Patient Medication Information: uses, side effects, how to take - Amitriptyline Hydrochloride Tablets USP
Serious Warnings and Precautions
To help avoid side effects and ensure proper use, before you take Amitriptyline Hydrochloride Tablets USP, talk to your healthcare professional if you have:
- a history of heart problems such as changes in heart rhythm, a slow heartbeat (bradycardia), heart disease or are taking medicines that effect your heart rhythm. A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG) and problems with the heart rhythm (rapid or irregular heartbeat) have been reported in people taking amitriptyline hydrochloride. This can be serious and cause sudden death. If you experience dizziness, fainting, a rapid heart beat or heart palpitations while taking Amitriptyline Hydrochloride Tablets USP get immediate medical help.
- a history of trouble emptying your bladder (urinary retention) or increased pressure in the eye (glaucoma) as Amitriptyline Hydrochloride Tablets USP can make these conditions worse.
- thyroid problems or are taking thyroid medication. Heart rhythm problems may develop when Amitriptyline Hydrochloride Tablets USP is taken with thyroid medicines.
- a history of seizures or fits. Amitriptyline Hydrochloride Tablets USP can make you more likely to have seizures or fits.
New or worsened emotional or behavioural problems:
- Get immediate medical help if you have any thoughts of suicide or harming yourself while you are taking Amitriptyline Hydrochloride Tablets USP. Close observation by a healthcare professional is necessary in this situation.
When you first start taking Amitriptyline Hydrochloride Tablets USP or when your dose is adjusted, you may
feel worse instead of better. This can include new or worsened feelings of agitation, hostility, anxiety, or impulsivity. Do not stop taking your medicine as it takes time for Amitriptyline Hydrochloride Tablets USP to work.
- It is important that you and your healthcare professional talk regularly during your treatment about how you are feeling. If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away.
You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:
- think your depression is getting worse, or
- are worried about changes in your behaviour
What is Amitriptyline Hydrochloride Tablets USP used for?
Amitriptyline Hydrochloride Tablets USP is used in adults to treat depression.
How does Amitriptyline Hydrochloride Tablets USP work?
Amitriptyline Hydrochloride Tablets USP is an antidepressant that belongs to a group of medicines known as tricyclic antidepressants. It is not known exactly how amitriptyline hydrochloride works. It is thought to increase the concentration of certain chemicals in the brain which can help with the symptoms of depression.
What are the ingredients in Amitriptyline Hydrochloride Tablets USP?
Medicinal ingredients: amitriptyline hydrochloride
Non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, purified talc and titanium dioxide.
In addition to the above ingredients, the tablets also contain the following non-medicinal ingredients:
10 mg tablets: triacetin and the dye FD&C Blue A1. Lake
25 mg tablets: polyethylene glycol and the dye D&C Yellow No. 10 Lake
50 mg tablets: triacetin and the dyes FD&C Yellow No.6 A1 Lake and FD&C Blue No.2 A1 Lake
75 mg tablets: polyethylene glycol and the dye Lake Sunset Yellow
Amitriptyline Hydrochloride Tablets USP comes in the following dosage forms:
Tablets: 10 mg, 25 mg, 50 mg and 75 mg
Do not use Amitriptyline Hydrochloride Tablets USP if you:
- are allergic to amitriptyline or any of the other ingredients of this medicine.
- have recently experienced a heart attack or heart failure.
- have a severe liver disease.
- are taking a medicine known as monoamine oxidase inhibitors (MAOIs), also used to treat depression.
- have taken a MAOI within the last 14 days.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Amitriptyline Hydrochloride Tablets USP. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have an enlarged prostate.
- have bipolar disorder.
- have schizophrenia.
- have a blood disease with abnormal particles in the blood called “blood dyscrasia”.
- have problems with your electrolytes including low levels of calcium, potassium or magnesium in your blood.
- are dehydrated or suffer from excessive sweating, vomiting or diarrhea, or an eating disorder.
- are undergoing electroconvulsive therapy (ECT) to treat mental health problems.
are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed. You and your healthcare professional should decide if you should breastfeed or take Amitriptyline Hydrochloride Tablets USP. You should not do both.
- are 65 years of age or older.
Other warnings you should know about:
Withdrawal symptoms: Do NOT stop taking Amitriptyline Hydrochloride Tablets USP without talking to your healthcare professional. You may need to lower your dose gradually and careful monitoring by your healthcare professional is required. Stopping Amitriptyline Hydrochloride Tablets USP suddenly may cause withdrawal symptoms including restlessness, nausea, headache, malaise (general discomfort), sleep disturbance, irritability and changes in behavior.
