Patient Medication Information: uses, side effects, how to take - Tirocap
What is TIROCAP™ used for?
TIROCAP™ is used in adults and children 6 years of and older:
- to treat hypothyroidism. This condition happens when the thyroid gland does not produce enough of the hormone, thyroxine.
- in combination with surgery and radioactive iodine therapy to treat certain types of thyroid cancer.
How does TIROCAP™ work?
TIROCAP™ contains levothyroxine sodium, which is the man-made form of thyroxine.
Thyroxine is a hormone that is produced by a normally functioning thyroid gland. In hypothyroidism, the thyroid gland does not produce enough thyroxine. This causes levels of thyroid hormones in the blood to drop. TIROCAP™ helps to replace or supplement thyroxine in the body.
What are the ingredients in TIROCAP™?
Medicinal ingredients: levothyroxine sodium
Non-medicinal ingredients: gelatin, glycerin and water.
TIROCAP™ comes in the following dosage forms:
Capsules: 13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg and 200 mcg
Do not use TIROCAP™ if:
- you are allergic to thyroid hormones or to any of the other ingredients in TIROCAP™.
- you have thyrotoxicosis. This also known as an overactive thyroid gland.
- you have uncorrected or untreated adrenal insufficiency. This is a condition where your adrenal glands do not make enough of the hormone cortisol.
- you are pregnant and also using medicines to treat an overactive thyroid.
- you have recently had a heart attack.
Serious Warnings and Precautions
Thyroid hormones, including TIROCAP™, either alone or with other medicines, should not be used to treat obesity or for weight loss. These medications can cause serious and life-threatening side effects.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TIROCAP™. Talk about any health conditions or problems you may have, including if you:
- are pregnant or plan to become pregnant. This is because your dose of TIROCAP™ will likely need to be increased;
- have any heart problems, whether or not you have received treatment for them. This includes a history of angina, heart attack, heart disease or hardening of the arteries;
have other medical problems, whether or not you have received treatment for them including:
- high blood pressure,
- osteoporosis,
- blood clotting disorders,
- a history of thyroid, adrenal and/or pituitary gland problems;
- have signs or symptoms of psychotic disorders;
- are switching from a different brand of levothyroxine;
- are a woman on long-term TIROCAP™ treatment. This is because you may experience bone loss. This is also known as lowered bone mineral density.
- develop myxedema coma. This is a type of severe hyperthyroidism and is a medical emergency.
- are taking a blood thinner such as warfarin. Your dose may need to be changed after starting TIROCAP™,
- are taking orlistat.
Other warnings you should know about:
Diabetes or adrenal cortical insufficiency: If you are receiving treatment for these conditions, the doses of those treatments may need to be changed after starting TIROCAP™. Monitor sugar levels in your blood and urine as directed by your doctor. Report any changes to your doctor right away.
Surgery: Tell your healthcare professional about any surgery (including dental surgery) you are planning. Before the surgery, tell your dentist or surgeon that you are taking TIROCAP™.
Breast-feeding: Small amounts of thyroid hormones will pass into your breast milk. Regardless, you can continue to take TIROCAP™ while you are breast-feeding. In fact, you should not stop your treatment, as normal levels of thyroid hormones will help maintain milk production.
Blood tests: You will need to have regular blood tests while you are receiving TIROCAP™. These will be done to make sure that you are receiving the correct dose. As well, the results of these tests will help your doctor to know how your treatment is affecting your blood.
If you are pregnant you will have blood tests done about every 4 weeks for the first half of your pregnancy. These tests will then be done at least once per week between weeks 26 and 32 of your pregnancy. Based on the results of these blood tests, your dose of TIROCAP™ may be changed.
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 TIROCAP™:
- Nutritional supplements such as calcium carbonate, ferrous sulfate and Vitamin B3 (niacin / nicotinic acid)
Medicines used to treat digestion problems such as:
- antacids that contain aluminium and magnesium (e.g., aluminium hydroxide and magnesium hydroxide, simethicone)
- proton pump inhibitors
- metoclopramide
- sucralfate
Medicines used to treat heart problems including high blood pressure such as:
- digitalis glycosides (e.g., digoxin)
- beta blockers (e.g., propranolol, atenolol, metoprolol)
- blood thinners such as heparin and warfarin
- amiodarone
- diuretics like furosemide
- nitroprusside
- Medicines used to lower high cholesterol such as colestipol, lovastatin and cholestyramine
- Medicines to lower levels of phosphorus in the blood such as sevelamer, lanthanum carbonate and sodium polystyrene sulfonate
Medicines to treat inflammatory conditions such as:
- Glucocorticoids (including dexamethasone, hydrocortisone and prednisone)
- non-steroidal anti-inflammatory drugs like fenamates and phenylbutazone and salicylates
- Medicines used to treat mental health problems and seizures such as amitriptyline maprotiline, sertraline, lithium, diazepam, phenytoin, phenobarbital, carbamazepine, chloral hydrate, perphenazine, methadone, heroin, aminoglutethemide and hydantoins.
