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Amiloride and hydrochlorothiazide (Oral route)

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:

Oral route(Tablet)

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 .

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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
  • 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.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Alacepril
  • Amphetamine
  • Amtolmetin Guacil
  • Arginine
  • Arsenic Trioxide
  • Aspirin
  • Benazepril
  • Benzphetamine
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Captopril
  • Celecoxib
  • Choline Salicylate
  • Cilazapril
  • Clonixin
  • Cyclophosphamide
  • Delapril
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Diclofenac
  • Diflunisal
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Dofetilide
  • Droperidol
  • Droxicam
  • Enalaprilat
  • Enalapril Maleate
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ibuprofen
  • Imidapril
  • Indomethacin
  • Ketanserin
  • Ketoprofen
  • Ketorolac
  • Levomethadyl
  • Lisdexamfetamine
  • Lisinopril
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Methamphetamine
  • Methotrexate
  • Metildigoxin
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Ouabain
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Potassium
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sotalol
  • Spirapril
  • Sulindac
  • Temocapril
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Trandolapril
  • Trimethoprim
  • Valdecoxib
  • 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
  • Topiramate

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:

  • Diabetes or
  • Hyperkalemia (high potassium in the blood) or
  • Kidney disease (e.g., anuria or diabetic nephropathy)—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 (e.g., cirrhosis or hepatic encephalopathy) or
  • Lung disease—Use with caution. May increase the chance of side effects .

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. 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 .

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—One tablet once a day. Your doctor may increase 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 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 .

This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal pain; confusion; difficulty breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs .

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
Abdominal pain
confusion
difficulty breathing
irregular heartbeats
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
shortness of breath
weakness or heaviness of the legs
Less common
Dizziness
fainting
fast or slow heartbeat
labored breathing
tightness in the chest
wheezing
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
convulsions
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
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
troubled breathing
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
weight gain
wrinkled skin

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
stomach pain
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.


Last Updated: 9/4/2017
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