Polocaine 20 mg/mL
MEPIVACAINE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Polocaine is a injection, solution containing mepivacaine hydrochloride at 20 mg/mL, taken infiltration. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Polocaine
- Generic Name
- MEPIVACAINE HYDROCHLORIDE
- NDC Code (Product)
63323-296- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INFILTRATION
- Marketing Status
- Application #
- ANDA089410
- Marketing Start
- 07/20/2009
Recall History
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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) 150 The following table…
Warnings
WARNINGS 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 hypersensitivity. 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 evidences of alteration in sensorium or vital signs. The solution which contains a vasoconstrictor (2% (20 mg/mL) Polocaine ® DENTAL with Levonordefrin 1:20,000) 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. The solution which contains a vasoconstrictor (2% (20 mg/mL) Polocaine ® DENTAL with Levonordefrin 1:20,000) also contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptibl…
Contraindications
CONTRAINDICATIONS Polocaine ® is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
Drug Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing vasopressors, such as Levonordefrin, Epinephrine or Norepinephrine, to patients receiving tricyclic antidepressants or monoamine oxidase inhibitors may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of Epinephrine. Solutions containing a vasoconstrictor should be used cautiously in the presence of diseases which may adversely affect the patient's cardiovascular system. Serious cardiac arrhythmias may occur if preparations containing a vasoconstrictor are employed in patients during or following the administration of potent inhalation anesthetics. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include o…
Adverse Reactions
ADVERSE REACTIONS Reactions to Polocaine ® are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels (which may be due to excessive dosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation), injection technique, or volume of injection. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient. Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of mepivacaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches. Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsi…
Frequently Asked Questions
What is Polocaine used for?
Polocaine contains MEPIVACAINE HYDROCHLORIDE. It is a injection, solution taken infiltration. Consult your doctor for specific uses.
Is Polocaine a controlled substance?
Polocaine is not classified as a controlled substance by the DEA.
What is the generic name for Polocaine?
The generic name for Polocaine is MEPIVACAINE HYDROCHLORIDE. There are 8 other brand versions of MEPIVACAINE HYDROCHLORIDE.
What is the NDC code for Polocaine 20 mg/mL?
The NDC (National Drug Code) for Polocaine 20 mg/mL is 63323-296, listed by Fresenius Kabi USA, LLC.