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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 (ie, 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.
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.
Mepivacaine 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 mepivacaine 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 mepivacaine cannot be recommended because of insufficient data on the clinical use of such mixtures.
Legal Issues
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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
POLOCAINE (Mepivacaine HCl Injection, USP), 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 mepivacaine 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 mepivacaine.
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:
The molecular formula is C15H22N2O • HCl.
It is a white, crystalline odorless, powder, soluble in water, but very resistant to both acid and alkaline hydrolysis.
Mepivacaine hydrochloride 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.
|
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
|
|
Calcium chloride
|
0.33
|
|
0.33
|
0.33
|
|
Methylparaben
|
|
1
|
|
|
1
|
*In Water for Injection
|
The pH of the solution is adjusted between 4.5 and 6.8 with sodium hydroxide or hydrochloric acid.
Sources
Polocaine Manufacturers
-
App Pharmaceuticals, Llc
Polocaine | App Pharmaceuticals, Llc
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 mepivacaine hydrochloride 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.
The recommended single adult dose (or the total of a series of doses given in one procedure) of mepivacaine hydrochloride for unsedated, healthy, normal-sized individuals should not usually exceed 400 mg. The recommended dosage is based on requirements for the average adult and should be reduced for elderly or debilitated patients.
While maximum doses of 7 mg/kg (550 mg) have been administered without adverse effect, these are not recommended, except in exceptional circumstances and under no circumstances should the administration be repeated at intervals of less than 1½ hours. The total dose for any 24-hour period should not exceed 1,000 mg because of a slow accumulation of the anesthetic or its derivatives or slower than normal metabolic degradation or detoxification with repeat administration (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Pediatric patients tolerate the local anesthetic as well as adults. However, the pediatric dose should be carefully measured as a percentage of the total adult dose based on weight, and should not exceed 5 mg/kg to 6 mg/kg (2.5 mg/lb to 3 mg/lb) in pediatric patients, especially those weighing less than 30 lbs. In pediatric patients under 3 years of age or weighing less than 30 lbs concentrations less than 2% (eg, 0.5% to 1.5%) should be employed.
Unused portions of solutions not containing preservatives, ie, those supplied in single-dose vials, should be discarded following initial use.
This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.
Recommended Concentrations and Doses of Mepivacaine Hydrochloride
Procedure
Concentration
mL
Total Dose
mg
Comments
Cervical,
1%
5-40
50-400
Pudendal block:
brachial,
one half of total
intercostal,
dose injected
pudendal
2%
5-20
100-400
each side.
nerve block
Transvaginal
1%
up to 30
up to 300
One half of total
block
(both sides)
(both sides)
dose injected
(paracervical
each side. See
plus pudendal)
PRECAUTIONS.
Paracervical
1%
up to 20
up to 200
One half of total
block
(both sides)
(both sides)
dose injected each
side. This is maxi-
mum recommended
dose per 90-minute
period in obstetrical
and non-obstetrical
patients. Inject slowly,
5 minutes between
sides. See
PRECAUTIONS.
Caudal and
1%
15-30
150-300
*Use only single-dose
Epidural block
1.5%
10-25
150-375
vials which do not
2%
10-20
200-400
contain a preservative.
Infiltration
1%
up to 40
up to 400
An equivalent amount
of a 0.5% solution
(prepared by diluting
the 1% solution with
Sodium Chloride
Injection, USP) may
be used for large
areas.
Therapeutic
1%
1-5
10-50
block (pain
2%
1-5
20-100
management)
Unused portions of solutions not containing preservatives should be discarded.
* Dosage forms listed as POLOCAINE-MPF (Mepivacaine HCl Injection, USP) are single-dose solutions which do not contain a preservative.
-
Dentsply Pharmaceutical
Polocaine | Dentsply Pharmaceutical
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 150 for Adults (400 mg)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.) 3 mg/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 Polocaine® 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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