Vivacaine (Page 3 of 3)

Treatment of Reactions

Toxic effects of local anesthetics require symptomatic treatment; there is no specific cure. The dentist should be prepared to maintain an airway and to support ventilation with oxygen and assisted or controlled respiration as required. Supportive treatment of the cardiovascular system includes intravenous fluids and, when appropriate, vasopressors (preferably those that stimulate the myocardium). Convulsions may be controlled with oxygen and intravenous administration, in small increments, of a barbiturate, as follows: preferably, an ultra-short-acting barbiturate such as thiopental or thiamylal; if this is not available, a short-acting barbiturate (e.g., secobarbital or pentobarbital) or diazepam. Intravenous barbiturates or anticonvulsant agents should only be administered by those familiar with their use.

DOSAGE AND ADMINISTRATION

As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.

The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (see CLINICAL PHARMACOLOGY). The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of bupivacaine with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, bupivacaine in dentistry is not recommended for children younger than 12 years.

Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion.

HOW SUPPLIED

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. Do not permit to freeze.

Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) – Sterile isotonic solutions containing sodium chloride. Each 1 mL contains 5 mg bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 7 mg sodium chloride, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted with sodium hydroxide or hydrochloric acid. Solutions of bupivacaine that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its colour is pinkish or darker than slightly yellow or if it contains a precipitate.

Vivacaine® (NDC 0362-9011-50) is available in cardboard boxes containing 5 blisters of 10 X 1.8 mL single-dose dental cartridges.

Manufactured for
Septodont Inc., Lancaster, PA, USA 17601
by NOVOCOL Pharmaceutical of Canada, Inc.,
Cambridge, Ontario, Canada N1R 6X3 Rev. 02/2020 (2382-6)

PRINCIPAL DISPLAY PANEL — 50 Cartridge Carton

NDC 0362-9011-50

Vivacaine®

Bupivacaine HCl 0.5% (5 mg/mL) and Epinephrine 1:200,000 Injection (as bitartrate)
(Bupivacaine Hydrochloride and Epinephrine Injection, USP)

WARNINGS:CONTAINS SULFITES

FOR DENTAL USE

Rx Only

Carton contains 50 single-dose cartridges. Each cartridge contains 1.8 mL

Manufactured for SEPTODONT, Inc.
Lancaster, PA, USA 17601
by Novocol Pharmaceutical of Canada, Inc.
Cambridge, ON N1R 6X3, Canada

PRINCIPAL DISPLAY PANEL -- 50 Cartridge Carton
(click image for full-size original)
VIVACAINE
bupivacaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-9011
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
epinephrine bitartrate (epinephrine) epinephrine 0.005 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium metabisulfite 0.5 mg in 1 mL
sodium chloride 7 mg in 1 mL
monothioglycerol 0.001 mL in 1 mL
ascorbic acid 2 mg in 1 mL
sodium lactate 0.0017 mL in 1 mL
edetate calcium disodium 0.1 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0362-9011-50 50 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 1.8 mL in 1 CARTRIDGE This package is contained within the CARTON (0362-9011-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077250 06/01/2013
Labeler — Septodont, Inc. (627058738)
Registrant — Novocol Pharmaceutical of Canada, Inc. (201719960)
Establishment
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE (0362-9011)

Revised: 06/2021 Septodont, Inc.

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