Brand Names:

• Dyazide
• Maxzide
• Moduretic 5-50

Dosage Forms:

• Capsule
• Tablet

Uses of This Medicine:

This medicine is a combination of two diuretics (water pills). It is commonly used to help reduce the amount of water in the body.

This combination is also used to treat high blood pressure (hypertension). High blood pressure adds to the work load 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.

Diuretics help to reduce the amount of water in the body by acting on the kidneys to increase the flow of urine. This also helps to lower blood pressure.

This combination is also used to treat problems caused by too little potassium in the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Studies on this combination medicine have been done only in adult patients, and there is no specific information comparing use of potassium-sparing diuretic and hydrochlorothiazide combinations in children with use in other age groups.

Older adults

Dizziness or lightheadedness and signs and symptoms of too much potassium in the body or too little potassium in the body may be more likely to occur in the elderly, who are more sensitive than younger adults to the effects of this medicine.

Pregnancy

In general, diuretics are not useful for normal swelling of feet and hands that occurs during pregnancy. They should not be taken during pregnancy unless recommended by your doctor.

Breast-feeding

Hydrochlorothiazide and spironolactone pass into breast milk. It is not known whether amiloride or triamterene passes into breast milk. Hydrochlorothiazide may also decrease the flow of breast milk. Therefore, you should avoid use of potassium-sparing diuretic and hydrochlorothiazide combinations during the first month of breast-feeding.

Other medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Amiloride
• Dofetilide
• Eplerenone
• Spironolactone
• Triamterene

Using medicines in this class 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
• 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

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.

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or
• Kidney disease or
• Liver disease Higher blood levels of potassium may occur, which may increase the chance of side effects.

• Gout (history of) or
• Kidney stones (history of) Triamterene and hydrochlorothiazide combination may make these conditions worse.

• Heart or blood vessel disease These medicines may cause high cholesterol levels or high triglyceride levels.

• Lupus erythematosus (history of) or
• Pancreatitis (inflammation of pancreas) Potassium-sparing diuretic and hydrochlorothiazide combinations may make these conditions worse.

• Menstrual problems in women or breast enlargement in men Spironolactone and hydrochlorothiazide combination may make these conditions worse.

Proper Use of This Medicine:

This medicine may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After you have taken the medicine for a while, these effects should lessen. In general, to keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.
• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea, vomiting, stomach pain, or cramps) continues, check with your doctor.

For patients taking this medicine for high blood pressure:

• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care 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. Therefore, 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.

Dosing

The dose medicines in this class 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 these medicines. 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 high blood pressure or lowering the amount of water in the body:
    • Adults 1 or 2 tablets a day.
    • Children Dose must be determined by your doctor.

• For oral dosage form (tablets):
  • For high blood pressure or lowering the amount of water in the body:
    • Adults 1 to 4 tablets a day.
    • Children Dose is based on body weight and must be determined by your doctor.

• For oral dosage form (capsules):
  • For high blood pressure or lowering the amount of water in the body:
    • Adults 1 or 2 capsules once a day.
    • Children Dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For high blood pressure or lowering the amount of water in the body:
    • Adults 1 to 4 tablets a day, depending on the strength of your tablet.
    • Children 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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

This medicine may cause a loss or increase of potassium in your body. Your doctor may have special instructions about whether or not you need to eat or drink foods or beverages that have a high potassium content (for example, orange or other citrus fruit juices), taking a potassium supplement, or using salt substitutes. Since too much potassium can be harmful, it is important not to change your diet on your own. Tell your doctor if you are already on a special diet (as for diabetes). Since salt substitutes and low-sodium milk may contain potassium, do not use them unless told to do so by your doctor. Check with your health care professional if you need a list of foods that are high in potassium or if you have any questions

Check with your doctor if you become sick and have severe or continuing vomiting or diarrhea. These problems may cause you to lose additional water and potassium and lead to low blood pressure.

For diabetic patients:

• Hydrochlorothiazide (contained in this combination medicine) may raise blood sugar levels. While you are taking this medicine, be especially careful in testing for sugar in your blood or urine.

Potassium-sparing diuretics and hydrochlorothiazide may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.
• If you have a severe reaction from the sun, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking triamterene and hydrochlorothiazide combination:

• Do not change brands of triamterene and hydrochlorothiazide without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

For patients taking this medicine for high blood pressure:

• Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Tell the doctor in charge that you are taking this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

In rats, spironolactone has been found to increase the risk of development of tumors. However, the doses given were many times the dose of spironolactone given to humans. It is not known whether spironolactone causes tumors in humans.

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 as soon as possible if any of the following side effects occur:

Rare

Black, tarry stools

blood in urine or stools

cough or hoarseness

fever or chills

joint pain

lower back or side pain

painful or difficult urination

pinpoint red spots on skin

skin rash or hives

stomach pain (severe) with nausea and vomiting

unusual bleeding or bruising

yellow eyes or skin

Rare

(Reported for triamterene only)

Bright red tongue

burning, inflamed feeling in tongue

cracked corners of mouth

Signs and symptoms of changes in potassium

Confusion

dryness of mouth

increased thirst

irregular heartbeat

mood or mental changes

muscle cramps or pain

numbness or tingling in hands, feet, or lips

shortness of breath or difficulty breathing

unusual tiredness or weakness

weak pulse

weakness or heaviness of legs

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

(less common with triamterene)

Loss of appetite

nausea and vomiting

stomach cramps and diarrhea

upset stomach

Less common

Decreased sexual ability

dizziness or lightheadedness when getting up from a lying or sitting position

headache

increased sensitivity of skin to sunlight

Less common

(Reported for amiloride only)

Constipation

Less common

(Reported for spironolactone only)

Breast tenderness in females

deepening of voice in females

enlargement of breasts in males

increased hair growth in females

irregular menstrual periods

sweating

Spironolactone sometimes causes enlarged breasts in males, especially when they take large doses of it for a long time. Breasts usually decrease in size gradually over several months after this medicine is stopped. If you have any questions about this, check with your doctor.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.