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 Image TRIAMTERENE AND HYDROCHLOROTHIAZIDE triamterene and hydrochlorothiazide capsule | ||||||||||||||||||||||||||||||||||||||
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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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