Pacira Pharmaceuticals Inc.

Pacira Pharmaceuticals Inc. Drugs

• Depodur
  

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  Depodur

  

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  DepoDur is intended only for lumbar epidural administration prior to surgery or after clamping of the umbilical cord during cesarean section. DepoDur may be administered via needle or catheter at the lumbar level. Administration of DepoDur at the thoracic level or higher is not recommended because it has not been studied. DepoDur may be administered undiluted or may be diluted up to 5 mL total volume with PRESERVATIVE-FREE 0.9% normal saline.

  Vials of DepoDur should be gently inverted to re-suspend the particles immediately prior to withdrawal from the vial. Avoid aggressive agitation. No further reconstitution or dilution is required.

  For major orthopedic surgery of the lower extremity the recommended dose of DepoDur is 15 mg. For lower abdominal or pelvic surgery, the recommended dose of DepoDur is 10-15 mg. Some patients may benefit from a 20-mg dose of DepoDur, but the incidence of serious adverse respiratory events was dose-related in clinical trials. For cesarean section, the recommended dose is 10 mg.

  DepoDur should be administered to elderly patients (>65 years) after careful evaluation of their underlying medical condition and consideration of the risks associated with DepoDur. Vigilant perioperative monitoring should be exercised for elderly patients receiving DepoDur. In general, as with all opiates, the dose for elderly or debilitated patients should be at the low end of the dosing range.

  While DepoDur is indicated for women undergoing cesarean section following clamping of the umbilical cord, DepoDur should not be administered to women for vaginal labor and delivery.

  The safety and effectiveness of DepoDur in pediatric patients below the age of 18 years have not been established and use in this population is not recommended.

  DepoDur should be administered by or under the direct supervision of a physician experienced in the technique of epidural administration and who is thoroughly familiar with the risks associated with the drug product. It should be administered only in settings where there is adequate patient monitoring. Resuscitative equipment and a specific antagonist (naloxone injection) should be immediately available for the management of respiratory depression. Patient monitoring should be continued for at least 48 hours after dosing, as delayed respiratory depression may occur (see WARNINGS).

  Improper placement of a needle or catheter in the epidural space should be ruled out before DepoDur is injected. Techniques to detect improper placement of a needle or catheter include: a) aspiration to check for the presence of blood or cerebrospinal fluid and/or b) administration of a 3-mL test dose of 1.5% PRESERVATIVE-FREE lidocaine and epinephrine (1:200,000). If a test dose is administered, the patient should be observed for tachycardia or sudden onset of segmental anesthesia, indicating that intrathecal injection has occurred. To minimize a pharmacokinetic interaction of DepoDur with the test dose, flush the epidural catheter with 1 mL of PRESERVATIVE-FREE 0.9% normal saline and wait at least 15 minutes after administration of the test dose.

  Do not mix DepoDur with any other medications. Once DepoDur has been administered, no other medication should be administered into the epidural space for at least 48 hours.

  Do not use an in-line filter during administration of DepoDur.

  Although DepoDur is a sterile agent, it does not contain any bacteriostatic agents. Therefore, DepoDur must be administered within 4 hours after withdrawal from the vial. Do not heat-sterilize or gas-sterilize.

  Discard any unused portion in a manner appropriate for Schedule II substances.

  PROTECT DEPODUR FROM FREEZING. DO NOT ADMINISTER DEPODUR IF IT IS SUSPECTED THAT THE VIAL HAS BEEN FROZEN.

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• Spectam Water Soluble C...
  

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  Spectam Water Soluble Concentrate

  

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  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.

  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. Surgery Dose of EXPAREL Volume of EXPAREL Bunionectomy1 106 mg 8 mL Hemorrhoidectomy2 266 mg 20 mL

  2.1 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 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 normal (0.9%) sterile saline for injection or lactated Ringer’s solution. 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.

  2.2 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 (7)].

  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 if the milligram dose of bupivacaine HCl solution exceeds 50% of the EXPAREL dose. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to toxicity [See Warnings and Precautions (5.1) and Overdosage (10)]. 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.

  2.3 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.

  2.4 Dosing in Special Populations

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

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