OVERDOSAGE SECTION.

OVERDOSAGE. Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis.Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice.To obtain up-to-date information about the treatment of overdose, good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container LabelNDC 0338-3551-48Vancomycin Injection, USPin 5% Dextrose500 mg per 100 mL(5 mg/mL)GALAXY Single-Dose Container Discard unused portion Code 2G3551Sterile Nonpyrogenic Iso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water forInjection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information. Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days underrefrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-761Carton LabelsThaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-764Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-764Vancomycin Injection, USP in 5% Dextrose 500 mg per 100 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3551-48Code 2G3551FOR BAR CODE POSITION ONLY(01) 20303383551485Vancomycin Injection, USP in 5% Dextrose 500 mg per 100 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3551-48Code 2G3551FOR BAR CODE POSITION ONLY(01) 20303383551485GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3551LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3551LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-861Container Label NDC 0338-3552-48Vancomycin Injection, USP in 5% Dextrose1 per 200 mL(5 mg/mL)GALAXY Single-Dose Container Discard unused portion Code 2G3552Sterile Nonpyrogenic Iso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information. Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-763Carton Labels Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-766Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-766Vancomycin Injection, USP in 5% Dextrose g per 200 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3552-48Code 2G3552FOR BAR CODE POSITION ONLY(01) 20303383552482Vancomycin Injection, USP in 5% Dextrose g per 200 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3552-48Code 2G3552FOR BAR CODE POSITION ONLY(01) 20303383552482GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3552LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3552LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-864Container LabelNDC 0338-3580-48Vancomycin Injection, USPin 5% Dextrose750 mg per 150 mL(5 mg/mL)GALAXYSingle-Dose Container Discard unused portionCode 2G3580Sterile NonpyrogenicIso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USPequivalent to 500 mg vancomycin with approx. g DextroseHydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Dosage: For intravenous use only. See prescribing information. Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-762Carton LabelsThaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-765Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-74-765Vancomycin Injection, USP in 5% Dextrose 750 mg per 150 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3580-48Code 2G3580FOR BAR CODE POSITION ONLY(01) 20303383580485Vancomycin Injection, USP in 5% Dextrose 750 mg per 150 mL (5 mg/ mL)Contains Single-Use bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3580-48Code 2G3580FOR BAR CODE POSITION ONLY(01) 20303383580485GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3580LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3580LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-862Container Label NDC 0338-3581-01Vancomycin Injection, USPin 0.9% Sodium Chloride500 mg per 100 mL(5 mg/mL)GALAXYSingle-Dose Container Discard unused portionCode 2G3590Sterile NonpyrogenicIso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Dosage: For intravenous use only. See prescribing information. Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-548Carton Labels Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-715Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-715Vancomycin Injection, USP in 0.9% Sodium Chloride 500 mg per 100 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3581-01Code 2G3590FOR BAR CODE POSITION ONLY(01) 20303383581017Vancomycin Injection, USP in 0.9% Sodium Chloride 500 mg per 100 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3581-01Code 2G3590FOR BAR CODE POSITION ONLY(01) 20303383581017GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3590LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3590LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-865Container LabelNDC 0338-3582-01Vancomycin Injection, USPin 0.9% Sodium Chloride750 mg per 150 mL(5 mg/mL)GALAXYSingle-Dose Container Discard unused portionCode 2G3591Sterile NonpyrogenicIso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Dosage: For intravenous use only. See prescribing information. Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-551Carton Labels Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-715Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-715Vancomycin Injection, USP in 0.9 Sodium Chloride 750 mg per 150 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3582-01Code 2G3591FOR BAR CODE POSITION ONLY(01) 20303383582014Vancomycin Injection, USP in 0.9 Sodium Chloride 750 mg per 150 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3582-01Code 2G3591FOR BAR CODE POSITION ONLY(01) 20303383582014GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3591LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3591LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-863Container LabelNDC 0338-3583-01Vancomycin Injection, USPin 0.9% Sodium Chloride1 per 200 mL(5 mg/mL)GALAXYSingle-Dose Container Discard unused portionCode 2G3592Sterile NonpyrogenicIso-osmoticEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Rx OnlyStore at or below -20C (-4F). Thaw at room temperature(25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.PL 2040 PlasticBaxter LogoBaxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA07-34-74-553Carton Labels Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-717Thaw at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.PL 2040 Plastic 07-04-77-717Vancomycin Injection, USP in 0.9 Sodium Chloride g per 200 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3583-01Code 2G3592FOR BAR CODE POSITION ONLY(01) 20303383583011Vancomycin Injection, USP in 0.9 Sodium Chloride g per 200 mL (5 mg/ mL)Contains Single-Dose bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20C/-4F.Rx OnlyNDC 0338-3583-01Code 2G3592FOR BAR CODE POSITION ONLY(01) 20303383583011GALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USAGALAXY Container Sterile NonpyrogenicEach 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.Baxter LogoBaxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USACODE: 2G3592LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX X(21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXXCODE: 2G3592LOT: XXXXXXXXXEXP: DD MMM YYQTY: QQSN: FOR PLACEMENT ONLY.(01) XXXXXXX XXXXX (21) XXXXXXXXX(17) XXXXXX(10) XXXXXXXXX07-06-77-866. Vancomycin Representative Container Label NDC 0338-3551-48. Vancomycin Representative Carton Label NDC 0338-3551-48 panel of 3. Vancomycin Representative Carton Label NDC 0338-3551-48 panel of 3. Vancomycin Representative Carton Label NDC 0338-3551-48 panel of 3. 2G3551 Carton Label representing product identifier. Vancomycin Representative Container Label 0338-3552-48 Vancomycin Representative Carton Label 0338-3552-48 panel of 3. Vancomycin Representative Carton Label 0338-3552-48 panel of 3. Vancomycin Representative Carton Label 0338-3552-48 panel of 3. 2G3552 Carton Label representing product identifier. Vancomycin Representative Container Label 0338-3580-48. Vancomycin Representative Carton Label 0338-3580-48 panel of 3. Vancomycin Representative Carton Label 0338-3580-48 panel of 3. Vancomycin Representative Carton Label 0338-3580-48 panel of 3. 2G3580 Carton Label representing product identifier. Vancomycin Representative Container Label 0338-3581-01 Vancomycin Representative Carton Label 0338-3581-01 panel of 3. Vancomycin Representative Carton Label 0338-3581-01 panel of 3. Vancomycin Representative Carton Label 0338-3581-01 panel of 3. 2G3590 Carton Label representing product identifier. Vancomycin Representative Container Label 0338-3582-01. Vancomycin Representative Carton Label 0338-3582-01 panel of 3. Vancomycin Representative Carton Label 0338-3582-01 panel of 3. Vancomycin Representative Carton Label 0338-3582-01 panel of 3. 2G3591 Carton Label representing product identifier. Vancomycin Representative Container Label 0338-3583-01. Vancomycin Representative Carton Label 0338-3583-01 panel of 3. Vancomycin Representative Carton Label 0338-3583-01 panel of 3. Vancomycin Representative Carton Label 0338-3583-01 panel of 3. 2G3592 Carton Label representing product identifier.

