Aldactazide 25: Uses, Side Effects and Dosage

What is ALDACTAZIDE used for?

ALDACTAZIDE is used in adults to:

• lower high blood pressure
• treat fluid retention (edema) caused by heart, liver and kidney problems.

How does ALDACTAZIDE work?

ALDACTAZIDE contains a combination of 2 drugs, spironolactone and hydrochlorothiazide:

• Spironolactone belongs to a class of medicines known as aldosterone receptor antagonists. It is a diuretic or “water pill” that increases urination.
• Hydrochlorothiazide is also a diuretic or “water pill” that increases urination.
• Increasing urination lowers blood pressure.
• It also gets rid of extra fluid in fluid retention (edema).

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking ALDACTAZIDE regularly even if you feel fine. Do not stop taking ALDACTAZIDE without talking to your healthcare professional.

What are the ingredients in ALDACTAZIDE?

Medicinal ingredients: Spironolactone and hydrochlorothiazide

Non-medicinal ingredients: Calcium sulfate, carnauba wax, corn starch, hypromellose, magnesium stearate, opaspray K-1-7076, peppermint flavouring, polyethylene glycol 400, povidone, stearic acid.

Serious Warnings and Precautions

Avoid potassium supplements, salt substitutes and foods containing high levels of potassium (e.g., bananas, prunes, raisins, and orange juice). ALDACTAZIDE causes the kidney to eliminate unneeded water and sodium from the body into the urine, but also reduces the loss of potassium.

Follow your healthcare professional’s directions for a low-salt or low-sodium diet and daily exercise program.

ALDACTAZIDE comes in the following dosage forms:

Tablets:

ALDACTAZIDE 25: 25 mg /25 mg of spironolactone and hydrochlorothiazide

ALDACTAZIDE 50: 50 mg /50 mg of spironolactone and hydrochlorothiazide

Do not use ALDACTAZIDE if:

• you are allergic to spironolactone or hydrochlorothiazide or to any non-medicinal ingredient in ALDACTAZIDE (see What are the ingredients in ALDACTAZIDE?).
• you are allergic to sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
• you have difficulty urinating or produce no urine.
• you have severe kidney disease, severe liver disease or Addison’s disease.
• you have high levels of potassium (hyperkalemia) or calcium (hypercalcemia) in your blood.

• you are pregnant.

• you are breastfeeding. ALDACTAZIDE passes into breast milk.
• you are taking eplerenone, used to treat heart failure and high blood pressure.
• you are taking heparin or low molecular weight heparin, used to prevent blood clotting.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ALDACTAZIDE. Talk about any health conditions or problems you may have, including if you:

• are allergic to penicillin.
• have diabetes or are taking medicines for diabetes.
• have liver or kidney problems.
• have or ever had lupus or gout.
• are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• are less than 18 years old.
• are taking a non-steroidal anti-inflammatory drug (NSAID) used to reduce pain and swelling, such as acetylsalicylic acid (ASA), ibuprofen, naproxen, and celecoxib.
• are taking an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in “PRIL”. It lowers blood pressure.
• are taking an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. It lowers blood pressure.
• are taking lithium, used to treat bipolar disease.
• are taking atorvastatin, used to lower cholesterol.
• are taking furosemide, a diuretic or “water pill” used to lower blood pressure.
• are having surgery (including dental surgery) and will be given an anesthetic. Be sure to tell the healthcare professional that you are taking ALDACTAZIDE.
• 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 medicines to suppress your immune system.

Other warnings you should know about:

Risk of skin cancer:

• ALDACTAZIDE contains hydrochlorothiazide. Taking hydrochlorothiazide may increase your risk of developing non-melanoma skin cancer. The risk is higher if you have been taking ALDACTAZIDE for many years (more than 3) or at a high dose.

• While taking ALDACTAZIDE:

  • 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.
  • You may become more sensitive to the sun while taking ALDACTAZIDE. 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 healthcare professional 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) while you are taking ALDACTAZIDE.

Sudden eye problems:

• ALDACTAZIDE contains hydrochlorothiazide. Taking hydrochlorothiazide can cause serious eye problems. These eye problems are related and can happen within hours to weeks of starting ALDACTAZIDE.

