Amitriptyline (Oral route)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of 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 .
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
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.
|All Trimesters||C||Animal 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.|
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.
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.
- Methylene Blue
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.
- Amtolmetin Guacil
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Choline Salicylate
- Doxorubicin Hydrochloride Liposome
- Eslicarbazepine Acetate
- Flufenamic Acid
- Inotuzumab Ozogamicin
- Iobenguane I 123
- Mefenamic Acid
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Peginterferon Alfa-2b
- Salicylic Acid
- Secretin Human
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
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.
- St John's Wort
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.
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.
Other 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:
- Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
- Heart attack, recent—Should not be used in patients with these conditions.
- Diabetes or
- Glaucoma or
- Heart disease or
- Overactive thyroid or
- Schizophrenia or
- Seizures, history of or
- Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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.
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.
- For depression:
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.
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.
Precautions While Using This Medicine:
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 .
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blood in urine or stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in consciousness
- changes in patterns and rhythms of speech
- chest pain or discomfort
- cold sweats
- confusion about identity, place, and time
- continuing ringing, buzzing, or other unexplained noise in ears
- cool, pale skin
- cough or hoarseness
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- decreased urine output
- difficulty in breathing
- difficulty in passing urine (dribbling)
- difficulty in speaking
- disturbance of accommodation
- disturbed concentration
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- double vision
- dry mouth
- false beliefs that cannot be changed by facts
- fast, slow, or irregular heartbeat
- fear or nervousness
- fever with or without chills
- flushed, dry skin
- fruit-like breath odor
- general feeling of tiredness or weakness
- hearing loss
- high fever
- high or low blood pressure
- inability to move arms, legs, or facial muscles
- inability to speak
- increased hunger
- increased need to urinate
- increased ocular pressure
- increased sweating
- increased thirst
- increased urination
- lack of coordination
- light-colored stools
- lip smacking or puckering
- loss of appetite
- loss of balance control
- loss of bladder control
- loss of consciousness
- lower back or side pain
- mental depression or anxiety
- muscle spasm or jerking of all extremities
- muscle tightness
- muscle trembling, jerking, or stiffness
- muscle twitching
- nausea and vomiting
- nightmares or unusually vivid dreams
- overactive reflexes
- painful or difficult urination
- passing urine more often
- pinpoint red spots on skin
- poor coordination
- pounding in the ears
- puffing of cheeks
- rapid or worm-like movements of tongue
- rapid weight gain
- seeing, hearing, or feeling things that are not there
- severe muscle stiffness
- shakiness and unsteady walk
- shortness of breath
- shuffling walk
- slow speech
- slurred speech
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- stiffness of limbs
- sudden loss of consciousness
- swelling of face, ankles, or hands
- swelling or puffiness of face
- swollen glands
- talking or acting with excitement you cannot control
- trouble in speaking
- trouble sleeping
- troubled breathing
- twisting movements of body pain or discomfort in arms, jaw, back, or neck
- unable to sleep
- uncontrolled chewing movements
- uncontrolled movements, especially of arms, face, neck, back, and legs
- unexplained weight loss
- unpleasant breath odor
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusually pale skin
- upper right abdominal pain
- vomiting of blood
- weakness in arms, hands, legs, or feet
- weight gain or loss
- yellow eyes and skin
- Symptoms of Overdose
- low body temperature
- muscle aches
- muscle weakness
- weak or feeble pulse
- Incidence not known
- Bigger, dilated, or enlarged pupils (black part of eye)
- black tongue
- breast enlargement in females
- decreased interest in sexual intercourse
- hair loss, thinning of hair
- hives or welts
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of eyes to light
- loss in sexual ability, desire, drive, or performance
- loss of sense of taste
- redness or other discoloration of skin
- severe sunburn
- skin rash
- swelling of testicles
- swelling of the breasts or breast soreness in males
- swelling of the parotid glands
- swelling or inflammation of the mouth
- unexpected or excess milk flow from breasts
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017