Amitriptyline Hydrochloride Tablets USP can cause serious side effects, including:
Angle-closure glaucoma: Amitriptyline Hydrochloride Tablets USP can cause angle-closure glaucoma (sudden eye pain). Having your eyes examined before you take Amitriptyline Hydrochloride Tablets USP could help identify if you are at risk of having angle-closure glaucoma. Talk to your healthcare professional right away if you have:
- eye pain;
- changes in vision;
- swelling or redness in or around the eye.
Serotonin toxicity (also known as Serotonin syndrome) or Neuroleptic malignant syndrome: Amitriptyline Hydrochloride Tablets USP can cause serotonin toxicity or neuroleptic malignant syndrome, rare but potentially life-threatening conditions. They can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity or neuroleptic malignant syndrome if you take Amitriptyline Hydrochloride Tablets USP with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.
Symptoms of serotonin toxicity or neuroleptic malignant syndrome include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, changes in reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Driving and Using Machines: Amitriptyline Hydrochloride Tablets USP can affect your ability to drive and operate machinery. Do not drive or operate machinery until you know how Amitriptyline Hydrochloride Tablets USP affects you.
Blood tests and monitoring: Amitriptyline Hydrochloride Tablets USP can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results. Your healthcare professional will also monitor your blood pressure and the health of your heart while you are taking Amitriptyline Hydrochloride Tablets USP.
Surgery: If you have a planned surgery, talk to your healthcare professional as soon as possible. They may ask you to stop taking Amitriptyline Hydrochloride Tablets USP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Amitriptyline Hydrochloride Tablets USP:
- medicines such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine which may be found in cough and cold medication and anesthetics used in surgery.
- other medicines used to treat depression such as other tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and paroxetine.
- triptans, used to treat migraine.
- anticholinergenic drugs such as certain medicines used to treat glaucoma, Parkinson’s disease and stomach and gut problems, like atropine and hyoscyamine.
cimetidine, used to treat stomach ulcers.
Serious Drug Interactions
- Do not take Amitriptyline Hydrochloride Tablets USP if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last 14 days as this can cause serious side effects.
- Taking Amitriptyline Hydrochloride Tablets USP and thyroid medication can cause heart rhythm problems.
- sedatives used to treat anxiety and sleep disorders.
- disulfiram, used to treat alcoholism.
- medicines used to treat schizophrenia and other mental health problems, such as pimozide, sertindole and haloperidol.
- high blood pressure medications such as clonidine and methyldopa.
- medicines used to treat irregular heartbeat such as quinidine, propafenone, flecainide, disopyramide, amiodarone, procainamide and sotalol.
- astemizole and terfenadine, used to treat allergies and hayfever.
- cisapride, used to treat certain types of indigestion.
- methadone, used to treat pain and for detoxification.
- diuretics or “water pills” such as furosemide.
- medicines used to treat bacterial infections such as erythromycin, clarithromycin, tacrolimus and ciprofloxacin.
- medicines used to treat malaria such as quinine, halofantrine and chloroquine .
- medicines used to treat fungal infections such as ketoconazole.
- domperidone used to treat nausea and vomiting and increase milk supply in breastfeeding mothers.
- medicines used to treat nausea and vomiting in cancer patients such as ondansetron.
- medicines used to treat cancer such as sunitinib and vorinostat.
- medicines used to treat breathing problems like asthma and COPD such as salmeterol .
You should avoid drinking alcohol while taking Amitriptyline Hydrochloride Tablets USP.
How to take Amitriptyline Hydrochloride Tablets USP:
- Always take Amitriptyline Hydrochloride Tablets USP exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Amitriptyline Hydrochloride Tablets USP can be taken with or without food.
- Swallow the tablets whole with water. Do not chew them.
Even if you feel better, do not stop taking Amitriptyline Hydrochloride Tablets USP without first talking to your healthcare professional. Stopping Amitriptyline Hydrochloride Tablets USP suddenly can cause serious withdrawal symptoms.
Usual dose:
Adults: The recommended initial dose is 25 mg three times a day.
Depending on your response to Amitriptyline Hydrochloride Tablets USP, your healthcare professional may gradually increase your dose to 150 mg per day divided in two doses.
