CITANEST PLAIN- prilocaine hydrochloride injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

PRILOCAINE HYDROCHLORIDE (UNII: MJW015BAPH) (PRILOCAINE - UNII:046O35D44R)

Dostupné s:

Dentsply Pharmaceutical Inc.

INN (Mezinárodní Name):

PRILOCAINE HYDROCHLORIDE

Složení:

PRILOCAINE HYDROCHLORIDE 40 mg in 1 mL

Podání:

SUBMUCOSAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), 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.

Přehled produktů:

4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), (NDC 66312-630-14) is dispensed in 1.8 mL single-dose cartridges, packed 50 per box.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CITANEST PLAIN- PRILOCAINE HYDROCHLORIDE INJECTION, SOLUTION
DENTSPLY PHARMACEUTICAL INC.
----------
4% CITANEST PLAIN DENTAL
PRILOCAINE HYDROCHLORIDE INJECTION, USP, 4% (72 MG/1.8 ML) (40 MG/ML)
(PRILOCAINE HCI INJECTION, USP)
For Local Anesthesia in Dentistry
Rx only
DESCRIPTION
4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4%
(72 mg/1.8 mL) (40
mg/mL), (prilocaine HCl Injection, USP), 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.
4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4%
(72 mg/1.8 mL) (40
mg/mL), contains prilocaine HCl, which is chemically designated as
propanamide, N-(2-
methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the
following structural
formula:
C
H
N O ∙ HCl molecular wt = 256.77
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
4% Citanest Plain
Dental
(Prilocaine
Hydrochloride
Injection, USP, 4% (72
mg/1.8 mL)
40.0
6.0 to 7.0
13
20
2
Note: Sodium hydroxide or hydrochloric acid may be used to
adjust the pH of 4% Citanest Plain Dental Injection (Prilocaine
Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL)).
(40 mg/mL))
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, 4% Citanest Plain Dental
Injection, Prilocaine
Hydrochlori