Amitriptyline

(a mee trip' ti leen)

PCaution when used during lactation : Caution when used during pregnancy

LCaution when used during lactation : Caution when used during lactation

Molecule Info

| See TERMINOLOGY & ABBREVIATIONS |

Indication & Dosage

Oral Depression Adult:Initially, 50-75mg daily in divided doses or as a single dose at night. May increase dose gradually to 150mg daily, if needed. Up to 300mg daily may be used in severe cases. Child: Adolescents(>16yr): 30-75 mg daily or in divided doses, preferably at bedtime. Elderly: 30-75mg daily or in divided doses, preferably at bedtime. Oral Nocturnal enuresis Child: >11 yr: 25-50mg at bedtime; 6-10 yr: 10-20mg at bedtime. Treatment should not continue >3 mth. Oral Neuropathic pain Adult:Initially, 10-25mg daily at night, may increase to 75mg daily if needed. Higher doses require specialist attention. Oral Prophylaxis ofmigraine Adult:Initially, 10mg at night. Maintenance: 50-75mg at night.

Administration

May be taken with or without food.

Overdosage

Symptoms: Excitement and restlessness with marked antimuscarinic effects, including dryness of the mouth, hot dry skin, dilated pupils, tachycardia, urinary retention and intestinal stasis. Severe symptoms include unconsciousness, convulsions and myoclonus, hyperreflexia, hypothermia, hypotension, metabolic acidosis, and respiratory and cardiac depression, with life-threatening cardiac arrhythmias that may recur some days after apparent recovery.

Contraindications

Hypersensitivity, use of MAO inhibitors within the last 14 days; acute recovery phase post-MI. Concurrent usage with cisapride.

Special Precautions

Bipolar illness, pregnancy, lactation elderly, CVS disease, renal or liver impairment, epilepsy, thyroid dysfunction, DM. Avoid abrupt withdrawal; urinary retention, prostatic hyperplasia; chronic constipation; angle-closure glaucoma; phaeochromocytoma. Monitor for signs of clinical worsening, suicidality or behavioural changes. May increase risks associated with electro-convulsive therapy. May affect ability to drive or operate machinery.

Adverse Drug Reactions

Postural hypotension, tachycardia, conduction disturbances. Dry mouth, wt gain, sour or metallic taste, stomatitis, constipation; blurring of vision, urinary retention, fatigue, dizziness, weakness, tremors, headache, confusion and delirium in elderly, sexual disturbances; peripheral neuropathy; urticaria, angioedema, sweating. Potentially Fatal: Cardiac arrhythmias.

Drug Interactions

Reduced effect of antihypertensives. Potentiates hypertensive effects of sympathomimetics. Concurrent use with altretamine may cause orthostatic hypotension. May increase adverse CV effects when used with amphetamines. May increase serum levels of carbamazepine. Increased risk of cardiac arrhythmias when used with Beta(β)-agonists. Absorption may be reduced when used with cholestyramine, colestipol or sucralfate. Additive sedative effects when used with CNS depressants. Concurrent use with CYP2D6 inhibtors (e.g. chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine) may increase serum levels of amitriptyline. May increase antidiabetic effect of tolazamide, chlorpropamide or insulin. May reduce absorption of levodopa. Increased risk of neurotoxicity when used with lithium. Increased risk of seizures when used with tramadol. May increase anticoagulant effect of warfarin. May cause QT prolongation and fatal arrhythmias when used with drugs that prolong QT interval.
Potentially Fatal: Increased risk of QT prolongation and arrhythmias when used with cisapride. Serious adverse effects e.g. hyperpyrexia, hypertension, tachycardia, confusion, seizures and deaths may occur when used with MAO inhibitors.

Food Interaction

Alcohol may enhance adverse effects.

Pregnancy Category

Category C: Either studies in animals have revealed adverse effects on the foetus  (teratogenic or embryocidal or other)  and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Storage

Oral: Store at 20-25°C.

Pharmacology

Amitriptyline is a TCA that exerts its action by blocking neuronal re-uptake of noradrenaline and serotonin thus increasing synaptic concentration of serotonin and/or norepinephrine in the CNS. Absorption: Readily absorbed from the GI tract . Distribution: Widely distributed; crosses the placenta; enters breast milk. Protein-binding: Extensive. Metabolism: Extensively 1st-pass effect; demethylated hepatically to nortriptyline . Excretion: Urine; 9-25 hr .

mph Class

Antidiuretics/Antidepressants

ATC Classification

N06AA09 - amitriptyline; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.

