Novocain
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
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, even in the absence of a history of hypersensitivity. Large doses of local anesthetics should not be used in patients with heartblock.
NOVOCAIN 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 NOVOCAIN 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 or disturbances of cardiac rhythm may occur.
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 NOVOCAIN 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
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 the production of local or regional analgesia and anesthesia by local infiltration and peripheral nerve block techniques.
The routes of administration and concentrations are: for local infiltration use 0.25% to 0.5% (via dilution) and for peripheral nerve blocks use 0.5% (via dilution), 1%, and 2%. (See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of NOVOCAIN.
History
There is currently no drug history available for this drug.
Other Information
Procaine hydrochloride is benzoic acid, 4-amino-, 2-(diethylamino) ethyl ester, monohydrochloride, the ester of diethylaminoethanol and para-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 and has a molecular weight of 272.78.
| Each mL contains |
1% Ampul |
1% Vial |
2% Vial |
| [Acetone sodium bisulfite is added as an antioxidant in all products, and chlorobutanol is added as an antimicrobial preservative in the multiple-dose vials.] |
|||
| Procaine hydrochloride |
10 mg |
10 mg |
20 mg |
| Acetone sodium bisulfite |
≤ 1 mg |
≤ 2 mg |
≤ 2 mg |
| Chlorobutanol |
– |
≤ 2.5 mg |
≤ 2.5 mg |
The solutions are made isotonic with sodium chloride and the pH is adjusted between 3 and 5.5 with sodium hydroxide and/or hydrochloric acid.
Procaine hydrochloride is related chemically and pharmacologically to the ester-type local anesthetics. It contains an ester linkage between the aromatic nucleus and the amino group.
NOVOCAIN is available as sterile solutions in concentrations of 1% and 2% for injection via local infiltration and peripheral nerve block.
Sources
Novocain Manufacturers
-
Hospira, Inc.
![Novocain (Procaine Hydrochloride) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Novocain | Hospira, Inc.
The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of NOVOCAIN should be reduced for elderly and debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional doses should be used when feasible.
For specific techniques and procedures, refer to standard textbooks.
For infiltration anesthesia, 0.25% or 0.5% solution; 350 mg to 600 mg is generally considered to be a single safe total dose. To prepare 60 mL of a 0.5% solution (5 mg/mL), dilute 30 mL of the 1% solution with 30 mL sodium chloride injection 0.9%. To prepare 60 mL of a 0.25% solution (2.5 mg/mL), dilute 15 mL of the 1% solution with 45 mL sodium chloride injection 0.9%. An anesthetic solution of 0.5 mL to 1 mL of epinephrine 1:1,000 per 100 mL may be added for vasoconstrictive effect (1:200,000 to 1:100,000). (See WARNINGS and PRECAUTIONS.)
For peripheral nerve block, 0.5% solution (up to 200 mL), 1% solution (up to 100 mL), or 2% solution (up to 50 mL). The use of the 2% solution should usually be limited to cases requiring a small volume of anesthetic solution (10 mL to 25 mL). An anesthetic solution of 0.5 mL to 1 mL of epinephrine 1:1,000 per 100 mL may be added for vasoconstrictive effect (1:200,000 to 1:100,000). (See WARNINGS and PRECAUTIONS.)
THE USUAL TOTAL DOSE DURING ONE TREATMENT SHOULD NOT EXCEED 1,000 MG.
This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use solutions if crystals, cloudiness, or discoloration is observed. Examine solution carefully before use. Reautoclaving increases likelihood of crystal formation. Solutions which are discolored or which contain particulate matter should not be administered.
Unused portions of solutions not containing preservatives should be discarded.
Pediatric Use:
In pediatric patients 15 mg/kg of a 0.5% solution for local infiltration is the maximum recommended dose.
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