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Manufacturer of Aldactone

Pfizer Inc.

Also know under brand names: Aldactone, Spironol

Active ingredient / generic name: spironolactone

Approximate US Retail Price for Aldactone

25 mg (30 ea): $32.99
50 mg (30 ea): $51.99
100 mg (30 ea): $75.99

Short leaflet

Aldactone (marketed under the trade names Aldactone, Novo-Spiroton, Spiractin, Spirotone, Verospiron or Berlactone) is a diuretic and is used as an antiandrogen.

It is a synthetic 17-lactone drug which is a renal competitive aldosterone antagonist in a class of pharmaceuticals called potassium-sparing diuretics, used primarily to treat heart failure, ascites in patients with liver disease, low-renin hypertension, hypokalemia, and Conn's syndrome as well as high blood pressure. On its own, Aldactone is only a weak diuretic, but it can be combined with other diuretics. About one person in one hundred with hypertension has elevated levels of aldosterone; in these persons the antihypertensive effect of Aldactone may exceed that of complex combined regimens of other antihypertensives. Due to its anti-androgen effect, it can also be used to treat hirsutism, and is a common component in hormone therapy for male-to-female transsexual and transgendered people. It is also used for treating hair loss and acne in women and can be used as a topical medication for treatment of male baldness.

Aldactone inhibits the effect of aldosterone by competing for intracellular aldosterone receptor in the distal tubule cells (it actually works on Aldosterone receptors in the collecting duct). This increases the excretion of water and sodium, while decreasing the excretion of potassium. Aldactone has a fairly slow onset of action, taking several days to develop and similarly the effect diminishes slowly. Aldactone has anti-androgen activity by binding to the androgen receptor and preventing it interacting with dihydrotestosterone.

Aldactone is fairly rapidly absorbed from the gastrointestinal tract. It is also rapidly metabolised and bound in plasma proteins. Many of its metabolites are also active and one of them, canrenone as potassium canrenoate, is used parenterally when rapid effect is needed. Aldactone's half-life is 85 minutes, but canrenone's half-life is 10 to 35 hours, depending on the dose. The main elimination route is in the urine and some also in the bile.

Aldactone was shown to have a significant mortality and morbidity benefit in the Randomized Aldactone Evaluation Study (RALES), which studied people with severe congestive heart failure (New York Heart Association functional class III or IV). Patients in the study arm of the trial (those receiving Aldactone) had a relative risk of death (when compared to the placebo group) equal to 0.70 or a 30% relative risk reduction. Patients in the study arm also had significantly less symptoms of CHF and were hospitalized less frequently.

The mechanism of this effect is also mediated by inhibiting aldosterone, which in heart failure leads to myocardial fibrosis, sodium retention, and vascular dysfunction.

Aldactone is associated with an increased risk of bleeding from the stomach and duodenum, but a causal relationship between the two has not been established. Since it also affects steroid receptors elsewhere in the body, it can cause gynecomastia, menstrual irregularities and testicular atrophy. Other side effects include ataxia, erectile dysfunction, drowsiness and rashes. A carcinogenic effect has been demonstrated in rats. Aldactone has been shown to be immunosuppressive in the treatment of sarcoidosis.

There are indications that taking this drug can reduce the odds for developing Alzheimer's. "We observed the greatest reduction in AD risk specifically with potassium-sparing diuretics. It is not clear why potassium-sparing diuretics in particular should be associated with a reduced risk of AD, but it is well known that both loop and thiazide diuretics reduce plasma potassium concentration while potassium-sparing diuretics (including triamterene, Aldactone, and amiloride hydrochloride) typically lead to increased concentrations. As yet unpublished findings from the Gothenberg Study also suggest that increased potassium levels may be associated with a reduced risk of dementia.34 Consistent with this idea are observations that low potassium concentrations are associated with oxidative stress,35-36 inflammation,35-36 platelet aggregation,37 and vasoconstriction,38 all of which are possible contributors to AD pathogenesis." See:

People using this drug should avoid salt substitutes containing potassium.

