Triamterene and Hydrochlorothiazide: Package Insert and Label Information (Page 3 of 3)

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 Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

The usual dose of triamterene and hydrochlorothiazide capsules is 1 or 2 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

Triamterene and Hydrochlorothiazide Capsules USP, 37.5 mg/25 mg are light yellow to yellow colored powder filled in size ‘4’ empty hard gelatin capsule having yellow opaque colored cap imprinted with “855” in black ink and white opaque colored body and are supplied as follows:

NDC 72578-090-01 in bottles of 100 capsules

NDC 72578-090-05 in bottles of 500 capsules

NDC 72578-090-10 in bottles of 1,000 capsules

NDC 72578-090-77 in unit-dose blister cartons of 100 (10 X 10) Unit-dose Capsules

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd., India

Distributed by:

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

Rev.: 01/21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-090-01 in bottles of 100 capsules

Triamterene and Hydrochlorothiazide Capsules, USP

37.5 mg/25 mg

Rx only

Viona

image
(click image for full-size original)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE triamterene and hydrochlorothiazide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-090
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
CELLULOSE, MICROCRYSTALLINE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
GLYCINE
HYPROMELLOSE 2910 (3 MPA.S)
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (yellow opaque colored cap) , WHITE (white opaque colored body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 855
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-090-01 100 CAPSULE in 1 BOTTLE None
2 NDC:72578-090-05 500 CAPSULE in 1 BOTTLE None
3 NDC:72578-090-10 1000 CAPSULE in 1 BOTTLE None
4 NDC:72578-090-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-090-30)
4 NDC:72578-090-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72578-090-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208358 02/21/2020
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Cadila Healthcare Limited (650199482)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (72578-090), MANUFACTURE (72578-090)

Revised: 01/2021 Viona Pharmaceuticals Inc

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