Moduretic 5-50

Name: Moduretic 5-50

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 .

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.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Alacepril
  • Amphetamine
  • Amtolmetin Guacil
  • Arginine
  • Arsenic Trioxide
  • Aspirin
  • Benazepril
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Captopril
  • Celecoxib
  • Choline Salicylate
  • Cilazapril
  • Clonixin
  • Cyclophosphamide
  • Delapril
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • 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
  • Lisinopril
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • 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.

  • Bepridil
  • Carbamazepine
  • Carbenoxolone
  • Cholestyramine
  • Ginkgo
  • Gossypol
  • Licorice
  • Quinidine
  • Topiramate

What is the most important information I should know about Moduretic 5-50 (hydrochlorothiazide and amiloride)?

You should not use this medicine if you have kidney disease, urination problems, diabetes, or high levels of potassium in your blood.

Some medicines can cause unwanted or dangerous effects when used with hydrochlorothiazide and amiloride. Your doctor may need to change your treatment plan if you use potassium supplements or certain diuretics (spironolactone, triamterene).

If you have diabetes, do not use hydrochlorothiazide and amiloride together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

How should I take Moduretic 5-50 (hydrochlorothiazide and amiloride)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take hydrochlorothiazide and amiloride with food.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated.

If you need surgery or medical tests, tell the doctor ahead of time that you are taking medication that contains hydrochlorothiazide. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light. Do not freeze.

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.

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.

For Healthcare Professionals

Applies to amiloride / hydrochlorothiazide: oral tablet

General

The most common adverse reactions were headache, weakness, nausea/anorexia, dizziness, and rash.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/anorexia, diarrhea, gastrointestinal pain, abdominal pain
Frequency not reported: Constipation, gastrointestinal bleeding, gastrointestinal disturbance, abdominal fullness, vomiting, flatulence

Amiloride:
Frequency not reported: Activation of probable preexisting peptic ulcer, dyspepsia, heartburn, dry mouth

Hydrochlorothiazide:
Frequency not reported: Pancreatitis, sialadenitis, cramping, gastric irritation[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Frequency not reported: Diaphoresis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, alopecia

Amiloride:
Frequency not reported: Alopecia, itching, diaphoresis

Hydrochlorothiazide:
Frequency not reported: Cutaneous vasculitis, photosensitivity, urticaria, purpura, toxic epidermal necrolysis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Syncope, paresthesia/numbness, vertigo, stupor, sleepiness, bad taste

Amiloride:
Frequency not reported: Encephalopathy, tremors, tinnitus, somnolence[Ref]

Other

Common (1% to 10%): Weakness, fatigue/tiredness
Frequency not reported: Malaise, chest pain, digitalis toxicity, gynecomastia

Amiloride:
Frequency not reported: Fatigability

Hydrochlorothiazide:
Frequency not reported: Fever[Ref]

Metabolic

Common (1% to 10%): Serum potassium greater than 5.5 mEq/L
Frequency not reported: Appetite changes, anorexia, thirst, gout, dehydration, symptomatic hyponatremia, electrolyte imbalance, hyponatremia

Hydrochlorothiazide:
Frequency not reported: Electrolyte imbalance, hyperglycemia, hyperuricemia, hypokalemia[Ref]

Cardiovascular

Common (1% to 10%): Arrhythmia
Frequency not reported: Tachycardia, orthostatic hypotension, angina pectoris, flushing

Amiloride:
Frequency not reported: Palpitation, partial heart block increased to complete heart block

Hydrochlorothiazide:
Frequency not reported: Vasculitis[Ref]

Musculoskeletal

Common (1% to 10%): Leg ache
Frequency not reported: Back pain, muscle cramps/spasm, joint pain

Amiloride:
Frequency not reported: Painful extremities, neck/shoulder ache[Ref]

Respiratory

Common (1% to 10%): Dyspnea
Frequency not reported: Hiccups, nasal congestion

Amiloride:
Frequency not reported: Shortness of breath, cough

Hydrochlorothiazide:
Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema[Ref]

Genitourinary

Frequency not reported: Impotence, nocturia, dysuria, incontinence

Amiloride:
Frequency not reported: Bladder spasm, polyuria, urinary frequency

Hydrochlorothiazide:
Frequency not reported: Glycosuria[Ref]

Psychiatric

Frequency not reported: Insomnia, nervousness, depression, mental confusion

Amiloride:
Frequency not reported: Libido decreased

Hydrochlorothiazide:
Frequency not reported: Restlessness[Ref]

Renal

Frequency not reported: Renal dysfunction, renal failure

Hydrochlorothiazide:
Frequency not reported: Interstitial nephritis[Ref]

Ocular

Frequency not reported: Visual disturbance

Amiloride:
Frequency not reported: Intraocular pressure increased

Hydrochlorothiazide:
Frequency not reported: Transient blurred vision, xanthopsia[Ref]

Immunologic

Frequency not reported: Anaphylactic reaction

Hydrochlorothiazide:
Frequency not reported: Anaphylactic reaction[Ref]

Hematologic

Amiloride:
Frequency not reported: Aplastic anemia, neutropenia

Hydrochlorothiazide:
Frequency not reported: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia[Ref]

Hepatic

Amiloride:
Frequency not reported: Abnormal liver function, jaundice

Hydrochlorothiazide:
Frequency not reported: Intrahepatic cholestatic jaundice[Ref]

Some side effects of Moduretic 5-50 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)