Studies of Aldactone and the related compound potassium canrenoate (which, like Aldactone, metabolizes to canrenone) in rats for one to two year periods show an increase in carcinogenesis in the thyroid gland, testes, liver, breasts, and myelocytic leukocytes. Mammalian cells, depending on the presence of metabolic activation, show mixed results for mutagenicity in vitro. In light of this research, Sandoz has recommended that unnecessary use of Aldactone be avoided.

Aldactone: Patient Education

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 or other diuretics while you are taking spironolactone.

Before using this medication, tell your doctor if you have liver disease, or if you use a steroid or another diuretic.

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

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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

Spironolactone is used to diagnose or treat a condition in which you have too much aldosterone in your body. Aldosterone is a hormone produced by your adrenal glands to help regulate the salt and water balance in your body.

Spironolactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome. This medication is also used to treat or prevent hypokalemia (low potassium levels in the blood).

Spironolactone may also be used for purposes other than those listed in this medication guide.

Do not use this medication if you have:

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Spironolactone passes into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using spironolactone.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking spironolactone. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store this medication at room temperature away from heat, light, and moisture.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a spironolactone overdose may include drowsiness, confusion, red skin rash, nausea, vomiting, or diarrhea.

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

Avoid using other medicines that make you light-headed (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to the side effects of spironolactone.

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 spironolactone.

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

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.

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.

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 any of these serious side effects:

Before taking this medication, tell your doctor if you are using any of the following drugs:

There may be other drugs not listed that can affect spironolactone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Your pharmacist has additional information about spironolactone written for health professionals that you may read.

Aldactone: Dosing

edema:

25-200 mg PO qd: Info: may div dose bid; for edema assoc. w/ CHF, cirrhosis, or nephrotic syndrome

HTN:

25-50 mg PO qd: Start: 12.5 mg/day; Info: may div bid

hyperaldosteronism, primary:

diagnosis, long test: Dose: 400 mg PO qd x21-28 days; Info: presumptive dx made if hypokalemia/HTN corrected

hypokalemia, diuretic induced:

25-100 mg PO qd: Info: may div bid; use if oral K supplement inappropriate

*CHF, NYHA Class III/IV:

25 mg PO qd: Info: in combo w/ standard tx; may incr. to 50 mg/day after 8wk for worsening CHF if K stable; may decr. to 25 mg qod if hyperkalemia

renal dosing:

adjust dose frequency: CrCl 10-50: give q12-24h; CrCl <10: contraindicated; anuria, acute renal insufficiency: contraindicated

Aldactone: Drug Interactions

Aldactone vs eplerenone: contraindicated: combo may result in severe hyperkalemia and additive effects

Aldactone vs potassium salts: avoid combo w/ oral potassium supplements, monitor potassium, check potassium content of supplement: combo may incr. risk of hyperkalemia and additive effects. Potassium salts: also know as potassium acid phosphate, potassium acid phosphate/sodium acid phosphate, potassium chloride, potassium citrate, potassium iodide, potassium phosphate, potassium phosphate/sodium phosphate, potassium phosphate/sodium phosphates, dibasic and monobasic

Aldactone vs A2R blocker/HCTZ combos: monitor BP, potassium, use for therapeutic advantage: combo may incr. risk of hypotension, hyperkalemia and additive effects. A2R blocker/HCTZ combos: also know as candesartan/hydrochlorothiazide, eprosartan/hydrochlorothiazide, hydrochlorothiazide/irbesartan, hydrochlorothiazide/losartan, hydrochlorothiazide/olmesartan, hydrochlorothiazide/valsartan, telmisartan/hydrochlorothiazide

Aldactone vs ACE inhibitor/HCTZ combos: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. ACE inhibitor/HCTZ combos: also know as benazepril/hydrochlorothiazide, captopril/hydrochlorothiazide, enalapril/hydrochlorothiazide, fosinopril/hydrochlorothiazide, hydrochlorothiazide/lisinopril, hydrochlorothiazide/moexipril, hydrochlorothiazide/quinapril

Aldactone vs ACE inhibitors: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. ACE inhibitors: also know as amlodipine/benazepril, benazepril, captopril, enalapril, enalaprilat, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, trandolapril/verapamil

