Quinapril Hydrochloride (Page 6 of 6)

Renal Impairment

Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows:

Creatinine Clearance
Maximum Recommended Initial Dose
>60 mL/min 10 mg
30–60 mL/min 5 mg
10–30 mL/min 2.5 mg
<10 mL/min Insufficient data for dosage recommendation

Patients should subsequently have their dosage titrated (as described above) to the optimal response.

Elderly (≥65 years)

The recommended initial dosage of quinapril hydrochloride tablets in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response.

Heart Failure

Quinapril hydrochloride tablets are indicated as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. The recommended starting dose is 5 mg twice daily. This dose may improve symptoms of heart failure, but increases in exercise duration have generally required higher doses. Therefore, if the initial dosage of quinapril hydrochloride tablets is well tolerated, patients should then be titrated at weekly intervals until an effective dose, usually 20 to 40 mg daily given in two equally divided doses, is reached or undesirable hypotension, orthostatis, or azotemia (see ) prohibit reaching this dose. WARNINGS

Following the initial dose of quinapril hydrochloride tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostatis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostatis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.

DOSE ADJUSTMENTS IN PATIENTS WITH HEART FAILURE AND RENAL IMPAIRMENT OR HYPONATREMIA

Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with heart failure and renal impairment, the recommended initial dose of quinapril hydrochloride tablets is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients with a creatinine clearance less than 10 mL/min (see , , and ). DOSAGE AND ADMINISTRATION, Heart FailureWARNINGSPRECAUTIONS, Drug Interactions

If the initial dose is well tolerated, quinapril hydrochloride tablets may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.

HOW SUPPLIED

NDC:68151-1022-1 in a PACKAGE of 1 TABLET, FILM COATEDS

Storage

Store at controlled room temperature 15º–30ºC (59º–86ºF).

Protect from light.

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LAB-0349-12.0 Revised June 2014

Quinapril 20 mg tabs

Label ImageLabel Image
QUINAPRIL HYDROCHLORIDE
quinapril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-1022(NDC:59762-5021)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL (QUINAPRILAT) QUINAPRIL 20 mg
Inactive Ingredients
Ingredient Name Strength
CANDELILLA WAX
CROSPOVIDONE
GELATIN
LACTOSE
MAGNESIUM CARBONATE
MAGNESIUM STEARATE
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 9mm
Flavor Imprint Code G;020;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-1022-1 1 TABLET, FILM COATED in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA019885 11/19/1991
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-1022)

Revised: 06/2014 Carilion Materials Management

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