DRUGS & SUPPLEMENTS

Teva-Triamterene Hctz

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Teva-Triamterene Hctz uses


DESCRIPTION

Each capsule of Teva-Triamterene Hctz (hydrochlorothiazide and triamterene) for oral use, with opaque red cap and opaque white body, contains Teva-Triamterene Hctz 25 mg and triamterene 37.5 mg, and is imprinted with the product name Teva-Triamterene Hctz and SB. Teva-Triamterene Hctz is a diuretic/antihypertensive agent and triamterene is an antikaliuretic agent.

Teva-Triamterene Hctz is slightly soluble in water. It is soluble in dilute ammonia, dilute aqueous sodium hydroxide, and dimethylformamide. It is sparingly soluble in methanol.

Teva-Triamterene Hctz is 6-chloro-3,4-dihydro-2H-1, 2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is:

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 and its structural formula is:

Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, D&C Red No. 33, FD&C Yellow No. 6, gelatin, glycine, lactose, magnesium stearate, microcrystalline cellulose, povidone, polysorbate 80, sodium starch glycolate, titanium dioxide, and trace amounts of other inactive ingredients.

Capsules of Teva-Triamterene Hctz meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Teva-Triamterene Hctz Capsules.

Teva-Triamterene Hctz chemical structure triamterene chemical structure

CLINICAL PHARMACOLOGY

Teva-Triamterene Hctz is a diuretic/antihypertensive drug product that combines natriuretic and antikaliuretic effects. Each component complements the action of the other. The Teva-Triamterene Hctz 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 Teva-Triamterene Hctz and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen, and chloride ions. Teva-Triamterene Hctz 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 Teva-Triamterene Hctz is not known.

The triamterene component of Teva-Triamterene Hctz 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 Teva-Triamterene Hctz. As with Teva-Triamterene Hctz, 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 Teva-Triamterene Hctz and triamterene components of Teva-Triamterene Hctz are similar. Onset of diuresis with Teva-Triamterene Hctz takes place within 1 hour, peaks at 2 to 3 hours and tapers off during the subsequent 7 to 9 hours.

Teva-Triamterene Hctz is well absorbed.

Upon administration of a single oral dose to fasted normal male volunteers, the following mean pharmacokinetic parameters were determined:


AUC(0-48)

ng*hrs/mL

(± SD)


Cmax

ng/mL

(± SD)


Median

Tmax

Hrs


Ae

Mg

(± SD)


Triamterene


148.7 (87.9)


46.4 (29.4)


1.1


2.7 (1.4)


hydroxytriamterene   sulfate


1,865 (471)


720 (364)


1.3


19.7 (6.1)


Teva-Triamterene Hctz


834 (177)


135.1 (35.7)


2.0


14.3 (3.8)


where AUC(0-48), Cmax, Tmax and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach Cmax, and amount excreted in urine over 48 hours.

A capsule of Teva-Triamterene Hctz is bioequivalent to a single-entity 25 mg Teva-Triamterene Hctz tablet and 37.5 mg triamterene capsule used in the double-blind clinical trial below.

In a limited study involving 12 subjects, coadministration of Teva-Triamterene Hctz with a high-fat meal resulted in: (1) an increase in the mean bioavailability of triamterene by about 67% (90% confidence interval = 0.99, 1.90), p-hydroxytriamterene sulfate by about 50% (90% confidence interval = 1.06, 1.77), Teva-Triamterene Hctz by about 17% (90% confidence interval = 0.90, 1.34); (2) increases in the peak concentrations of triamterene and p-hydroxytriamterene; and (3) a delay of up to 2 hours in the absorption of the active constituents.

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CLINICAL TRIALS

A placebo-controlled, double-blind trial was conducted to evaluate the efficacy of Teva-Triamterene Hctz. This trial demonstrated that Teva-Triamterene Hctz (25 mg hydrochlorothiazide/37.5 mg triamterene) was effective in controlling blood pressure while reducing the incidence of hydrochlorothiazide-induced hypokalemia. This trial involved 636 patients with mild to moderate hypertension controlled by Teva-Triamterene Hctz 25 mg daily and who had hypokalemia (serum potassium <3.5 mEq/L) secondary to the Teva-Triamterene Hctz. Patients were randomly assigned to 4 weeks’ treatment with once-daily regimens of 25 mg Teva-Triamterene Hctz plus placebo, or 25 mg Teva-Triamterene Hctz combined with one of the following doses of triamterene: 25 mg, 37.5 mg, 50 mg, or 75 mg.

Blood pressure and serum potassium were monitored at baseline and throughout the trial. All five treatment groups had similar mean blood pressure and serum potassium concentrations at baseline (mean systolic blood pressure range: 137±14 mmHg to 140±16 mmHg; mean diastolic blood pressure range: 86±9 mmHg to 88±8 mmHg; mean serum potassium range: 2.3 to 3.4 mEq/L with the majority of patients having values between 3.1 and 3.4 mEq/L).

