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Side Effects & Adverse Reactions
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER ANY LOCAL ANESTHETIC DRUG IS USED. Spinal anesthesia should only be administered by those qualified to do so.
Large doses of local anesthetics should not be used in patients with heartblock.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.
Usage in Pregnancy. Safe use of NOVOCAIN has not been established with respect to adverse effects on fetal development. Careful consideration should be given to this fact before administering this drug to women of childbearing potential particularly during early pregnancy. This does not exclude the use of the drug at term for obstetrical analgesia. Vasopressor agents (administered for the treatment of hypotension or added to the anesthetic solution for vasoconstriction) should be used with extreme caution in the presence of oxytocic drugs as they may produce severe, persistent hypertension with possible rupture of a cerebral blood vessel.
Solutions which contain a vasoconstrictor should be used with extreme caution in patients receiving drugs known to produce alterations in blood pressure (i.e., monoamine oxidase inhibitors (MAOI), tricyclic antidepressants, phenothiazines, etc.), as either severe sustained hypertension or hypotension may occur.
Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
Contains acetone 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 nonasthmatic people.
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
NOVOCAIN is indicated for spinal anesthesia.
History
There is currently no drug history available for this drug.
Other Information
NOVOCAIN, procaine hydrochloride, is benzoic acid, 4-amino-, 2-(diethylamino) ethyl ester, monohydrochloride, the ester of diethylaminoethanol and aminobenzoic acid, with the following structural formula:
It is a white crystalline, odorless powder that is freely soluble in water, but less soluble in alcohol. Each mL contains 100 mg procaine hydrochloride and 4 mg acetone sodium bisulfite as antioxidant. DO NOT USE SOLUTIONS IF CRYSTALS, CLOUDINESS, OR DISCOLORATION IS OBSERVED. EXAMINE SOLUTIONS CAREFULLY BEFORE USE. REAUTOCLAVING INCREASES LIKELIHOOD OF CRYSTAL FORMATION.
Sources
Novocaine Manufacturers
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Hospira, Inc.
Novocaine | Hospira, Inc.
As with all local anesthetics, the dose of NOVOCAIN 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 dose needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.
RECOMMENDED DOSAGE FOR SPINAL ANESTHESIA Extent of Anesthesia NOVOCAIN10% Solution
Total Dose(mg)
Site of Injection(lumbar interspace)
Volume of 10% Solution(mL)
Volume of Dilution(mL)
Perineum 0.5 0.5 50 4th Perineum and lowerextremities
1 1 100 3rd or 4th Up to costal margin 2 1 200 2nd, 3rd or 4thThe diluent may be sterile normal saline, sterile distilled water, spinal fluid; and for hyperbaric technique, sterile dextrose solution.
The usual rate of injection is 1 mL per 5 seconds. Full anesthesia and fixation usually occur in 5 minutes.
STERILIZATION
The drug in intact ampuls is sterile. The preferred method of destroying bacteria on the exterior of ampuls before opening is heat sterilization (autoclaving). Immersion in antiseptic solution is not recommended.
Autoclave at 15-pound pressure, at 121°C (250°F), for 15 minutes. The diluent dextrose may show some brown discoloration due to caramelization.
Protect solutions from light.
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