Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2005
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Triamterene and Hydrochlorothiazide (Capsule)
|
| dailymed-instance:dosage |
The usual dose of triamterene and hydrochlorothiazide capsules 50 mg/25 mg is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect.
|
| dailymed-instance:descripti... |
Triamterene is an antikaliuretic agent and hydrochlorothiazide is a diuretic/antihypertensive agent. At 50��C, triamterene is practically insoluble in water (less than 0.1%). It is soluble in formic acid, sparingly soluble in methoxyethanol, and very slightly soluble in alcohol. Triamterene is 2,4,7-triamino-6-phenylpteridine with a chemical formula of CHNand a molecular weight of 253.27. The structural formula for triamterene is: Hydrochlorothiazide is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide with a chemical formula of CHClNOSand a molecular weight of 297.73. The structural formula for hydrochlorothiazide is: Each capsule for oral administration contains 50 mg triamterene and 25 mg hydrochlorothiazide. Inactive ingredients include: FD&C Red #40, gelatin, lactose (monohydrate), magnesium stearate, povidone, starch (corn), and titanium dioxide. Meets USP Dissolution Test 2.
|
| dailymed-instance:clinicalP... |
Triamterene and hydrochlorothiazide is a diuretic/antihypertensive drug product that combines natriuretic and antikaliuretic effects. Each component complements the action of the other. The hydrochlorothiazide component blocks the reabsorption of sodium and chloride ions, and thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide and may reduce glomerular filtration rate. The exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known. The triamterene component of triamterene and hydrochlorothiazide exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen ions. Its natriuretic activity is limited by the amount of sodium reaching its site of action. Although it blocks the increase in this exchange that is stimulated by mineralocorticoids (chiefly aldosterone) it is not a competitive antagonist of aldosterone and its activity can be demonstrated in adrenalectomized rats and patients with Addison's disease. As a result, the dose of triamterene required is not proportionally related to the level of mineralocorticoid activity, but is dictated by the response of the individual patients, and the kaliuretic effect of concomitantly administered drugs. By inhibiting the distal tubular exchange mechanism, triamterene maintains or increases the sodium excretion and reduces the excess loss of potassium, hydrogen and chloride ions induced by hydrochlorothiazide. As with hydrochlorothiazide, triamterene may reduce glomerular filtration and renal plasma flow. Via this mechanism it may reduce uric acid excretion, although it has no tubular effect on uric acid reabsorption or secretion. Triamterene does not affect calcium excretion. No predictable antihypertensive effect has been demonstrated for triamterene. Duration of diuretic activity and effective dosage range of the hydrochlorothiazide and triamterene components are similar. Onset of diuresis with triamterene and hydrochlorothiazide takes place within 1 hour, peaks at 2 to 3 hours and tapers off during the subsequent 7 to 9 hours. The bioavailability of the triamterene and hydrochlorothiazide components from this capsule formulation is, in each case about 50% of that observed with an aqueous suspension of the components. .
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Antikaliuretic Therapy and Potassium Supplementation: Triamterene and hydrochlorothiazide 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 triamterene and hydrochlorothiazide except in severe cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary.<br/>Impaired Renal Function: Triamterene and hydrochlorothiazide is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment.<br/>Hypersensitivity: Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication.<br/>Hyperkalemia: Triamterene and hydrochlorothiazide should not be used in patients with preexisting elevated serum potassium.
|
| dailymed-instance:supply |
Triamterene and hydrochlorothiazide capsules for oral administration are available as 50 mg/25 mg: opaque red cap/opaque red body, body and cap imprinted GG 580 in white ink, filled with yellow powder and supplied as: NDC 0781-2715-01 bottles of 100NDC 0781-2715-10 bottles of 1000NDC 0781-2715-13 unit dose packages of 100 Store at 20��-25��C (68��-77��F) (see USP Controlled Room Temperature). Protect from light. Protect from moisture. Dispense in a tight, light-resistant container.
|
| dailymed-instance:boxedWarn... |
Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing diuretic combinations, including triamterene and hydrochlorothiazide. 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 frequentintervals especially in patients first receiving triamterene and hydrochlorothiazide, when dosages are changed or with any illness that may influence renal function.
