Spironolactone and hydrochlorothiazide

What is Spironolactone and hydrochlorothiazide?

• Spironolactone and hydrochlorothiazide (Aldactazide) is a combination of Spironolactone, an aldosterone antagonist and Hydrochlorothiazide, a diuretic and antihypertensive used to treat high blood pressure.
• This medication is also used to treat patients with edema (fluid retention) caused by various conditions, including heart, liver, or kidney disease.

Spironolactone

Spironolactone 3D ball

Hydrochlorothiazide

What are the uses of this medicine?

Spironolactone and hydrochlorothiazide (Aldactazide) is used for: Edematous conditions for patients with:

• Congestive heart failure
• Cirrhosis of the liver accompanied by edema and/or ascites
• The nephrotic syndrome
• Essential hypertension
• Aldactazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

How does this medicine work?

• Aldactazide is a combination of two diuretic agents with different but complementary mechanisms and sites of action, thereby providing additive diuretic and antihypertensive effects.
• Additionally, the spironolactone component helps to minimize the potassium loss characteristically induced by the thiazide component.
• The diuretic effect of spironolactone is mediated through its action as a specific pharmacologic antagonist of aldosterone, primarily by competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Hydrochlorothiazide promotes the excretion of sodium and water primarily by inhibiting their reabsorption in the cortical diluting segment of the distal renal tubule.
• The diuretic and antihypertensive effects of the individual components are potentiated when spironolactone and hydrochlorothiazide are given concurrently.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• anuria
• acute renal insufficiency
• significant impairment of renal excretory function
• hypercalcemia
• hyperkalemia
• Addison's disease
• allergic to thiazide diuretics or to other sulfonamide-derived drugs
• acute or severe hepatic failure

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• aldosterone blocking medications such as eplerenone (Inspra)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel)
• captopril (Capoten)
• enalapril (Vasotec, in Vaseretic)
• fosinopril
• lisinopril (in Prinzide, in Zestoretic)
• moexipril (Univasc, in Uniretic)
• perindopril (Aceon)
• quinapril (Accupril, in Accuretic, in Quinaretic)
• ramipril (Altace)
• trandolapril (Mavik, in Tarka)
• angiotensin II antagonists (angiotensin receptor blockers; ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, Benicar HCT), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Diovan HCT, Exforge)
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin), indomethacin (Indocin, Tivorbex)
• cholestyramine (Prevalite); digoxin (Lanoxin)
• heparin and low molecular weight heparins such as enoxaparin (Lovenox)
• lithium (Lithobid)
• medications for diabetes or high blood pressure
• potassium-sparing diuretics (water pills) such as amiloride (Midamor) or triamterene (Dyrenium, in Dyazide, in Maxzide)
• potassium supplements

Concomitant administration of Aldactazide with the following drugs or potassium sources may lead to severe hyperkalemia:

• other potassium-sparing diuretics
• ACE inhibitors
• angiotensin II receptor antagonists
• aldosterone blockers
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
• heparin and low molecular weight heparin
• other drugs or conditions known to cause hyperkalemia
• potassium supplements
• diet rich in potassium
• salt substitutes containing potassium

Is this medicine FDA approved?

• Yes is was FDA approved.

How should this medicine be used?

Recommended dosage: Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome):

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

Essential hypertension:

• 50 mg to 100 mg each of spironolactone and hydrochlorothiazide daily, given in a single dose or in divided doses.
• Concurrent potassium supplementation is not recommended when Aldactazide is used in the long-term management of hypertension or in the treatment of most edematous conditions.

Administration:

• The combination of spironolactone and hydrochlorothiazide comes as a tablet to take by mouth.
• It usually is taken once or twice a day.
• To help you remember to take spironolactone and hydrochlorothiazide, take it around the same time(s) every day.
• If you are to take it once a day, take it in the morning; if you are to take it twice a day, take it in the morning and in the late afternoon to avoid going to the bathroom during the night.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Aldactazide oral tablets

This medicine is available in fallowing brand namesː

• Aldactazide

What side effects can this medication cause?

The most common side effects of this medicine include:

• loss of appetite
• stomach pain
• frequent urination
• dizziness
• headache
• enlarged or painful breasts
• irregular menstrual periods
• difficulty maintaining or achieving an erection
• vaginal bleeding in post-menopausal women
• drowsiness
• vomiting
• diarrhea
• nausea

What special precautions should I follow?

• Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with Aldactazide therapy. Excessive potassium intake may cause hyperkalemia in patients receiving Aldactazide.
• Aldactazide should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
• Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia.
• Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus.
• Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute angle-closure glaucoma and elevated intraocular pressure. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
• The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Hydrochlorothiazide can cause hypokalemia and hyponatremia.
• Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
• Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
• Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Aldactazide.
• Gynecomastia may develop in association with the use of spironolactone.
• Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
• Patients who receive Aldactazide should be advised to avoid potassium supplements and foods containing high levels of potassium including salt substitutes.
• Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• drowsiness
• mental confusion
• maculopapular or erythematous rash
• nausea
• vomiting
• dizziness
• diarrhea
• hyponatremia
• hyperkalemia
• hepatic coma

Management of overdosage:

• Induce vomiting or evacuate the stomach by lavage.
• There is no specific antidote.
• Treatment is supportive to maintain hydration, electrolyte balance, and vital functions.
• Patients who have renal impairment may develop spironolactone-induced hyperkalemia.
• In such cases, Aldactazide should be discontinued immediately.
• Start intravenous administration of calcium chloride solution, sodium bicarbonate solution, and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation.
• Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered.
• Persistent hyperkalemia may require dialysis.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with Aldactazide in pregnant women.
• Therefore, the use of Aldactazide in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• SPIRONOLACTONE
• HYDROCHLOROTHIAZIDE

Inactive Ingredients:

• CALCIUM SULFATE, UNSPECIFIED FORM
• STARCH, CORN
• HYDROXYPROPYL CELLULOSE, UNSPECIFIED
• HYPROMELLOSE, UNSPECIFIED
• FERRIC OXIDE RED
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Distributed by:

• Pfizer Pharmaceuticals LLC

What should I know about storage and disposal of this medication?

• Store below 77°F (25°C).

• Dailymed label info on Spironolactone and hydrochlorothiazide
• FDA Spironolactone and hydrochlorothiazide

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