Ampicillin (Page 3 of 3)

For Intramuscular Use

Dissolve the contents of a vial with the amount of Sterile Water for Injection or Bacteriostatic Water for Injection listed in the table below:

Amount of Approximate Approximate
NDC Label Diluent to be Available Concentration (in
No. Claim Added (mL) Volume (mL) mg/mL)
63323-387-10 250 mg 0.9 1 250
63323-388-10 500 mg 1.7 2 250
63323-389-10 1 g 3.4 4 250
63323-399-23 2 g 6.8 8 250

While ampicillin for injection 1 g and 2 g vials are primarily for intravenous use, the contents may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.4 or 6.8 mL Sterile Water for Injection or Bacteriostatic Water for Injection respectively. The resulting solution will provide a concentration of 250 mg per mL.

For Direct Intravenous Use

Add 5 mL Sterile Water for Injection or Bacteriostatic Water for Injection to the 250 and 500 mg vials and administer slowly over a 3 to 5 minute period. Ampicillin for Injection, 1 g or 2 g, may also be given by direct intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection or Bacteriostatic Water for Injection, respectively, and administer slowly over at least 10 to 15 minutes. CAUTION: More rapid administration may result in convulsive seizures.

For Administration by Intravenous Drip

Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with intravenous solution. Stability studies on ampicillin at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

Room Temperature (25°C)

Diluent

Concentrations

Stability Periods

Sterile Water for Injection

up to 30 mg/mL

8 hours

Sodium Chloride Injection USP, 0.9%

up to 30 mg/mL

8 hours

M/6 Sodium Lactate Injection

up to 30 mg/mL

8 hours

5% Dextrose in Water

10 to 20 mg/mL

2 hours

5% Dextrose in Water

up to 2 mg/mL

4 hours

5% Dextrose in 0.45% NaCl Inj.

up to 2 mg/mL

4 hours

10% Invert Sugar in Water

up to 2 mg/mL

4 hours

Lactated Ringer’s Injection

up to 30 mg/mL

8 hours

Refrigerated (4°C)

Diluent

Concentrations

Stability Periods

Sterile Water for Injection

30 mg/mL

48 hours

Sterile Water for Injection

up to 20 mg/mL

72 hours

Sodium Chloride Injection USP, 0.9%

30 mg/mL

48 hours

Sodium Chloride Injection USP, 0.9%

up to 20 mg/mL

72 hours

Lactated Ringer’s Injection

up to 30 mg/mL

24 hours

M/6 Sodium Lactate Injection

up to 30 mg/mL

8 hours

5% Dextrose in Water

up to 20 mg/mL

4 hours

5% Dextrose and 0.45% NaCl Inj.

up to 10 mg/mL

4 hours

10% Invert Sugar

up to 20 mg/mL

3 hours

Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED:

Ampicillin for Injection, USP for IM or IV Injection. Ampicillin sodium equivalent to 250, 500 mg, 1 or 2 grams of ampicillin per vial.

Product No. NDC No.
308710 63323-387-10 250 mg vial
308810 63323-388-10 500 mg vial
308910 63323-389-10 1 g vial
309923 63323-399-23 2 g vial
Packaged in tens.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

The container closure is not made with natural rubber latex.


Manufactured for:

fresenius kabi logo
Lake Zurich, IL 60047

Made in Italy

45931GRevised: July 2015

PRINCIPAL DISPLAY PANEL — 250 mg per Vial

Ampicillin for Injection, USP 250 mg carton label
(click image for full-size original)

NDC 63323-387-10
308710

AMPICILLIN
FOR INJECTION, USP

ampicillin sodium equivalent to
250 mg
ampicillin

For IV or IM Use
Rx only10 Vials

PRINCIPAL DISPLAY PANEL — 500 mg per Vial

Ampicillin for Injection, USP 500 mg carton label
(click image for full-size original)

NDC 63323-388-10
308810

AMPICILLIN
FOR INJECTION, USP

ampicillin sodium equivalent to
500 mg
ampicillin

For IV or IM Use
Rx only10 Vials

PRINCIPAL DISPLAY PANEL — 1 g per Vial

Ampicillin for Injection, USP 1 g carton label
(click image for full-size original)

NDC 63323-389-10
308910

AMPICILLIN
FOR INJECTION, USP

ampicillin sodium equivalent to
1 g
ampicillin

For IV or IM Use
Rx only10 Vials

PRINCIPAL DISPLAY PANEL — 2 g per Vial

Ampicillin for Injection, USP 2 g carton label
(click image for full-size original)

NDC 63323-399-23
309923

AMPICILLIN
FOR INJECTION, USP

ampicillin sodium equivalent to
2 g
ampicillin

For IV Use
Rx only10 Vials

AMPICILLIN ampicillin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-387
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 250 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-387-10 10 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (63323-387-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062719 05/12/1987
AMPICILLIN ampicillin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-388
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 500 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-388-10 10 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (63323-388-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062719 05/12/1987
AMPICILLIN ampicillin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-389
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-389-10 10 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (63323-389-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062719 05/12/1987
AMPICILLIN ampicillin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-399
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 2 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-399-23 10 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (63323-399-23)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062797 07/12/1993
Labeler — APP Pharmaceuticals, Inc. (608775388)
Registrant — Istituto Biochimico Italiano Giovanni Lorenzini SpA (432432581)
Establishment
Name Address ID/FEI Operations
Istituto Biochimico Italiano Giovanni Lorenzini SpA 432432581 MANUFACTURE (63323-387), MANUFACTURE (63323-388), MANUFACTURE (63323-389), MANUFACTURE (63323-399)

Revised: 11/2007 APP Pharmaceuticals, Inc.

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