Hydrochlorothiazide And Triamterene (Dyazide)

Trade Name : DYAZIDE

GlaxoSmithKline LLC

CAPSULE

Strength 2537.5 mg/1mg/1

HYDROCHLOROTHIAZIDE; TRIAMTERENE Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrochlorothiazide And Triamterene (Dyazide) which is also known as DYAZIDE and Manufactured by GlaxoSmithKline LLC. It is available in strength of 25; 37.5 mg/1; mg/1 per ml. Read more

Hydrochlorothiazide And Triamterene (Dyazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Each capsule of DYAZIDE (hydrochlorothiazide and triamterene) for oral use, with opaque red cap and opaque white body, contains hydrochlorothiazide 25u00a0mg and triamterene 37.5u00a0mg, 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-2-1, 2, 4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is:
At 50u00b0C, 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.u00a033, FD&C Yellow No.u00a06, 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.

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 Addisonu2019s 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 of DYAZIDE are similar. Onset of diuresis with DYAZIDE takes place within 1u00a0hour, peaks at 2 to 3u00a0hours, and tapers off during the subsequent 7 to 9u00a0hours.
DYAZIDE is well absorbed.
Upon administration of a single oral dose to fasted normal male volunteers, the following mean pharmacokinetic parameters were determined:
where AUC C, T and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach C, and amount excreted in urine over 48u00a0hours.
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 ).
In a limited study involving 12u00a0subjects, coadministration of DYAZIDE with a high-fat meal resulted in: (1) an increase in the mean bioavailability of triamterene by about 67% (90% confidence intervalu00a0=u00a00.99, 1.90), p-hydroxytriamterene sulfate by about 50% (90% confidence intervalu00a0=u00a01.06, 1.77), hydrochlorothiazide by about 17% (90% confidence intervalu00a0=u00a00.90, 1.34); (2) increases in the peak concentrations of triamterene and p-hydroxytriamterene; and (3) a delay of up to 2u00a0hours in the absorption of the active constituents.

A placebo-controlled, double-blind trial was conducted to evaluate the efficacy of DYAZIDE. This trial demonstrated that DYAZIDE (25u00a0mg hydrochlorothiazide/37.5u00a0mg 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 hydrochlorothiazide 25u00a0mg daily and who had hypokalemia (serum potassium <3.5u00a0mEq/L) secondary to the hydrochlorothiazide. Patients were randomly assigned to 4 weeksu2019 treatment with once-daily regimens of 25u00a0mg hydrochlorothiazide plus placebo, or 25u00a0mg hydrochlorothiazide combined with one of the following doses of triamterene: 25u00a0mg, 37.5u00a0mg, 50u00a0mg, or 75u00a0mg.
Blood pressure and serum potassium were monitored at baseline and throughout the trial. All 5 treatment groups had similar mean blood pressure and serum potassium concentrations at baseline (mean systolic blood pressure range: 137 u00b1 14u00a0mmHg to 140 u00b1 16u00a0mmHg; mean diastolic blood pressure range: 86 u00b1 9u00a0mmHg to 88 u00b1 8u00a0mmHg; mean serum potassium range: 2.3 to 3.4u00a0mEq/L with the majority of patients having values between 3.1 and 3.4u00a0mEq/L).
While all triamterene regimens reversed hypokalemia, at Weeku00a04 the 37.5-mg regimen proved optimal compared with the other tested regimens. On this regimen, 81% of the patients had a significant (<0.05) reversal of hypokalemia vs. 59% of patients on the placebo/hydrochlorothiazide regimen. The mean serum potassium concentration on 37.5u00a0mg triamterene went from 3.2 u00b1 0.2u00a0mEq/L at baseline to 3.7 u00b1 0.3u00a0mEq/L at Weeku00a04, a significantly greater (<0.05) improvement than that achieved with placebo/hydrochlorothiazide (i.e., 3.2 u00b1 0.2u00a0mEq/L at baseline and 3.5 u00b1 0.4u00a0mEq/L at Weeku00a04). Also, 51% of patients in the 37.5-mg triamterene group had an increase in serum potassium of u22650.5u00a0mEq/L at Weeku00a04 vs. 33% in the placebo group. The 37.5-mg triamterene/25-mg hydrochlorothiazide regimen also maintained control of blood pressure; mean supine systolic blood pressure at Week 4 was 138 u00b1 21u00a0mmHg while mean supine diastolic blood pressure was 87 u00b1 13u00a0mmHg.

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.
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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Adverse effects are listed in decreasing order of severity.

The usual dose of DYAZIDE is 1 or 2 capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see , ).

Electrolyte imbalance is the major concern (see ). 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 50u00a0tablets of a product containing a combination of 50u00a0mg triamterene and 25u00a0mg hydrochlorothiazide has been reported.
Although triamterene is largely protein-bound (approximately 67%), there may be some benefit to dialysis in cases of overdosage.

Capsules containing 25u00a0mg hydrochlorothiazide and 37.5u00a0mg triamterene, in bottles of 1,000u00a0capsules; in Patient-Pak unit-of-use bottles of 100.
They are supplied as follows:
NDC 0007-3650-22u2013in Patient-Pak unit-of-use bottles of 100.
NDC 0007-3650-30u2013bottles of 1,000.
Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Protect from light. Dispense in a tight, light-resistant container.n n
GlaxoSmithKline
Research Triangle Park, NC 27709n n
Trademarks are owned by or licensed to the GSK group of companies.
u00a92017 GSK group of companies or its licensor.n n
October 2017
DYZ:75PIn

NDC 0007-3650-22
Arrayn- DYAZIDE
Arrayn- 25 MG HYDROCHLOROTHIAZIDE AND 37.5 MG TRIAMTERENE CAPSULES
Arrayn- 100 Capsules
R only
Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F).
Do not accept if membrane seal under cap is missing or broken.
Protect from light. Dispense in a tight, light-resistant container.
Each capsule contains 25 mg hydrochlorothiazide and 37.5 mg triamterene.
DYAZIDE capsules meet Drug Release Test 3 as published in the current USP monograph for Triamterene and Hydrochlorothiazide Capsules.
Usual Dosage:
Important:
Trademarks are owned by or licensed to the GSK group of companies.
GlaxoSmithKline
RTP, NC 27709
Made in Canada
2018 GSK group of companies or its licensor.

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Hydrochlorothiazide And Triamterene (Dyazide)

Trade Name : DYAZIDE

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Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Hydrochlorothiazide And Triamterene (Dyazide)

Trade Name : DYAZIDE

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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