PEDIATRIC USE SECTION.

Pediatric Use. In pediatric patients, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing in pediatric patients (see PRECAUTIONS). The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic containers into the single-dose, premixed intravenous preparation has not been determined.

PRECAUTIONS SECTION.

PRECAUTIONS. Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin.Risk of High Sodium Load:Each 100mL solution of Vancomycin Injection, USP contains 0.9 of Sodium Chloride, USP. Avoid use of Vancomycin Injection, USP with Sodium Chloride, USP in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake.Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.Reversible neutropenia has been reported in patients receiving vancomycin (see ADVERSE REACTIONS). Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.Vancomycin is irritating to tissue and must be given by secure intravenous route of administration. Pain, tenderness, and necrosis occur with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can be minimized by slow infusion of the drug and by rotation of venous access sites.There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin as 60-minute infusion prior to anesthetic induction. The safety and efficacy of vancomycin administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well-controlled trials.Reports have revealed that administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in syndrome of chemical peritonitis. To date, this syndrome has ranged from cloudy dialysate alone to cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.Prescribing vancomycin in the absence of proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.. Drug Interactions. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Usage in Pediatrics under PRECAUTIONS) and anaphylactoid reactions (see ADVERSE REACTIONS).Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.. Pregnancy. Teratogenic Effects. Animal reproduction studies have not been conducted with vancomycin. It is not known whether vancomycin can affect reproduction capacity. In controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. Because the number of patients treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin causes fetal harm. Vancomycin should be given to pregnant woman only if clearly needed.. Nursing Mothers. Vancomycin is excreted in human milk. Caution should be exercised when vancomycin is administered to nursing woman. Because of the potential for adverse events, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.. Pediatric Use. In pediatric patients, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing in pediatric patients (see PRECAUTIONS). The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic containers into the single-dose, premixed intravenous preparation has not been determined.. Geriatric Use. The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients (see DOSAGE AND ADMINISTRATION).. Information for Patients. Severe Dermatologic ReactionsAdvise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters, (see WARNINGS).Patients should be counseled that antibacterial drugs including vancomycin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When vancomycin is prescribed to treat 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 vancomycin or other antibacterial drugs in the future.Diarrhea is common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Infusion-Related Events. During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (red neck) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if vancomycin is given by slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin was administered at rate of 10 mg/min or less.. Nephrotoxicity. Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving vancomycin.. Gastrointestinal. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).. Ototoxicity. few dozen cases of hearing loss associated with vancomycin have been reported. Most of these patients had kidney dysfunction or preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.. Hematopoietic. Reversible neutropenia, usually starting week or more after onset of therapy with vancomycin or after total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported. Although causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm3) has been reported rarely.. Phlebitis. Inflammation at the injection site has been reported.. Miscellaneous. Patients have been reported to have had anaphylaxis, drug fever, nausea, chills, eosinophilia, rashes including exfoliative dermatitis, Stevens-Johnson syndrome (see WARNINGS, Severe Dermatologic Reactions), and vasculitis in association with administration of vancomycin.Chemical peritonitis has been reported following intraperitoneal administration of vancomycin (see PRECAUTIONS).. Post Marketing Reports. The following adverse reactions have been identified during post-approval use of vancomycin. Because these reactions are reported voluntarily from population of uncertain size, it is not possible to reliably estimate their frequency or establish causal relationship to drug exposure.. Skin and Subcutaneous Tissue Disorders. Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) (see WARNINGS, Severe Dermatologic Reactions).

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION.

ANIMAL PHARMACOLOGY. In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin 25 mg/kg, at concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. In subjects with normal kidney function, multiple intravenous dosing of g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL hours after infusion, and mean plasma concentrations of approximately mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL hours after infusion, and mean plasma concentrations of about 10 mcg/mL hours after infusion. The plasma concentrations during multiple dosing are similar to those after single dose.The mean elimination half-life of vancomycin from plasma is to hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days. The distribution coefficient is from 0.3 to 0.43 L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in hours. Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials (see PRECAUTIONS).Total systemic and renal clearance of vancomycin may be reduced in the elderly.Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.. Microbiology. The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.. Synergy. The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many strains of Staphylococcus aureus, Streptococcus bovis, enterococci, and the viridans group streptococci. Vancomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.. Aerobic gram-positive microorganisms. DiphtheroidsEnterococci (e.g., Enterococcus faecalis)Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains)Streptococcus bovisViridans group streptococciThe following in vitro data are available, but their clinical significance is unknown. Vancomycin exhibits in vitro MICs of mcg/mL or less against most (>=90%) strains of streptococci listed below and MICs of mcg/mL or less against most (>=90%) strains of other listed microorganisms; however, the safety and effectiveness of vancomycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.. Aerobic gram-positive microorganisms. Listeria monocytogenesStreptococcus pyogenesStreptococcus pneumoniae (including penicillin-resistant strains)Streptococcus agalactiae. Anaerobic gram-positive microorganisms. Actinomyces speciesLactobacillus species. Susceptibility Test Methods. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: http://www.fda.gov/STIC.

