Aldactazide

DRUG DESCRIPTION

ALDACTAZIDE oral tablets contain:

spironolactone . . . . . . . . . . . . . . . . . . . 25 mg
hydrochlorothiazide . . . . . . . . . . . . . . . . 25 mg

or

spironolactone . . . . . . . . . . . . . . . . . . . 50 mg
hydrochlorothiazide . . . . . . . . . . . . . . . . 50 mg

Spironolactone (ALDACTONE®), an aldosterone antagonist, is 17-hydroxy-7?mercapto-3-oxo-17?-pregn-4-ene-21-carboxylic acid &gama;-lactone acetate and has the following structural formula:

Spironolactone Structural Formula Illustration

Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:

Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.

Inactive ingredients include calcium sulfate, corn starch, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

What are the possible side effects of hydrochlorothiazide and spironolactone (Aldactazide)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow...

Read All Potential Side Effects and See Pictures of Aldactazide »

What are the precautions when taking spironolactone and hydrochlorothiazide (Aldactazide)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either spironolactone or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and...

Read All Potential Precautions of Aldactazide »


Aldactazide Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, loss of appetite, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, vomiting, fast heartbeat, severe dizziness, confusion, unusual decrease in the amount of urine, fainting, seizures.

This product may infrequently cause high potassium levels (hyperkalemia). This can lead to serious (rarely fatal) heart rhythm problems. Tell your doctor immediately if you develop any symptoms of high potassium levels, including muscle weakness, slow/irregular heartbeat, numb/tingling skin.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain, breast enlargement in men (gynecomastia).

Tell your doctor immediately if any of these rare but serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), yellowing eyes/skin, dark urine, severe stomach/abdominal pain, decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either spironolactone or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent dehydration/loss of too much body water. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This product may affect the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Spironolactone and hydrochlorothiazide both pass into breast milk but are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Aldactazide Patient Information Including Side Effects

Brand Names: Aldactazide

Generic Name: hydrochlorothiazide and spironolactone (Pronunciation: HYE dro KLOR oh THY a zide and spir ON oh LAK tone)

  • What is hydrochlorothiazide and spironolactone (Aldactazide)?
  • What are the possible side effects of hydrochlorothiazide and spironolactone (Aldactazide)?
  • What is the most important information I should know about hydrochlorothiazide and spironolactone (Aldactazide)?
  • What should I discuss with my doctor before taking hydrochlorothiazide and spironolactone (Aldactazide)?
  • How should I take hydrochlorothiazide and spironolactone (Aldactazide)?
  • What happens if I miss a dose (Aldactazide)?
  • What happens if I overdose (Aldactazide)?
  • What should I avoid while taking hydrochlorothiazide and spironolactone (Aldactazide)?
  • What other drugs will affect hydrochlorothiazide and spironolactone (Aldactazide)?
  • Where can I get more information?

What is hydrochlorothiazide and spironolactone (Aldactazide)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Spironolactone is a potassium-sparing diuretic that also prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

The combination of hydrochlorothiazide and spironolactone is used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome. This medication also treats high blood pressure (hypertension).

Hydrochlorothiazide and spironolactone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and spironolactone (Aldactazide)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea or vomiting;
  • dizziness, headache;
  • gas, stomach pain; or
  • skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydrochlorothiazide and spironolactone (Aldactazide)?

Do not use this medication if you have kidney disease, urination problems, or high levels of potassium in your blood. Do not use potassium supplements while you are taking hydrochlorothiazide and spironolactone.

Before using this medication, tell your doctor if you have heart or liver disease, diabetes, a breathing disorder, gout, lupus, an allergy to sulfa drugs, or a pancreas disorder. Tell your doctor if you use a steroid or another blood pressure medicine.

Avoid drinking alcohol, which can increase some of the side effects of hydrochlorothiazide and spironolactone.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking hydrochlorothiazide and spironolactone.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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