Patient Medication Information: uses, side effects, how to take - Trandate
Serious warnings and precautions box
Liver disorders: TRANDATE may cause severe liver problems. This rare and serious side effect has occurred in patients taking TRANDATE for both short and long periods. It also developed progressively, and with very little symptoms. It is usually reversible, but there has been rare cases of hepatic necrosis (cell death in the liver), and even death.
What TRANDATE is used for:
TRANDATE is used in adults (18 years of age or older) to treat high blood pressure (also known as hypertension). It can be used alone or with other medicines to treat this condition.
How TRANDATE works:
TRANDATE belongs to a group of medicines called “beta-blockers”. It lowers blood pressure by:
- making your heart beat more slowly and less forcefully;
- relaxing your blood vessels so that your blood flows more easily.
This medicine does not cure your disease but helps to control it.
The ingredients in TRANDATE are:
Medicinal ingredient: labetalol hydrochloride
Non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake (100 mg tablets only), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol 8000, purified water, Sunset Yellow Aluminum Lake (100 mg tablets only), and titanium dioxide
TRANDATE comes in the following dosage form:
Tablets: 100 mg and 200 mg.
Do not use TRANDATE if you:
- are allergic to labetalol hydrochloride or any of the other ingredients in TRANDATE.
- have heart failure and your symptoms are getting worse (e.g., you feel more tired, are out of breath more often, or have swelling of the ankles).
- have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs.
- have a slow or irregular heartbeat.
- have a problem with your heart’s electrical conduction called atrioventricular block (also known as “AV block”).
- have asthma or a history of lung problems (e.g., bronchitis or emphysema).
- have serious problems with blood flow in your feet and legs.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRANDATE. Talk about any health conditions or problems you may have, including if you:
- have heart failure. Your healthcare professional will ensure your condition is under control before taking TRANDATE.
- have chest pain (angina pectoris).
- are taking any other medicines.
- have or are at risk for diabetes. TRANDATE may make you more prone to low blood sugar, especially if you also take insulin or oral diabetes medications.
- have a condition called pheochromocytoma (a tumour of the adrenal gland).
- have thyroid problems.
- have liver problems.
- have a history of severe allergic reactions.
are pregnant, think you might be pregnant or are planning on becoming pregnant. TRANDATE is not usually recommended for use during pregnancy. Your healthcare professional will consider the benefit of you being treated with TRANDATE against the risk to your unborn baby.
- are breastfeeding or planning to breastfeed. You should not breastfeed while taking TRANDATE.
- are going to have an operation or surgery. Let the medical staff of the operation or surgery know, in particular the anesthetist, that you are taking TRANDATE.
- are 65 years of age or older.
Other warnings you should know about:
TRANDATE can cause serious side effects, including:
- Heart failure: Patients taking TRANDATE can develop heart failure. Your healthcare professional will check you for signs and symptoms of heart failure during your treatment with TRANDATE.
Bradycardia (abnormally slow heartbeat): Your heart rate may lower while you are taking TRANDATE. If it gets too low, your dose may be reduced or your healthcare
- professional may tell you how to safely stop your treatment with TRANDATE.
Allergic reactions: While you are taking TRANDATE:
- a severe allergic reaction may be harder to treat.
- you may be more likely to have a severe allergic reaction if you have a history of them.
See the Serious side effects and what to do about them table for more information on these and other serious side effects.
Check-ups and testing: Based on your health history, your healthcare professional may perform blood tests regularly during your treatment with TRANDATE. This is to monitor:
- your blood sugar levels;
- the health of your heart, liver, and thyroid.
It is also recommended that you get regular eye exams while taking TRANDATE to monitor the health of your eyes.
Taking TRANDATE may also affect the results of urine tests. If you need to have a urine test, tell your healthcare professional that you are taking TRANDATE.
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 TRANDATE:
- medicines used to treat high blood pressure, chest pain and heart rhythm problems (e.g., verapamil, diltiazem, diuretics (also known as “water pills”), nitroglycerin).
- insulin, or medications taken by mouth to treat high levels of sugar in the blood (diabetes).
- epinephrine, used to treat severe allergic reactions.
- anesthetics, medicines used during surgery (e.g., halothane).
- medicines used to reduce the amount of acid in the stomach (e.g., cimetidine).
- medicines used to treat depression (e.g., tricyclic antidepressants).
- medicines used to treat multiple sclerosis (e.g., fingolimod).
How to take TRANDATE:
- Take TRANDATE exactly as your healthcare professional has told you to.