CONTRAINDICATIONS SECTION.

CONTRAINDICATION. Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

DESCRIPTION SECTION.

DESCRIPTION. Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) contains vancomycin, added as Vancomycin Hydrochloride, USP. It is tricyclic glycopeptide antibiotic drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24o HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is frozen, iso-osmotic, sterile, nonpyrogenic premixed 100 mL, 150 mL, or 200 mL solution containing 500 mg, 750 mg, or g Vancomycin respectively as Vancomycin hydrochloride. Each 100 mL of solution contains approximately g of Dextrose Hydrous, USP or 0.9 of Sodium Chloride, USP. The pH of the solution may have been adjusted with hydrochloric acid and/or sodium hydroxide. Thawed solutions have pH in the range of 3.0 to 5.0. After thawing to room temperature, this solution is intended for intravenous use only.This GALAXY container is fabricated from specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.. Vancomycin Hydrochloride Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is intended for intravenous use only.Vancomycin in the GALAXY Container (PL 2040 Plastic) is not to be administered orally. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion related events may occur, however, at any rate or concentration.. Patients With Normal Renal Function. Adults. The usual daily intravenous dose is g divided either as 500 mg every hours or g every 12 hours. Each dose should be administered at no more than 10 mg/min or over period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.. Pediatric patients. The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every hours. Each dose should be administered over period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.. Neonates. In pediatric patients up to the age of month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every hours thereafter up to the age of month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.. Patients With Impaired Renal Function and Elderly Patients. Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:DOSAGE TABLE FOR VANCOMYCININ PATIENTS WITH IMPAIRED RENAL FUNCTION(Adapted from Moellering et al)1 Creatinine Clearance mL/min Vancomycin Dose mg/24 1001,545901,390801,235701,080609255077040620304652031010155The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on daily basis. In anuria, dose of 1,000 mg every to 10 days has been recommended.When only the serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.Men:Weight (kg) (140 age in years) 72 serum creatinine concentration (mg/dL)Women: 0.85 above valueThe serum creatinine must represent steady state of renal function. Otherwise, the estimated value for creatinine clearance is not valid. Such calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity. The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) routes have not been established.Intermittent infusion is the recommended method of administration.. Directions for use of Vancomycin Injection, USP in GALAXY plastic container (PL 2040). Vancomycin Injection, USP in GALAXY plastic container (PL 2040) is for intravenous administration only.. Storage. Store in freezer capable of maintaining temperature at or below -20C (-4F).. Thawing of Plastic Containers:. 1.Thaw frozen containers at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in waters baths or by microwave irradiation. Do not force thaw. 2.Check for minute leaks by squeezing the bag firmly. If leaks are detected, discard solution because sterility may be impaired.3.Do not add supplemental medication.4.Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals are not intact, the container should be discarded.5.The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature (25C/77F) or for 30 days when stored under refrigeration (5C/41F).6.Do not refreeze thawed antibiotics.. 1.Thaw frozen containers at room temperature (25C/77F) or under refrigeration (5C/41F). Product should not be thawed by immersion in waters baths or by microwave irradiation. Do not force thaw. 2.Check for minute leaks by squeezing the bag firmly. If leaks are detected, discard solution because sterility may be impaired.. 3.Do not add supplemental medication.. 4.Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals are not intact, the container should be discarded.. 5.The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature (25C/77F) or for 30 days when stored under refrigeration (5C/41F).. 6.Do not refreeze thawed antibiotics.. Preparation for Intravenous Administration:. 1.Suspend container from eyelet support.2.Remove protector from outlet port at bottom of container.3.Attach administration set. Refer to complete directions accompanying set.4.Use sterile equipment.Caution: Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.Rx only.. 1.Suspend container from eyelet support.. 2.Remove protector from outlet port at bottom of container.. 3.Attach administration set. Refer to complete directions accompanying set.. 4.Use sterile equipment.

