Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mg

DESCRIPTION

id: 96501256-902d-4c6e-866a-084387a14325
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP  and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula:

CLINICAL PHARMACOLOGY

id: a328eae3-6b25-4b11-b2c5-78ab33bb9015
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Triamterene and hydrochlorothiazide is a diuretic, antihypertensive drug product, principally due to its hydrochlorothiazide component; the triamterene component reduces the excessive potassium loss which may occur with hydrochlorothiazide use.

INDICATIONS AND USAGE

id: 2e7cbca1-c1b7-432b-9626-f18ca1ea41f5
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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 tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). Triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary.

WARNINGS

id: 2f784770-ba31-4575-8e9f-8876171e0b57
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Hyperkalemia Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-conserving diuretic combinations, including triamterene and hydrochlorothiazide. Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill patients. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving triamterene and hydrochlorothiazide, 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 mild hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, triamterene and hydrochlorothiazide 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 ). 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 hydrochlorothiazide and the pharmacologically active metabolite of triamterene, the sulfate ester of hydroxytriamterene, have been shown to be reduced and the plasma levels increased following triamterene and hydrochlorothiazide administration to elderly patients and patients with impaired renal function. Hyperkalemia has been reported in diabetic patients with the use of potassium-conserving agents even in the absence of apparent renal impairment. Accordingly, triamterene and hydrochlorothiazide should be avoided in diabetic patients. If it is employed, serum electrolytes must be frequently monitored. Because of the potassium-sparing properties of angiotensin-converting enzyme (ACE) inhibitors, triamterene and hydrochlorothiazide should be used cautiously, if at all, with these agents (see PRECAUTIONS, Drug Interactions ).

ADVERSE REACTIONS

id: eb8fa432-bcb3-43b0-a31d-b6fd05212314
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Side effects observed in association with the use of triamterene and hydrochlorothiazide tablets, other combination products containing triamterene/hydrochlorothiazide, and products containing triamterene or hydrochlorothiazide include the following: Gastrointestinal:  jaundice (intrahepatic cholestatic jaundice), pancreatitis, nausea, appetite disturbance, taste alteration, vomiting, diarrhea, constipation, anorexia, gastric irritation, cramping. Central Nervous System:  drowsiness and fatigue, insomnia, headache, dizziness, dry mouth, depression, anxiety, vertigo, restlessness, paresthesias. Cardiovascular:  tachycardia, shortness of breath and chest pain, orthostatic hypotension (may be aggravated by alcohol, barbiturates or narcotics). Renal:  acute renal failure, acute interstitial nephritis, renal stones composed of triamterene in association with other calculus materials, urine discoloration. Hematologic:  leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, 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.

OVERDOSAGE

id: 611a706d-86f5-4fae-9d49-1bd709ec38bb
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

No specific data are available regarding triamterene and hydrochlorothiazide overdosage in humans and no specific antidote is available. Fluid and electrolyte imbalances are the most important concern. Excessive doses of the triamterene component may elicit hyperkalemia, dehydration, nausea, vomiting and weakness and possibly hypotension. Overdosing with hydrochlorothiazide has been associated with hypokalemia, hypochloremia, hyponatremia, dehydration, lethargy (may progress to coma) and gastrointestinal irritation. Treatment is symptomatic and supportive. Therapy with triamterene and hydrochlorothiazide should be discontinued. Induce emesis or institute gastric lavage. Monitor serum electrolyte levels and fluid balance. Institute supportive measures as required to maintain hydration, electrolyte balance, respiratory, cardiovascular and renal function.

DOSAGE AND ADMINISTRATION

id: 968589ca-cd31-477d-8de3-74b20da34f84
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Note:  37.5 mg/25 mg = 37.5 mg triamterene and 25 mg hydrochlorothiazide           75 mg/50 mg = 75 mg triamterene and 50 mg hydrochlorothiazide The usual dose of Triamterene and Hydrochlorothiazide 37.5 mg/25 mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS ). The usual dose of Triamterene and Hydrochlorothiazide 75 mg/50 mg is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS
). There is no experience with the use of more than one 75 mg/50 mg tablet daily or more than two 37.5 mg/25 mg tablets daily. Clinical experience with the administration of two 37.5 mg/25 mg tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction. Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg triamterene/25 mg hydrochlorothiazide directly. In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg of triamterene and hydrochlorothiazide, the dose should be increased to two 37.5 mg/25 mg tablets daily as a single dose, or one 75 mg/50 mg tablet 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 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide should be monitored clinically and for serum potassium after the transfer.

HOW SUPPLIED

id: a4c9448c-4f4b-41bf-a622-1eea471ea108
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/ 25 mg are available for oral administration as green, oval bioconvex tablets, scored and engraved “37.5” bisect “25” on one side, “APO” on the other side. Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg are available for oral administration as yellow, oval bioconvex tablets, scored and engraved “75” bisect “50” on one side, “APO” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0983-1	37.5 mg / 25 mg	30 Tablets in a Blister Pack	GREEN	60505-2656

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. APOTEX INC. TRIAMTERENE HYDROCHLOROTHIAZIDE TABLETS, USP 37.5 mg/25 mg and

75 mg/50 mg

Manufactured by:	Manufactured for:
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	33326

This Product was Repackaged By: State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PACKAGE LABEL

id: bac3d29a-a48a-47ff-b04b-9031c38e65a7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Label Image for 53808-0983
37.5mg / 25mg