Aldactazide

• Generic Name: spironolactone and hydrochlorothiazide
• Brand Name: Aldactazide

Aldactazide (Spironolactone and Hydrochlorothiazide) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Aldactazide Side Effects Center

What Is Aldactazide?

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

What Are Side Effects of Aldactazide?

Common side effects of Aldactazide include:

• dizziness,
• lightheadedness,
• loss of appetite,
• diarrhea,
• nausea,
• vomiting,
• headache,
• gas,
• stomach pain, or
• skin rash.

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

• joint pain,
• breast pain,
• breast enlargement in men (gynecomastia),
• easy bruising or bleeding,
• unusual change in the amount of urine (not including the normal increase in urine when you first start this drug),
• yellowing eyes or skin,
• dark urine,
• severe stomach or abdominal pain,
• decrease in vision, or
• eye pain.

Dosage for Aldactazide

The usual maintenance dose of Aldactazide is 100 mg each of spironolactone and hydrochlorothiazide daily, given in a single dose or in divided doses, but may range from 25 mg to 200 mg of each component daily depending on patient response.

What Drugs, Substances, or Supplements Interact with Aldactazide?

Aldactazide may interact with medications that cause light-headedness (e.g., cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety), other blood pressure medications, lithium, digoxin, steroids, blood thinners, insulin or oral diabetes medicines, ACE inhibitors, indomethacin, or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications you use.

Aldactazide During Pregnancy and Breastfeeding

During pregnancy, Aldactazide should be used only when prescribed. Spironolactone and hydrochlorothiazide both pass into breast milk but are unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Aldactazide (spironolactone and hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Aldactazide Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• breast swelling and tenderness;
• low blood cell counts--easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

• drowsiness, dizziness, lack of energy;
• leg cramps;
• weakness;
• feeling like you might pass out;
• severe pain in your upper stomach spreading to your back, nausea and vomiting; or
• electrolyte imbalance.

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.

Read the entire detailed patient monograph for Aldactazide (Spironolactone and Hydrochlorothiazide)

 

Aldactazide Professional Information

SIDE EFFECTS

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

Hydrochlorothiazide

Body as a whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics, or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialoadenitis, cramping, constipation, gastric irritation, nausea, anorexia.

Eye Disorders: acute myopia and acute angle closure glaucoma (see WARNINGS).

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm.

Nervous system/psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis (seeWARNINGS).

Skin: Erythema multiforme, pruritus.

Special senses: Transient blurred vision, xanthopsia.

Spironolactone

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive: Gynecomastia (see PRECAUTIONS), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia, electrolyte disturbances (see WARNINGS and PRECAUTIONS).

Musculoskeletal: Leg cramps.

Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure).

Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritus.

Post Marketing Experience

Non-Melanoma Skin Cancer

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

DRUG INTERACTIONS

ACE inhibitors, Angiotensin II receptor antagonists, aldosterone blockers, potassium supplements, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia:

Concomitant administration may lead to severe hyperkalemia.

Alcohol, Barbiturates, Or Narcotics

Potentiation of orthostatic hypotension may occur.

Antidiabetic Drugs (E.g., Oral Agents, Insulin)

Dosage adjustment of the antidiabetic drug may be required (see PRECAUTIONS).

Corticosteroids, ACTH

Intensified electrolyte depletion, particularly hypokalemia, may occur.

Pressor Amines (E.g., Norepinephrine)

Both spironolactone and hydrochlorothiazide reduce the vascular responsiveness to norepinephrine.

Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with ALDACTAZIDE.

Skeletal Muscle Relaxants, Nondepolarizing (E.g., Tubocurarine)

Possible increased responsiveness to the muscle relaxant may result.

Lithium

Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics. Combination of NSAIDs, e.g., indomethacin, with potassiumsparing diuretics has been associated with severe hyperkalemia. Therefore, when ALDACTAZIDE and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Acetylsalicylic Acid

Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when ALDACTAZIDE and acetylsalicylic acid are used concomitantly, ALDACTAZIDE may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained.

Digoxin

Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. Monitor serum digoxin levels and adjust dose accordingly. Thiazide-induced electrolyte disturbances, i.e. hypokalemia, hypomagnesemia, increase the risk of digoxin toxicity, which may lead to fatal arrhythmic events (see PRECAUTIONS).

Cholestyramine

Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine.

Read the entire FDA prescribing information for Aldactazide (Spironolactone and Hydrochlorothiazide)

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&Copy; Aldactazide Patient Information is supplied by Cerner Multum, Inc. and Aldactazide Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.