PRILOCAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

prilocaine hydrochloride (UNII: MJW015BAPH) (prilocaine - UNII:046O35D44R)

Available from:

Septodont Inc.

INN (International Name):

prilocaine hydrochloride

Composition:

prilocaine hydrochloride 40 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Prilocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type and in those rare patients with congenital or idiopathic methemoglobinemia.

Product summary:

Prilocaine Hydrochloride Injection, USP, 4% (NDC 0362-9014-50) is dispensed in 1.8 mL cartridges, packed 50 per box. Sterilization, Storage and Technical Procedures:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRILOCAINE HYDROCHLORIDE- PRILOCAINE HYDROCHLORIDE INJECTION, SOLUTION
SEPTODONT INC.
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PRILOCAINE HYDROCHLORIDE INJECTION, USP, 4%
For Local Anesthesia in Dentistry
Rx only
DESCRIPTION
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.
TABLE 1. COMPOSITION
PRODUCT IDENTIFICATION
FORMULA (MG/ML)
PRILOCAINE HCL
PH
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%.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Prilocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and
conduction of impulses, thereby effecting local anesthetic action.
ONSET AND DURATION OF ACTION
When used for infiltration injection in dental patients, the time of
onset of anesthesia averages less than
2 minutes with an average duration of soft tissue anesthesia of
approximately 2 hours.
Based on electrical stimulation studies, Prilocaine Hydrochloride
Injection, USP, 4% provides a
duration of pulpal anesthesia of approximately 10 minutes in maxillary
infiltration injections. In clinical
studies, this has been found to provide complete anesthesia for
procedures lasting an average of 20
minutes.
When used for inferior alveolar nerve block, the time of onset of
Prilocaine Hydrochloride Injection,
USP, 4% averages less than three minutes with an average duration of
soft