Indicated for:

• The treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.

• DYAZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

DYAZIDE may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since DYAZIDE may enhance the action of these agents, dosage adjustments may be necessary.

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

DYAZIDE should not be given to patients receiving other potassium-sparing agents such as spironolactone, amiloride, or other formulations containing triamterene. Concomitant potassium-containing salt substitutes should also not be used.–Potassium supplementation should not be used with DYAZIDE except in severe cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels.

DYAZIDE is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment.

Thiazides should be used with caution in patients with impaired hepatic function. They can precipitate hepatic coma in patients with severe liver disease. Potassium depletion induced by the thiazide may be important in this connection.

DYAZIDE should not be used in patients with preexisting elevated serum potassium.

If hyperkalemia is present, triamterene and hydrochlorothiazide capsules should be discontinued immediately and a thiazide alone should be substituted.

Potassium-sparing therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

Caution should be exercised when administering triamterene and hydrochlorothiazide capsules to patients with diabetes, since thiazides may cause hyperglycemia, glycosuria, and alter insulin requirements in diabetes. Also, diabetes mellitus may become manifest during thiazide administration.

Electrolyte imbalance, often encountered in such conditions as heart failure, renal disease or cirrhosis of the liver, may also be aggravated by diuretics and should be considered during therapy with triamterene and hydrochlorothiazide when using high doses for prolonged periods or in patients on a salt-restricted diet.

Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.

Triamterene and hydrochlorothiazide may produce an elevated blood urea nitrogen level, creatinine level or both.

Thiazide may decrease serum PBI levels without sign of thyroid disturbance.

Calcium excretion is decreased by thiazides. Pathologic changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy.

Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including DYAZIDE. 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 first receiving DYAZIDE, when dosages are changed or with any illness that may influence renal function.

DYAZIDE should be used with caution in patients with a history of renal stones.

Lithium generally should not be given with diuretics.

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

Concurrent use with chlorpropamide may increase the risk of severe hyponatremia.

A possible interaction resulting in acute renal failure has been reported in a few patients on triamterene and hydrochlorothiazide capsules when treated with indomethacin, a nonsteroidal anti-inflammatory agent. Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene and hydrochlorothiazide capsules.

Concurrent use of hydrochlorothiazide with amphotericin B or corticosteroids or corticotropin (ACTH) may intensify electrolyte imbalance, particularly hypokalemia, although the presence of triamterene minimizes the hypokalemic effect.

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).

Exchange resins, such as sodium polystyrene sulfonate, whether administered orally or rectally, reduce serum potassium levels by sodium replacement of the potassium; fluid retention may occur in some patients because of the increased sodium intake.

Chronic or overuse of laxatives may reduce serum potassium levels by promoting excessive potassium loss from the intestinal tract; laxatives may interfere with the potassium-retaining effects of triamterene.

The effectiveness of methenamine may be decreased when used concurrently with hydrochlorothiazide because of alkalinization of the urine.

Thiazides have been shown to decrease arterial responsiveness to norepinephrine (an effect attributed to loss of sodium). This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the paralyzing effect of nondepolarizing muscle relaxants such as tubocurarine (an effect attributed to potassium loss); consequently caution should be observed in patients undergoing surgery.

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.

Thiazides and triamterene in combination have not been studied in nursing mothers. Triamterene appears in animal milk; this may occur in humans. Thiazides are excreted in human breast milk. If use of the combination drug product is deemed essential, the patient should stop nursing.

GoToSource 

• Use in patients under the age of 18. GoToSource

• Menière’s disease. GoToSource

• Prevention of formation of kidney stones. GoToSource

• Diabetes insipidus. GoToSource

Noncardiogenic pulmonary edema (fluid in the lung). GoToSource

Lichenoid photosensitivity (skin disorder). GoToSource

Acute interstitial nephritis (kidney disorder). GoToSource

Hyponatremia (low blood sodium level). GoToSource

Long-term (≥5 years) use of antihypertensive medication increases risk of invasive breast cancer. GoToSource

Lip cancer. GoToSource

Myopia and acute angle-closure glaucoma. GoToSource

Hyperuricemia (high level of uric acid level in blood) and gout (a type of arthritis). GoToSource

New-onset diabetes. GoToSource

Hypokalemia (low blood potassium level), impaired glucose tolerance and increased serum cholesterol. GoToSource

Orthostatic hypotension (fall in blood pressure when upright position is assumed), hypercalcemia (high blood calcium level), hypochloremia (low blood chloride level) and hypomagnesemia (low blood magnesium level). GoToSource

Polyuria (excessive passage of urine) and dehydration. GoToSource

Decreased libido, erectile dysfunction and pancreatitis (inflammation of the pancreas). GoToSource

Increased risk of hip fractures. GoToSource 

Lawsuits filed for lip cancer.