Dyrenium (Triamterene)
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Dyrenium (Triamterene)

DYRENIUM®
(triamterene USP) Capsules 50 mg and 100 mg
potassium-sparing diuretic

DRUG DESCRIPTION

Each capsule for oral use, with opaque red cap and body, contains Triamterene USP, 50 or 100 mg, and is imprinted with the product name, DYRENIUM (triamterene) , strength (50 mg or 100 mg) and WPC 002 (for the 50- mg strength) and WPC 003 (for the 100-mg strength). Inactive ingredients consist of D&C Red No. 33, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Magnesium Stearate NF, Sodium Lauryl Sulfate NF, Titanium Dioxide USP and Silicon Dioxide NF

Triamterene is 2,4,7-triamino-6-phenyl-pteridine:

DYRENIUM (triamterene) structural formula illustration

Its molecular weight is 253.27. At 50°C, triamterene is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide and dimethylformamide. It is sparingly soluble in methanol.

What are the possible side effects of triamterene (Dyrenium)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, stomach pain, low fever, loss of...

Read All Potential Side Effects and See Pictures of Dyrenium »

What are the precautions when taking triamterene (Dyrenium)?

See also Warning and How to Use sections.

Before taking triamterene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease (inability to make urine), severe liver disease, high potassium blood level.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (e.g., kidney stones), liver problems, other untreated salt/mineral imbalance (e.g., low sodium blood...

Read All Potential Precautions of Dyrenium »

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Dyrenium (triamterene) is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism.

Dyrenium (triamterene) may be used alone or with other diuretics, either for its added diuretic effect or its potassium- sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.

Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy (however, see PRECAUTIONS below) when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

DOSAGE AND ADMINISTRATION

Adult Dosage

Dosage should be titrated to the needs of the individual patient. When used alone, the usual starting dose is 100 mg twice daily after meals. When combined with another diuretic or antihypertensive agent, the total daily dosage of each agent should usually be lowered initially and then adjusted to the patient s needs. The total daily dosage should not exceed 300 mg. Please refer to PRECAUTIONS- General.

When Dyrenium (triamterene) is added to other diuretic therapy or when patients are switched to Dyrenium (triamterene) from other diuretics, all potassium supplementation should be discontinued.

HOW SUPPLIED

Capsules: 50 mg in bottles of 100, and 100 mg in bottles of 100.

Storage

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F)[See USP Controlled Room Temperature]. Dispense in a tight, light resistant container.

50 mg 100s: NDC 65197-002-01
100 mg 100s: NDC 65197-003-01

DATE OF ISSUANCE OCTOBER 2005. Manufactured for: WellSpring Pharmaceutical Corporation, Bradenton, FL 34202-4101. USA. By: WellSpring Pharmaceutical Canada Corp. Oakville, Ontario L6H 1M5 Canada. FDA Rev date: 2/28/2002.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first, regardless of frequency. All adverse effects occur rarely (that is, 1 in 1000, or less).

Hypersensitivity: anaphylaxis, rash, photosensitivity.

Metabolic: hyperkalemia, hypokalemia.

Renal: azotemia, elevated BUN and creatinine, renal stones, acute interstitial nephritis (rare), acute renal failure (one case of irreversible renal failure has been reported).

Gastrointestinal: jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea.

Hematologic: thrombocytopenia, megaloblastic anemia.

Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth.

Read the Dyrenium (triamterene) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary.

A possible interaction resulting in acute renal failure has been reported in a few subjects when indomethacin, a nonsteroidal anti-inflammatory agent, was given with triamterene. Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene.

The effects of the following drugs may be potentiated when given together with triamterene: antihypertensive medication, other diuretics, preanesthetic and anesthetic agents, skeletal muscle relaxants (non- depolarizing).

Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.

The following agents, given together with triamterene, may promote serum potassium accumulation and possibly result in hyperkalemia because of the potassium-sparing nature of triamterene, especially in patients with renal insufficiency: blood from blood bank (may contain up to 30 mEq of potassium per liter of plasma or up to 65 mEq per liter of whole blood when stored for more than 10 days); low-salt milk (may contain up to 60 mEq of potassium per liter); potassium-containing medications (such as parenteral penicillin G potassium); salt substitutes (most contain substantial amounts of potassium).