DRUG INTERACTIONS SECTION.

Drug Interactions. Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Usage in Pediatrics under PRECAUTIONS) and anaphylactoid reactions (see ADVERSE REACTIONS).Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.

GERIATRIC USE SECTION.

Geriatric Use. The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients (see DOSAGE AND ADMINISTRATION).

HOW SUPPLIED SECTION.

HOW SUPPLIED/STORAGE AND HANDLING. Vancomycin Injection, USP is supplied as frozen, iso-osmotic, premixed solution in 100 mL, 150 mL, or 200 mL single dose GALAXY plastic container (PL 2040) in the following vancomycin doses:Vancomycin Injection, USP in 5% Dextrose2G3551500 mg/100 mL in single dose GALAXY containerNDC 0338-3551-482G3580750 mg/150 mL in single dose GALAXY containerNDC 0338-3580-482G35521 g/200 mL in single dose GALAXY containerNDC 0338-3552-48Vancomycin Injection, USP in 0.9% Sodium Chloride2G3590500 mg/100 mL in single dose GALAXY containerNDC 0338-3581-012G3591750 mg/150 mL in single dose GALAXY containerNDC 0338-3582-012G35921 g/200 mL in single dose GALAXY containerNDC 0338-3583-01Store at or below -20C (-4F).See DIRECTIONS FOR USE OF Vancomycin Injection, USP in GALAXY plastic container (PL 2040). The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature (25C/77F) or for 30 days when stored under refrigeration (5C/41F). Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Severe Dermatologic ReactionsAdvise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters, (see WARNINGS).Patients should be counseled that antibacterial drugs including vancomycin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When vancomycin is prescribed to treat 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 vancomycin or other antibacterial drugs in the future.Diarrhea is common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

MICROBIOLOGY SECTION.

Microbiology. The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

NURSING MOTHERS SECTION.

Nursing Mothers. Vancomycin is excreted in human milk. Caution should be exercised when vancomycin is administered to nursing woman. Because of the potential for adverse events, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PREGNANCY SECTION.

Pregnancy. Teratogenic Effects. Animal reproduction studies have not been conducted with vancomycin. It is not known whether vancomycin can affect reproduction capacity. In controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. Because the number of patients treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin causes fetal harm. Vancomycin should be given to pregnant woman only if clearly needed.

REFERENCES SECTION.

REFERENCES. 1.Moellering RC, Krogstad DJ, Greenblatt DJ: Vancomycin therapy in patients with impaired renal function: nomogram for dosage. Ann Inter Med 1981;94:343.. 1.Moellering RC, Krogstad DJ, Greenblatt DJ: Vancomycin therapy in patients with impaired renal function: nomogram for dosage. Ann Inter Med 1981;94:343.

SPL UNCLASSIFIED SECTION.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

STORAGE AND HANDLING SECTION.

Storage. Store in freezer capable of maintaining temperature at or below -20C (-4F).

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects. Animal reproduction studies have not been conducted with vancomycin. It is not known whether vancomycin can affect reproduction capacity. In controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. Because the number of patients treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin causes fetal harm. Vancomycin should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

WARNINGS. Infusion Reactions. Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest.Vancomycin should be administered over period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions.. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients receiving vancomycin, especially patients with underlying renal impairment, patients with co-morbidities that predispose to renal impairment and patients receiving concomitant therapy with drug known to be nephrotoxic.. Ototoxicity. Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations.. Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters.Discontinue Vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.Dosage of vancomycin must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).. Clostridium Difficile Associated Diarrhea (CDAD). Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.C. difficile produces toxins and which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.. Hemorrhagic Occlusive Retinal Vasculitis (HORV). Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for prophylaxis of endophthalmitis.