Isocaine
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Questions & Answers
Side Effects & Adverse Reactions
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS).
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hyper- sensitivity.
Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed. The practitioner should be alert to early evidence of alteration in sensorium or vital signs.
The solution which contains a vasoconstrictor should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes, etc.
Isocaine 2% with Levonordefrin 1:20,000 injection (Mepivacaine Hydrochloride and Levonordefrin Injection, USP) contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Isocaine 3% injection (Mepivacaine Hydrochloride Injection USP 3%) is SULFITE FREE.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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
ISOCAINE is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
History
There is currently no drug history available for this drug.
Other Information
ISOCAINE (Mepivacaine Hydrochloride), a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula:
It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis.
Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-a-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula:
It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water.
DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED.
ISOCAINE 3% Injection and ISOCAINE 2% with Levonordefrin 1:20,000 Injection are sterile solutions for injection.
| COMPOSITION | CARTRIDGE | |
|---|---|---|
| Each mL contains: | 2% | 3% |
| Mepivacaine Hydrochloride | 20 mg | 30 mg |
| Levonordefrin (as the base) | 0.05 mg | - |
| Sodium Chloride | 4 mg | 3 mg |
| Sodium Bisulfite | 1 mg | - |
| Water For Injection, qs. ad. | 1 mL | 1 mL |
| The pH of the 2% cartridge solution is adjusted between 3.3 and 5.5 with NaOH or HCI. | ||
| The pH of the 3% cartridge solution is adjusted between 4.5 and 6.8 with NaOH or HCI. | ||
Sources
Isocaine Manufacturers
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Septodont Inc
![Isocaine (Mepivacaine Hydrochloride) Injection, Solution Isocaine With Levonordefrin (Mepivcaine Hydrochloride And Levonordefrin) Injection, Solution [Septodont Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isocaine | Septodont 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 1.8 mL (36 mg of 2% or 54 mg of 3%).
Five 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 Patient =
Pediatric Patient's Weight (lbs.) × Maximum Recommended Dose
150 for Adults (400 mg.)The following table, approximating these calculations, may also be used as a guide.
Maximum Allowable Dosage 3% Mepivacaine
(Plain) 2% Mepivacaine
1:20,000 Levonordefrin 3 mg/lb
270 mg max.) 3 mg/lb
(180 mg max.) Weight
(lb.) Mg Number of
Cartridges Mg Number of
Cartridges 20 60 1.1 60 1.6 30 90 1.7 90 2.5 40 120 2.2 120 3.3 50 150 2.8 150 4.2 60 180 3.3 180 5.0 80 240 4.4 180 5.0 100 270 5.0 180 5.0 120 270 5.0 180 5.0Adapted from Malamed, Stanley F: Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.
When using ISOCAINE 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 CARTRIDGESAs 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.
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