Details for: APO TRIAZIDE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00441775 | APO TRIAZIDE | TRIAMTERENE; HYDROCHLOROTHIAZIDE | 50 MG; 25 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-TRIAZIDE is used in adults for:
- Swelling due to:
- steroid use
- heart, liver or kidney problems
- other unknown causes
- High blood pressure (also called hypertension)
What it does
APO-TRIAZIDE contains a combination of 2 drugs, triamterene and hydrochlorothiazide:
- Triamterene helps the body lose excess salt but keep a normal amount of potassium (an electrolyte) in the blood.
- Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers blood pressure.
This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking APO-TRIAZIDE regularly even if you feel fine.
When it should not be used
Do not take APO-TRIAZIDE if you:
- Are allergic to triamterene and hydrochlorothiazide, or to any non-medicinal ingredient in the formulation.
- Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
- Have difficulty urinating or produce no urine.
- Have severe or worsening kidney or liver problems.
- Are breastfeeding. APO-TRIAZIDE passes into breast milk.
- Have high potassium levels (hyperkalemia).
- Have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
What the medicinal ingredient is
Triamterene and hydrochlorothiazide.
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and sunset yellow aluminium lake 40 %
What dosage form it comes in
Tablet; triamterene 50 mg and hydrochlorothiazide 25 mg.
Warnings and precautions
BEFORE you use APO-TRIAZIDE talk to your doctor, nurse, or pharmacist if you:
- Are allergic to penicillin.
- Have diabetes, liver or kidney disease.
- Have a history of kidney stones.
- Have lupus or gout.
- Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- Are using any form of potassium supplementation.
- Are taking any other potassium-conserving medications or “water pills”.
- Are pregnant or thinking of becoming pregnant.
- Are less than 18 or over 65 years
oldof age. - Have had skin cancer or have a family history of skin cancer.
- Have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.
Risk of skin cancer:
APO-TRIAZIDE contains hydrochlorothiazide. Treatment with hydrochlorothiazide may increase the risk of developing non-melanoma skin cancer. The risk is higher if you have been taking APO-TRIAZIDE for many years (more than 3) or at a high dose.
While taking APO-TRIAZIDE:
- Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
- Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
- Talk to your doctor immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) during the treatment.
Hydrochlorothiazide in APO-TRIAZIDE can cause Sudden Eye Disorders:
- Myopia: sudden nearsightedness or blurred vision.
- Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
These eye disorders are related and can develop within hours to weeks of starting APO-TRIAZIDE.
You may become sensitive to the sun while taking APO-TRIAZIDE. Exposure to sunlight should be minimized until you know how you respond.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to APO-TRIAZIDE. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with APO-TRIAZIDE:
- Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
- Amphotericin B, an antifungal drug.
- Anticancer drugs, including cyclophosphamide and methotrexate.
- Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
- Antidiabetic drugs, including insulin and oral medicines.
- Bile acid resins used to lower cholesterol.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Digoxin, a heart medication.
- Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
- Drugs used to treat epilepsy, including carbamazepine and topiramate.
- Gout medications, including allopurinol and probenecid.
- Lithium used to treat bipolar disease.
- Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
- Other blood pressure lowering drugs. When taken in combination with APO-TRIAZIDE, they may cause excessively low blood pressure.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
Proper use of this medication
Take APO-TRIAZIDE exactly as prescribed. It is recommended to take your dose at about the same time every day.
APO-TRIAZIDE should be taken after a meal.
Usual Adult dose
Patients should be individually titrated for each component separately.
For Edema: usually 1 tablet twice daily. In some patients, one tablet every day or every other day may be indicated.
For Hypertension: usually 1 tablet twice daily, dosage may be increased or decreased according to patient’s need. Maximum daily dose should not exceed 4 tablets.
Do not adjust your dosage by yourself. Please consult your doctor and follow the given advice.
Overdose
If you think you have taken too much APO-TRIAZIDE contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.
Missed Dose
If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.
Side effects and what to do about them
Side effects may include:
- muscle cramps, spasms, and pain, weakness, restlessness
- dizziness, pins and needles in your fingers, headache
- constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth, dry mouth
- reduced libido
- bleeding under the skin, rash, red patches on the skin
If any of these affects you severely, tell your doctor, nurse or pharmacist.
APO-TRIAZIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk to your doctor, nurse, or pharmacist Only if severe | Talk to your doctor, nurse, or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up. | ✔ | ||
| Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly. | ✔ | ||
| Uncommon | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Increased blood sugar: frequent urination, thirst, and hunger | ✔ | ||
| Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | ✔ | ||
| Rare | |||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | ✔ | ||
| Very Rare | |||
| Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | ✔ | ||
| Unknown | |||
Eye Disorders:
|
✔ | ||
| Anemia: fatigue, loss of energy, weakness, shortness of breath. | ✔ | ||
| Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-TRIAZIDE, contact your doctor, nurse, or pharmacist.
How to store
Store at room temperature, 15-30°C (59-86°F).
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by contacting DISpedia, Apotex's Drug Information Service, at: 1-800-667-4708.
This leaflet can also be found at http://www.apotex.ca/products
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9
Last revised: June 4, 2019