Amiloride And Hydrochlorothiazide (Oral Route)

    Amiloride And Hydrochlorothiazide (Oral Route)

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    Description and Brand Names of Amiloride And Hydrochlorothiazide (Oral Route)

    US Brand Name

    1. Moduretic 5-50

    Descriptions

    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 .

    This product is available in the following dosage forms:

    • Tablet

    Before Using Amiloride And Hydrochlorothiazide (Oral Route)

    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

    Breastfeeding

    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.

    Drug Interactions

    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

    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 Amiloride And Hydrochlorothiazide (Oral Route)

    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

    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 Amiloride And Hydrochlorothiazide (Oral Route)

    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

    1. Abdominal pain
    2. confusion
    3. difficulty breathing
    4. irregular heartbeats
    5. nausea or vomiting
    6. nervousness
    7. numbness or tingling in the hands, feet, or lips
    8. shortness of breath
    9. weakness or heaviness of the legs

    Less common

    1. Dizziness
    2. fainting
    3. fast or slow heartbeat
    4. labored breathing
    5. tightness in the chest
    6. wheezing

    Rare

    1. Ankle, knee, or great toe joint pain
    2. arm, back, or jaw pain
    3. blistering, peeling, or loosening of the skin
    4. bloody or black, tarry stools
    5. bloody urine
    6. burning while urinating
    7. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    8. chest pain, discomfort, or heaviness
    9. chills
    10. cloudy urine
    11. cold sweats
    12. coma
    13. constipation
    14. convulsions
    15. cough
    16. cracks in the skin
    17. decreased awareness or responsiveness
    18. decreased frequency or amount of urine
    19. diarrhea
    20. difficult or painful urination
    21. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    22. dry mouth
    23. fever
    24. headache
    25. increase in heart rate
    26. increased blood pressure
    27. increased thirst
    28. itching
    29. joint pain, stiffness, or swelling
    30. lightheadedness
    31. loss of appetite
    32. loss of heat from the body
    33. lower back or side pain
    34. muscle pain or cramps
    35. pounding heartbeat or pulse
    36. rapid breathing
    37. red skin lesions, often with a purple center
    38. red, irritated eyes
    39. red, swollen skin
    40. scaly skin
    41. severe sleepiness
    42. severe stomach pain
    43. sore throat
    44. sores, ulcers, or white spots in the mouth or on the lips
    45. sunken eyes
    46. sweating
    47. swelling of the face, ankles, hands, fingers, or lower legs
    48. troubled breathing
    49. unusual tiredness or weakness
    50. vomiting of blood or material that looks like coffee grounds
    51. weight gain
    52. wrinkled skin

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

    Symptoms of overdose

    1. Drowsiness
    2. irritability
    3. mood changes
    4. pain or weakness in the hands or feet
    5. trembling
    6. 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

    1. Rash
    2. weight loss

    Less common

    1. Leg ache
    2. stomach pain

    Rare

    1. Bad taste
    2. bloated, full feeling
    3. blurred or loss of vision
    4. changes in appetite
    5. decreased interest in sexual intercourse
    6. discouragement
    7. disturbed color perception
    8. double vision
    9. excess air or gas in the stomach or intestines
    10. feeling of constant movement of self or surroundings
    11. feeling of warmth
    12. feeling sad or empty
    13. general feeling of discomfort or illness
    14. hair loss or thinning of hair
    15. hiccups
    16. inability to have or keep an erection
    17. increased sweating
    18. increased urge to urinate during the night
    19. indigestion
    20. loss in sexual ability, desire, drive, or performance
    21. loss of bladder control
    22. loss of interest or pleasure
    23. muscle spasm
    24. night blindness
    25. overbright appearance of lights
    26. passing of gas
    27. redness of the face, neck, arms, and occasionally upper chest
    28. seeing halos around lights
    29. sensation of spinning
    30. sleepiness
    31. sleeplessness
    32. stomach fullness or discomfort
    33. stuffy nose
    34. swelling of the breasts or breast soreness in both females and males
    35. trouble concentrating
    36. trouble sleeping
    37. tunnel vision
    38. unable to sleep
    39. 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.