Aldactone vs aliskiren: monitor potassium: combo may incr. risk of hyperkalemia and additive effects

Aldactone vs amlodipine/A2R blocker combos: monitor BP, potassium, use for therapeutic advantage: combo may incr. risk of hypotension, hyperkalemia and additive/synergistic effects. Amlodipine/A2R blocker combos: also know as amlodipine/olmesartan, amlodipine/valsartan

Aldactone vs angiotensin II receptor blockers: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. Angiotensin II receptor blockers: also know as candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan

Aldactone vs aspirin/caffeine/CNS depressant combos: caution advised w/ high-dose aspirin or salicylates; monitor BP, renal fxn, potassium: combo may decr. antihypertensive, diuretic, and natriuretic efficacy, incr. risk of hyperkalemia and inhibition of renal prostaglandins, sodium and fluid retention. Aspirin/caffeine/CNS depressant combos: also know as aspirin/butalbital/caffeine, aspirin/butalbital/caffeine/codeine, aspirin/caffeine/dihydrocodeine

Aldactone vs bismuth subsalicylate: caution advised w/ high-dose aspirin or salicylates; monitor BP, renal fxn, potassium: combo may decr. antihypertensive, diuretic, and natriuretic efficacy, incr. risk of hyperkalemia and inhibition of renal prostaglandins, sodium and fluid retention

Aldactone vs bismuth subsalicylate/metronidazole/tetracycline: caution advised w/ high-dose aspirin or salicylates; monitor BP, renal fxn, potassium: combo may decr. antihypertensive, diuretic, and natriuretic efficacy; may incr. risk of hyperkalemia and antagonistic effects; salicylate-induced inhibition of renal prostaglandins, sodium and fluid retention; mechanism unknown

Aldactone vs cyclosporine: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. Cyclosporine: also know as cyclosporine modified, cyclosporine non-modified

Aldactone vs digoxin: monitor digoxin levels: combo may incr. digoxin levels, risk of toxicity and renal excretion decreased

Aldactone vs diuretics, potassium-sparing: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. Diuretics, potassium-sparing: also know as amiloride, spironolactone, triamterene

Aldactone vs diuretics, potassium-sparing/HCTZ: monitor potassium: combo may incr. risk of hyperkalemia and additive effects. Diuretics, potassium-sparing/HCTZ: also know as amiloride/hydrochlorothiazide, hydrochlorothiazide/spironolactone, hydrochlorothiazide/triamterene

Aldactone vs drospirenone: monitor potassium: combo w/ drospirenone may incr. risk of hyperkalemia and additive effects. Drospirenone: also know as drospirenone/estradiol, drospirenone/ethinyl estradiol

Aldactone vs enalapril/felodipine: monitor potassium: combo may incr. risk of hyperkalemia and additive effects

Aldactone vs heparin: monitor potassium: combo may incr. risk of hyperkalemia, risk may be greater w/ chronic heparin tx and additive effects

Aldactone vs hydrocodone/ibuprofen: caution advised, monitor K: combo may decr. diuretic, natriuretic, antihypertensive effects of diuretics; some NSAIDs may incr. risk of hyperkalemia and antagonistic effects; additive effects

Aldactone vs ibuprofen/oxycodone: caution advised, monitor K: combo may decr. diuretic, natriuretic, antihypertensive effects of diuretics; some NSAIDs may incr. risk of hyperkalemia and antagonistic effects, additive effects

Aldactone vs lansoprazole/naproxen: caution advised, monitor K: combo may decr. diuretic efficacy, some NSAIDs may incr. risk of hyperkalemia and antagonistic effects, additive effects

Aldactone vs lithium: monitor levels: combo may incr. lithium levels, risk of toxicity and renal excretion decreased

Aldactone vs NSAIDs: caution advised, monitor K: combo may decr. diuretic, natriuretic, antihypertensive effects of diuretics; some NSAIDs may incr. risk of hyperkalemia and antagonistic effects, additive effects. NSAIDs: also know as diclofenac potassium, diclofenac sodium, diclofenac/misoprostol, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, ibuprofen lysine, indomethacin, ketoprofen, ketorolac, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin

