Triamterene and Hydrochlorothiazide (Page 5 of 5)

Skin

Erythema multiforme, including Stevens-Johnson syndrome; exfoliative dermatitis, including toxic epidermal necrolysis.

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 REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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

OVERDOSAGE

Electrolyte imbalance is the major concern (see WARNINGS). 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 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.

HOW SUPPLIED

Product: 50090-6944

NDC: 50090-6944-0 90 CAPSULE in a BOTTLE

Triamterene and Hydrochlorothiazide

Label ImageLabel Image
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
triamterene and hydrochlorothiazide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6944(NDC:0781-2074)
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
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
GLYCINE
MAGNESIUM STEARATE
POLYSORBATE 80
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white capsules with single black ink bands) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code GG;606
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-6944-0 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074821 06/05/1997
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-6944), REPACK (50090-6944)

Revised: 02/2024 A-S Medication Solutions

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