Triamterene and Hydrochlorothiazide (Page 4 of 4)

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 tablets.

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 tablets.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE:

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:

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 dosage of triamterene and hydrochlorothiazide as a tablet is 37.5 mg/25 mg or 75 mg/50 mg daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than 75 mg/50 mg daily of triamterene and hydrochlorothiazide. Clinical experience with the administration of 37.5 mg/25 mg of triamterene and hydrochlorothiazide twice 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 this 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg/25 mg product 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 triamterene and hydrochlorothiazide, the dose should be increased to 75 mg/50 mg daily as a single dose. 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 of triamterene may be safely changed to 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets should be monitored clinically and for serum potassium after the transfer.

HOW SUPPLIED:

Triamterene and Hydrochlorothiazide Tablets, USP, 37.5 mg/25 mg, are light green, round, scored tablets, debossed with Watson 424 and are available in bottles of 30, 100 and 500.

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, are yellow, round, scored tablets, debossed with Watson 348 and are available in bottles of 30, 100, 500 and 1000.

Bottles of 30 and 100 tablets are provided with child-resistant closures.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: November 2014

PRINCIPAL DISPLAY PANEL

NDC 0591-0424 -01
Triamterene
and
Hydrochlorothiazide
Tablets, USP
37.5mg/25mgActavis 100 Tablets Rx Only

Triamterene and Hydrochlorothiazide Tablets, USP
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0591-0348 -01
Triamterene
and
Hydrochlorothiazide
Tablets, USP 75mg/50mg

Actavos 100 Tablets Rx Only

Triamterene and Hydrochlorothiazide Tablets, USP
(click image for full-size original)

TRIAMTERENE AND HYDROCHLOROTHIAZIDE triamterene and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0424
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMTERENE (TRIAMTERENE) TRIAMTERENE 37.5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL 8000
POVIDONE
MAGNESIUM STEARATE
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (Light green) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code WATSON;424
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0424-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0591-0424-05 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0591-0424-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073449 09/23/1993
TRIAMTERENE AND HYDROCHLOROTHIAZIDE triamterene and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0348
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMTERENE (TRIAMTERENE) TRIAMTERENE 75 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL 8000
POVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code WATSON;348
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0348-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0591-0348-05 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0591-0348-10 1000 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:0591-0348-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071851 09/23/1993
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 11/2014 Actavis Pharma, Inc.

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