Prilocaine Hydrochloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES THAT MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.
To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided.
Prilocaine has been associated with the development of methemoglobinemia. Very young patients, patients with congenital or idiopathic methemoglobinemia, or patients with glucose-6-phosphate deficiencies are more susceptible to methemoglobinemia.
Patients taking drugs associated with drug induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, napthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine are also at greater risk for developing methemoglobinemia.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Prilocaine Hydrochloride Injection, USP, 4% is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
There is currently no drug history available for this drug.
Prilocaine Hydrochloride Injection, USP, 4% is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1.
Prilocaine Hydrochloride Injection, USP, 4% contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The specific quantitative composition is shown in Table 1.
|Product Identification||Formula (mg/mL)|
|Prilocaine Hydrochloride Injection, USP, 4%||40.0||6.0 to 7.0|
Note: Sodium hydroxide or hydrochloric acid may be used to adjust the pH of Prilocaine Hydrochloride Injection, USP, 4%.