Cefoxitin and Dextrose (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

Allergic Reactions

Inform patients that Cefoxitin for Injection and Dextrose Injection is a cephalosporin that can cause allergic reactions in some individuals [see Warnings and Precautions (5.1)].

Clostridium difficile -Associated Diarrhea

Inform patients that diarrhea is a common problem caused by antibacterials, including Cefoxitin for Injection and Dextrose Injection, and it usually ends when the antibacterial is discontinued.

Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If this occurs, advise patients to contact their physician as soon as possible.

Drug Resistance

Patients should be counseled that antibacterial drugs including Cefoxitin for Injection and Dextrose Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefoxitin for Injection and Dextrose Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefoxitin for Injection and Dextrose Injection or other antibacterial drugs in the future.

Rx only

DUPLEX is a registered trademark of B. Braun Medical Inc.

Clinitest is a registered trademark of Siemens Healthcare Diagnostics Inc.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-002-978 LD-100-4

PRINCIPAL DISPLAY PANEL — 50 mL Container Label

Cefoxitin for Injection
and Dextrose Injection

1g*

REF 3123-11
NDC 0264-3123-11

DUPLEX® CONTAINER

50 mL

Use only after mixing contents of both chambers.
For IV Use Only Iso-osmotic Single-Dose Sterile/Nonpyrogenic

* Contains cefoxitin sodium equivalent to 1 g cefoxitin.

Reconstitution: Hold container with set port in a downward direction and fold
the diluent chamber just below the solution meniscus. To activate seal, squeeze
folded diluent chamber until seal between diluent and drug chamber opens,
releasing diluent into drug chamber. Agitate the reconstituted solution until the
drug powder is completely dissolved. Fold the container a second time and
squeeze until seal between drug chamber and set port opens.

After reconstitution each 50 mL single dose unit contains: Cefoxitin Sodium USP
(equivalent to 1 g cefoxitin) with approx. 2 g (4% w/v) Hydrous Dextrose USP in
Water for Injection USP. Sodium content is 53.8 mg (2.3 mEq) per gram of cefoxitin.
Approximate osmolality: 290 mOsmol/kg
Prior to Reconstitution: Store at 20-25°C (68-77°F). Excursions permitted to
15-30°C (59-86°F). [See USP Controlled Room Temperature.] Use only if container
and seals are intact. Do not peel foil strip until ready for use. After foil strip
removal, product must be used within 7 days, but not beyond the labeled
expiration date. Protect from light after removal of foil strip.
After Reconstitution: Use only if prepared solution is clear and free from
particulate matter. Use within 12 hours if stored at room temperature or within
7 days if stored under refrigeration. Do not use in a series connection. Do not
introduce additives into this container. Prior to administration check for minute
leaks by squeezing container firmly. If leaks are found, discard container and
solution as sterility may be impaired. Do not freeze.

Not made with natural rubber latex, PVC or DEHP.

Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524

Prepared in USA. API from USA and Italy.

Y37-002-561LD-204-3

EXP

LOT

PEEL HERE

Drug Chamber

Discard unit if foil strip is damaged. Peel foil strip only when ready for use. Visually inspect drug prior to reconstitution.

See package insert for complete directions for reconstitution and administration.

LD-336-1 X27-001-485

PRINCIPAL DISPLAY PANEL — 50 mL Container Label-

Cefoxitin for Injection and Dextrose Injection

2g*
REF 3125-11
NDC 0264-3125-11

DUPLEX® CONTAINER

50 mL

Use only after mixing contents of both chambers.
For IV Use Only Iso-osmotic Single-Dose Sterile/Nonpyrogenic
* Contains cefoxitin sodium equivalent to 2 g cefoxitin.

Reconstitution: Hold container with set port in a downward direction and fold
the diluent chamber just below the solution meniscus. To activate seal, squeeze
folded diluent chamber until seal between diluent and drug chamber opens,
releasing diluent into drug chamber. Agitate the reconstituted solution until the
drug powder is completely dissolved. Fold the container a second time and
squeeze until seal between drug chamber and set port opens.

After reconstitution each 50 mL single dose unit contains: Cefoxitin Sodium USP
(equivalent to 2 g cefoxitin) with approx. 1.1 g (2.2% w/v) Hydrous Dextrose USP in
Water for Injection USP. Sodium content is 53.8 mg (2.3 mEq) per gram of cefoxitin.
Approximate osmolality: 290 mOsmol/kg
Prior to Reconstitution: Store at 20-25°C (68-77°F). Excursions permitted to
15-30°C (59-86°F). [See USP Controlled Room Temperature.] Use only if container
and seals are intact. Do not peel foil strip until ready for use. After foil strip
removal, product must be used within 7 days, but not beyond the labeled
expiration date. Protect from light after removal of foil strip.
After Reconstitution: Use only if prepared solution is clear and free from
particulate matter. Use within 12 hours if stored at room temperature or within
7 days if stored under refrigeration. Do not use in a series connection. Do not
introduce additives into this container. Prior to administration check for minute
leaks by squeezing container firmly. If leaks are found, discard container and
solution as sterility may be impaired. Do not freeze.

Not made with natural rubber latex, PVC or DEHP.
Rx only

B. Braun Medical Inc.
Bethlehem, PA 18018-3524

Prepared in USA. API from USA and Italy.
Y37-002-562LD-205-3

EXP

LOT

PEEL HERE

Drug Chamber

Discard unit if foil strip is damaged. Peel foil strip only when ready for use. Visually inspect drug prior to reconstitution.

See package insert for complete directions for reconstitution and administration.

LD-336-1 X27-001-485

CEFOXITIN AND DEXTROSE cefoxitin sodium injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-3123 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFOXITIN SODIUM (CEFOXITIN) CEFOXITIN 1 g in 50 mL

Inactive Ingredients Ingredient Name Strength DEXTROSE 2 g in 50 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0264-3123-11 24 CONTAINER in 1 CASE contains a CONTAINER 1 50 mL in 1 CONTAINER This package is contained within the CASE (0264-3123-11)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA065214 03/10/2006

CEFOXITIN AND DEXTROSE cefoxitin sodium injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-3125 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFOXITIN SODIUM (CEFOXITIN) CEFOXITIN 2 g in 50 mL

Inactive Ingredients Ingredient Name Strength DEXTROSE 1.1 g in 50 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0264-3125-11 24 CONTAINER in 1 CASE contains a CONTAINER 1 50 mL in 1 CONTAINER This package is contained within the CASE (0264-3125-11)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA065214 03/10/2006

Labeler — B. Braun Medical Inc. (002397347)

Revised: 07/2019 B. Braun Medical Inc.