Prescription Drug Information: Quinapril (Page 3 of 3)

OVERDOSAGE

Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats.

No specific information is available on the treatment of overdosage with quinapril. The most likely clinical manifestation would be symptoms attributable to severe hypotension.

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

No data are available to suggest physiological maneuvers (eg, maneuvers to change pH of the urine) that might accelerate elimination of quinapril and its metabolites.

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

DOSAGE AND ADMINISTRATION

HypertensionMonotherapy

The recommended initial dosage of quinapril tablets in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2 to 6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40 to 80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.

Concomitant Diuretics

If blood pressure is not adequately controlled with quinapril tablets monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril tablets (see WARNINGS). Then, if blood pressure is not controlled with quinapril tablets alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril tablets should be used with careful medical supervision for several hours and until blood pressure has stabilized.

The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS , and Drug Interactions).

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 ClearanceMaximum Recommended Initial Dose
Greater Than 60 mL/min10 mg
30 to 60 mL/min5 mg
10 to 30 mL/min2.5 mg
Less Than 10 mL/minInsufficient data for dosage recommendation

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

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

Elderly (greater than or equal to 65 years)

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

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 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 WARNINGS , and PRECAUTIONS , Drug Interactions.)

If the initial dose is well tolerated, quinapril 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

Quinapril tablets, USP are supplied as follows:

5 mg tablets: White to off-white, round, convex faced, film coated tablets, debossed with “ 18 ’’ on one side and break line on the other side.

Bottles of 30 NDC 54868-5279-0

10 mg tablets: White to off-white, round, convex faced, film coated tablets, debossed with “ RX549 ’’ on one side and plain on the other side.

Bottles of 30 NDC 54868-5245-0
Bottles of 60 NDC 54868-5245-1
Bottles of 90 NDC 54868-5245-2

20 mg tablets: White to off-white, round, convex faced, film coated tablets, debossed with “ RX550 ’’ on one side and plain on the other side.

Bottles of 30 NDC 54868-5241-0
Bottles of 60 NDC 54868-5241-1
Bottles of 90 NDC 54868-5241-2

40 mg tablets: White to off-white, round, convex faced, film coated tablets, debossed with “ RX551 ’’ on one side and plain on the other.

Bottles of 30 NDC 54868-5246-0
Bottles of 60 NDC 54868-5246-2
Bottles of 90 NDC 54868-5246-1

Dispense in well-closed containers as defined in the USP.

Protect from light.

Store at controlled room temperature 20 to 25º C (68º to 77º F) with excursions permitted between 15 to 30º C (59 to 86º F). (See USP).


Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

by: Ohm Laboratories, Inc.

North Brunswick, NJ 08902 USA

June 2007

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

Quinapril tablets, USP

5 mg tablets

image of Quinapril 5 mg package label
(click image for full-size original)

10 mg tablets

image of Quinapril 10 mg package label
(click image for full-size original)

20 mg tablets

image of Quinapril 20 mg package label
(click image for full-size original)

40 mg tablets

image of Quinapril 40 mg package label
(click image for full-size original)

QUINAPRIL quinapril tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5279(NDC:63304-548)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRIL) QUINAPRIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
POLYVINYL ALCOHOL
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (convex faced) Size 5mm
Flavor Imprint Code 18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5279-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076607 07/22/2005
QUINAPRIL quinapril tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5245(NDC:63304-549)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRIL) QUINAPRIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
POLYVINYL ALCOHOL
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (convex faced) Size 7mm
Flavor Imprint Code RX549
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5245-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5245-1 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5245-2 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076607 03/07/2005
QUINAPRIL quinapril tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5241(NDC:63304-550)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRIL) QUINAPRIL HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
POLYVINYL ALCOHOL
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (convex faced) Size 9mm
Flavor Imprint Code RX550
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5241-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5241-1 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5241-2 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076607 03/03/2005
QUINAPRIL quinapril tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5246(NDC:63304-551)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUINAPRIL HYDROCHLORIDE (QUINAPRIL) QUINAPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM CARBONATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
TALC
LECITHIN, SOYBEAN
POLYVINYL ALCOHOL
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (convex faced) Size 11mm
Flavor Imprint Code RX551
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5246-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5246-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5246-2 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076607 11/28/2007
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 01/2010 Physicians Total Care, Inc.

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