While all triamterene regimens reversed hypokalemia, at week 4 the 37.5 mg regimen proved optimal compared with the other tested regimens. On this regimen, 81% of the patients had a significant (p<0.05) reversal of hypokalemia vs. 59% of patients on the placebo/hydrochlorothiazide regimen. The mean serum potassium concentration on 37.5 mg triamterene went from 3.2±0.2 mEq/L at baseline to 3.7±0.3 mEq/L at week 4, a significantly greater (p<0.05) improvement than that achieved with placebo/hydrochlorothiazide (i.e., 3.2±0.2 mEq/L at baseline and 3.5±0.4 mEq/L at week 4). Also, 51% of patients in the 37.5 mg triamterene group had an increase in serum potassium of ≥0.5 mEq/L at week 4 vs. 33% in the placebo group. The 37.5 mg triamterene/25 mg Teva-Triamterene Hctz regimen also maintained control of blood pressure; mean supine systolic blood pressure at week 4 was 138±21 mmHg while mean supine diastolic blood pressure was 87±13 mmHg.

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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.

Teva-Triamterene Hctz is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on Teva-Triamterene Hctz alone.

Teva-Triamterene Hctz is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.

Teva-Triamterene Hctz may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since Teva-Triamterene Hctz may enhance the action of these agents, 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 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.

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CONTRAINDICATIONS

Antikaliuretic Therapy and Potassium Supplementation

Teva-Triamterene Hctz 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 Teva-Triamterene Hctz 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.

Impaired Renal Function

Teva-Triamterene Hctz is contraindicated in patients with anuria, acute and chronic renal insufficiency or significant renal impairment.

Hypersensitivity

Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication.

Hyperkalemia

Teva-Triamterene Hctz should not be used in patients with preexisting elevated serum potassium.

WARNINGS

Hyperkalemia: Abnormal elevation of serum potassium levels can occur with all potassium-sparing diuretic combinations, including Teva-Triamterene Hctz. 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 Teva-Triamterene Hctz, 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 hyperkalemia may not be associated with ECG changes.

If hyperkalemia is present, Teva-Triamterene Hctz should be discontinued immediately and a thiazide alone 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 solution, sodium bicarbonate solution, 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. Patients with mild renal functional 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 Teva-Triamterene Hctz and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following administration of Teva-Triamterene Hctz to elderly patients and patients with impaired renal function.

Hyperkalemia has been reported in diabetic patients with the use of potassium-sparing agents even in the absence of apparent renal impairment. Accordingly, serum electrolytes must be frequently monitored if Teva-Triamterene Hctz is used in diabetic patients.

Metabolic or Respiratory Acidosis

Potassium-sparing 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 Teva-Triamterene Hctz is employed, frequent evaluations of acid/base balance and serum electrolytes are necessary.

Acute Myopia and Secondary Angle-Closure Glaucoma

Teva-Triamterene Hctz, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue Teva-Triamterene Hctz as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

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PRECAUTIONS

Diabetes

Caution should be exercised when administering Teva-Triamterene Hctz 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.

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 Teva-Triamterene Hctz cautiously and be alert for such early signs of impending coma as confusion, drowsiness, and tremor; if mental confusion increases discontinue Teva-Triamterene Hctz 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.

Hypokalemia

Hypokalemia is uncommon with Teva-Triamterene Hctz; 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 is demonstrated by repeat serum potassium determinations, Teva-Triamterene Hctz should be discontinued and potassium chloride supplementation initiated. Less serious hypokalemia should be evaluated with regard to other coexisting conditions and treated accordingly.

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 therapy with Teva-Triamterene Hctz 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.

Hypochloremia

Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances, 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.

Renal Stones

Triamterene has been found in renal stones in association with the other usual calculus components. Teva-Triamterene Hctz should be used with caution in patients with a history of renal stones.

Laboratory Tests

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 Teva-Triamterene Hctz and substitute a thiazide diuretic alone until potassium levels return to normal.

Serum Creatinine and BUN

Teva-Triamterene Hctz 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 rather than renal toxicity; levels usually return to normal when Teva-Triamterene Hctz is discontinued. If azotemia increases, discontinue Teva-Triamterene Hctz. Periodic BUN or serum creatinine determinations should be made, especially in elderly patients and in patients with suspected or confirmed renal insufficiency.

Serum PBI

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

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.

Drug Interactions

Angiotensin-converting Enzyme Inhibitors

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

Oral Hypoglycemic Drugs

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

Nonsteroidal Anti-inflammatory Drugs

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

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 Teva-Triamterene Hctz.

Surgical Considerations

Thiazides have been shown to decrease arterial responsiveness to norepinephrine. 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.

Other Considerations

Concurrent use of Teva-Triamterene Hctz 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 Teva-Triamterene Hctz; dosage adjustments may be necessary.

Teva-Triamterene Hctz 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 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 Teva-Triamterene Hctz because of alkalinization of the urine.

Drug/Laboratory Test Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies have not been conducted with Teva-Triamterene Hctz, or with triamterene alone.

