Pronunciation:

spir-on-oh-LAK-tone, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Aldactazide

Dosage Forms:

• Tablet

Warnings:

This drug has been reported to be tumorigenic in rat chronic toxicity studies. Use this drug only as indicated. Fixed-dose spironolactone/hydrochlorothiazide is not indicated for the initial treatment of edema or hypertension .

Classifications:

Therapeutic—

Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic—

Aldosterone Receptor Antagonist

Chemical—

Thiazide

Uses of This Medicine:

Spironolactone and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). 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 helps prevent 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).

Spironolactone and hydrochlorothiazide are both diuretic medicines (water pills). They reduce the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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.

• Dofetilide
• 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
• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Alacepril
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arginine
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Cosyntropin
• Cyclosporine
• Dapagliflozin
• Delapril
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalaprilat
• Enalapril Maleate
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Imidapril
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Mitotane
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oliceridine
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentopril
• Perindopril
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium
• Potassium Phosphate
• Pramlintide
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Repotrectinib
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sparsentan
• Spirapril
• Sufentanil
• Sulindac
• Tacrolimus
• Tapentadol
• Temocapril
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Tramadol
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Vonoprazan
• 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.

• Aminolevulinic Acid
• Bepridil
• Carbamazepine
• Cholestyramine
• Digitoxin
• Ginkgo
• 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
• Hypercalcemia (high calcium in the blood) or
• Hyperkalemia (high potassium in the blood) or
• Kidney disease, severe or
• Liver disease, severe or
• Sulfa drug allergy, history of—Should not be used in patients with these conditions.

• Asthma, history of—May increase likelihood of having an allergic reaction.

• Diabetes or
• Electrolyte imbalances (eg, low chloride, magnesium, potassium, or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle-closure or
• Gout or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Liver disease or
• Myopia (changes in the eyeball causing vision problems), acute or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Sympathectomy—Blood pressure–lowering effects of this medicine may be increased.

Proper Use of This Medicine:

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.

Swallow the tablet whole. Do not break, crush, or chew it.

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) each of spironolactone and hydrochlorothiazide 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 high blood pressure:
    • Adults—At first, 50 to 100 milligrams (mg) each of spironolactone and hydrochlorothiazide 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.

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 This Medicine:

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 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 (Aldactone®).

Check with your doctor immediately if blurred vision, difficulty reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

This medicine may cause dizziness, drowsiness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to this medicine before you drive, use machines, 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.

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 affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

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.

This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

Back or leg pains

blistering, peeling, or loosening of the skin

bloody or black, tarry stools

bloody or cloudy urine

blue lips and fingernails

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

clay-colored stools

clear or bloody discharge from the nipple

confusion

cough or hoarseness

dark urine

decreased appetite

diarrhea

difficult, fast, or noisy breathing

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast or irregular heartbeat

fever with or without chills

flushed, dry skin

fruit-like breath odor

general body swelling

general feeling of discomfort or illness

greatly decreased frequency of urination or amount of urine

hives or welts, skin rash

increased hunger

increased thirst

inverted nipple

joint pain, stiffness, or swelling

lower back or side pain

lump in the breast or under the arm

muscle cramps or pain

nausea and vomiting

numbness, tingling, pain, or weakness in the hands, feet, or lips

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

persistent non-healing sore

pink growth

pinpoint red or purple spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

reddish patch or irritated area

redness or swelling of the breast

redness, soreness, or itching skin

seizures

shiny bump

sore on the skin of the breast that does not heal

sores, ulcers, or white spots on the lips or in the mouth

stomach cramping, burning, or tenderness

swelling of the face, hands, fingers, feet, or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trembling

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

white, yellow or waxy scar-like area

yellow eyes or skin

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

Symptoms of overdose

Difficulty with sleeping

disorientation

drowsiness to profound coma

hallucination

lethargy

lightheadedness

mood or other mental changes

rash with flat lesions or small raised lesions on the skin

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

Absent, missed, or irregular menstrual periods

bleeding after menopause

burning feeling in the chest or stomach

discoloration of the skin

feeling of constant movement of self or surroundings

inability to have or keep an erection

increased sensitivity of the skin to sunlight

muscle spasm

restlessness

sensation of spinning

severe sunburn

stomach upset

stopping of menstrual bleeding

swelling of the breasts or breast soreness in both females and males

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.