Aldactone vs octreotide: monitor fluid and electrolytes; consider lower diuretic dose: combo may alter diuretic requirements, incr. risk of electrolyte abnormalities and additive effects, antagonistic effects

Aldactone vs oprelvekin: monitor fluid and electrolytes w/ chronic diuretic tx: combo may incr. risk of severe hypokalemia and mechanism unknown

Aldactone vs polyethylene glycol/electrolytes: monitor electrolytes: combo may incr. risk of seizures and electrolyte abnormalities. Polyethylene glycol/electrolytes: also know as polyethylene glycol/electrolytes, polyethylene glycol/electrolytes and bisacodyl, polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid

Aldactone vs salicylates: caution advised w/ high-dose aspirin or salicylates; monitor BP, renal fxn, potassium: combo may decr. antihypertensive, diuretic, and natriuretic efficacy, incr. risk of hyperkalemia and inhibition of renal prostaglandins, sodium and fluid retention. Salicylates: also know as aspirin, aspirin, buffered/pravastatin, aspirin/carisoprodol, aspirin/codeine, aspirin/dipyridamole, aspirin/oxycodone, choline magnesium trisalicylate, salsalate

Aldactone vs sodium phosphate: monitor renal fxn: combo may incr. risk of nephrotoxicity and overlapping toxicity

Aldactone vs tacrolimus: monitor potassium: combo may incr. risk of hyperkalemia and additive effects

Aldactone vs tizanidine: caution advised, monitor BP: combo may incr. risk of hypotension and additive effects

Aldactone vs trimethoprim/sulfamethoxazole: monitor potassium: combo may incr. risk of hyperkalemia and additive effects

Aldactone vs apomorphine: caution advised: combo may incr. risk of orthostatic hypotension, MI, pneumonia, falls, other apomorphine adverse effects and additive effects

Aldactone vs aspirin/caffeine/orphenadrine: caution advised w/ high-dose aspirin or salicylates; monitor BP, renal fxn: combo may decr. antihypertensive, diuretic, and natriuretic efficacy, incr. risk of hyperkalemia and inhibition of renal prostaglandins, sodium and fluid retention

Aldactone vs COX 2 inhibitors: caution advised: combo may decr. diuretic, natriuretic, antihypertensive effects of potassium-sparing diuretics and antagonistic effects. COX 2 inhibitors: also know as celecoxib

Aldactone vs diclofenac topical: caution advised, monitor K: combo may decr. diuretic, natriuretic, antihypertensive effects of diuretics; some NSAIDs may incr. risk of hyperkalemia and antagonistic effects, additive effects; up to 10% systemic absorption of diclofenac topical gel; minimal absorption w/ patch. Diclofenac topical: also know as diclofenac epolamine topical, diclofenac topical

Aldactone vs iloprost inhaled: caution advised: combo may incr. risk of hypotension and additive/synergistic effects

Aldactone vs MAOIs, non-selective: caution advised: combo may incr. risk of hypotension and additive effects. MAOIs, non-selective: also know as isocarboxazid, phenelzine, procarbazine, selegiline transdermal, tranylcypromine

Aldactone vs maraviroc: caution advised: combo may incr. risk of orthostatic hypotension and additive effects

Aldactone vs mitotane: caution advised: combo may decr. mitotane efficacy and mechanism unknown

Aldactone vs nitrites/sodium thiosulfate: caution advised: combo w/ nitrites may incr. risk of hypotension and additive effects. Nitrites/sodium thiosulfate: also know as amyl nitrite/sodium nitrite/sodium thiosulfate

Aldactone vs tadalafil: caution advised: combo may incr. risk of hypotension and additive effects

Aldactone: Adverse Reactions

hyperkalemia, severe

agranulocytosis

anaphylaxis

hepatotoxicity

renal failure

nausea

abdominal pain

diarrhea

headache

confusion

hirsutism

gynecomastia

sexual dysfxn

menstrual irregularities

fever

rash

hyperkalemia

metabolic acidosis

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Yes, Aldactone today sold under many names; here is only few:

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