Dyrenium (triamterene) may raise blood glucose levels; for adult-onset diabetes, dosage adjustments of hypoglycemic agents may be necessary during and/or after therapy; concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

Drug/Laboratory Test Interactions

Triamterene and quinidine have similar fluorescence spectra; thus, triamterene will interfere with the fluorescent measurement of quinidine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium (triamterene) . Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium (triamterene) , when dosages are changed or with any illness that may influence renal function.

There have been isolated reports of hypersensitivity reactions; therefore, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions.

Periodic BUN and serum potassium determinations should be made to check kidney function, especially in patients with suspected or confirmed renal insufficiency. It is particularly important to make serum potassium determinations in elderly or diabetic patients receiving the drug; these patients should be observed carefully for possible serum potassium increases.

If hyperkalemia is present or suspected, an electrocardiogram should be obtained. If the ECG shows no widening of the QRS or arrhythmia in the presence of hyperkalemia, it is usually sufficient to discontinue Dyrenium (triamterene) and any potassium supplementation, and substitute a thiazide alone. Sodium polystyrene sulfonate (Kayexalate®‚ Sanofi Synthelabo) may be administered to enhance the excretion of excess potassium. The presence of a widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy. For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes. For asystole, bradycardia or A-V block transvenous pacing is also recommended.

The effect of calcium and sodium bicarbonate is transient and repeated administration may be required. When indicated by the clinical situation, excess K+ may be removed by dialysis or oral or rectal administration of Kayexalate®. Infusion of glucose and insulin has also been used to treat hyperkalemia.

PRECAUTIONS

General

Dyrenium (triamterene) tends to conserve potassium rather than to promote the excretion as do many diuretics and, occasionally, can cause increases in serum potassium which, in some instances, can result in hyperkalemia. In rare instances, hyperkalemia has been associated with cardiac irregularities.

Electrolyte imbalance often encountered in such diseases as congestive heart failure, renal disease or cirrhosis may be aggravated or caused independently by any effective diuretic agent including Dyrenium (triamterene) . The use of full doses of a diuretic when salt intake is restricted can result in a low-salt syndrome.

Triamterene can cause mild nitrogen retention, which is reversible upon withdrawal of the drug, and is seldom observed with intermittent (every-other-day) therapy.

Triamterene may cause a decreasing alkali reserve, with the possibility of metabolic acidosis.

By the very nature of their illness, cirrhotics with splenomegaly sometimes have marked variations in their blood. Since triamterene is a weak folic acid antagonist, it may contribute to the appearance of megaloblastosis in cases where folic acid stores have been depleted. Therefore, periodic blood studies in these patients are recommended. They should also be observed for exacerbations of underlying liver disease.

Triamterene has elevated uric acid, especially in persons predisposed to gouty arthritis.

Triamterene has been reported in renal stones in association with other calculus components. Dyrenium (triamterene) should be used with caution in patients with histories of renal stones.

Carcinogenesis: In studies conducted under the auspices of the National Toxicology Program, groups of rats were fed diets containing 0, 150, 300 or 600 ppm of triamterene, and groups of mice were fed diets containing 0, 100, 200 or 400 ppm triamterene. Male and female rats exposed to the highest tested concentration received triamterene at about 25 and 30 mg/kg/day, respectively. Male and female mice exposed to the highest tested concentration received triamterene at about 45 and 60 mg/kg/day, respectively.

There was an increased incidence of hepatocellular neoplasia (primarily adenomas) in male and female mice at the highest dosage level. These doses represent 7.5X and 10X the Maximum Recommended Human Dose (MRHD) of 300 mg/kg/day (or 6 mg/kg/day based on a 50 kg patient) for male and female mice, respectively, when based on body weight and 0.7X and 0.9X the MRHD when based on body-surface area.

Although hepatocellular neoplasia (exclusively adenomas) in the rat study was limited to triamterene-exposed males, incidence was not dosedependent and there was no statistically significant difference from control incidence at any dose level.

Mutagenesis: Triamterene was not mutagenic in bacteria (Salmonella typhimurium strains TA98, TA100, TA1535 or TA1537) with or without metabolic activation. It did not induce chromosomal aberrations in Chinese hamster ovary (CHO) cells in vitro with or without metabolic activation, but it did induce sister chromatid exchanges in CHO cells in vitro with and without metabolic activation.

Impairment of Fertility: Studies of the effects of triamterene on animal reproductive function have not been conducted.

