Nocita

Information provided by Elanco:

Description:

NOCITA (bupivacaine liposome injectable suspension) is a sterile, non-pyrogenic, white to off-white, preservative-free, aqueous suspension of multivesicular lipid-based particles containing bupivacaine. Each milliliter of NOCITA contains 13.3 mg of bupivacaine. Inactive ingredients and their nominal concentrations are: cholesterol, 4.7 mg/mL; 1,2-dipalmitoyl-sn-glycero-3 phospho-rac-(1-glycerol) (DPPG), 0.9 mg/mL; tricaprylin, 2.0 mg/mL; and 1,2 dierucocylphosphatidylcholine (DEPC), 8.2 mg/mL. Bupivacaine is related chemically and pharmacologically to the amide-type local anesthetics. Chemically, bupivacaine is 1-butyl-N-(2, 6-dimethylphenyl)-2-piperidinecarboxamide with a molecular weight of 288.4. Bupivacaine structural formula is shown in the illustration to the right.

Indication:

For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs.

Dosage and Administration:

NOCITA is for single dose administration only. A dose of 5.3 mg/kg (0.4 mL/kg) is administered by infiltration injection into the tissue layers at the time of incisional closure. A single dose administered during surgical closure may provide up to 72 hours of pain control.

Dosing Instructions:

• Wear gloves when handling and administering NOCITA (see WARNINGS).
• NOCITA should not be allowed to come into contact with topical antiseptics. When a topical antiseptic such as povidone iodine or chlorhexidine is applied, the area should be allowed to dry before NOCITA is administered into the surgical site.
• Do not shake vial. Invert the vial multiple times to re-suspend the particles immediately prior to withdrawal of the product from the vial.
• Do not puncture the vial multiple times. Puncture the vial stopper once with a single 25 gauge or larger needle. Use aseptic technique to sequentially attach and fill sterile syringes for dosing. Each syringe should be prepared for single patient use only. Discard the vial after all doses are withdrawn.
• Following withdrawal from the vial into a syringe, NOCITA may be stored at controlled room temperature of 68° F to 77° F (20° C to 25° C) for up to 4 hours. Because the formulation does not contain preservative, the syringe(s) must be discarded after 4 hours.
• If the dose volume of NOCITA (0.4 mL/kg) is not sufficient to cover the surgical site, add up to an equal volume of normal (0.9%) sterile saline or Lactated Ringer’s solution. If saline or Lactated Ringer’s is added to the NOCITA dose, administer the entire volume by tissue infiltration into the surgical site. Do not mix with water or other hypotonic solutions as it will result in disruption of the liposomal particles (see CLINICAL PHARMACOLOGY).Do not mix NOCITA with other local anesthetics or other drugs prior to administration (see PRECAUTIONS).
• Use a 25 gauge or larger bore needle for administration.
• Administer by infiltration injection: Inject slowly into the tissues using an infiltration injection technique. To obtain adequate coverage, infiltrate all of the tissues in each surgical closure layer. Aspirate frequently to prevent intravascular administration (see CONTRAINDICATIONS).

Contraindications:

Do not administer by intravenous or intra-arterial injection. If accidental intravascular administration occurs, monitor for cardiovascular (dysrhythmias, hypotension, hypertension) and neurologic (tremors, ataxia, seizures) adverse reactions.

Do not use for intra-articular injection. In humans, local anesthetics administered into a joint may cause chondrolysis.

Warnings:

Not for use in humans. Keep out of reach of children.

NOCITA is an amide local anesthetic. In case of accidental injection or accidental topical exposure, contact a physician and seek medical attention immediately.

Wear gloves when handling vials to prevent accidental topical exposure.

Precautions:

Do not administer concurrently with bupivacaine HCl, lidocaine or other amide local anesthetics. A safe interval from time of bupivacaine HCl, lidocaine or other amide local anesthetic administration to time of NOCITA administration has not been determined. 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.

The safe use of NOCITA in dogs with cardiac disease has not been evaluated.

The safe use of NOCITA in dogs with hepatic or renal impairment has not been evaluated. NOCITA is metabolized by the liver and excreted by the kidneys.

The ability of NOCITA to achieve effective anesthesia has not been studied. Therefore, NOCITA is not indicated for pre-incisional or pre-procedural loco-regional anesthetic techniques that require deep and complete sensory block in the area of administration.

The safe use of NOCITA for surgical procedures other than cranial cruciate ligament surgery has not been evaluated (see ANIMAL SAFETY and ADVERSE REACTIONS).

The safe use of NOCITA has not been evaluated in dogs younger than 5 months old.

The safe use of NOCITA has not been evaluated in dogs that are pregnant, lactating, or intended for breeding.