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
Diabetes: Caution should be exercised when administering triamterene and hydrochlorothiazide 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.<br/>Bioavailability: The bioavailability of the hydrochlorothiazide and triamterene components of triamterene and hydrochlorothiazide capsules is about 50% of the maximum obtainable with oral therapy. Theoretically, a patient transferred from therapy with hydrochlorothiazide with or without triamterene might show an increase in blood pressure, fluid retention, or change in serum potassium. Extensive clinical experience with triamterene and hydrochlorothiazide capsules, however, suggests that these conditions have not been commonly observed in clinical practice.<br/>Impaired Hepatic Function: 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. Administer triamterene and hydrochlorothiazide cautiously and be alert for such early signs of impending coma as confusion, drowsiness and tremor; if mental confusion increases discontinue triamterene and hydrochlorothiazide for a few days. Attention must be given to other factors that may precipitate hepatic coma, such as blood in the gastrointestinal tract or preexisting potassium depletion.<br/>Hypokalemia: Hypokalemia is uncommon with triamterene and hydrochlorothiazide; but, should it develop, corrective measures should be taken such as potassium supplementation or increased intake of potassium-rich foods. Institute such measures cautiously with frequent determinations of serum potassium levels, especially in patients receiving digitalis or with a history of cardiac arrhythmias. If serious hypokalemia (serum potassium less than 3.0 mEq/L) is demonstrated by repeat serum potassium determinations, triamterene and hydrochlorothiazide should be discontinued and potassium chloride supplementation initiated. Less serious hypokalemia should be evaluated with regard to other coexisting conditions and treated accordingly.<br/>Electrolyte Imbalance: 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 triamterene and hydrochlorothiazide therapy when using high doses for prolonged periods or in patients on a salt-restricted diet. Serum determinations of electrolytes should be performed, and are particularly important if the patient is vomiting excessively or receiving fluids parenterally. Possible fluid and electrolyte imbalance may be indicated by such warning signs as: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal symptoms.<br/>Hypochloremia: 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. Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.<br/>Renal Stones: Triamterene has been found in renal stones in association with the other usual calculus components. Triamterene and hydrochlorothiazide should be used with caution in patients with a history of renal stones.<br/>Laboratory Tests:<br/>Serum Potassium: 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. If hypokalemia should develop, corrective measures should be taken such as potassium supplementation or increased dietary intake of potassium-rich foods. Institute such measures cautiously with frequent determinations of serum potassium levels. Potassium levels persistently above 6 mEq per liter require careful observation and treatment. 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. Discontinue corrective measures for hypokalemia immediately if laboratory determinations reveal an abnormal elevation of serum potassium. Discontinue triamterene and hydrochlorothiazide and substitute a thiazide diuretic alone until potassium levels return to normal.<br/>Serum Creatinine and BUN: Triamterene and hydrochlorothiazide may produce an elevated blood urea nitrogen level, creatinine level or both. This apparently is secondary to a reversible reduction of glomerular filtration rate or a depletion of intravascular fluid volume (prerenal azotemia) rather than renal toxicity; levels usually return to normal when triamterene and hydrochlorothiazide is discontinued. If azotemia increases, discontinue triamterene and hydrochlorothiazide. Periodic BUN or serum creatinine determinations should be made, especially in elderly patients and in patients with suspected or confirmed renal insufficiency.<br/>Serum PBI: Thiazide may decrease serum PBI levels without sign of thyroid disturbance.<br/>Parathyroid Function: Thiazides should be discontinued before carrying out tests for parathyroid function. 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. The common complications of hyperparathyroidism such as bone resorption and peptic ulceration have not been seen.<br/>Drug Interactions:<br/>Angiotensin-converting enzyme inhibitors: Potassium-sparing agents should be used with caution in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to an increased risk of hyperkalemia.<br/>Oral hypoglycemic drugs: Concurrent use with chlorpropamide may increase the risk of severe hyponatremia.<br/>Nonsteroidal anti-inflammatory drugs: A possible interaction resulting in acute renal failure has been reported in a few patients on triamterene and hydrochlorothiazide when treated with indomethacin, a nonsteroidal anti-inflammatory agent. Caution is advised in administering nonsteroidal anti-inflammatory agents with triamterene and hydrochlorothiazide.