EXPAREL Suspension for solution for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Pacira Pharmaceuticals Inc.

Λέξεις κλειδιά

65250-133 65250-266

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1. Indications and Usage

EXPAREL is indicated: In patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia In adults as an interscalene brachial plexus nerve block to produce postsurgical ...

2. Dosage and Administration

2.1 Important Dosage and Administration Information EXPAREL is intended for single-dose administration only. Different formulations of bupivacaine are not bioequivalent even if the milligram strength is ...

3. Dosage Forms and Strengths

EXPAREL (bupivacaine liposome injectable suspension) is a white to off-white, milky aqueous suspension that is available in the following vial sizes: 266 mg/20 mL (13.3 mg/mL) single-dose vial 133 mg/10 ...

4. Contraindications

EXPAREL is contraindicated in obstetrical paracervical block anesthesia. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia ...

5. Warnings and Precautions

5.1 Warnings and Precautions for Bupivacaine Containing Products The safety and effectiveness of bupivacaine and other amide-containing products depend on proper dosage, correct technique, adequate precautions, ...

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 ...

6.1. Clinical Trials Experience

Adverse Reactions Reported in All Local Infiltration Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a ...

6.2. Postmarketing Experience

Because adverse reactions reported during postmarketing are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal ...

7. Drug Interactions

The toxic effects of local anesthetics are additive and their co-administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic ...

8.1. Pregnancy

Risk Summary There are no studies conducted with EXPAREL in pregnant women. In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits ...

8.2. Lactation

Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug ...

8.4. Pediatric Use

The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this ...

8.5. Geriatric Use

Of the total number of patients in the EXPAREL 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 ...

8.6. Hepatic Impairment

Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater ...

8.7. Renal Impairment

Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing ...

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 ...

11. Description

EXPAREL is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam drug delivery system) containing bupivacaine. Bupivacaine is ...

12.1. Mechanism of Action

Local anesthetics block the generation and the conduction of nerve impulses presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, ...

12.2. Pharmacodynamics

Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems. At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, ...

12.3. Pharmacokinetics

Administration of EXPAREL results in systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. [See ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine have not been conducted. Mutagenesis The mutagenic potential of bupivacaine has not been determined. Impairment ...

14. Clinical Studies

14.1 Studies Confirming Efficacy The efficacy of EXPAREL compared to placebo was demonstrated in three multicenter, randomized, double-blinded clinical studies. For local analgesia via infiltration, one ...

16.1. How Supplied

EXPAREL (bupivacaine liposome injectable suspension) is a white to off-white milky aqueous suspension that is available in the following single-dose vials. 266 mg/20 mL (13.3 mg/mL) single-dose vial, (NDC ...

16.2. Storage and Handling

Storage: Store EXPAREL vials refrigerated between 2°C to 8°C (36°F to 46°F). EXPAREL may be held at a controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 30 days in sealed, intact ...

17. 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 ...