Pro-Triazide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PRO-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:

PRO-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 PRO-TRIAZIDE regularly even if you feel fine.

When it should not be used:

Do not take PRO-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. PRO-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

Because lactose is a non-medicinal ingredient in PRO-TRIAZIDE.

What the medicinal ingredients are:

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 forms it comes in:

Tablet; triamterene 50 mg and hydrochlorothiazide 25 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use PRO-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 old of age.

Hydrochlorothiazide in PRO-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 PRO-TRIAZIDE.

You may become sensitive to the sun while taking PRO-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 PRO-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 PRO-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

  PRO-TRIAZIDE, they may cause excessively low blood pressure.

• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.

PROPER USE OF THIS MEDICATION

Take PRO-TRIAZIDE exactly as prescribed. It is recommended to take your dose at about the same time every day.

PRO-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 PRO-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.

PRO-TRIAZIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking PRO-TRIAZIDE, contact your doctor, nurse, or pharmacist.

HOW TO STORE IT

Store at room temperature, 15-30°C (59-86°F).

Keep out of reach and sight of children.

REPORTING SUSPECTED 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:

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• 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 Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.

Pro Doc Ltée, Laval, Québec, H7L 3W9

Last revised: July 28, 2014