Pronunciation:

a-MIL-oh-ride hye-droe-KLOR-ide, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Moduretic 5-50

Dosage Forms:

• Tablet

Warnings:

May cause hyperkalemia, which is potentially fatal if uncorrected. The risk is higher in patients with renal impairment or diabetes mellitus. Monitor serum potassium levels carefully in any patient receiving therapy. .

Classifications:

Therapeutic—

Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic—

Amiloride

Chemical—

Thiazide

Uses of This Medicine:

Amiloride and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

This medicine is also used to treat water retention (edema) in patients with congestive heart failure.

Amiloride 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. Amiloride keeps your body from losing too much potassium when urine flow is increased.

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 amiloride and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of amiloride and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require an adjustment in the dose for patients receiving amiloride and hydrochlorothiazide combination.

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.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Alacepril
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arginine
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Bupropion
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Dapagliflozin
• Delapril
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Dofetilide
• 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 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
• Carbenoxolone
• Cholestyramine
• Ginkgo
• Gossypol
• Licorice
• Quinidine

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Potassium Containing Food

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
• Diabetes or
• Hyperkalemia (high potassium in the blood) or
• Kidney disease (eg, anuria or diabetic nephropathy) or
• Sulfa drug allergy—Should not be used in patients with these conditions.

• Gout or
• Hyperuricemia (high uric acid in the blood) or
• Hypochloremia (low chloride in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Parathyroid disease or
• Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse.

• Heart disease or
• Liver disease, severe (eg, cirrhosis or hepatic encephalopathy) or
• Lung disease—Use with caution. May increase the chance of side effects.

Proper Use of This Medicine:

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

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. 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 including heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the tablet whole. Do not break, crush, or chew it. It is best to take this medicine with food.

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 hypertension or edema:
    • Adults—At first, one tablet once a day. Your doctor may adjust your dose if needed. Each tablet contains 50 milligrams (mg) hydrochlorothiazide and 5 mg amiloride.
    • 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.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness of the legs.

Make sure your doctor knows if you are also taking potassium supplements or salt substitutes containing potassium, or certain diuretics such as spironolactone (Aldactazide®, Aldactone®), triamterene (Dyrenium®), or other products containing amiloride. Using these medicines together may cause serious problems.

This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Dizziness may be worse if you lose too much water from your body. You can lose water by sweating, having diarrhea, or vomiting. Tell your doctor if this medicine makes you feel lightheaded or dizzy after you have been vomiting or had diarrhea.

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 over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

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:

More common

Confusion

difficulty breathing

irregular heartbeat

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

stomach pain

trouble breathing

weakness or heaviness of the legs

Less common

Dizziness

fainting

fast or slow heartbeat

labored breathing

tightness in the chest

Rare

Ankle, knee, or great toe joint pain

arm, back, or jaw pain

blistering, peeling, or loosening of the skin

bloody or black, tarry stools

bloody urine

burning while urinating

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

chest pain, discomfort, or heaviness

chills

cloudy urine

cold sweats

coma

constipation

cough

cracks in the skin

decreased awareness or responsiveness

decreased frequency or amount of urine

diarrhea

difficult or painful urination

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

dry mouth

fever

headache

increase in heart rate

increased blood pressure

increased thirst

itching

joint pain, stiffness, or swelling

lightheadedness

loss of appetite

loss of heat from the body

lower back or side pain

muscle pain or cramps

pounding heartbeat or pulse

rapid breathing

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

seizures

severe sleepiness

severe stomach pain

sore throat

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

sunken eyes

sweating

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

trouble breathing

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weight gain

wrinkled skin

Incidence not known

Persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

white, yellow or scar-like area

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

Symptoms of overdose

Drowsiness

irritability

mood changes

pain or weakness in the hands or feet

trembling

weak pulse

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:

More common

Rash

weight loss

Less common

Leg ache

Rare

Bad taste

bloated, full feeling

blurred or loss of vision

changes in appetite

decreased interest in sexual intercourse

discouragement

disturbed color perception

double vision

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

feeling of warmth

feeling sad or empty

general feeling of discomfort or illness

hair loss or thinning of hair

hiccups

inability to have or keep an erection

increased sweating

increased urge to urinate during the night

indigestion

loss in sexual ability, desire, drive, or performance

loss of bladder control

loss of interest or pleasure

muscle spasm

night blindness

overbright appearance of lights

passing of gas

redness of the face, neck, arms, and occasionally upper chest

seeing halos around lights

sensation of spinning

sleepiness

sleeplessness

stomach fullness or discomfort

stuffy nose

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

trouble concentrating

trouble sleeping

tunnel vision

unable to sleep

waking to urinate at night

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.