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.
LAB-0349-12.0 Revised June 2014
Quinapril 20 mg tabs
Label Image QUINAPRIL HYDROCHLORIDE quinapril hydrochloride tablet, film coated | ||||||||||||||||||||
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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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