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Basic Drug Info
Drug Name:Triamterene and Hydrochlorothiazide
Manufacturer:Watson Laboratories, Inc.
Other Info:Rx only



Clinical Trials:


Indications and Usage

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.Triamterene and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs such as beta-blockers.

Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary.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 in 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.

Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in 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.
Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Pre-Eclampsia -- A complication of PREGNANCY, characterized by a complex of symptoms including maternal HYPERTENSION and PROTEINURIA with or without pathological EDEMA. Symptoms may range between mild and severe. Pre-eclampsia usually occurs after the 20th week of gestation, but may develop before this time in the presence of trophoblastic disease.

Septic Toxemia -- A condition produced by the presence of toxins or other harmful substances in the BLOOD.

Fluid overload -- abnormal increase in the volume of circulating fluid (plasma) in the body.

Cardiovascular Diseases -- Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

GENERALIZED EDEMA --

Sensory Discomfort -- A feeling of mental or physical uneasiness, pain, or distress.

Contraindications

Hyperkalemia: Triamterene and hydrochlorothiazide should not be used in the presence of elevated serum potassium levels (greater than or equal to 5.5 mEq/liter).

If hyperkalemia develops, this drug should be discontinued and a thiazide alone should be substituted.Antikaliuretic Therapy or Potassium Supplementation: Triamterene and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents such as spironolactone, amiloride HCI or other formulations containing triamterene.

Concomitant potassium supplementation in the form of medication, potassium-containing salt substitute, or potassium-enriched diets should also not be used.Impaired Renal Function: Triamterene and hydrochlorothiazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment.Hypersensitivity: Triamterene and hydrochlorothiazide should not be used in patients who are hypersensitive to triamterene or hydrochlorothiazide or other sulfonamide-derived drugs.
Anuria -- Absence of urine formation. It is usually associated with complete bilateral ureteral (URETER) obstruction, complete lower urinary tract obstruction, or unilateral ureteral obstruction when a solitary kidney is present.

Chronic Kidney Insufficiency -- Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Hyperkalemia Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide.

Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment) or elderly or severely ill patients.

Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed, or with any illness that may influence renal function. If hyperkalemia is suspected (warning signs include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia and shock), an electrocardiogram (ECG) should be obtained.

However, it is important to monitor serum potassium levels because mild hyperkalemia may not be associated with ECG changes.If hyperkalemia is present, triamterene and hydrochlorothiazide should be discontinued immediately and a thiazide only should be substituted.

If the serum potassium exceeds 6.5 mEq/liter, more vigorous therapy is required.

The clinical situation dictates the procedures to be employed.

These include the intravenous administration of calcium chloride injection, sodium bicarbonate injection and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation.

Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered.

Persistent hyperkalemia may require dialysis.The development of hyperkalemia associated with potassium-sparing diuretics is accentuated in the presence of renal impairment (seeCONTRAINDICATIONS).

Patients with mild renal function impairment should not receive this drug without frequent and continuing monitoring of serum electrolytes.

Cumulative drug effects may be observed in patients with impaired renal function.

The renal clearances of hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following triamterene and hydrochlorothiazide administration to elderly patients and patients with impaired renal function.Hyperkalemia has been reported in diabetic patients with the use of potassium-conserving agents even in the absence of apparent renal impairment.

Accordingly, triamterene and hydrochlorothiazide should be avoided in diabetic patients.

If it is employed, serum electrolytes must be frequently monitored.Because of the potassium-sparing properties of angiotensin-converting enzyme (ACE) inhibitors, triamterene and hydrochlorothiazide should be used cautiously, if at all, with these agents (seePRECAUTIONS, Drug Interactions).Metabolic or Respiratory Acidosis: Potassium-conserving therapy should also be avoided in severely ill patients in whom respiratory or metabolic acidosis may occur.

Acidosis may be associated with rapid elevations in serum potassium levels.

If triamterene and hydrochlorothiazide is employed, frequent evaluations of acid/base balance and serum electrolytes are necessary.

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