Triamterene and Hydrochlorothiazide (Page 4 of 4)

ADVERSE REACTIONS:

Side effects observed in association with the use of triamterene and hydrochlorothiazide tablets, other combination products containing triamterene and 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Whenever adverse reactions are moderate to severe, therapy should be reduced or withdrawn.

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.

Postmarketing Experience:

Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

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 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 the 75 mg/50 mg product, directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to the 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 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 of hydrochlorothiazide and 50 mg to 100 mg of triamterene may be safely changed to one triamterene and hydrochlorothiazide 37.5 mg/25 mg tablet daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide tablets should be monitored clinically and for serum potassium after the transfer.

Triamterene and Hydrochlorothiazide Tablets USP, 37.5 mg/25 mg, are light green, round, scored tablets, debossed with Watson 424 and are available in

NDC: 70518-1662-00

PACKAGING: 30 in 1 BLISTER PACK

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Triamterene and Hydrochlorothiazide

GENERIC: Triamterene and Hydrochlorothiazide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1662-0

COLOR: green

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: WATSON;424

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • TRIAMTERENE 37.5mg in 1
  • HYDROCHLOROTHIAZIDE 25mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • POLACRILIN POTASSIUM
  • POLYETHYLENE GLYCOL 8000
  • POVIDONE
  • FD&C BLUE NO. 2–ALUMINUM LAKE
Remedy_Label
(click image for full-size original)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
triamterene and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1662(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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
POLYETHYLENE GLYCOL 8000
POVIDONE
FD&C BLUE NO. 2–ALUMINUM LAKE
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:70518-1662-0 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073449 11/12/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2021 REMEDYREPACK INC.

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