Amiloride

Amiloride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• heartburn
• loss of appetite
• nausea
• diarrhea
• vomiting
• gas

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• dry mouth; thirst; numbness and tingling; confusion; muscle weakness, stomach pain, or cramps; fast heartbeat and other signs of dehydration and electrolyte imbalance
• yellowing of the skin or eyes
• chest pain
• rash
• itching
• hives
• difficulty breathing or swallowing

Amiloride may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

• Midamor^®

Amiloride is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Amiloride is used to treat or prevent hypokalemia (low potassium levels in the blood) in people with high blood pressure or congestive heart failure.

Amiloride is usually given together with other medicines.

Amiloride may also be used for purposes not listed in this medication guide.

You should not use amiloride if you have kidney problems, if you are unable to urinate, or if you have high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking amiloride.

Amiloride can raise the levels of potassium in your blood. You will need frequent blood tests while taking this medicine.

Call your doctor right away if you have unusual tiredness, numbness or tingling, slow heartbeats, muscle weakness or limp feeling.

You should not use amiloride if you are allergic to it, or if:

• you have kidney disease or are unable to urinate;
• you have problems with your kidneys caused by diabetes;
• you have high potassium levels (hyperkalemia);
• you take a potassium supplement; or
• you take another potassium-sparing diuretic such Moduretic, spironolactone, or triamterene.

To make sure amiloride is safe for you, tell your doctor if you have:

• diabetes;
• heart disease;
• breathing problems;
• cirrhosis or other liver disease;
• if you are on a low-salt diet; or
• if you are severely ill or debilitated.

Amiloride is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether amiloride passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Amiloride may be found in some form under the following brand names:

• Midamor

• Moduretic

Amiloride is part of the drug class:

• Other potassium sparing agents

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amiloride falls into category B. There are no well-done studies that have been done in humans with amiloride. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Take amiloride exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The amiloride dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Amiloride is usually taken with another diuretic. 

The recommended starting dose is 5 mg once daily. The dose may be increased to 10 mg once daily.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take amiloride with food.

Your doctor may recommend you eat certain foods or take supplements to keep your potassium from getting too low. Follow the diet and medication plan created for you by your doctor or nutrition counselor.

While using amiloride, you will need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using amiloride. You may need to stop taking amiloride at least 3 days before having a glucose tolerance test.

Store at room temperature away from moisture, heat, or freezing temperatures.

In the U.S.

• Midamor

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic, Potassium Sparing

Amiloride is used in combination 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 .

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

Amiloride is a type of diuretic (water pill) that helps prevent your body from losing too much potassium. It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure .

amiloride is available only with your doctor's prescription .

In addition to the use of amiloride, 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 amiloride 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 amiloride with food .

Dosing

The dose of amiloride 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 amiloride. 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—5 milligrams (mg) 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 amiloride, 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.

It is very important that your doctor check your progress at regular visits to make sure amiloride 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 .

amiloride 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 .

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:

• Abdominal pain
• confusion
• difficulty with breathing
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• weakness or heaviness of the legs

• Agitation
• back pain
• blurred vision
• coma
• dizziness
• drowsiness
• fever
• hallucinations (seeing things that aren't there)
• headache
• irritability
• labored breathing
• mood or mental changes
• seizures (convulsions)
• stiff neck
• tightness in the chest
• unusual tiredness or weakness
• vomiting
• wheezing

• Arm or jaw pain
• bloody or black, tarry stools
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in vision
• chest pain, discomfort, or heaviness
• chills
• clay-colored stools
• cold sweats
• constipation
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fainting
• fast, pounding, racing, or slow heartbeat or pulse
• itching
• light-colored stools
• loss of appetite
• loss of vision
• rash
• shakiness in the legs, arms, hands, or feet
• stomach pain, severe
• sweating
• trembling or shaking of the hands or feet
• unpleasant breath odor
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

• Continuing stomach pain
• cough
• lower back or side pain
• pale skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• unusual bleeding or bruising

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

• Decreased urination
• dry mouth
• increase in heart rate
• lightheadedness
• muscle cramps or pain
• pain or weakness in the hands or feet
• rapid breathing
• sunken eyes
• thirst
• wrinkled 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:

• Diarrhea
• weight loss

• Changes in appetite
• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

• Acid or sour stomach
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• discouragement
• disturbed color perception
• double vision
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• feeling sad or empty
• frequent urination
• full or bloated feeling
• hair loss or thinning of hair
• hearing loss
• increased need to urinate
• increased volume of pale, dilute urine
• indigestion
• joint pain
• leg ache or pain
• loss of interest or pleasure
• neck or shoulder ache
• night blindness
• overbright appearance of lights
• pain in the chest below the breastbone
• passing of gas
• passing urine more often
• pressure in the stomach
• seeing halos around lights
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• stomach fullness, discomfort, or upset
• stuffy nose
• swelling of abdominal or stomach area
• swelling of the breasts or breast soreness in both females and males
• trouble concentrating
• trouble sleeping
• tunnel vision
• unable to sleep

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.

• It is used to treat or prevent low potassium levels.
• It may be given to you for other reasons. Talk with the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Electrolyte Imbalance and BUN Increases

Hyponatremia and hypochloremia may occur when Amiloride HCl is used with other diuretics and increases in BUN levels have been reported. These increases usually have accompanied vigorous fluid elimination, especially when diuretic therapy was used in seriously ill patients, such as those who had hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema. Therefore, when Amiloride HCl is given with other diuretics to such patients, careful monitoring of serum electrolytes and BUN levels is important. In patients with pre-existing severe liver disease, hepatic encephalopathy, manifested by tremors, confusion, and coma, and increased jaundice, have been reported in association with diuretics, including Amiloride HCl.

When Amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See WARNINGS).

Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy.

In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Amiloride HCl and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including Amiloride HCl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

Blocks epithelial sodium channels in the late distal convoluted tubule (DCT), and collecting duct which inhibits sodium reabsorption from the lumen. This effectively reduces intracellular sodium, decreasing the function of Na+/K+ATPase, leading to potassium retention and decreased calcium, magnesium, and hydrogen excretion. As sodium uptake capacity in the DCT/collecting duct is limited, the natriuretic, diuretic, and antihypertensive effects are generally considered weak.

Absorption

30% to 90% (Macfie 1981)

Distribution

Vd: 350 to 380 L (Macfie 1981)

Metabolism

Does not undergo hepatic metabolism

Excretion

Urine (~50%; as unchanged drug); feces (~40%)

Oral: Geriatric patients also show decreased clearance of amiloride: use with caution. Refer to adult dosing.

Do not use potassium-containing salt substitutes.

I & O, daily weights, blood pressure, serum electrolytes, renal function; signs/symptoms of hyperkalemia

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your pharmacist can provide more information about amiloride.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Animal studies have shown that amiloride is excreted into rat milk in concentrations higher than those found in blood.

There are no data on the excretion of amiloride into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.