Chirocaine is indicated for the production of local or regional anesthesia for surgery and obstetrics, and for post-operative pain management.

Surgical Anesthesia:   Epidural, peripheral neural blockade; and local infiltration.

Pain Mangement:   continuous epidural infusion or intermittent epidural neural blockade; continuous or intermittent peripheral neural blockade or local infiltration.

For continuous epidural analgesia, Chirocaine may be administered in combination with epidural fentanyl or clonidine.

The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The dose of any local anesthetic differs with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the intensity of the block, the degree of muscle relaxation required, the duration of the anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as impaired cardiovascular function, advanced liver disease, or severe renal dysfunction, require special attention.

To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly. Use an adequate test dose (3-5 mL) of a short-acting local anesthetic solution containing epinephrine prior to induction of complete nerve block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. It is recommended that adequate time be allowed for the onset of anesthesia following administration of each test dose.

Disinfecting agents containing heavy metals, which cause release of ions (mercury, zinc, copper, etc.), should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.

When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

When a container is required to have a sterile outside, glass containers may be autoclaved once. Stability has been demonstrated following an autoclave cycle at 121°C for 15 minutes.

These products are intended for single use and do not contain preservatives; any solution remaining from an open container should be discarded.

For specific techniques and procedures, refer to standard contemporary textbooks.

Chirocaine Compatibility and Admixtures

Chirocaine may not be compatible with alkaline solutions having a pH greater than 8.5. Studies have shown that Chirocaine is compatible with 0.9% Sodium Chloride Injection USP and with saline solutions containing fentanyl and clonidine. Compatibility studies with other parenteral products have not been studied.

Dilution Stability

Chirocaine ^® diluted in 0.9% Sodium Chloride Injection is physically and chemically stable when stored in PVC (polyvinyl chloride) bags at ambient room temperature for up to 24 hours. Aseptic techniques should be used to prepare the diluted product. Admixtures of Chirocaine should be prepared for single patient use only and used within 24 hours of preparation. The unused portion of diluted Chirocaine should be discarded after each use.

NOTE: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions that are not clear and colorless should not be used.

The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur.

Epidural doses of up to 375 mg have been administered incrementally to patients during a surgical procedure.

The maximum dose in 24 hours for intraoperative block and post-operative pain management was 695 mg.

The maximum dose administered as a post-operative epidural infusion over 24 hours was 570 mg.

The maximum dose administered to patients as a single fractionated injection was 300 mg for brachial plexus block.

Chirocaine, 2.5 mg levobupivacaine in each mL.

10 mL Single Use Vials. (NDC 59011-997-10)

30 mL Single Use Vials. (NDC 59011-997-30)

Chirocaine, 5.0 mg levobupivacaine in each mL.

10 mL Single Use Vials. (NDC 59011-998-10)

30 mL Single Use Vials. (NDC 59011-998-30)

Chirocaine, 7.5 mg levobupivacaine in each mL.

10 mL Single Use Vials. (NDC 59011-999-10)

30 mL Single Use Vials. (NDC 59011-999-30)

STORAGE

Store Chirocaine at controlled room temperature, 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F).

Rx ONLY

Manufactured by

Ben Venue Laboratories, Inc.

Bedford, OH 44146

For

Purdue Pharma L.P.

Stamford, CT 06901-3431

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