What Aldactazide is used for and how to use it
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Aldactazide Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Ascites, Edema, Heart Failure (Congestive Heart Failure), High Blood Pressure (Hypertension), Nephrotic Syndrome
Class: Potassium sparing diuretics with thiazides
Form: Tablets
Ingredients: spironolactone, hydrochlorothiazide, calcium sulfate, carnauba wax, corn starch, magnesium stearate, opaspray K-1-7076, peppermint flavouring, povidone, hypromellose, polyethylene glycol 400, stearic acid

(spironolactone and hydrochlorothiazide tablets USP)

About This Medication

What the Medication is Used For

ALDACTAZIDE is used to treat high blood pressure and fluid retention (edema) caused by various conditions, including heart disease, cirrhosis of the liver and nephrotic syndrome.

What it Does

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

  • Spironolactone belongs to a class of medicines known as aldosterone receptor antagonists.
  • 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 ALDACTAZIDE regularly even if you feel fine. Do not stop taking ALDACTAZIDE without talking to your doctor.

ALDACTAZIDE causes the kidney to eliminate unneeded water and sodium from the body into the urine, but also reduces the loss of potassium.

When it Should not Be Used

Do not take ALDACTAZIDE if you:

  • Are allergic to spironolactone or hydrochlorothiazide or to any nonmedicinal ingredient in the formulation.
  • Are allergic to 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 kidney disease, severe liver disease or Addison’s disease
  • Have high levels of potassium (hyperkalemia) or calcium (hypercalcemia) in your blood
  • Are pregnant
  • Are breastfeeding. ALDACTAZIDE passes into breast milk.
  • Are taking eplerenone (INSPRA)
  • Are taking heparin or low molecular weight heparin used to prevent blood clotting

What the Medicinal Ingredient Is

Spironolactone and hydrochlorothiazide tablets.

What the Non-medicinal Ingredients Are

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

What Dosage Forms it Comes In

Tablets: 25/25 mg and 50/50 mg of spironolactone and hydrochlorothiazide

Warnings and Precautions

Avoid potassium supplements, salt substitutes and foods containing high levels of potassium (e.g., bananas, prunes, raisins, and orange juice). Follow your doctor's directions for a low-salt or lowsodium diet and daily exercise program

Before you receive ALDACTAZIDE, talk to your doctor, nurse, or pharmacist if you:

  • Are allergic to penicillin.
  • Have diabetes, liver or kidney disease
  • 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 medications for diabetes
  • Are taking a Non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce pain and swelling. Examples include Aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and celecoxib (Celebrex)
  • 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 Lipitor (atorvastatin) or Lasix (furosemide)
  • Are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ALDACTAZIDE, call your doctor.
  • Are a man and develop tender or enlarged breast tissue
  • Are having surgery (including dental surgery) and will be given an anesthetic. Be sure to tell the doctor or dentist that you are taking ALDACTAZIDE.

Hydrochlorothiazide in ALDACTAZIDE 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 ALDACTAZIDE.

    You may become sensitive to the sun while taking ALDACTAZIDE. 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 ALDACTAZIDE. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is decreased (sometimes leading to falls and fractures or broken bones). Do not drive a car or operate machinery until you know how this drug affects you. Remember that alcohol can add to the drowsiness caused by this drug.

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 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, 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.
  • Drugs that cause hyperkalemia (high levels of potassium in blood) including aminoglycoside antibiotics, cisplatin and foscarnet
  • Gout medications, including allopurinol and probenecid.
  • Lithium used to treat bipolar disorder (manicdepressive illness)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), use to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Other blood pressure lowering drugs, 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

Proper Use of This Medication

Take ALDACTAZIDE exactly as prescribed by your doctor. It is recommended to take your dose at about the same time every day.

ALDACTAZIDE can be taken with or without food. If ALDACTAZIDE causes upset stomach, take it with food or milk.

Always follow your doctor’s instructions carefully.

ALDACTAZIDE comes as a tablet to take by mouth. It is usually taken once a day in the morning.

Food increases the effect of ALDACTAZIDE. Patients with kidney and liver problems, and the elderly are particularly at risk. If you take this medication with food, your doctor must monitor you for signs that can be associated with excessive exposure of ALDACTAZIDE. Overdose symptoms include nausea, vomiting, drowsiness, dizziness, decreased consciousness, coma, mental confusion, diarrhea, red spots/bruising/rash and irregular results on blood tests including increased serum potassium levels. These symptoms usually disappear when ALDACTAZIDE is discontinued.

