Spironolactone and hydrochlorothiazide (Oral)

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.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working correctly and to decide if you should keep taking it. Blood and urine tests may be needed to look for unwanted effects.

Do not take other medicines unless your doctor has discussed them with you. This is especially true for potassium supplements or salt substitutes with potassium, certain diuretics (like amiloride, triamterene (Dyazide®, Dyrenium®, Maxzide®, Midamor®, Moduretic®), or other products containing spironolactone (Aldactone®).

Contact your doctor right away if you experience blurred vision, difficulty reading, eye pain, or any other changes in your vision during or after treatment. These could be signs of a serious eye problem, and your doctor may want an eye specialist to check your eyes.

This medicine may cause dizziness, drowsiness, lightheadedness, or fainting, especially when you suddenly get up from lying down or sitting. Be aware of how this medicine affects you before you drive, operate machinery, or do anything that could be dangerous. If you feel dizzy, lie down to avoid fainting, then sit for a few moments before standing up to prevent the dizziness from returning.

Contact your doctor immediately if you become ill while taking this medicine, particularly if you have severe or ongoing nausea, vomiting, or diarrhea that does not stop. These issues may lead to losing too much water or salt and could cause 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 your blood sugar levels. Check with your doctor if you notice any changes in your blood or urine sugar test results.

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

This medicine may increase your risk of developing skin cancer (such as non-melanoma skin cancer). Avoid sun exposure and use sunscreen when outdoors. Stay away from sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when combined with this medicine. Inform your doctor if you are consuming alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless your doctor has discussed them with you. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks and benefits. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how the age of children affects the use of spironolactone and hydrochlorothiazide combination. Safety and effectiveness have not been established.

Geriatric

There is no information on how age affects the use of spironolactone and hydrochlorothiazide combination in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits against the possible risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines can be used together even if there might be an interaction. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not a complete list.

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 needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• 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
• 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
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentopril
• Perindopril
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium
• Potassium Phosphate
• Pramlintide
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sparsentan
• Spirapril
• Sulindac
• Tacrolimus
• Tapentadol
• Temocapril
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Zofenopril

Using this medicine with any of the following medicines may increase the chance of certain side effects, but using both medicines might be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Aminolevulinic Acid
• Bepridil
• Carbamazepine
• Cholestyramine
• Digitoxin
• Ginkgo
• Gossypol
• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal issue) or
• Anuria (not able to pass urine) or
• Hypercalcemia (high calcium in the blood) or
• Hyperkalemia (high potassium in the blood) or
• Severe kidney disease or
• Severe liver disease or
• History of sulfa drug allergy—Should not be used in patients with these conditions.

• History of asthma—May increase the chance of having an allergic reaction.

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

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

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.

In the U.S.

• Aldactazide

Available Dosage Forms:

• Tablet

Therapeutic Class: Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic Class: Aldosterone Receptor Antagonist

Chemical Class: Thiazide

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.