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Exparel

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Exparel

INDICATIONS

EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia.

EXPAREL has not been studied for use in patients younger than 18 years of age.

DOSAGE AND ADMINISTRATION

EXPAREL is intended for single-dose administration only. The recommended dose of EXPAREL is based on the surgical site and the volume required to cover the area.

Surgery Dose of EXPAREL Volume of EXPAREL
Bunionectomy1 106 mg 8 mL
Hemorrhoidectomy2 266 mg 20 mL
1Infiltrate 7 mL of EXPAREL into the tissues surrounding the osteotomy and 1 mL into the subcutaneous tissue.
2Dilute 20 mL of EXPAREL with 10 mL of saline, for a total of 30 mL, and divide the mixture into six 5 mL aliquots. Perform the anal block by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers.

Injection Instructions

EXPAREL should be injected slowly into soft tissues of the surgical site with frequent aspiration to check for blood and minimize the risk of intravascular injection.

  • EXPAREL is intended for single-dose infiltration only.
  • EXPAREL should be administered with a 25 gauge or larger bore needle.
  • The maximum dosage of EXPAREL should not exceed 266 mg (20 mL, 1.3% of undiluted drug).
  • Do not administer EXPAREL if the product is discolored.
  • Do not administer EXPAREL if it is suspected that the vial has been frozen as reflected by the temperature indicator or exposed to high temperature (greater than 40°C or 104°F) for an extended period.
  • EXPAREL can be administered undiluted or diluted up to 0.89 mg/mL (i.e. 1:14 dilution by volume) with preservative-free normal (0.9%) sterile saline for injection.
  • Vials of EXPAREL should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial.
  • Diluted suspensions of EXPAREL should be used within 4 hours of preparation in a syringe.

Administration Precautions

Some physicochemical incompatibilities exist between EXPAREL and certain other drugs. Direct contact of EXPAREL with these drugs results in a rapid increase in free (unencapsulated) bupivacaine, altering EXPAREL characteristics and potentially affecting the safety and efficacy of EXPAREL. Therefore, admixing EXPAREL with other drugs prior to administration is not recommended [See DRUG INTERACTIONS].

  • Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more.
  • Bupivacaine HCl, when injected immediately before EXPAREL, may impact the pharmacokinetic and/or physicochemical properties of the drugs when the milligram dose of bupivacaine HCl solution exceeds 50% of the EXPAREL dose. EXPAREL contains bupivacaine; therefore, coadministration of both drugs will increase the overall exposure to bupivacaine.
  • When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL.

When administered in recommended doses and concentrations, bupivacaine HCl does not ordinarily produce irritation or tissue damage and does not cause methemoglobinemia.

Non-Interchangeability with Other Formulations of Bupivacaine

Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

Dosing in Special Populations

EXPAREL has not been studied in patients younger than 18 years of age, pregnant patients or patients who are nursing.

HOW SUPPLIED

Dosage Forms And Strengths

EXPAREL (bupivacaine liposome injectable suspension)

  • 10 mL single use vial, 1.3% (13.3 mg/mL)
  • 20 mL single use vial, 1.3% (13.3 mg/mL)

Storage And Handling

EXPAREL (bupivacaine liposome injectable suspension) is available in single-use vials for infiltration.

10 mL single use vial, 1.3% (13.3 mg/mL) packaged in cartons of 10 (NDC 65250-133-10)

20 mL single use vial, 1.3% (13.3 mg/mL) packaged in cartons of 10 (NDC 65250-266-20)

Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL.

Storage

EXPAREL vials should be stored 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 one month in sealed, intact (unopened) vials. Vials should not be re-refrigerated. As a convenience to the hospital pharmacist, each vial label includes space to record the date when the vial has been removed from refrigeration.

EXPAREL should not be frozen as reflected by the temperature indicator or exposed to high temperatures (greater than 40°C or 104°F) for an extended period. Do not administer EXPAREL if it is suspected of having been frozen as reflected by the temperature indicator or exposed to high temperatures.

Check the freeze indicator and discard product if it has been triggered. The freeze indicator turns from green to white when exposed to freezing temperatures.

Handling
  • Vials of EXPAREL should be inverted to re-suspend the particles immediately prior to withdrawal from the vial. Multiple inversions may be necessary to re-suspend the particles if the contents of the vial have settled.
  • Vials should be visually inspected before use.
  • Do not filter.
  • Do not heat before use.
  • Do not autoclave.
  • EXPAREL should be administered with a 25 gauge or larger bore needle.
  • EXPAREL can be administered undiluted or diluted up to 0.89 mg/mL (i.e. 1:14 dilution by volume) with preservative-free normal (0.9%) sterile saline for injection.
  • Following withdrawal from the vial, EXPAREL may be stored at controlled room temperature of 20°C to 25°C (68°F to 77°F) for up to 4 hours prior to administration.
  • Discard any unused portion in an appropriate manner.

Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA. Trademark of Pacira Pharmaceuticals, Inc. Revised: October 2011

Last reviewed on RxList: 11/10/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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