Fosinopril Sodium (Page 7 of 7)
For Hypertensive or Heart Failure Patients With Renal Impairment
In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than in patients with normal renal function. Since hepatobiliary elimination partially compensates for diminished renal elimination, the total body clearance of fosinoprilat does not differ appreciably with any degree of renal insufficiency (creatinine clearances <80 mL/min/1.73m2), including end-stage renal failure (creatinine clearance <10 mL/min/1.73m2). This relative constancy of body clearance of active fosinoprilat, resulting from the dual route of elimination, permits use of the usual dose in patients with any degree of renal impairment. (See WARNINGS, Anaphylactoid Reactions During Membrane Exposure and PRECAUTIONS, Hemodialysis .)
Fosinopril Sodium Tablets for oral administration are available as:
20 mg: White to off-white, capsule-shaped tablets, debossed “E 42” on one side and plain on the other side, packaged with a desiccant and supplied as:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP with a child-resistant closure, as required.
Protect from moisture.
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.
Princeton, NJ 08540
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
| FOSINOPRIL SODIUM |
fosinopril sodium tablet
|Labeler — Dispensing Solutions, Inc. (066070785)|
|Registrant — PSS World Medical, Inc. (101822682)|
|Dispensing Solutions, Inc.||066070785||relabel (68258-6106), repack (68258-6106)|
Revised: 07/2013 Dispensing Solutions, Inc.
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