Triamterene and Hydrochlorothiazide (Triamterene and Hydrochlorothiazide)

Select Strength and Packaging*

Ask for Quote

Trade Name: Triamterene and Hydrochlorothiazide

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: CAPSULE, HUMAN PRESCRIPTION DRUG

Strength: 37.5; 25 mg/1; mg/1

Storage and handling

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

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

Each triamterene and hydrochlorothiazide capsule for oral use contains triamterene 37.5 mg and hydrochlorothiazide 25 mg. 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-2n n n -1, 2, 4-benzothiadiazine-7- sulfonamide 1,1-dioxide, and its structural formula is:n nn
Molecular Formula: Cn n n Hn n n CINn n n On n n Sn n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. 297.74n nn
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:
Molecular Formula: Cn n n Hn n n Nn n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. 253.26n nn
Inactive ingredients consist of lactose monohydrate, pregelatinized starch, sodium starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and magnesium stearate. The capsule shell consists of titanium dioxide and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.
Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution Test 3 as published in the current USP monograph for triamterene and hydrochlorothiazide capsules.

The triamterene and hydrochlorothiazide capsule 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 capsules, USP 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 triamterene and hydrochlorothiazide capsules, USP are similar. Onset of diuresis with triamterene and hydrochlorothiazide capsules, USP takes place within 1 hour, peaks at 2 to 3 hours and tapers off during the subsequent 7 to 9 hours.
Triamterene and hydrochlorothiazide capsules, USP are well absorbed.
Upon administration of a single oral dose to fasted normal male volunteers, the following mean pharmacokinetic parameters were determined:
where AUCn n n , Cn n n , Tn n n and Ae represent area under the plasma concentration versus time plot, maximum plasma concentration, time to reach Cn n n , and amount excreted in urine over 48 hours.n nn
One triamterene and hydrochlorothiazide capsule 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 n n n ).n nn
In a limited study involving 12 subjects, coadministration of triamterene and hydrochlorothiazide capsules, USP 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.
A placebo-controlled, double-blind trial was conducted to evaluate the efficacy of triamterene and hydrochlorothiazide capsules, USP. This trial demonstrated that triamterene and hydrochlorothiazide capsules, USP (37.5 mg triamterene/25 mg hydrochlorothiazide) were 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 25 mg daily and who had hypokalemia (serum potassium <3.5 mEq/L) secondary to the hydrochlorothiazide. Patients were randomly assigned to 4 weeksu2019 treatment with once-daily regimens of 25 mg hydrochlorothiazide plus placebo, or 25 mg hydrochlorothiazide 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: 137u00b114 mmHg to 140u00b116 mmHg; mean diastolic blood pressure range: 86u00b19 mmHg to 88u00b18 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 3.2u00b10.2 mEq/L at baseline to 3.7u00b10.3 mEq/L at week 4, a significantly greater (p<0.05) improvement than that achieved with placebo/hydrochlorothiazide (i.e., 3.2u00b10.2 mEq/L at baseline and 3.5u00b10.4 mEq/L at week 4). Also, 51% of patients in the 37.5 mg triamterene group had an increase in serum potassium of u2265 0.5 mEq/L at week 4 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 138u00b121 mmHg while mean supine diastolic blood pressure was 87u00b113 mmHg.

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, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary.
Usage in Pregnancy:
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.

Antikaliuretic Therapy and Potassium Supplementation:
Potassium supplementation should not be used with triamterene and hydrochlorothiazide capsules, USP 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:
Hypersensitivity:
Hyperkalemia:

No data

No data

Adverse effects are listed in decreasing order of severity.
Hypersensitivity:
Cardiovascular:
Metabolic:
Gastrointestinal:
Renal:
Hematologic:
Musculoskeletal:
Central Nervous System:
Miscellaneous:
Thiazides alone have been shown to cause the following additional adverse reactions:
Central Nervous System:
Ophthalmic:
Respiratory:
Other:
Hematologic:
Neonate and infancy:
Skin:

Electrolyte imbalance is the major concern (seeu00a0n n n 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.n nn
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.

The usual dose of triamterene and hydrochlorothiazide capsules, USP is one or two capsules given once daily, with appropriate monitoring of serum potassium and of the clinical effect (see n n n ).n n n

Triamterene and Hydrochlorothiazide Capsules, USP contain 37.5 mg triamterene and 25 mg hydrochlorothiazide, and are available in size # 4 white opaque/white opaque capsules imprinted with Logo u201cLANNETTu201d on the cap and u201c1632u201d on the body. They are supplied as follows:
Bottles of 30, NDC 66267-510-30n n
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Manufactured by:n nLannett Company, Inc.n nPhiladelphia, PA 19136n nMade in the USAn
Revised 04/11, Revision 1
10-582

No data

Select Strength and Packaging*

Ask for Quote

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Triamterene and Hydrochlorothiazide (Triamterene and Hydrochlorothiazide) which is also known as Triamterene and Hydrochlorothiazide and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 37.5; 25 mg/1; mg/1.

Triamterene and Hydrochlorothiazide (Triamterene and Hydrochlorothiazide) 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.