Bupivacaine Hydrochloride (Page 6 of 6)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been conducted.

Mutagenesis

The mutagenic potential of bupivacaine hydrochloride has not been determined.

Impairment of Fertility

The effect of bupivacaine on fertility has not been determined.

16 HOW SUPPLIED/STORAGE AND HANDLING

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 ° F to 86 °F). [See USP Controlled Room Temperature.]

Bupivacaine hydrochloride injection, USP ―Solutions of Bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121 °C (250 °F) for 15 minutes. Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate.

NDC No.

Container

Fill

Quantity

0.25% — Contains 2.5 mg bupivacaine hydrochloride per mL.

0143-9328-10

Multiple Dose Vial

50 mL

Carton of 10 vials

0.5% — Contains 5 mg bupivacaine hydrochloride per mL.

0143-9329-10

Multiple Dose Vial

50 mL

Carton of 10 vials


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 [see Contraindications (4)].

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)].

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised: February 2021

PIN434-WES/5

PRINCIPAL DISPLAY PANEL

NDC 0143-9328 -01 Rx only

50 mL Multiple-Dose Vial

Bupivacaine HCl Injection, USP 0.25%

125 mg per 50 mL

(2.5 mg/mL)

For Infiltration and Nerve Block

Not for Caudal, Epidural, or Spinal Anesthesia

Preservative Added

9328-01
(click image for full-size original)

NDC 0143-9328 -10 Rx only

Bupivacaine HCl Injection, USP 0.25%

125 mg per 50 mL

(2.5 mg/mL)

For Infiltration and Nerve Block

Not for Caudal, Epidural, or Spinal Anesthesia

Preservative Added

10 x 50 mL Multiple-Dose Vials

9328-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9329 -01 Rx only

50 mL Multiple-Dose Vial

Bupivacaine HCl Injection, USP 0.5%

250 mg per 50 mL

(5 mg/mL)

For Nerve Block

Not for Caudal, Epidural, or Spinal Anesthesia

Preservative Added

9329-01
(click image for full-size original)

NDC 0143-9329 -10 Rx only

Bupivacaine HCl Injection, USP 0.5%

250 mg per 50 mL

(5 mg/mL)

For Nerve Block

Not for Caudal, Epidural, or Spinal Anesthesia

Preservative Added

10 x 50 mL Multiple-Dose Vials

9329-10
(click image for full-size original)

Representative Serialization Image

representative serialization image
(click image for full-size original)

BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9328
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE 8.6 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9328-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0143-9328-01)
1 NDC:0143-9328-01 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0143-9328-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205141 02/11/2021
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9329
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE 8.1 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9329-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0143-9329-01)
1 NDC:0143-9329-01 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0143-9329-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205141 02/11/2021
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 02/2021 Hikma Pharmaceuticals USA Inc.

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