Bupivacaine Hydrochloride with Dextrose Injection

1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable suspension contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in adults ( 1 ). …

• DOSAGE AND ADMINISTRATION Bupivacaine liposome injectable suspension is for single administration only
• Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products even if the strength is the same
• Therefore, it is not possible to convert a dose from other bupivacaine products to a bupivacaine liposome injectable suspension dose and vice versa
• Do not dilute bupivacaine liposome injectable suspension with water or other hypotonic solutions
• The recommended dose of bupivacaine liposome injectable suspension for: Local infiltration
• In adults is up to a maximum dose of 266 mg
• See Full Prescribing Information for guidance on dose selection
• Interscalene brachial plexus nerve block
• In adults is 133 mg
• For the nerve block, administer additional analgesics, which may include other immediate-release local anesthetics, as appropriate
• See Full Prescribing Information for important preparation and administration instructions and compatibility considerations
• Important Dose, Preparation, and Administration Instructions Bupivacaine liposome injectable suspension is for single administration only
• Bupivacaine liposome injectable suspension is not substitutable with other bupivacaine products even if the strength is the same
• Therefore, it is not possible to convert a dose from other bupivacaine products to a bupivacaine liposome injectable suspension dose and vice versa. …

3. DOSAGE FORMS AND STRENGTHS Bupivacaine liposome injectable suspension is a white to off-white, milky aqueous suspension that is available in the following vial sizes: 1.3% (133 mg/10 mL) (13.3 mg/mL) single-dose vial 1.3% (266 mg/20 mL) (13.3 mg/mL) single-dose vial Injectable suspension: 1.3% (133 mg/10 mL) (13.3 mg/mL) in a single-dose vial ( 3 ) 1.3% (266 mg/20 mL) (13.3 mg/mL) in a single-d …

• Safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical: Local analgesia via infiltration
• In pediatric patients aged less than 6 years old
• Regional analgesia via interscalene brachial plexus nerve block
• In pediatric patients

Of the total number of patients in the bupivacaine liposome injectable suspension local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. …

• PATIENT COUNSELING INFORMATION 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
• Inform patients in advance that bupivacaine liposome injectable suspension can cause temporary loss of sensation or motor activity that may last for up to 5 days
• Manufactured by: Jiangsu Hengrui Pharmaceuticals Co., Ltd. …

• CONTRAINDICATIONS Bupivacaine liposome injectable suspension is contraindicated in obstetrical paracervical block anesthesia [ see Use in Specific Populations ]
• While bupivacaine liposome injectable suspension has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death
• Bupivacaine liposome injectable suspension is contraindicated in obstetrical paracervical block anesthesia

7. DRUG INTERACTIONS The toxic effects of local anesthetics are additive and concomitant use should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [ See Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Overdosage ( 10 ) ]. Avoid additional use of local anesthetics within 96 hours following administration of bupivacaine liposome injectable suspension. …

5. WARNINGS AND PRECAUTIONS Monitor cardiovascular status, neurological status, and vital signs during and after injection of bupivacaine liposome injectable suspension ( 5.1 ). Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use bupivacaine liposome injectable suspension cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations ( 5.1 ). Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.1 ). …

6. ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [ see Warnings and Precautions ( 5.1 ) ] Cardiovascular System Reactions [ see Warnings and Precautions ( 5.1 ) ] Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] Chondrolysis [ see Warnings and Precautions ( 5.1 ) ] Methemoglobinemia [ see Warnings and Precautions ( 5.1 ) ] Accidental intravascular injection [ see Warnings and Precautions ( 5.2 ) ] Adverse reactions reported with an incidence greater than or equal to 10% following bupivacaine lipos …

8.1 Pregnancy Risk Summary There are no studies conducted with bupivacaine liposome injectable suspension in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. …

10. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution [ See Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . …

Storage Store bupivacaine liposome injectable suspension vials refrigerated between 2° to 8°C (36° to 46°F). Bupivacaine liposome injectable suspension may be held at a controlled room temperature of 20° to 25°C (68° to 77°F) for up to 30 days in sea …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.