<br/>Lithium: Lithium generally should not be given with diuretics because they reduce its renal clearance and increase the risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy with triamterene and hydrochlorothiazide.<br/>Surgical considerations: 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.<br/>Other Considerations: 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. Thiazides may add to or potentiate the action of other antihypertensive drugs. See INDICATIONS AND USAGE for concomitant use with other antihypertensive drugs. The effect of oral anticoagulants may be decreased when used concurrently with hydrochlorothiazide; dosage adjustments may be necessary. Triamterene and hydrochlorothiazide may raise the level of blood uric acid; dosage adjustments of antigout medication may be necessary to control hyperuricemia and gout. 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 ofpotassium 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.<br/>Drug/Laboratory Test Interactions: Triamterene and quinidine have similar fluorescence spectra; thus, triamterene and hydrochlorothiazide will interfere with the fluorescent measurement of quinidine.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Carcinogenesis: Long term studies have not been conducted with triamterene and hydrochlorothiazide combination, or with triamterene alone.<br/>Mutagenesis: Studies of the mutagenic potential of triamterene and hydrochlorothiazide combination, or of triamterene alone have not been performed.<br/>Impairment of Fertility: Studies of the effects of triamterene and hydrochlorothiazide combination, or of triamterene alone on animal reproductive function have not been conducted.<br/>Pregnancy: Category C:<br/>Teratogenic Effects:<br/>Nonteratogenic Effects: Thiazides and triamterene have been shown to cross the placental barrier and appear in cord blood. The use of thiazides and triamterene in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possible other adverse reactions which have occurred in the adult.<br/>Nursing Mothers: 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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
|
| dailymed-instance:overdosag... |
Electrolyte imbalance is the major concern . Symptoms reported include: polyuria, nausea, vomiting, weakness, lassitude, fever, flushed face, and hyperactive deep tendon reflexes. If hypotension occurs, it may be treated with pressor agents such as levarterenol to maintain blood pressure. Carefully evaluate the electrolyte pattern and fluid balance. Induce immediate evacuation of the stomach through emesis or gastric lavage. 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. Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.
|
| dailymed-instance:genericMe... |
Triamterene and Hydrochlorothiazide
|
| dailymed-instance:fullName |
Triamterene and Hydrochlorothiazide (Capsule)
|
| dailymed-instance:adverseRe... |
Adverse effects are listed in decreasing order of frequency; however, the most serious adverse effects are listed first regardless of frequency. The serious adverse effects associated with triamterene and hydrochlorothiazide capsules have commonly occurred in less than 0.1% of patients treated with this product. Hypersensitivity: anaphylaxis, rash, urticaria, photosensitivity. Cardiovascular: arrhythmia, postural hypotension. Metabolic: diabetes mellitus, hyperkalemia, hyperglycemia, glycosuria, hyperuricemia, hypokalemia, hyponatremia, acidosis, hypochloremia. Gastrointestinal: jaundice and/or liver enzyme abnormalities, pancreatitis, nausea and vomiting, diarrhea, constipation, abdominal pain. Renal: acute renal failure (one case of irreversible renal failure has been reported), interstitial nephritis, renal stones composed primarily of triamterene, elevated BUN and serum creatinine, abnormal urinary sediment. Hematologic: leukopenia, thrombocytopenia and purpura, megaloblastic anemia. Musculoskeletal: muscle cramps. Central Nervous System: weakness, fatigue, dizziness, headache, dry mouth. Miscellaneous: impotence, sialadenitis. Thiazides alone have been shown to cause the following additional adverse reactions: Central Nervous System: paresthesias, vertigo. Ophthalmic: xanthopsia, transient blurred vision. Respiratory: allergic pneumonitis, pulmonary edema, respiratory distress. Other: necrotizing vasculitis, exacerbation of lupus. Hematologic: aplastic anemia, agranulocytosis, hemolytic anemia. Neonate and Infancy: thrombocytopenia and pancreatitis���rarely, in newborns whose mothers have received thiazides during pregnancy.
|
| dailymed-instance:indicatio... |
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 capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the action of these agents, dosage adjustments may be necessary.<br/>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 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.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Triamterene and Hydrochlorothiazide
|