Bupivacaine

Indications

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

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

). • 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 Discard the vial after all doses are withdrawn.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

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

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. Adverse Reactions: Safety was evaluated in 123 NOCITA treated dogs and 59 saline (placebo) treated dogs in a field study in dogs that underwent cranial cruciate ligament stabilization surgery. Dogs enrolled in the study were 1-13 years of age, and weighed 3.4 to 61.3 kg. NOCITA was administered by infiltrative injection at the surgical site at a dose of 5.3 mg/kg (0.4 mL/kg). Table D-1. Adverse Reactions Reported During the Study in the Safety Population (any dog that received treatment) Note: If an animal experienced the same event more than once, only the first occurrence was tabulated. Adverse Reaction NOCITA (n = 123) Saline (n = 59) Discharge from the Incision 4 (3.3%) 0 (0.0%) Incisional Inflammation (erythema and/or edema) 3 (2.4%) 0 (0.0%) Vomiting 3 (2.4%) 0 (0.0%) Abnormalities on Urinalysis (isosthenuria ± proteinuria) 2 (1.6%) 0 (0.0%) Increased ALP 2 (1.6%) 0 (0.0%) Surgical Limb Edema ± Erythema 1 (0.8%) 3 (5.1%) Soft Stool/Diarrhea 1 (0.8%) 1 (1.7%) Inappetence 1 (0.8%) 1 (1.7%) Fever 1 (0.8%) 0 (0.0%)

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. Structural formula

Storage

Unopened vials should be stored refrigerated between 36° F to 46° F (2° C to 8° C) NOCITA may be held at a controlled room temperature of 68° F to 77° F (20° C to 25° C ) for up to 30 days in sealed, intact (unopened) vials. Do not re-refrigerate. Do Not Freeze.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming bupivacaine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.