Prescription Drug Information: Carbocaine (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of Mepivacaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnacy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with this solution. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can effect reproductive capacity. This solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to a nursing woman.

Pediatric Use

Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Reactions to CARBOCAINE are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels (which may be due to excessive dosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation), injection technique, or volume of injection.

A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of mepivacaine, with slow, incomplete, or no recovery. These post-markeing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant. They may be the result of direct drug effect or more commonly in dental practice, the result of vasovagal reaction, particularly if the patient is in the sitting position. Failure to recognize premonitory signs such as sweating, feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and administration of oxygen. Vasoactive drugs such as Ephedrine or Methoxamine may be administered intravenously.

Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic and are characterized by cutaneous lesions of delayed onset or urticaria, edema and other manifestations of allergy. The detection of sensitivity by skin testing is of limited value. As with other local anesthetics, anaphylactoid reactions to Mepivacaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. Localized puffiness and swelling may occur.

OVERDOSAGE

Treatment of a patient with toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation (respiration) as required. This usually will be sufficient in the management of most reactions. Should a convulsion persist despite ventilatory therapy, small increments of anticonvulsive agents may be given intravenously, such as benzodiazephine (e.g., diazepam) or ultrashort-acting barbiturates (e.g., thiopental or thiamylal) or short-acting barbiturates (e.g., pentobarbital or secobarbital). Cardiovascular depression may require circulatory assistance with intravenous fluids and/or vasopressor (e.g., Ephedrine) as dictated by the clinical situation. Allergic reactions should be managed by conventional means.

IV and SC LD50 ‘s in mice for Mepivacaine Hydrochloride 3% are 33 and 258 mg/kg, respectively. The acute IV and SC LD50 ‘s in mice for Mepivacaine Hydrochloride 2% with Levonordefrin 1:20,000 are 30 and 184 mg/kg, respectively.

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 — 3% Cartridge Carton

50 Single-Dose Cartridges 1.7 mL
NDC 0362-0753-05

Cook-Waite®

Carbocaine® 3% (30 mg/mL)
(mepivacaine hydrochloride injection, USP)

WITHOUT VASOCONSTRICTOR

PRINCIPAL DISPLAY PANEL -- 3% Cartridge Carton
(click image for full-size original)
CARBOCAINE
mepivacaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-0753
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
Inactive Ingredients
Ingredient Name Strength
Sodium chloride 6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0362-0753-05 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CARTRIDGE in 1 BLISTER PACK This package is contained within the CARTON (0362-0753-05) and contains a CARTRIDGE
1 1.7 mL in 1 CARTRIDGE This package is contained within a BLISTER PACK and a CARTON (0362-0753-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088387 06/21/2018
Labeler — Septodont, Inc. (627058738)
Registrant — Novocol Pharmaceutical of Canada, Inc. (201719960)
Establishment
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE (0362-0753)

Revised: 09/2020 Septodont, Inc.

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