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Side Effects & Adverse Reactions
LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
Local anesthetic solutions containing antimicrobial preservatives (i.e., those supplied in multiple-dose vials) should not be used for epidural or caudal anesthesia because safety has not been established with regard to intrathecal injection, either intentionally or inadvertently, of such preservatives.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.
It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics.
CARBOCAINE with epinephrine or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of CARBOCAINE containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result.
Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
Mixing or the prior or intercurrent use of any local anesthetic with CARBOCAINE cannot be recommended because of insufficient data on the clinical use of such mixtures.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CARBOCAINE is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks.
The routes of administration and indicated concentrations for CARBOCAINE are:
local infiltration |
0.5% (via dilution) or 1% |
peripheral nerve blocks |
1% and 2% |
epidural block |
1%, 1.5%, 2% |
caudal block |
1%, 1.5%, 2% |
See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of CARBOCAINE.
History
There is currently no drug history available for this drug.
Other Information
Mepivacaine hydrochloride is 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-methyl, monohydrochloride and has the following structural formula:
C15H22N2O • HCl
It is a white crystalline odorless powder, soluble in water, but very resistant to both acid and alkaline hydrolysis.
CARBOCAINE is a local anesthetic available as sterile isotonic solutions (clear, colorless) in concentrations of 1%, 1.5%, and 2% for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks.
Mepivacaine hydrochloride is related chemically and pharmacologically to the amide-type local anesthetics. It contains an amide linkage between the aromatic nucleus and the amino group.
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Composition of Available Solutions* |
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1% Single-Dose 30 mL Vial mg/mL |
1% Multiple-Dose 50 mL Vial mg/mL |
1.5% Single-Dose 30 mL Vial mg/mL |
2% Single-Dose 20 mL Vial mg/mL |
2% Multiple-Dose 50 mL Vial mg/mL |
|
Mepivacaine hydrochloride |
10 |
10 |
15 |
20 |
20 |
Sodium chloride |
6.6 |
7 |
5.6 |
4.6 |
5 |
Potassium chloride |
0.3 |
0.3 |
0.3 |
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Calcium chloride |
0.33 |
0.33 |
0.33 |
||
Methylparaben |
1 |
1 |
The pH of the solution is adjusted between 4.5 and 6.8 with sodium hydroxide or hydrochloric acid.
Sources
Carbocaine Manufacturers
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Hospira, Inc.
Carbocaine | Woonsocket Prescription Center,incorporated
this product does not contain directions or complete warnings for adult use find the right dose on chart below. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Tablets Under 48 Under 6 Ask a doctor 48-59 6-8 2 60-71 9-10 2 1/2 72-95 11 3 -
Caresteam Health, Inc.
Carbocaine | Caresteam Health, Inc.
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) 150The 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 5.3When 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.
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