Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4165
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DYAZIDE (Capsule)
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The usual dose of DYAZIDE
is one or two capsules given once daily, with appropriate monitoring
of serum potassium and of the clinical effect (see WARNINGS, Hyperkalemia).
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Each capsule of DYAZIDE (hydrochlorothiazide
and triamterene) for oral use, with opaque red cap and opaque white
body, contains hydrochlorothiazide 25 mg and triamterene 37.5 mg,
and is imprinted with the product name DYAZIDE and SB. Hydrochlorothiazide
is a diuretic/antihypertensive agent and triamterene is an antikaliuretic
agent. 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, 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 DYAZIDE meet Drug
Release Test 3 as published in the current USP monograph for Triamterene
and Hydrochlorothiazide Capsules.
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DYAZIDE 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 DYAZIDE 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 kaliureticeffect 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 of DYAZIDE are similar.
Onset of diuresis with DYAZIDE takes place within 1 hour, peaks
at 2 to 3 hours and tapers off during the subsequent 7 to 9 hours. DYAZIDE is well absorbed. Upon
administration of a single oral dose to fasted normal male volunteers,
the following mean pharmacokinetic parameters were determined: where AUCC, Tand Ae represent area under the plasma concentration versus
time plot, maximum plasma concentration, time to reach C, and amount excreted in urine over 48 hours. A capsule of DYAZIDE is bioequivalent
to a single-entity 25 mg hydrochlorothiazide tablet and 37.5 mg
triamterene capsule used in the double-blind clinical trial below
(see Clinical Trials). In a limited study
involving 12 subjects, coadministration of DYAZIDE 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),
hydrochlorothiazide 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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Antikaliuretic Therapy and
Potassium Supplementation: 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. If potassium supplementation
is used, careful monitoring of the serum potassium level is necessary.<br/>Impaired Renal Function: DYAZIDE 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: DYAZIDE should not be used in patients with preexisting
elevated serum potassium.
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Capsules containing 25 mg hydrochlorothiazide
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 DYAZIDE is
a registered trademark of GlaxoSmithKline. ��2007,
GlaxoSmithKline. All rights reserved. June 2007DYZ:72PI
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Hyperkalemia: 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.
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Diabetes: Caution should be exercised when administering DYAZIDE
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/>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 DYAZIDE
cautiously and be alert for such early signs of impending coma as
confusion, drowsiness, and tremor; if mental confusion increases discontinue
DYAZIDE 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 DYAZIDE; 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,
DYAZIDE 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
therapy with DYAZIDE 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. DYAZIDE 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 DYAZIDE and substitute a thiazide diuretic alone until
potassium levels return to normal.<br/>Serum Creatinine and BUN: DYAZIDE 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 DYAZIDE is discontinued.
If azotemia increases, discontinue DYAZIDE. 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 DYAZIDE when treated
with indomethacin, a nonsteroidal anti-inflammatory agent. Caution
is advised in administering nonsteroidal anti-inflammatory agents
with DYAZIDE.<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 DYAZIDE.<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. DYAZIDE 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 hydrochlorothiazide because of alkalinization
of the urine.<br/>Drug/Laboratory Test Interactions: Triamterene and quinidine have similar fluorescence
spectra; thus, DYAZIDE will interfere with the fluorescent measurement
of quinidine.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility:<br/>Carcinogenesis: Long-term studies have not been conducted with DYAZIDE
(the triamterene/hydrochlorothiazide combination), or with triamterene
alone.<br/>Mutagenesis: Studies of the mutagenic potential of DYAZIDE (the
triamterene/hydrochlorothiazide combination), or of triamterene alone
have not been performed.<br/>Impairment of Fertility: Studies of the effects of DYAZIDE (the triamterene/hydrochlorothiazide
combination), or of triamterene alone on animal reproductive function
have not been conducted.<br/>Pregnancy:<br/>Category C:<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.
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Electrolyte imbalance is the major concern (see
WARNINGS section). 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.
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hydrochlorothiazide and triamterene
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DYAZIDE (Capsule)
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Adverse effects are listed in decreasing order
of severity.<br/>Hypersensitivity: Anaphylaxis, rash, urticaria, subacute cutaneous
lupus erythematosus-like reactions, photosensitivity.<br/>Cardiovascular: Arrhythmia, postural hypotension.<br/>Metabolic: Diabetes mellitus, hyperkalemia, hypokalemia, hyponatremia,
acidosis, hypercalcemia, hyperglycemia, glycosuria, hyperuricemia,
hypochloremia.<br/>Gastrointestinal: Jaundice and/or liver enzyme abnormalities, pancreatitis,
nausea and vomiting, diarrhea, constipation, abdominal pain.<br/>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.<br/>Hematologic: Leukopenia, thrombocytopenia and purpura, megaloblastic
anemia.<br/>Musculoskeletal: Muscle cramps.<br/>Central Nervous System: Weakness, fatigue, dizziness, headache, dry mouth.<br/>Miscellaneous: Impotence, sialadenitis. Thiazides
alone have been shown to cause the following additional adverse reactions:<br/>Central Nervous System: Paresthesias, vertigo.<br/>Ophthalmic: Xanthopsia, transient blurred vision.<br/>Respiratory: Allergic pneumonitis, pulmonary edema, respiratory
distress.<br/>Other: Necrotizing vasculitis, exacerbation of lupus.<br/>Hematologic: Aplastic anemia, agranulocytosis, hemolytic anemia.<br/>Neonate and infancy: Thrombocytopenia and pancreatitis���rarely,
in newborns whose mothers have received thiazides during pregnancy.
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Hyperkalemia: 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. 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, DYAZIDE 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 (see
CONTRAINDICATIONS section). 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 hydrochlorothiazideand the pharmacologically active metabolite of triamterene, the sulfate
ester of hydroxytriamterene, have been shown to bereduced and the
plasma levels increased following administration of DYAZIDE 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 DYAZIDE is used in diabetic patients.<br/>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 DYAZIDE is employed, frequent evaluations of
acid/base balance and serum electrolytes are necessary.
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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 is 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.<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.
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DYAZIDE
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