Pregnancy: Category C

Teratogenic Effects: Reproduction studies have been performed in rats at doses as high as 20 times the Maximum Recommended Human Dose (MRHD) on the basis of body weight, and 6 times the MRHD on the basis of body-surface area, without evidence of harm to the fetus due to triamterene. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects: Triamterene has been shown to cross the placental barrier and appear in cord blood. The use of triamterene in pregnant women requires that the anticipated benefits be weighed against possible hazards to the fetus. These possible hazards include adverse reactions which have occurred in the adult.

Nursing Mothers: Triamterene has not been studied in nursing mothers. Triamterene appears in animal milk and is likely present in human milk. If use of the drug product is deemed essential, the patient should stop nursing.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In the event of overdosage, it can be theorized that electrolyte imbalance would be the major concern, with particular attention to possible hyperkalemia. Other symptoms that might be seen would be nausea and vomiting, other G.I. disturbances and weakness. It is conceivable that some hypotension could occur. As with an overdose of any drug, immediate evacuation of the stomach should be induced through emesis and gastric lavage. Careful evaluation of the electrolyte pattern and fluid balance should be made. There is no specific antidote.

Reversible acute renal failure following ingestion of 50 tablets of a product containing a combination of 50 mg triamterene and 25 mg hydrochlorothiazide has been reported.

The oral LD50 in mice is 380 mg/kg. The amount of drug in a single dose ordinarily associated with symptoms of overdose or likely to be life-threatening is not known.

Although triamterene is 67% protein bound, there may be some benefit to dialysis in cases of overdosage.

CONTRAINDICATIONS

Anuria. Severe or progressive kidney disease or dysfunction, with the possible exception of nephrosis. Severe hepatic disease. Hypersensitivity to the drug or any of its components.

Dyrenium (triamterene) should not be used in patients with pre-existing elevated serum potassium, as is sometimes seen in patients with impaired renal function or azotemia, or in patients who develop hyperkalemia while on the drug. Patients should not be placed on dietary potassium supplements, potassium salts or potassium-containing salt substitutes in conjunction with Dyrenium (triamterene) .

Dyrenium (triamterene) should not be given to patients receiving other potassium-sparing agents, such as spironolactone, amiloride hydrochloride, or other formulations containing triamterene. Two deaths have been reported in patients receiving concomitant spironolactone and Dyrenium (triamterene) or Dyazide®. Although dosage recommendations were exceeded in one case and in the other serum electrolytes were not properly monitored, these two drugs should not be given concomitantly.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Triamterene has a unique mode of action; it inhibits the reabsorption of sodium ions in exchange for potassium and hydrogen ions at that segment of the distal tubule under the control of adrenal mineralocorticoids (especially aldosterone). This activity is not directly related to aldosterone secretion or antagonism; it is a result of a direct effect on the renal tubule.

The fraction of filtered sodium reaching this distal tubular exchange site is relatively small, and the amount which is exchanged depends on the level of mineralocorticoid activity. Thus, the degree of natriuresis and diuresis produced by inhibition of the exchange mechanism is necessarily limited. Increasing the amount of available sodium and the level of mineralocorticoid activity by the use of more proximally acting diuretics will increase the degree of diuresis and potassium conservation.

Triamterene occasionally causes increases in serum potassium which can result in hyperkalemia. It does not produce alkalosis, because it does not cause excessive excretion of titratable acid and ammonium.

Triamterene has been shown to cross the placental barrier and appear in the cord blood of animals.

Pharmacokinetics

Onset of action is 2 to 4 hours after ingestion. In normal volunteers the mean peak serum levels were 30 ng/mL at 3 hours. The average percent of drug recovered in the urine (0 to 48 hours) was 21%. Triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. Both the plasma and urine levels of this metabolite greatly exceed triamterene levels. Triamterene is rapidly absorbed, with somewhat less than 50% of the oral dose reaching the urine. Most patients will respond to Dyrenium (triamterene) during the first day of treatment. Maximum therapeutic effect, however, may not be seen for several days. Duration of diuresis depends on several factors, especially renal function, but it generally tapers off 7 to 9 hours after administration.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

To help avoid stomach upset, it is recommended that the drug be taken after meals.

If a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.

If a dose is missed, the patient should not take more than the prescribed dose at the next dosing interval.