• These eye problems include:

  • Choroidal effusion: An abnormal buildup of liquid in your eye that may result in vision changes.
  • Myopia: Sudden nearsightedness or blurred vision.
  • Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
• If your vision changes, stop taking ALDACTAZIDE and get immediate medical help.

Breast development in males: ALDACTAZIDE contains spironolactone. Spironolactone can cause breast development in males. If you are male and develop tender or enlarged breast tissue while you are taking ALDACTAZIDE, talk to your healthcare professional.

Blood tests: ALDACTAZIDE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Driving and using machines: ALDACTAZIDE can cause dizziness, lightheadedness, or fainting, especially after the first dose and when the dose is increased. This can sometimes lead to falls and broken bones. Alcohol, medicines used to reduce anxiety and help you sleep and strong pain killers called narcotics, can make these side effects worse. Do not drive a car or do other tasks that require attention until you know how ALDACTAZIDE affects you.

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 ALDACTAZIDE:

• Adrenocorticotropic hormone (ACTH) used to treat West Syndrome.
• 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, used to treat fungal infections.
• Medicines used to treat cancer, including cyclophosphamide and methotrexate.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
• Medicines used to treat diabetes, 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.
• Medications that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
• Medicines used to treat epilepsy, including carbamazepine and topiramate.
• Medicines that cause high levels of potassium in blood (hyperkalemia) including aminoglycoside antibiotics, cisplatin and foscarnet.
• Gout medications, including allopurinol and probenecid.
• Lithium used to treat bipolar disorder (manic-depressive illness)
• Nonsteroidal anti-inflammatory drugs (NSAIDs), use to reduce pain and swelling, including ibuprofen, naproxen, and celecoxib.
• Other blood pressure lowering medications, including diuretics. When taken in combination with ALDACTAZIDE, they may cause excessively low blood pressure.
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocuranine.

How to take ALDACTAZIDE:

• Take ALDACTAZIDE exactly as prescribed by your healthcare professional.

• ALDACTAZIDE can be taken with or without food. If ALDACTAZIDE causes upset stomach, take it with food or milk. If you take ALDACTAZIDE with food and you have liver or kidney problems or are elderly, you must tell your healthcare professional. Taking ALDACTAZIDE with food can cause more medicine to be absorbed into your body which can increase your risk of certain side effects or overdose.

• ALDACTAZIDE is usually taken once a day in the morning. It is recommended that you take your dose at about the same time every day.

Usual Dose:

• High blood pressure in adults:

  ALDACTAZIDE 25: 2 to 4 tablets per day.

  ALDACTAZIDE 50: 1 to 2 tablets per day.

• Fluid retention (edema) in adults:

  ALDACTAZIDE 25: 2 to 4 tablets per day.

  ALDACTAZIDE 50: 1 to 2 tablets per day.

• Fluid retention (edema) in children: The healthcare professional will decide on the right dose based on their body weight.

Overdose:

Signs of overdose can include nausea, vomiting, drowsiness, dizziness, decreased alertness, coma, mental confusion, diarrhea, red spots or rash on the skin, bruising, and high levels of potassium in your blood (stomach pain, chest pain, irregular heartbeat, muscle weakness, numbness). If you notice any of these symptoms while you are taking ALDACTAZIDE get immediate medical help.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next dose at the usual time. Do not take a double dose to make up for a missed dose.

What are possible side effects from using ALDACTAZIDE?

These are not all the possible side effects you may have when taking ALDACTAZIDE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• constipation
• diarrhea
• nausea, vomiting
• decreased appetite
• upset stomach, indigestion
• stomach pain and cramps
• enlargement of the glands in your mouth
• dryness of mouth
• dizziness, spinning sensation (vertigo)
• numbness and tingling
• headache
• drowsiness
• muscle cramps spasms, pain and/or weakness
• restlessness
• reduced libido
• In men: difficulty in getting or maintaining erections
• In women: breast discomfort, irregular or missed menstrual periods, postmenopausal bleeding
• rash

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

Store ALDACTAZIDE at room temperature 15 to 25°C

Keep ALDACTAZIDE out of the reach and sight of children.

If you want more information about ALDACTAZIDE: 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 http://www.pfizer.ca, or by calling 1-800-463-6001.

Last Revised JAN 25, 2022