsiness; constipation; diarrhea; difficulty speaking or swallowing; dilation of the urinary tract; disturbed concentration; dizziness; drowsiness; dry mouth; excitement; fever; hair loss; headache; heartburn; hives; incoordination; increased pressure in the eye; inflammation of the tongue; irritability; itching; loss of appetite; mood swings; nausea; nightmares; numbness; rash; restlessness; ringing in the ears; sensitivity to sunlight; sleeplessness; sweating; swelling; swelling of the face and tongue; sore throat; tearing; tingling; tiredness; upset stomach; urinary retention; vomiting; weakness; weight gain.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; delusions; disorientation; fast heartbeat; fainting; hallucinations; involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs; lightheadedness; pounding in the chest; seizures; tremors; unusual bleeding or bruising; yellowing of the skin or eyes.

    This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include flushing, fast or irregular heartbeat, dry mouth, drowsiness, confusion, agitation, enlarged pupils, seizures, loss of consciousness, hallucinations, stupor, mydriasis, hyperpyrexia, paralytic ileus, urinary retention, decreased GI motility, cardiovascular toxicity, rhabdomyolysis, renal failure, respiratory depression, cyanosis, shock, diaphoresis, aspiration, ARDS, hyperthermia, hypothermia, polyradiculoneuropathy, muscle rigidity, disorders of ocular motility, vomiting.

    Proper storage of Amitriptyline :

    Store Amitriptyline at room temperature, below 86 degrees F (30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amitriptyline out of the reach of children and away from pets.

    General information:

    • If you have any questions about Amitriptyline , please talk with your doctor, pharmacist, or other health care provider.
    • Amitriptyline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • Do not use Amitriptyline for other health conditions.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • If your symptoms do not improve after taking Amitriptyline for 4 weeks, inform your doctor.
    • If using Amitriptyline for an extended period of time, obtain refills before your supply runs out.

    This information is a summary only. It does not contain all information about Amitriptyline . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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