Laboratory Tests

Hyperkalemia will rarely occur in patients with adequate urinary output, but it is a possibility if large doses are used for considerable periods of time. If hyperkalemia is observed, Dyrenium (triamterene) should be withdrawn. The normal adult range of serum potassium is 3.5 to 5.0 mEq per liter, with 4.5 mEq often being used for a reference point. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. Normal potassium levels tend to be higher in neonates (7.7 mEq per liter) than in adults.

Serum potassium levels do not necessarily indicate true body potassium concentration. A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular potassium concentration. Because Dyrenium (triamterene) conserves potassium, it has been theorized that in patients who have received intensive therapy or been given the drug for prolonged periods, a rebound kaliuresis could occur upon abrupt withdrawal. In such patients, withdrawal of Dyrenium (triamterene) should be gradual.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

To help avoid stomach upset, it is recommended that the drug be taken after meals.

If a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.

If a dose is missed, the patient should not take more than the prescribed dose at the next dosing interval.

Laboratory Tests

Hyperkalemia will rarely occur in patients with adequate urinary output, but it is a possibility if large doses are used for considerable periods of time. If hyperkalemia is observed, Dyrenium (triamterene) should be withdrawn. The normal adult range of serum potassium is 3.5 to 5.0 mEq per liter, with 4.5 mEq often being used for a reference point. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. Normal potassium levels tend to be higher in neonates (7.7 mEq per liter) than in adults.

Serum potassium levels do not necessarily indicate true body potassium concentration. A rise in plasma pH may cause a decrease in plasma potassium concentration and an increase in the intracellular potassium concentration. Because Dyrenium (triamterene) conserves potassium, it has been theorized that in patients who have received intensive therapy or been given the drug for prolonged periods, a rebound kaliuresis could occur upon abrupt withdrawal. In such patients, withdrawal of Dyrenium (triamterene) should be gradual.

Last reviewed on RxList: 5/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Dyrenium Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TRIAMTERENE - ORAL

(trye-AM-ter-een)

COMMON BRAND NAME(S): Dyrenium

WARNING: This medication can raise your body's potassium levels. This effect is more likely to occur in the elderly and in patients with kidney disease, diabetes, or serious illness. Potassium levels must be closely monitored on a regular basis while taking this medication. If not treated, very high potassium levels can sometimes be fatal. If you develop any of the following symptoms, tell your doctor immediately: muscle weakness, slow/irregular heartbeat.

USES: Triamterene is used to reduce extra fluid in the body (edema) caused by conditions such as congestive heart failure, liver disease, and kidney disease. Getting rid of extra water helps to reduce fluid in the lungs so that you can breathe easier. It also helps to decrease swelling of the arms, legs, and stomach/abdomen.

Triamterene is a certain kind of "water pill" (potassium-sparing diuretic). It works by increasing the amount of urine you make, allowing your body to get rid of extra salt (sodium) and water while also preventing the kidneys from getting rid of too much potassium.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used with other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

HOW TO USE: Take this medication by mouth after meals to reduce stomach upset, usually once or twice daily or as directed by your doctor. It is best to avoid taking this medication within 4 hours of your bedtime to avoid having to get up to urinate. Consult your doctor or pharmacist if you have questions about your dosing schedule.

The dosage is based on your medical condition and response to therapy. For the treatment of edema, do not take more than 300 milligrams daily. For the treatment of high blood pressure in adults, the recommended maximum daily dose is 100 milligrams, especially if taking triamterene with other medications for this condition.

This drug may increase the potassium levels in your blood. Consult your doctor or pharmacist before using any products containing potassium (e.g., potassium supplements such as potassium chloride, salt substitutes). Do not increase the amount of potassium in your diet (e.g., bananas, orange juice) unless approved by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take up to several weeks before the full benefit of this drug takes effect.

Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition does not improve or if it worsens (e.g., swelling increases, your routine blood pressure readings increase).

Disclaimer

Dyrenium Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, tiredness, headache, stomach upset, or diarrhea may occur as your body adjusts to the medication. You may also experience increased sensitivity to the sun. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, triamterene may cause a loss of too much body water (dehydration) and salt (minerals). Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, thirst, muscle cramps/weakness, fast/irregular heartbeat, nausea, vomiting, severe dizziness, unusual decrease in the amount of urine, fainting, confusion, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of a kidney stone (e.g., pain in the side/back/abdomen, painful urination, blood in the urine, fever, chills), joint pain (e.g., big toe pain).

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, stomach/abdominal pain, persistent nausea/vomiting, unusual/persistent tiredness, yellowing eyes/skin, dark urine, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Dyrenium (triamterene) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Warning and How to Use sections.