Usual Dose

Edema in adults: (congestive heart failure, hepatic cirrhosis or nephrotic syndrome): Daily dosage of 2 to 4 tablets of ALDACTAZIDE 25 or 1 to 2 tablets of ALDACTAZIDE 50 in single or divided doses should be adequate for most patients, but may range from 2 to 8 tablets daily of ALDACTAZIDE 25 or 1 to 4 tablets of ALDACTAZIDE 50.

Edema in children: The usual daily maintenance dose of ALDACTAZIDE should be that which provides 0.75 to 1.5 mg of spironolactone per pound of body weight (1.65 to 3.3 mg/kg).

Essential hypertension: A daily dosage of 2 to 4 ALDACTAZIDE 25 tablets or 1 to 2 ALDACTAZIDE 50 tablets in single or divided doses, will be adequate for most patients, but may range from 2 to 8 tablets of ALDACTAZIDE 25 or 1 to 4 tablets of ALDACTAZIDE 50.

Overdose

If you think you have taken too much ALDACTAZIDE 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:

Gastrointestinal: Constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth, indigestion, dryness of mouth, abdominal pain, and cramps.

Central nervous system: Dizziness, pins and needles in your fingers, headache, a feeling that you or your surroundings are moving, sensation of tingling or numbness and drowsiness.

Cardiovascular: low blood pressure while you are standing (postural hypotension), may be aggravated by alcohol, barbiturates, or narcotics.

Hypersensitivity: sensitivity to light, fever, difficulty breathing, anaphylactic reactions.

Musculoskeletal:Muscle cramps, spasms, and pain, weakness, restlessness

Psychiatric: Reduced libido

Reproductive: In men: breast swelling, difficulty in getting or maintaining erections. In women: breast discomfort, irregular or missed menstrual periods, postmenopausal bleeding.

Skin: Bleeding under the skin, rash, red patches on the skin.

Other: Blurred vision, thirst, frequent urination, and fatigue.

If any of these affect you severely, tell your doctor, nurse or pharmacist

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

Serious Side Effects how Often They Happen and What to Do About Them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
seek
immediate
medical
help
Only if
severe
In all
cases
 
CommonLow Blood
Pressure:

Dizziness,
fainting,
lightheadedness.
May occur when
you go from
sitting to standing
up (may be
exacerbated by
alcohol,
barbiturates, or
narcotics).
Y
Decreased levels
of potassium in
the blood:

Irregular
heartbeats,
muscle weakness
and generally
feeling unwell.
Y
UncommonAllergic
Reaction:

Rash, hives,
swelling of the
face, lips, tongue
or throat,
difficulty
swallowing or
breathing,
redness, intense
itching and
burning,
anaphylactic
reactions.
Y
Kidney
Disorder:

Change in
frequency of
urination, nausea,
vomiting,
swelling of
extremities,
fatigue
Y
Liver Disorder:
Yellowing of the
skin or eyes, dark
urine, abdominal
pain, nausea,
vomiting, loss of
appetite
Y
Increased Blood
Sugar
:
Frequent
urination, thirst
and hunger
Y
Electrolyte
Imbalance
:
Weakness,
drowsiness,
muscle pain or
cramps, rapid,
slow or irregular
heartbeat
Y
ConfusionY
Enlarged or
painful breasts in
men
Y
FeverY
Vomiting bloodY
Rapid, excessive
weight loss
Y
Shortness of
breath
Y
Skin rashY
Yellowing of the
skin or eyes
Y
Stomach ulcer
(burning pain in
the gut, vomiting)
Y
Blood problems
(loss of energy,
severe anemia).
Y
Impaired sense of
sight
Y
Chest pain,
difficulty
breathing
Y
RareDecreased
Platelets:

Bruising,
bleeding, fatigue
and weakness
Y
Decreased White
Blood Cells:

Infections,
fatigue, fever,
aches, pains, and
flu-like symptoms
Y
Very RareToxic Epidermal
Necrolysis:

Severe skin
peeling,
especially in
mouth and eyes
Y
UnknownEye Disorders:
-Myopia:

Sudden near
sightedness or
blurred vision
-Glaucoma:
Increased
pressure in your
eye, eye pain
Y
Anemia:
Fatigue, loss of
energy, weakness,
shortness of
breath
Y
Inflammation of
the Pancreas:

Abdominal pain
that lasts and gets
worse when you
lie down, nausea,
vomiting
Y

This is not a complete list of side effects. If you have any unexpected effects while taking ALDACTAZIDE, contact your doctor, nurse, or pharmacist.

How to Store It

Store ALDACTAZIDE at room temperature 15 to 25°C

Keep ALDACTAZIDE out of the 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:

  • 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.

NOTES: 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 found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001