Dyrenium 100 mg/1

Triamterene · CAPSULE · Advanz Pharma (US) Corp.

No Recall History

Plain English

Dyrenium is a capsule containing triamterene at 100 mg/1, taken oral. Manufactured by Advanz Pharma (US) Corp..

Key Facts

Brand Name: Dyrenium
Generic Name: Triamterene
NDC Code (Product): 59212-003
Manufacturer: Advanz Pharma (US) Corp.
Strength: 100 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA013174
Drug Class: Potassium-sparing Diuretic [EPC]
Marketing Start: 01/01/1999

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease479 reports

fatigue469 reports

drug ineffective444 reports

pain432 reports

nausea416 reports

diarrhoea398 reports

dyspnoea344 reports

dizziness336 reports

renal failure329 reports

headache312 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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 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 restricti…

Dosage & Administration

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 from other diuretics, all potassium supplementation should be discontinued.

Contraindications

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. Dyrenium 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 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. 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…

Drug Interactions

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 o…

Adverse Reactions

ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Dyrenium used for?

Dyrenium contains Triamterene. It is a capsule taken oral. Consult your doctor for specific uses.

Is Dyrenium a controlled substance?

Dyrenium is not classified as a controlled substance by the DEA.

What is the generic name for Dyrenium?

The generic name for Dyrenium is Triamterene. There are 11 other brand versions of Triamterene.

What is the NDC code for Dyrenium 100 mg/1?

The NDC (National Drug Code) for Dyrenium 100 mg/1 is 59212-003, listed by Advanz Pharma (US) Corp..

Product NDC

59212-003

Package NDC

59212-003-01

Other Triamterene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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