Before taking triamterene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease (inability to make urine), severe liver disease, high potassium blood level.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (e.g., kidney stones), liver problems, other untreated salt/mineral imbalance (e.g., low sodium blood level), loss of too much body water (dehydration), gout, conditions causing low folic acid blood levels (e.g., alcoholic cirrhosis, pregnancy).

If you have diabetes, triamterene may affect your blood sugar levels. Check your blood sugar levels regularly as directed and share the results with your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your anti-diabetic medication or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent these effects and dehydration. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be more sensitive to the effects of this drug, especially high blood potassium levels.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Dyrenium Consumer (continued)

DRUG INTERACTIONS: See also the How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: eplerenone, potassium-containing products (e.g., potassium supplements such as potassium chloride, salt substitutes), other potassium-sparing "water pills" (diuretics such as amiloride, spironolactone, other products containing triamterene), tacrolimus.

If you are currently using any of these medications, tell your doctor or pharmacist before starting triamterene.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (e.g., benazepril, lisinopril), angiotensin receptor blockers (ARBs such as losartan, valsartan), chlorpropamide, drospirenone, lithium.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure (e.g., pseudoephedrine, phenylephrine) or reduce the effect of this medication (e.g., ibuprofen, naproxen). Ask your pharmacist about the safe use of those products.

This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness, muscle weakness, slow/irregular heartbeat.

NOTES: Do not share this medication with others.

Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests (e.g., blood mineral levels such as potassium, kidney and liver function tests) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure, and share the readings with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Dyrenium Patient Information Including Side Effects

Brand Names: Dyrenium

Generic Name: triamterene (Pronunciation: try AM teh reen)

What is triamterene (Dyrenium)?

Triamterene is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Triamterene is used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney condition called nephrotic syndrome.

Triamterene is also used to treat edema caused by having too much aldosterone in your body. Aldosterone is a hormone produced by the adrenal glands to help regulate the salt and water balance in your body.

Triamterene may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of triamterene (Dyrenium)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Continue using triamterene and talk with your doctor if you have any of these less serious side effects:

  • mild nausea, vomiting, or diarrhea;
  • dizziness, headache;
  • dry mouth; or
  • skin rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dyrenium (triamterene) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about triamterene (Dyrenium)?

Do not use this medication if you have kidney disease, urination problems, severe liver disease, or high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking triamterene.

Before using this medication, tell your doctor if you have heart or liver disease, diabetes, gout, or a history of kidney stones. Tell your doctor if you are using another diuretic.

Avoid drinking alcohol, which can increase some of the side effects of triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking triamterene.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Side Effects Centers

Dyrenium Patient Information including How Should I Take

What should I discuss with my doctor before taking triamterene (Dyrenium)?

Do not use this medication if you have:

  • kidney disease or are unable to urinate;
  • severe liver disease;
  • high potassium levels (hyperkalemia); or
  • if you are taking potassium supplements, or another potassium-sparing diuretic such as Dyazide, Maxzide, amiloride (Midamor, Moduretic), or spironolactone (Aldactone, Aldactazide).

Before using triamterene, tell your doctor if you have:

  • diabetes;
  • heart disease;
  • liver disease;
  • gout;
  • a history of kidney stones; or
  • if you are using another diuretic.

If you have any of these conditions, you may not be able to use triamterene, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Triamterene may pass into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take triamterene (Dyrenium)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water.

Take this medication after eating a meal.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Triamterene can interfere with the results of certain medical tests. Tell any doctor who treats you that you are using triamterene.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking triamterene. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from heat, light, and moisture.

Side Effects Centers

Dyrenium Patient Information including If I Miss a Dose

What happens if I miss a dose (Dyrenium)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Dyrenium)?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a triamterene overdose may include increased urination, nausea, vomiting, weakness, fever, warmth or flushing in your face, or muscle spasms.

What should I avoid while taking triamterene (Dyrenium)?

Avoid drinking alcohol, which can increase some of the side effects of triamterene.

Avoid using other medicines that make you light-headed (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to the side effects of triamterene.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

What other drugs will affect triamterene (Dyrenium)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • lithium;
  • insulin or diabetes medicine taken by mouth;
  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others; or
  • indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Motrin, Advil), diclofenac (Voltaren), naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

If you are using any of these drugs, you may not be able to use triamterene, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect triamterene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about triamterene written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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