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Moduretic 5-50

Generic Name: amiloride and hydrochlorothiazide (Oral route)

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

Oral route(Tablet)

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

Commonly used brand name(s)

In the U.S.

  • Moduretic 5-50

Available Dosage Forms:

  • Tablet

Therapeutic Class: Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic Class: Amiloride

Chemical Class: Thiazide

Uses For Moduretic 5-50

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 .

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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 Moduretic 5-50

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.

Pediatric

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 .

Geriatric

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 Category Explanation
All Trimesters B Animal 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.

Interactions with 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.

  • Acetyldigoxin
  • Alacepril
  • Arginine
  • Arsenic Trioxide
  • Benazepril
  • Captopril
  • Cilazapril
  • Cyclophosphamide
  • Delapril
  • Deslanoside
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dofetilide
  • Droperidol
  • Enalaprilat
  • Enalapril Maleate
  • Flecainide
  • Fosinopril
  • Imidapril
  • Ketanserin
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Methotrexate
  • Metildigoxin
  • Moexipril
  • Ouabain
  • Pentopril
  • Perindopril
  • Potassium
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Tacrolimus
  • Temocapril
  • Trandolapril
  • 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.

  • Aceclofenac
  • Acemetacin
  • Alacepril
  • Amtolmetin Guacil
  • Aspirin
  • Benazepril
  • Bepridil
  • Bromfenac
  • Bufexamac
  • Captopril
  • Carbamazepine
  • Carbenoxolone
  • Celecoxib
  • Chlorpropamide
  • Cholestyramine
  • Choline Salicylate
  • Cilazapril
  • Clonixin
  • Delapril
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Enalaprilat
  • Enalapril Maleate
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ginkgo
  • Glipizide
  • Gossypol
  • Ibuprofen
  • Ibuprofen Lysine
  • Imidapril
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Licorice
  • Lisinopril
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Quinidine
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Spirapril
  • Sulindac
  • Temocapril
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Topiramate
  • Trandolapril
  • Valdecoxib
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

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 Moduretic 5-50

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 Moduretic 5-50

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 .

Moduretic 5-50 Side Effects

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.

See also: Side effects (in more detail)

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