- Medicines to treat diabetes including insulin, tolbutamide and other medicines taken by mouth that help to lower sugar levels in the blood
- Medicines to treat some cancers including imatinib, sunitinib, 5-fluorouracil, octreotide, mitotane, asparaginase, tamoxifen, interferon alpha, interleukin-2 and mercaptopurine
- Medicines used for weight loss such as diet pills and orlistat
- Medicines to treat thyrotoxicosis and hyperthyroidism including thioamides
- Iodide, which is used for imaging like x-rays and CT scans
- A medicine to treat Parkinson’s disease and restless leg syndrome called dopamine
Medicines to treat bacterial, viral or fungal infections such as:
- medicines to treat HIV and AIDS including ritonavir, lopinavir, indinavir
- medicines to treat tuberculosis including para-aminosalicylate and ethionamide
- sulfonamides
- rifampin
- resorcinol
- Medicines for asthma or other breathing problems such as theophyline
- Medicines for colds, sinus problems, hay fever or other allergies (including nose drops or sprays)
Hormones such as:
- Estrogens that are taken by mouth including birth control pills
- Growth hormones such as somatotropin
- Muscle building hormones including anabolic steroids
Other medicines used to treat thyroid problems such as:
- methimazole or carbimazole
- propylthiouracil (PTU)
- A medicine used to treat bone loss called Raloxifene
Some medicines may interfere with blood tests done to measure levels of thyroid hormone in your blood. Be sure to tell your healthcare professional of all medicines you are taking before and at the time of any blood tests.
Eating certain foods including soybean flour, cotton seed meal, walnuts, calcium and calcium-fortified orange juice and dietary fiber may lower your ability to absorb TIROCAP™. You may require a change to your dose.
How to take TIROCAP™:
- Exactly as your healthcare professional tells you.
Once per day on an empty stomach. Take your dose 30 minutes to 1 hour before breakfast.
- Swallow capsules whole. Do NOT cut, crush or chew them.
- If your child cannot swallow the capsules whole, tell your healthcare professional. They may suggest a different medication.
- If you are using other medicines, take your TIROCAP™ 4 hours before or 4 hours after these other medicines.
Usual dose:
The usual dose of TIROCAP™ will be different for everyone. Your healthcare professional will decide on the dose that is right for you. Your dose will depend on:
- the type of thyroid condition you have,
- your age,
- your weight,
- other conditions or illnesses you have, including any heart problems;
- how long you had symptoms of thyroid problems, and
- how severe your symptoms are.
A child’s dose will change as they grow and get older.
Do not change the amount of TIROCAP™ you take or how often you take it, unless your healthcare professional tells you to. You are likely to start at a lower dose. Your dose may be increased a little at a time until you reach the dose that is right for you.
Do not stop taking your TIROCAP™ without talking to your healthcare professional first.
Food and drink can affect how your body absorbs TIROCAP™. For this reason, if you take your dose regularly within one hour of some foods, you may need your dose changed.
Thyroid hormone replacement is usually taken for life.
Overdose:
Symptoms of a TIROCAP™ overdose may not appear until several days after taking too much of it.
Signs and symptoms of overdose may include: weight loss, increased appetite, heart palpitations (fast or irregular beating of the heart), chest pain, nervousness, diarrhea, abdominal cramps, sweating, fast heartbeat, fever, changes in period bleeding, convulsions and seizures (fits). Coma and death are also possible.
| If you think you have taken too much TIROCAP™, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take a dose, take the missed dose as soon as you remember it, unless it is almost time for your next dose. If it is, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at once to make up for a missed dose. If you miss more than two doses, check with your healthcare professional.
What are possible side effects from using TIROCAP™?
These are not all the possible side effects you may feel when taking TIROCAP™. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- inability to tolerate heat
- excessive sweating
- flushing
- rash
- nervousness
- anxiety or irritability
- rapid changes in emotions
- trouble sleeping
- restlessness
- temporary hair loss
- headache
- diarrhea
- nausea
- vomiting
- abdominal cramps
- fever
- fatigue
- muscle weakness or spasms
- tremors
- shortness of breath
- changes in menstrual cycle
- trouble having a child (impaired fertility)
- reduced adult height due to early closure of growth plates in bones
TIROCAP™ can cause abnormal test results. Your healthcare professional will decide when to perform blood tests and other diagnostic tests and will interpret the results.
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 | ||
| UNKNOWN | |||
| Heart Problems: chest pain, rapid or irregular heartbeat, palpitations, shortness of breath | ✓ | ||
| Heart Attack: crushing chest pain that radiates to the left arm and/or jaw, sweating, nausea, vomiting, shortness of breath | ✓ | ||
| Heart Failure: shortness of breath when you exert yourself or lie down, fatigue, weakness, swelling in the legs, ankles and feet, rapid or irregular heartbeat, persistent cough | ✓ | ||
| Serious Allergic Reactions: rash, hives, itching, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
| Osteoporosis (decrease of bone mineral density): back pain, loss of height over time, stooped posture, broken bones | ✓ | ||
| Seizure (fits): muscle twitching, changes in emotions, confusion, loss of consciousness with uncontrollable shaking | ✓ | ||
| Appetite disorder: weight increased or weight loss | ✓ | ||
| Pseudomotor cerebri (increased pressure in the brain in children): headaches, vison problems or complete vision loss, seeing double, ringing in the ears, pain in the arms | ✓ | ||
| Slipped capital femoral epiphysis (a weakened hip joint in children): stiffness or pain in the knee or groin, walking with a limp, inability to bear weight on the affected side | ✓ | ||
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 |
|---|
| UNKNOWN | |||
|---|---|---|---|
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness, fainting, chest pain or pressure, swelling in ankles and legs, racing pulse, heart palpitations | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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 TIROCAP™ at 15°C to 25°C. Protect it from heat, light and moisture.
Keep out of reach and sight of children.
If you want more information about TIROCAP™:
- 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); the manufacturer’s website, www.TIROCAP.com, or by calling (905) 477-4553.