- TRANDATE should be taken preferably after food.
- It is important to continue taking TRANDATE regularly even if you feel fine.
- Your healthcare professional may add another medicine like a diuretic (“water pill”) for you to take along with TRANDATE to treat your high blood pressure.
- Do not stop taking TRANDATE or change your dose without consulting your healthcare professional. This can be dangerous. If you suddenly stop taking TRANDATE, this could cause chest pains or a heart attack. If your healthcare professional decides that you should stop taking TRANDATE, your dose will be reduced slowly over a period of 2 weeks before you stop taking the medicine completely. Your healthcare professional will closely monitor your health during this time.
Usual dose:
Your healthcare professional will decide how much TRANDATE you should take each day depending on your condition.
They may also change your dose depending on how you respond to the treatment.
Usual starting dose: 100 mg twice a day.
Usual maintenance dose: 200 mg to 400 mg twice a day.
Maximum dose: 1200 mg per day (600 mg twice a day).
Overdose:
Symptoms of overdose with TRANDATE may include:
- very low blood pressure (may occur when you go from lying or sitting to standing up);
- an abnormally slow or irregular heart beat;
- heart failure (your heart doesn’t pump enough blood for your body’s needs);
- difficulty breathing, tightness in your chest;
- low blood sugar.
If you think you, or a person you are caring for, have taken too much TRANDATE, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
Possible side effects from using TRANDATE:
These are not all the possible side effects you may have when taking TRANDATE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with TRANDATE may include:
- dizziness
- headache
- nausea or vomiting
- lack of energy
- general feeling of discomfort
- aches and pains
- muscle cramps
- shaking (tremor)
- blurred vision
- nosebleeds
- indigestion
- change in taste
- constipation
- dry mouth
- sore throat
- stuffy nose
- “pins and needles” sensation on the skin
- itchy skin
- inability to keep or maintain an erection
- loss of sex drive
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | ||||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Only if severe | In all cases | |||||
| Only if severe | In all cases | |||||
| Common | ||||||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up). | ✓ | |||||
| Chest pain | ✓ | |||||
| Raynaud’s phenomenon (episodes of reduced blood flow): cold feeling in fingers and toes (and sometimes nose, lips and ears), prickly or stinging feeling, change in skin colour to white then blue. | ✓ | |||||
| Depression (sad mood that won’t go away): difficulty sleeping, sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive), or thoughts of death or suicide. | ✓ | |||||
| Rare | ||||||
| Bradycardia (abnormally slow heartbeat): decreased heart rate that causes you to be dizzy or faint. | ✓ | |||||
| Allergic reactions: rash, hives swelling of the lips, face, tongue, throat or neck, difficulty breathing, swallowing or speaking, wheezing, drop in blood | ✓ | |||||
| pressure, feeling sick to your stomack, or vomiting | ||||||
| Congestive heart failure (heat does not pump blood as well as it should): shortness of breath, fatigue, weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, or reduced ability to exercise. | ✓ | |||||
| Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing with wheezing or coughing. | ✓ | |||||
| Liver disorders: yellowing of the skin or eyes (jaundice), right upper stomach area pain, swelling, unusual dark urine, nausea, vomiting, or unusual tiredness. | ✓ | |||||
| Unknown | ||||||
| Lupus-like syndrome: joint pain, muscle pain, fatigue, fever, chest pain when you cough or breath. | ✓ | |||||
| Hypoglycemia (low blood sugar): thirst, frequent urination, hunger, nausea and dizziness, fast heartbeat, tingling trembling, nervousness, sweating, low energy. | ✓ | |||||
| Peyronie's disease (a condition where scar tissue forms under the skin of the penis): penile pain, shortening of the penis, erection problems, or significant bend to the penis. | ✓ | |||||
| Toxic myopathy (muscle damage caused by medications): muscle weakness (especially of your upper arms, shoulders and thighs), muscle cramps, stiffness and spasms, fatigue with exercise, lack of energy. | ✓ | |||||
| Skin reactions: rash, itchiness, flushing, red patches of skin covered with thick, silvery scales, dry cracked skin that may | ✓ | |||||
| bleed, burning, or soreness. | ||||||
| Angioedema (swelling of tissue under the skin): difficulty breathing, swollen face, hands and feet, genitals tongue, throat, swelling of the digestive tract causing diarrhea, nausea or vomiting. | ✓ | |||||
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store between 15°C and 30°C. Keep out of reach and sight of children.
If you want more information about TRANDATE:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com; or by calling 1-844-483-5636.