of hyperkalemia. serum potassium should be monitored frequently.

an 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. thiazides 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.

75 mg/50 mg directly. patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg directly. in patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked therapy may be initiated with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg. if an optimal blood pressure response is not obtained with triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg, the dose should be increased to two 37.5 mg/25 mg (37.5 mg triamterene and 25 mg hydrochlorothiazide) tablets daily as a single dose, or one triamterene and hydrochlorothiazide tablets, 75 mg/50 mg daily. if blood pressure still is not controlled, another antihypertensive agent may be added ( see precautions: drug interactions ). clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg daily. all patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets, 75 mg/50 mg should be monitored clinically and for serum potassium after the transfer.

ia, hemolytic anemia and megaloblastosis. ophthalmic: xanthopsia, transient blurred vision. hypersensitivity: anaphylaxis, photosensitivity, rash, urticaria, purpura, necrotizing angiitis (vasculitis, cutaneous vasculitis), fever, respiratory distress including pneumonitis. other: muscle cramps and weakness, decreased sexual performance and sialadenitis. whenever adverse reactions are moderate to severe, therapy should be reduced or withdrawn. altered laboratory findings serum electrolytes: hyperkalemia, hypokalemia, hyponatremia, hypomagnesemia, hypochloremia ( see warnings and precautions ). creatinine , blood urea nitrogen: reversible elevations in bun and serum creatinine have been observed in hypertensive patients treated with triamterene and hydrochlorothiazide. glucose: hyperglycemia, glycosuria and diabetes mellitus ( see precautions ). serum uric acid , pbi and calcium: ( see precautions ). other: elevated liver enzymes have been reported in patients receiving triamterene and hydrochlorothiazide. postmarketing experience non-melanoma skin cancer: hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. in a study conducted in the sentinel system, increased risk was predominantly for squamous cell carcinoma (scc) and in white patients taking large cumulative doses. the increased risk for scc in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional scc case for every 6,700 patients per year.

of hyperkalemia. serum potassium should be monitored frequently.

at doses as high as 20 times the maximum recommended human dose (mrhd) on the basis of body-weight, and 6 times the mrhd 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. hydrochlorothiazide hydrochlorothiazide was orally administered to pregnant mice and rats during respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively. at these doses, which are multiples of the mrhd equal to 3000 for mice and 1000 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.

ma levels are attained in approximately 2 hours. it is excreted rapidly and unchanged in the urine. well controlled studies have demonstrated that doses of hydrochlorothiazide as low as 25 mg given once daily are effective in treating hypertension, but the dose-response has not been clearly established. triamterene triamterene is a potassium-conserving (antikaliuretic) diuretic with relatively weak natriuretic properties. it exerts its diuretic effect on the distal renal tubule to inhibit the reabsorption of sodium in exchange for potassium and hydrogen. with this action, triamterene increases sodium excretion and reduces the excessive loss of potassium and hydrogen associated with hydrochlorothiazide. triamterene is not a competitive antagonist of the mineralocorticoids and its potassium-conserving effect is observed in patients with addison's disease, i.e., without aldosterone. triamterene's onset and duration of activity is similar to hydrochlorothiazide. no predictable antihypertensive effect has been demonstrated with triamterene. triamterene is rapidly absorbed following oral administration. peak plasma levels are achieved within one hour after dosing. triamterene is primarily metabolized to the sulfate conjugate of hydroxytriamterene. both the plasma and urine levels of this metabolite greatly exceed triamterene levels. the amount of triamterene added to 50 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide tablets, 75 mg/50 mg was determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (50 mg given once daily). single daily doses of 75 mg triamterene resulted in greater increases in serum potassium than lower doses (25 mg and 50 mg), while doses greater than 75 mg of triamterene resulted in no additional elevations in serum potassium levels. the amount of triamterene added to the 25 mg of hydrochlorothiazide in triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg was also determined from steady-state dose-response evaluations in which various doses of liquid preparations of triamterene were administered to hypertensive persons who developed hypokalemia with hydrochlorothiazide (25 mg given once daily). single daily doses of 37.5 mg triamterene resulted in greater increases in serum potassium than a lower dose (25 mg), while doses greater than 37.5 mg of triamterene, i.e., 75 mg and 100 mg, resulted in no additional elevations in serum potassium levels. the dose-response relationship of triamterene was also evaluated in patients rendered hypokalemic by hydrochlorothiazide given 25 mg twice daily. triamterene given twice daily increased serum potassium levels in a dose related fashion. however, the combination of triamterene and hydrochlorothiazide given twice daily also appeared to produce an increased frequency of elevation in serum bun and creatinine levels. the largest increases in serum potassium, bun and creatinine in this study were observed with 50 mg of triamterene given twice daily, the largest dose tested. ordinarily, triamterene does not entirely compensate for the kaliuretic effect of hydrochlorothiazide and some patients may remain hypokalemic while receiving triamterene and hydrochlorothiazide. in some individuals, however, it may induce hyperkalemia ( see warnings ). the triamterene and hydrochlorothiazide components of triamterene and hydrochlorothiazide tablets are well absorbed and are bioequivalent to liquid preparations of the individual components administered orally. food does not influence the absorption of triamterene or hydrochlorothiazide from triamterene and hydrochlorothiazide tablets. the hydrochlorothiazide component of triamterene and hydrochlorothiazide tablets is bioequivalent to single entity hydrochlorothiazide tablet formulations.

om light. dispense in a tight, light-resistant container as defined in the usp. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. manufactured by: cadila healthcare ltd. matoda, ahmedabad, india distributed by: zydus pharmaceuticals ( usa) inc. pennington, nj 08534 rev.: 08/20