Bupivacaine Hydrochloride (Page 8 of 10)

17 PATIENT COUNSELING INFORMATION

Allergic-Type Reactions

Assess if the patient has had allergic-type reactions to amide-type local anesthetics or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple-dose vials or sulfites in epinephrine-containing solutions [see Contraindications (4), Warnings and Precautions (5.8), Adverse Reactions (6)].

Temporary Loss of Sensation and Motor Activity After Caudal or Epidural Anesthesia

When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of caudal or epidural anesthesia.

Instructions After Dental Injection of Bupivacaine Hydrochloride Injection

Advise patients receiving dental injections of Bupivacaine Hydrochloride Injection not to chew solid foods or to test the anesthetized area by biting or probing until anesthesia has worn off (up to 7 hours) [see Warnings and Precautions (5.16)].

Methemoglobinemia

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue [see Warnings and Precautions (5.3)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1176-5.0

PRINCIPAL DISPLAY PANEL — 125 mg/50 mL Vial Label — 9043

50 mL
Multiple-dose Fliptop Vial

0.25% Bupivacaine HCl
125 mg/50 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine and Epinephrine Inj., USP
FOR INFILTRATION AND NERVE BLOCK ONLY

Warning: Contains Sulfites

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 125 mg/50 mL Vial Carton

One/NDC 0409-9043-11

50 mL
Multiple-dose Fliptop Vial

Sterile, nonpyrogenic

0.25% Bupivacaine
Hydrochloride
125 mg/50 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine
and Epinephrine
Injection, USP
Rx only

FOR INFILTRATION AND
NERVE BLOCK ONLY

Not for caudal, epidural
or spinal anesthesia.

PROTECT FROM LIGHT.

Store in carton until contents are used.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL — 50 mg/10 mL Vial Label — 9045

10 mL Single-dose Teartop Vial
Rx only

0.5% Bupivacaine HCl
50 mg/10 mL (5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP

FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.

Warning: Contains Sulfites

Hospira

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL — 50 mg/10 mL Vial Carton

10 mL Single-dose Teartop Vial
Sterile, Nonpyrogenic
Rx only
NDC 0409-9045-01

Contains 10 of NDC 0409-9045-11

0.5% Bupivacaine Hydrochloride
50 mg/10 mL (5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.
Not for spinal anesthesia.

Each mL contains bupivacaine HCl, anhyd. 5 mg; epinephrine 5 mcg; sodium chloride 8.5 mg; sodium metabisulfite 0.1 mg added
as antioxidant; edetate calcium disodium, anhyd. 0.1 mg added as stabilizer. pH 4.0 (3.3 to 5.5). May contain HCl and/or NaOH for pH adjustment. Contains no antimicrobial preservative. Discard unused portion after initial use.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL — 250 mg/50 mL Vial Label — 9046

50 mL
Multiple-dose Vial

0.5% Bupivacaine HCl
250 mg/50 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine and Epinephrine Inj., USP

FOR NERVE BLOCK ONLY

Warning: Contains Sulfites

LOT ##-###-AA EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 250 mg/50 mL Vial Carton

One/NDC 0409-9046-11

50 mL
Multiple-dose Fliptop Vial

Sterile, nonpyrogenic

0.5% Bupivacaine
Hydrochloride
250 mg/50 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine
and Epinephrine
Injection, USP

FOR NERVE BLOCK ONLY.

Not for caudal, epidural or spinal anesthesia.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL — 25 mg/10 mL Vial Label — 9042

10 mL Single-dose Teartop Vial

0.25% Bupivacaine HCl
25 mg/10 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP
Rx only

FOR INFILTRATION, NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA.

Warning: Contains Sulfites