Benazepril Hydrochloride and Hydrochlorothiazide (Page 6 of 6)

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of either benazepril or hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:

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 ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

Benazepril

Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombocytopenia, eosinophilic pneumonitis.

Hydrochlorothiazide

Digestive

Pancreatitis, small bowel angioedema, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and anorexia.

Neurologic

Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.

Musculoskeletal

Muscle spasm.

Hematologic

Aplastic anemia, agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Metabolic

Hyperglycemia, glycosuria, and hyperuricemia, pyrexia, asthenia, parathyroid gland changes with hypercalcemia and hypophosphatemia.

Hypersensitivity

Anaphylactoid reactions, necrotizing angiitis, respiratory distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash, and photosensitivity.

Skin

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

Clinical Laboratory Test Findings

Serum Electrolytes

See PRECAUTIONS.

Creatinine and BUN

Minor reversible increases in serum creatinine and BUN were observed in patients with essential hypertension treated with benazepril hydrochloride and hydrochlorothiazide. Such increases occurred most frequently in patients with renal artery stenosis (see PRECAUTIONS).

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.

OVERDOSAGE

No specific information is available on the treatment of overdosage with benazepril hydrochloride and hydrochlorothiazide; treatment should be symptomatic and supportive. Therapy with benazepril hydrochloride and hydrochlorothiazide should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.

Single oral doses of 1 g/kg of benazepril caused reduced activity in mice, and doses of 3 g/kg were associated with significant lethality. Reduction of activity in rats was not seen until they had received doses of 5 g/kg, and doses of 6 g/kg were not lethal. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg.

Data from human overdoses of benazepril are scanty, but the most common manifestation of human benazepril overdosage is likely to be hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

Laboratory determinations of serum levels of benazepril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of benazepril overdose.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of benazepril and its metabolites. Benazeprilat is only slightly dialyzable, but dialysis might be considered in overdosed patients with severely impaired renal function (see WARNINGS).

Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of benazepril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of benazepril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat benazepril overdose by infusion of normal saline solution.

DOSAGE AND ADMINISTRATION

Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg.

Switch Therapy

A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with benazepril hydrochloride and hydrochlorothiazide tablets. The usual recommended starting dose is 10/12.5 mg once daily to control blood pressure.

Replacement Therapy

The combination may be substituted for the titrated individual components.

HOW SUPPLIED

NDC: 63629-2680-1: 30 Tablets in a BOTTLE

NDC: 63629-2680-2: 90 Tablets in a BOTTLE

NDC: 63629-2680-3: 100 Tablets in a BOTTLE

NDC: 63629-2680-4: 60 Tablets in a BOTTLE

Benazepril/Hctz 20mg/12.5mg Tablet

Label
(click image for full-size original)
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
benazepril hydrochloride and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2680(NDC:0185-0211)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
FD&C BLUE NO. 2
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POLOXAMER 188
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
ZINC STEARATE
HYDROGENATED CASTOR OIL
STARCH, CORN
Product Characteristics
Color PURPLE ((lavender)) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code E211
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-2680-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:63629-2680-2 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:63629-2680-3 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:63629-2680-4 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076631 02/11/2004
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-2680), RELABEL (63629-2680)

Revised: 04/2022 Bryant Ranch Prepack

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