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 .)

HOW SUPPLIED

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:

NDC 68258-6106-03

STORAGE

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.

Sandoz Inc.

Princeton, NJ 08540

OS7960

Rev. 05/13

MF0041REV05/13

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 68258-6106-XX

NDC 66336-6106-03

image description
(click image for full-size original)
FOSINOPRIL SODIUM
fosinopril sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-6106(NDC:0185-0042)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
ZINC STEARATE
Product Characteristics
Color WHITE (Off-White) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code E42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-6106-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076483 04/23/2004
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (68258-6106), repack (68258-6106)

Revised: 07/2013 Dispensing Solutions, Inc.

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