Carbocaine with Neo-Cobefrin (Page 3 of 3)

DOSAGE AND ADMINISTRATION

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

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).

5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient’s weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated.

Maximum dose for pediatric population =
Child’s Weight (lbs.) × Maximum Recommended Dose for Adults (400 mg)
150

The following table, approximating these calculations, may also be used as a guide. This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the pediatric patient’s weight or (for 2% mepivacaine) calculated maximum amount of drug:

Maximum Allowable Dosage *
3% Mepivacaine
(Plain)
2% Mepivacaine
1:20,000 Levonordefrin
3 mg/lb
(270 mg max.)
3mg/lb
(180 mg max.)
Weight
(lb.)
mg Number of Cartridges mg Number of Cartridges
*
Adapted from Malamed, Stanley F: Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.
20 60 1.2 60 1.8
30 90 1.8 90 2.6
40 120 2.3 120 3.5
50 150 2.9 150 4.4
60 180 3.5 180 5.3
80 240 4.7 180 5.3
100 270 5.3 180 5.3
120 270 5.3 180 5.3

When using CARBOCAINE for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

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

DISINFECTION OF CARTRIDGES

As in the case of any cartridge, the diaphragm should be disinfected before needle puncture. The diaphragm should be thoroughly swabbed with either pure 91% isopropyl alcohol or 70% ethyl alcohol, USP, just prior to use. Many commercially available alcohol solutions contain ingredients which are injurious to container components, and therefore, should not be used. Cartridges should not be immersed in any solution.

HOW SUPPLIED

CARBOCAINE 3% (30 mg/mL) injection (mepivacaine hydrocholoride injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton (NDC 0362-0753-05). CARBOCAINE 2% (20 mg/mL) with NEO-COBEFRIN 1:20,000 injection, USP (mepivacaine hydrochloride and levonordefrin injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton (NDC 0362-0931-05).

Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the flap. The mepivacaine 2% (20 mg/mL) solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate. Cartridge warmers should not be used with CARBOCAINE products.

Manufactured by
Novocol Pharmaceutical of Canada, Inc.
Cambridge, Ontario, Canada N1R 6X3

Rev. 04/2020 (2222-2)

Cook-Waite is a trademark of Septodont Holdings SAS.

PRINCIPAL DISPLAY PANEL — 2% Cartridge Carton

50 Single-Dose Cartridges 1.7 mL
NDC 0362-0931-05

Cook-Waite®

Carbocaine® 2% (20 mg/mL)
with Neo-Cobefrin® 1:20,000

(mepivacaine hydrochloride and levonordefrin injection, USP)

PRINCIPAL DISPLAY PANEL -- 2% Cartridge Carton
(click image for full-size original)
CARBOCAINE WITH NEO-COBEFRIN
mepivacaine hydrochloride and levonordefrin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-0931
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride (Mepivacaine) Mepivacaine Hydrochloride 30 mg in 1 mL
Levonordefrin (LEVONORDEFRIN) Levonordefrin 0.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium chloride 4 mg in 1 mL
Potassium metabisulfite 1.2 mg in 1 mL
Edetate disodium 0.25 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID 0.5 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0362-0931-05 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CARTRIDGE in 1 BLISTER PACK This package is contained within the CARTON (0362-0931-05) and contains a CARTRIDGE
1 1.7 mL in 1 CARTRIDGE This package is contained within a BLISTER PACK and a CARTON (0362-0931-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088388 11/19/2018
Labeler — Septodont, Inc. (627058738)
Registrant — Novocol Pharmaceutical of Canada, Inc. (201719960)
Establishment
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE (0362-0931)

Revised: 09/2020 Septodont, Inc.

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