Description
Spironolactone is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. Lowering blood pressure can reduce the risk of strokes and heart attacks. Spironolactone is also used to lessen the need for hospitalization for heart failure.
Spironolactone is also used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone. This medicine may also be used to treat fluid retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.
Spironolactone is a potassium-sparing diuretic (water pill). It prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. This medicine is also used to treat or prevent hypokalemia (low potassium levels in the blood).
This medicine is available only with your doctor’s prescription.
This product is available in the following dosage forms:
- Tablet
- Suspension
Before Using
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
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of spironolactone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving spironolactone.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
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.
- Colchicine
- Eplerenone
- Potassium Citrate
- 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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Alacepril
- Amtolmetin Guacil
- Arginine
- Arsenic Trioxide
- Aspirin
- Benazepril
- Benzhydrocodone
- Bromfenac
- Bufexamac
- Buprenorphine
- Captopril
- Cefepime
- Celecoxib
- Choline Salicylate
- Cilazapril
- Clonixin
- Codeine
- Cosyntropin
- Cyclosporine
- Dabigatran Etexilate
- Delapril
- Dexibuprofen
- Dexketoprofen
- Diazoxide
- Diclofenac
- Diflunisal
- Digoxin
- Dihydrocodeine
- Dipyrone
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Droperidol
- Droxicam
- Enalaprilat
- Enalapril Maleate
- Ensartinib
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.
- Digitoxin
- Gossypol
- Licorice
Other Interactions
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:
- Addison's disease (adrenal problem) or
- 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 (eg, low chloride, magnesium, or sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Gout or
- Kidney disease or
- Liver disease, severe (eg, cirrhosis)—Use with caution. May make these conditions worse.
Proper Use
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.
You may take this medicine with or without food, but it should be taken the same way (with or without food) each day.
Shake the oral liquid well before each use. Measure it with a marked measuring spoon, oral syringe, or medicine cup.
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 edema:
- For oral dosage form (suspension):
- Adults—At first, 75 milligrams (mg) (15 milliliters [mL]) per day, taken in either single or divided doses. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—At first, 100 milligrams (mg) per day, taken in either single or divided doses. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- For heart failure:
- For oral dosage form (suspension):
- Adults—At first, 20 milligrams (mg) (4 milliliters [mL]) per day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- For high blood pressure:
- For oral dosage form (suspension):
- Adults—At first, 20 milligrams (mg) (4 milliliters [mL]) to 75 mg (15 mL) per day, taken 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 oral dosage form (tablets):
- Adults—At first, 25 to 100 milligrams (mg) per day, taken in either single or divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- For too much aldosterone in the body:
- For oral dosage form (tablets):
- Adults—Use and dose must be determined by your doctor. The dose is usually 100 to 400 milligrams (mg) per day to prepare for surgery.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
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
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 and urine tests may be needed to check for unwanted effects.
Do not take this medicine together with eplerenone (Inspra®). Using these medicines together may cause serious 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, certain diuretics (eg, amiloride, triamterene (Dyazide®, Dyrenium®, Maxzide®, Midamor®, Moduretic®), or other products containing spironolactone (Aldactazide®).
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs. Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
Spironolactone may worsen kidney function in patients with low to no salt in their body or in those who take other blood pressure medicines (eg, ARB, ACE inhibitor). Talk to your doctor if you have concerns about this.
Dizziness, lightheadedness, or fainting may also occur, especially when you get up suddenly from a lying or sitting position. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.
This medicine may also cause electrolyte imbalances (including low sodium, magnesium, and calcium in the blood, hypochloremic alkalosis) and an increase in your uric acid and blood sugar levels. Talk to your doctor if you have concerns.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.
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.
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
- Bleeding gums
- bloody or black, tarry stools
- bloody urine
- blurred vision
- breast pain
- chest pain
- clay-colored stools
- clear or bloody discharge from the nipple
- cloudy urine
- confusion
- constipation
- cough
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- diarrhea
- difficulty with swallowing
- dimpling of the breast skin
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- fast or irregular heartbeat
- fever with or without chills
- general feeling of tiredness or weakness
- headache
- heartburn
- hives, itching, or skin rash
- hoarseness
- increased thirst
- indigestion
- inverted nipple
- loss of appetite
- loss of consciousness
- lower back or side pain
- lump in the breast or under the arm
- muscle pain or cramps
- muscle spasms or twitching
- nausea
- painful or difficult urination
- persistent crusting or scaling of the nipple
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness or swelling of the breast
- seizures
- severe stomach pain
- shakiness and unsteady walk
- 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
- stomach cramping, burning, or tenderness
- swelling of the face, fingers, feet, ankles, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- trembling
- troubled breathing
- unpleasant breath odor
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- weight gain
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Irregular heartbeat
- nervousness
- numbness or tingling in the hands, feet, or lips
- rash with flat lesions or small raised lesions on the skin
- reddened skin
- 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
- decreased interest in sexual intercourse
- hair loss or thinning of the hair
- inability to have or keep an erection
- leg cramps
- loss in sexual ability, desire, drive, or performance
- pain in the nipples
- sores, welts, 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.
DRG-20071534