 

Brand/Product Info


Total Products : 6      
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AMILIN Opsonin Pharma Limited Amitriptyline hydrochloride 10mg & 25mg Tablet 100's each: 50.00 & 80.00 MRP
AMIT General Pharmaceuticals Ltd Amitriptyline hydrochloride 10mg & 25mg Tablet 100's each: 56.00 & 100.00 MRP
AMITRIPTYLINE GlaxoSmithKline Bangladesh Limited Amitriptyline hydrochloride 25mg Tablet 500's: 400.99 MRP
TRIP 10 Medicon Laboratories Ltd Amitriptyline 10mg Tablet 100's: 50.00 MRP
TRYPTIN 10 Square Pharmaceuticals Ltd. Amitriptyline 10mg Tablet 20x10's: 170.00 MRP
TRYPTIN 25 Square Pharmaceuticals Ltd. Amitriptyline 25mg Tablet 20x10's: 352.00 MRP

Gen. MedInfo

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as amitriptyline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take amitriptyline, but in some cases, a doctor may decide that amitriptyline is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take amitriptyline or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking amitriptyline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amitriptyline. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

 

Why is this medication prescribed?

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.

How should this medicine be used?

Amitriptyline may come as a tablet to take by mouth. It is usually taken one to four times a day. Take amitriptyline at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor 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.

Other uses for this medicine

Amitriptyline is also used to treat eating disorders, post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection), and to prevent migraine headaches. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions should I follow?

Before taking amitriptyline,

  • tell your doctor if you are allergic to amitriptyline or any other medications.
  • tell your doctor if you are taking cisapride   or monoamine oxidase  inhibitors such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, or if you have taken an MAO inhibitor during the past 14 days. Your doctor will probably tell you that you should not take amitriptyline.
  • tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antihistamines; cimetidine; diet pills; disulfiram; guanethidine; ipratropium; quinidine; medications for irregular heartbeats such as flecainide  and propafenone; medications for anxiety, asthma, colds, irritable bowel disease, mental illness, nausea, Parkinson's disease, seizures, ulcers, or urinary problems; other antidepressants; phenobarbital; sedatives; selective serotonin reuptake inhibitors  such as citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline; sleeping pills; thyroid medications; and tranquilizers. Tell your doctor if you have stopped taking fluoxetine in the past 5 weeks. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have recently had a heart attack. Your doctor will probably tell you not to take amitriptyline.
  • tell your doctor if you drink large amounts of alcohol and if you have or have ever had glaucoma; an enlarged prostate; difficulty urinating; seizures; an overactive thyroid gland; diabetes; schizophrenia; or liver, kidney, or heart disease.
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking amitriptyline, consult your doctor. Do not breast-feed while you are taking amitriptyline.
  • talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take amitriptyline because it is not as safe or effective as other medication that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking amitriptyline.
  • you should know that amitriptyline may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Amitriptyline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • drowsiness
  • weakness or tiredness
  • nightmares
  • headaches
  • dry mouth
  • constipation
  • difficulty urinating
  • blurred vision
  • pain, burning, or tingling in the hands or feet
  • changes in sex drive or ability
  • excessive sweating
  • changes in appetite or weight
  • confusion
  • unsteadiness

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, consult your doctor immediately:

  • slow or difficult speech
  • dizziness or faintness
  • weakness or numbness of an arm or a leg
  • crushing chest pain
  • rapid, pounding, or irregular heartbeat
  • severe skin rash or hives
  • swelling of the face and tongue
  • yellowing of the skin or eyes
  • jaw, neck, and back muscle spasms
  • uncontrollable shaking of a part of the body
  • fainting
  • unusual bleeding or bruising
  • seizures
  • hallucinating (seeing things or hearing voices that do not exist)

Amitriptyline may cause other side effects. Consult your doctor if you have any unusual problems while taking this medication.

In case of emergency/overdose

In case of overdose, consult your Health care provider (HCP). If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include:

  • irregular heartbeat
  • seizures
  • coma
  • confusion
  • problems concentrating
  • hallucinating
  • agitation
  • drowsiness
  • rigid muscles
  • vomiting
  • fever
  • cold body temperature

This medication may cause other side effects.  Consult your doctor if you have any unusual problems while taking this.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

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.

 


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.