Pronunciation:

trye-AM-ter-een, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Dyazide
• Maxzide

Dosage Forms:

• Tablet
• Capsule

Warnings:

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/L (5.5 mmol/L)) can occur. Risk of hyperkalemia is increased in patients with renal impairment, diabetes (with or without renal impairment), the elderly, or severely ill. Serum potassium levels must be monitored at frequent intervals, especially in hydrochlorothiazide/triamterene-naive patients, when dosages are changed, or with any illness that may influence renal function

Classifications:

Therapeutic—

Diuretic, Potassium Sparing/Thiazide Combination

Pharmacologic—

Diuretic, Potassium Sparing

Chemical—

Thiazide

Uses of This Medicine:

Triamterene and hydrochlorothiazide combination is used alone or with other medicines to treat water retention (edema) or 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.

Triamterene 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. Triamterene helps prevent your body from absorbing too much salt and keeps your potassium levels from getting too low.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of triamterene and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of triamterene and hydrochlorothiazide combination in geriatric patients. However, elderly patients are more likely to have kidney problems and high blood potassium (hyperkalemia), which may require caution in patients receiving this medicine.

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.

Other 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.

• Amiloride
• Dofetilide
• Eplerenone
• Potassium Citrate
• Spironolactone

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.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Alacepril
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arginine
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Cyclosporine
• Dapagliflozin
• Delapril
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Dofetilide
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalaprilat
• Enalapril Maleate
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Imidapril
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oliceridine
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentopril
• Perindopril
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pixantrone
• Porfimer
• Potassium
• Potassium Phosphate
• Pramlintide
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sparsentan
• Spirapril
• Sufentanil
• Sulindac
• Tacrolimus
• Tapentadol
• Temocapril
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Tramadol
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Vonoprazan
• 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.

• Amantadine
• Aminolevulinic Acid
• Bepridil
• Carbamazepine
• Cholestyramine
• Ginkgo
• Gossypol
• Licorice

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 is usually not recommended, 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.

• Tobacco

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:

• Anuria (not able to pass urine) or
• Hyperkalemia (high potassium in the blood) or
• Kidney problems (eg, kidney failure), severe or
• Sulfa drug allergy (eg, sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Diabetes or
• Weakened immune system, severe—May increase risk for more serious medical problems (eg, hyperkalemia, metabolic acidosis).

• Electrolyte imbalance or
• Glaucoma, secondary angle closure or
• Gout or
• Heart failure or
• Heart rhythm problems (eg, arrhythmia), history of or
• Hyperuricemia (high uric acid in the blood) or
• Hypochloremia (low chloride in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Kidney stones, history of or
• Liver disease (including cirrhosis) or
• Parathyroid disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

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 (salt). 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.

Swallow the capsule whole. Do not break, crush, or chew it.

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 (capsules):
  • For hypertension or edema:
    • Adults—One or two capsules once a day. Each capsule contains 25 milligrams (mg) hydrochlorothiazide and 37.5 mg triamterene.
    • 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 This Medicine:

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 and urine tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are also taking potassium supplements or salt substitutes containing potassium, or certain diuretics such as amiloride (Midamor®, Moduretic®), spironolactone (Aldactazide®, Aldactone®), or other products containing triamterene. Using these medicines together may cause serious problems.

This medicine may increase the amount of potassium in your blood (hyperkalemia). Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness of the legs.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Dizziness may be worse if you lose too much water from your body. You can lose water by sweating, having diarrhea, or vomiting. Tell your doctor if this medicine makes you feel lightheaded or dizzy after you have been vomiting or had diarrhea.

Check with your doctor right away if you experience drowsiness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

This medicine may cause serious kidney problems, including kidney stones. Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, loss of appetite, nausea, vomiting, unusual tiredness or weakness, swelling of the face, fingers, or lower legs, weight gain, or trouble breathing.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests. The results of some tests may be affected by this medicine.

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.

Side Effects of This Medicine:

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:

Incidence not known

Agitation

back or leg pains

black, tarry stools

bleeding gums

blisters, hives, itching, skin rash

bloating

blood in the urine or stools

blue lips and fingernails

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

chills

clay-colored stools

cloudy urine

cold sweats

coma

confusion

constipation

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

dark urine

decreased urine output

depression

difficult, fast, or noisy breathing

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

drowsiness

dry mouth

fast, slow, or irregular heartbeat

fever with or without chills

flushed, dry skin

fruit-like breath odor

general body swelling

general feeling of discomfort, illness, or weakness

greatly decreased frequency of urination or amount of urine

headache

hostility

incoherent speech

increased hunger

increased sweating

increased thirst

increased urination

indigestion

irritability

joint pain, stiffness, or swelling

lethargy

loss of appetite

loss of consciousness

lower back or side pain

metallic taste

mood changes

muscle pain, cramps, weakness, or twitching

nausea or vomiting

nervousness

nosebleeds

numbness or tingling in the hands, feet, or lips

pain in the groin or genitals

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

persistent non-healing sore

pink growth

pinpoint red or purple spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

reddish patch or irritated area

seizures

sharp back pain just below the ribs

shiny bump

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomachache

stupor

sugar in the urine

swelling of the face, ankles, hands, feet, or lower legs

swollen or painful glands

thickening of bronchial secretions

trouble breathing

unexplained weight loss

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

weak pulse

weakness or heaviness of the legs

white, yellow or waxy scar-like area

yellow eyes or skin

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

Symptoms of overdose

Face is warm or hot to touch

frequent urination

increased volume of pale, dilute urine

loss of strength or energy

pain or weakness in the hands or feet

redness to face

reflexes are unusually strong

trembling

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:

Incidence not known

Decreased interest in sexual intercourse

feeling of constant movement of self or surroundings

inability to have or keep an erection

increased sensitivity of the skin to sunlight

loss in sexual ability, desire, drive, or performance

redness or other discoloration of the skin

sensation of spinning

severe sunburn

welts

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.