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Aldactone



A







Generic Name: spironolactone (Oral route)

spir-on-oh-LAK-tone

Oral route(Tablet)

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Spironolactone should be used only in those conditions specified as indications for use. Unnecessary use of this drug should be avoided .

Commonly used brand name(s)

In the U.S.

Aldactone

Available Dosage Forms:

Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Aldosterone Receptor Antagonist

Uses For Aldactone

Spironolactone is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. It may also be used to treat water retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.

Spironolactone is also used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone.

Spironolactone is a type of a diuretic medicine (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. It can be used to prevent or treat hypokalemia (low potassium levels in the blood).

This medicine is available only with your doctor’s prescription.

Before Using Aldactone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of spironolactone in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of spironolactone in geriatric patients.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Eplerenone Triamterene

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alacepril Arginine Arsenic Trioxide Benazepril Captopril Cilazapril Delapril Digoxin Droperidol Enalaprilat Enalapril Maleate Fosinopril Imidapril Levomethadyl Lisinopril Lithium Moexipril Pentopril Perindopril Potassium Quinapril Ramipril Sotalol Spirapril Tacrolimus Temocapril Trandolapril Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac Acemetacin Alclofenac Apazone Benoxaprofen Bromfenac Bufexamac Carprofen Clometacin Clonixin Dexketoprofen Diclofenac Diflunisal Digitoxin Dipyrone Droxicam Etodolac Etofenamate Felbinac Fenbufen Fenoprofen Fentiazac Floctafenine Flufenamic Acid Flurbiprofen Gossypol Ibuprofen Indomethacin Indoprofen Isoxicam Ketoprofen Ketorolac Licorice Lornoxicam Meclofenamate Mefenamic Acid Meloxicam Nabumetone Naproxen Niflumic Acid Nimesulide Oxaprozin Oxyphenbutazone Phenylbutazone Pirazolac Piroxicam Pirprofen Propyphenazone Proquazone Sulindac Suprofen Tenidap Tenoxicam Tiaprofenic Acid Tolmetin Zomepirac Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anuria (not able to pass urine) or Hyperkalemia (high potassium in the blood) or Kidney disease, severe—Should not be used in patients with these conditions. Electrolyte imbalance (e.g., low chloride, magnesium, potassium, or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Liver disease, severe (e.g., cirrhosis)—Use with caution. May make these conditions worse. Proper Use of Aldactone

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) and potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For edema: Adults—At first, 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. For heart failure: Adults—At first, 25 milligrams (mg) per day. Your doctor may adjust your dose if needed and tolerated. Children—Use and dose must be determined by your doctor. For high blood pressure: Adults—At first, 50 to 100 milligrams (mg) per day, given in either single or divided doses. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. For low potassium in the blood: Adults—25 to 100 milligrams (mg) per day. Children—Use and dose must be determined by your doctor. For too much aldosterone in the body: Adults—400 milligrams (mg) for 4 days, or 400 mg per day for 3 to 4 weeks to diagnose the condition. Then, 100 to 400 mg per day after the diagnosis is confirmed. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Aldactone

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium; or certain diuretics such as amiloride (Midamor®, Moduretic®), triamterene (Dyazide®, Dyrenium®, Maxzide®), or other products containing spironolactone (Aldactazide®).

This medicine may increase the amount of potassium in your blood (hyperkalemia). Stop using this medicine and check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having medical tests. The results of some tests may be affected by this medicine.

This medicine may cause the formation of certain tumors in your body. Check with your doctor right away if you notice an unusual lump anywhere in your body or if you have any unusual signs or symptoms while you are using this medicine.

Aldactone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known Abdominal or stomach cramping, burning, or tenderness bloody or black, tarry stools bloody urine chills clay-colored stools clear or bloody discharge from the nipple cloudy urine constipation cough or hoarseness dark urine decrease in urine output or decrease in urine-concentrating ability decreased appetite diarrhea difficulty with swallowing dimpling of the breast skin dizziness fast heartbeat fever with or without chills general feeling of tiredness or weakness headache heartburn hives increased blood pressure increased thirst indigestion inverted nipple itching loss of appetite lower back or side pain lump in the breast or under the arm nausea and vomiting painful or difficult urination persistent crusting or scaling of the nipple puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness or swelling of the breast severe stomach pain shakiness and unsteady walk shortness of breath skin rash sore on the skin of the breast that does not heal sore throat sores, ulcers, or white spots on the lips or in the mouth swelling of the face, fingers, feet, or lower legs swollen, painful, or tender lymph glands in the neck, armpit, or groin tightness in the chest troubled breathing unpleasant breath odor unsteadiness, trembling, or other problems with muscle control or coordination unusual bleeding or bruising unusual tiredness or weakness vomiting of blood or material that looks like coffee grounds weight gain wheezing yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Coma confusion convulsions difficulty with breathing drowsiness irregular heartbeat muscle pain or cramps nervousness numbness or tingling in the hands, feet, or lips rash with flat lesions or small raised lesions on the skin reddened skin swelling of the ankles or hands weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known Burning feeling in the chest or stomach sores, welting, or blisters stomach upset swelling of the breasts or breast soreness in both females and males unusual dullness or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Aldactone side effects (in more detail)

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More Aldactone resources Aldactone Side Effects (in more detail)Aldactone DosageAldactone Use in Pregnancy & BreastfeedingDrug ImagesAldactone Drug InteractionsAldactone Support Group9 Reviews for Aldactone - Add your own review/rating Aldactone Prescribing Information (FDA) Aldactone Consumer Overview Aldactone Monograph (AHFS DI) Aldactone MedFacts Consumer Leaflet (Wolters Kluwer) Spironolactone Prescribing Information (FDA) Spironolactone Professional Patient Advice (Wolters Kluwer) Compare Aldactone with other medications AcneAlopeciaEdemaHeart FailureHigh Blood PressureHirsutismHypokalemiaPrimary HyperaldosteronismPrimary Hyperaldosteronism Diagnosis





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