The usual maintenance dose is 50 to 100 mg per day.
Overdose:
Signs of an overdose may include:
- temporary confusion
- drowsiness
- low body temperature (hypothermia)
- heart rhythm problems such as an irregular heartbeat
- heart failure
- abnormal eye movement
- convulsions
- severe low blood pressure
- constipation
- coma
Missed Dose:
If you forget to take Amitriptyline Hydrochloride Tablets USP, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do NOT take two doses at the same time to make up for a missed dose.
What are possible side effects from using Amitriptyline Hydrochloride Tablets USP?
These are not all the possible side effects you may have when taking Amitriptyline Hydrochloride Tablets USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting
- stomach pain
- constipation
- diarrhea
- drowsiness
- dizziness
- fatigue
- restlessness
- headache
- dry mouth, sore mouth
- unpleasant taste in the mouth
- black tongue
- itching
- changes in weight (loss or gain)
If you think you, or a person you are caring for, have taken too much Amitriptyline Hydrochloride Tablets USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- weakness
- increased sweating
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Mania: elevated or irritated mood, decreased need for sleep, racing thoughts, uneasiness | √ | ||
| VERY RARE | |||
Serotonin Toxicity or Neuroleptic Malignant Syndrome: Reactions which may cause feelings of agitation or restlessness, muscle twitching, involuntary eye movements, flushing, heavy sweating, high body temperature (>38°C), or rigid muscles. | √ | ||
| UNKNOWN FREQUENCY | |||
Allergic reaction: rash, hives, swelling of the face, lips and tongue or throat, difficulty swallowing or breathing. | √ | ||
Bone marrow depression: easy bruising, bleeding, nose bleeds, bleeding gums, red spots on the skin, fever and chills, rash, extreme fatigue, pale skin and lips | √ | ||
| Difficulty passing urine | √ | ||
Electrical problems with the heart (QT interval prolongation): dizziness, fainting, fast heartbeat, palpitations, abnormal heart rate | √ | ||
Gastrointestinal disorders: Heart burn, diarrhoea, black tongue, constipation, dry mouth, unpleasant taste, swollen salivary gland, bowel obstruction, change in weight (loss or gain) | √ | ||
Glaucoma: increased pressure in the eye, pupil dilation, blurred vision, eye pain | √ | ||
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
Heart attack: chest pain, tightness or pressure that may spread to your neck, jaw or back, nausea, indigestion, shortness of breath, cold sweat, fatigue, dizziness | √ | ||
Heart problems (enlarged heart, heart disease): weakness, fatigue, shortness of breath especially during exercise, light- headedness, chest pain, palpitations, fainting, swelling in your feet, ankles and legs | √ | ||
High blood pressure: headache, fatigue, vision problems | √ | ||
Increased or decreased blood sugar: frequent urination, thirst, hunger, shakiness, sweating and chills, irritability, confusion, dizziness | √ | ||
Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | ||
Mental health problems: confusion, hallucinations, trouble sleeping, excitement, nightmares, problems with attention, anxiety | √ | ||
Nervous system problems: shaking, numbness and tingling of the hands and feet, clumsiness and lack of coordination, loss of balance, uncontrolled twitching or jerking, slurred speech, ringing in the ears, coma | √ | ||
New or worsened emotional or behavioural problems: feeling angry, aggressive, worried, agitated, hostile or impulsive, feeling violent, feeling like you are not yourself or that you are less inhibited | √ | ||
Photosensitivity: Increased sensitivity of the skin to sun | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Reproductive problems: swelling of testicles, impotence in men, increase in breast tissue (in men and women), change in sex drive | √ | ||
Stroke: sudden numbness or weakness in the face, arm or leg, confusion, trouble speaking, blurred vision, trouble walking, dizziness, loss of balance | √ | ||
Seizures or fits: uncontrollable shaking with or without loss of consciousness | √ | ||
Thoughts of death or suicide: thoughts about hurting or killing yourself or other people | √ | ||
| Unusual hair loss or thinning | √ | ||
Withdrawal symptoms: nausea, headache, irritability, restlessness, dream and sleep disturbance, generally feeling unwell, irritability, behavioural changes | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health- products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15°C to 30°C). Keep in a tightly closed container. Keep out of reach and sight of children.
If you want more information about Amitriptyline Hydrochloride Tablets USP:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); Find the Patient Medication Information on the
manufacturer’s website (https://strides.com/), or by calling 1-888-318-0234.