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amitriptyline
AMITRIPTYLINE HCL 10 MG TAB
This medicine is a white, round, film-coated tablet imprinted with "M77".
AMITRIPTYLINE HCL 25 MG TAB
This medicine is a light green, round, film-coated tablet imprinted with "M 51".
AMITRIPTYLINE HCL 50 MG TAB
This medicine is a brown, round, film-coated tablet imprinted with "M 36".
AMITRIPTYLINE HCL 75 MG TAB
This medicine is a blue, round, film-coated tablet imprinted with "M 37".
AMITRIPTYLINE HCL 100 MG TAB
This medicine is a orange, round, film-coated tablet imprinted with "M 38".
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amitriptyline Overview

Amitriptyline is used to treat symptoms of depression. Amitriptyline is in a class 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.

Amitriptyline comes as a tablet to take by mouth. It is usually taken one to four times a day. Take amitriptyline at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amitriptyline 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 amitriptyline and gradually increase your dose.

It may take a few weeks or longer before you feel the full benefit of amitriptyline. Continue to take amitriptyline even if you feel well. Do not stop taking amitriptyline without talking to your doctor. If you suddenly stop taking amitriptyline, you may experience withdrawal symptoms such as nausea, headache, and lack of energy. Your doctor will probably decrease your dose gradually.

Antidepressants 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 Amitriptyline hydrochloride tablets 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. Amitriptyline hydrochloride is not approved for use in pediatric patients.

AMITRIPTYLINE WARNING

I thought I'd share my recent experience dealing with Cymbalta- something I'd never given a thought to.

Last week, Tuesday night is when it started, I came down with a stomach bug. It was bad; I couldn't keep water down and if I took my oral meds of course they came right back up. I'd start to feel a little better and then it would hit again. Thank God that I'm on the patch for pain because I don't know how I would have controlled my pain.

By Saturday night, although feeling a little better, I still hadn't ingested much more than water. I woke up with body wracking spasms, I mean my entire body would clench up and then relax again. I looked like Linda Blair in "The Exorsist". I had almost no control of my muscles. My husband took me to the ER- I thought I was low on potassium or just plain dehydrated.

Actually I was suffering from Seratonin Withdrawl Syndrome! Because of the stomach flu and the abrupt stopping of Cymbalta my body was completly devoid of seratonin. When you take Cymbalta your body can actually stop producing it's own seratonin. I had no idea that something like that, while it's rare, could happen.

I guess the moral of the story is "Don't be like Griff!" If you are sick for that long you should see a doctor, especially with the kinds of medications a lot of us are taking. I'm fine now but never, never again want to go through something like that. It almost makes me want to turn in my medication badge and go it solo......almost.

AMITRIPTYLINE USES

This medication is used to treat mental/mood problems such as depression. It may help improve mood and feelings of well-being, relieve anxiety and tension, help you sleep better, and increase your energy level. This medication belongs to a class of medications called tricyclic antidepressants. It works by affecting the balance of certain natural chemicals (neurotransmitters such as serotonin) in the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat nerve pain (such as peripheral neuropathy, postherpetic neuralgia), eating disorder (bulimia), other mental/mood problems (such as anxiety, panic disorder), or to prevent migraine headaches.

How to use amitriptyline

Read the Medication Guide provided by your pharmacist before you start taking amitriptyline and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually 1 to 4 times daily or as directed by your doctor. If you take it only once a day, take it at bedtime to help reduce daytime sleepiness. The dosage is based on your medical condition and response to treatment.

To reduce your risk of side effects (such as drowsiness, dry mouth, dizziness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, and sleep change. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms immediately.

This medication may not work right away. You may see some benefit within a week. However, it may take up to 4 weeks before you feel the full effect.

Tell your doctor if your condition persists or worsens (such as your feelings of sadness get worse, or you have thoughts of suicide).

AMITRIPTYLINE SIDE EFFECTS

Drowsiness, dizziness, dry mouth, blurred vision, constipation, weight gain, or trouble urinating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, persistent heartburn, shaking, mask-like facial expressions, muscle spasms, severe stomach/abdominal pain, decreased sexual ability/desire, enlarged/painful breasts.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, severe dizziness, fainting, seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness, severe confusion, sweating, fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

AMITRIPTYLINE PRECAUTIONS

Before taking amitriptyline, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (such as nortriptyline), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that may increase your risk of seizures (such as other brain disease, alcohol withdrawal).

Amitriptyline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using amitriptyline, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using amitriptyline safely.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be more sensitive to the side effects of this drug, especially dry mouth, dizziness, drowsiness, confusion, constipation, difficulty urinating, and QT prolongation (see above). Dizziness, drowsiness, and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Since untreated depression can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

AMITRIPTYLINE INTERACTIONS

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: arbutamine, disulfiram, levodopa, thyroid supplements, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin), anticholinergic drugs (such as benztropine, belladonna alkaloids), certain drugs for high blood pressure (drugs that work in the brain such as clonidine, guanabenz, reserpine).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of amitriptyline from your body, thereby affecting how amitriptyline works. These drugs include cimetidine, terbinafine, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide), antidepressants (such as SSRIs including paroxetine/fluoxetine/fluvoxamine). This is not a complete list.

Many drugs besides amitriptyline may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, cisapride, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using amitriptyline, report all medications you are currently using to your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain decongestants or ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Also report the use of drugs which might increase seizure risk when combined with amitriptyline including isoniazid (INH), phenothiazines (such as thioridazine), theophylline, or tricyclic antidepressants (such as nortriptyline), among others. Consult your doctor or pharmacist for details.

Amitriptyline is very similar to nortriptyline. Do not use medications containing nortriptyline while using amitriptyline.

AMITRIPTYLINE OVERDOSE

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as EKG, liver tests, amitriptyline blood level) may be performed from time to time to monitor your progress or check for side effects. Keep all medical appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.

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