Teva-Triamterene Hctz

Two-year feeding studies in mice and rats, conducted under the auspices of the National Toxicology Program (NTP), treated mice and rats with doses of Teva-Triamterene Hctz up to 600 and 100 mg/kg/day, respectively. On a body-weight basis, these doses are 600 times (in mice) and 100 times (in rats) the Maximum Recommended Human Dose (MRHD) for the Teva-Triamterene Hctz component of Teva-Triamterene Hctz at 50 mg/day (or 1.0 mg/kg/day based on 50 kg individuals). On the basis of body-surface area, these doses are 56 times (in mice) and 21 times (in rats) the MRHD. These studies uncovered no evidence of carcinogenic potential of Teva-Triamterene Hctz in rats or female mice, but there was equivocal evidence of hepatocarcinogenicity in male mice.

Mutagenesis

Studies of the mutagenic potential of Teva-Triamterene Hctz, or of triamterene alone have not been performed.

Teva-Triamterene Hctz

Teva-Triamterene Hctz was not genotoxic in in vitro assays using strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of Salmonella typhimurium (the Ames test); in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations; or in in vivo assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity) test, and in the mouse Lymphoma Cell (mutagenicity) assays, using concentrations of Teva-Triamterene Hctz of 43 to 1300 mcg/mL. Positive test results were also obtained in the Aspergillus nidulans nondisjunction assay, using an unspecified concentration of Teva-Triamterene Hctz.

Impairment of Fertility

Studies of the effects of Teva-Triamterene Hctz, or of triamterene alone on animal reproductive function have not been conducted.

Teva-Triamterene Hctz

Teva-Triamterene Hctz had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation. Corresponding multiples of the MRHD are 100 (mice) and 4 (rats) on the basis of body-weight and 9.4 (mice) and 0.8 (rats) on the basis of body-surface area.

Pregnancy: Category C

Teratogenic Effects

Teva-Triamterene Hctz

Animal reproduction studies to determine the potential for fetal harm by Teva-Triamterene Hctz have not been conducted. However, a One Generation Study in the rat approximated composition of Teva-Triamterene Hctz by using a 1:1 ratio of triamterene to Teva-Triamterene Hctz ; there was no evidence of teratogenicity at those doses which were, on a body-weight basis, 15 and 30 times, respectively, the MRHD, and on the basis of body-surface area, 3.1 and 6.2 times, respectively, the MRHD.

The safe use of Teva-Triamterene Hctz in pregnancy has not been established since there are no adequate and well-controlled studies with Teva-Triamterene Hctz in pregnant women. Teva-Triamterene Hctz should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Triamterene

Reproduction studies have been performed in rats at doses as high as 20 times the MRHD on the basis of body-weight, and 6 times the human dose 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.

Teva-Triamterene Hctz

Teva-Triamterene Hctz was orally administered to pregnant mice and rats during respective periods of major organogenesis at doses up to 3,000 and 1,000 mg/kg/day, respectively. At these doses, which are multiples of the MRHD equal to 3,000 for mice and 1,000 for rats, based on body-weight, and equal to 282 for mice and 206 for rats, based on body-surface area, there was no evidence of harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

 

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.

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Adverse effects are listed in decreasing order of severity.

Hypersensitivity

Anaphylaxis, rash, urticaria, subacute cutaneous lupus erythematosus-like reactions, photosensitivity.

Cardiovascular

Arrhythmia, postural hypotension.

Metabolic

Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia, acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia, hypochloremia.

Gastrointestinal

Jaundice and/or liver enzyme abnormalities, pancreatitis, nausea and vomiting, diarrhea, constipation, abdominal pain.

Renal

Acute renal failure, 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.

Skin

Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.

DOSAGE AND ADMINISTRATION

The usual dose of Teva-Triamterene Hctz is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect.

OVERDOSAGE

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 Teva-Triamterene Hctz has been reported. Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.

HOW SUPPLIED

Capsules containing 25 mg Teva-Triamterene Hctz and 37.5 mg triamterene, in bottles of 1,000 capsules; in Patient-Pak unit-of-use bottles of 100.

They are supplied as follows:

NDC 0007-3650-22–in Patient-Pak unit-of-use bottles of 100.

NDC 0007-3650-30–bottles of 1,000.

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Dispense in a tight, light-resistant container.

GlaxoSmithKline

Research Triangle Park, NC 27709

Teva-Triamterene Hctz is a registered trademark of GlaxoSmithKline.

©2011, GlaxoSmithKline. All rights reserved.

February 2011

DYZ:74PI

Teva-Triamterene Hctz pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Teva-Triamterene Hctz available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Teva-Triamterene Hctz destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Teva-Triamterene Hctz Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Teva-Triamterene Hctz pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Teva-Triamterene Hctz?

Depending on the reaction of the Teva-Triamterene Hctz after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Teva-Triamterene Hctz not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Teva-Triamterene Hctz addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Teva-Triamterene Hctz, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Teva-Triamterene Hctz consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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