CITANEST FORTE- prilocaine hydrochloride and epinephrine bitartrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRILOCAINE HYDROCHLORIDE (UNII: MJW015BAPH) (PRILOCAINE - UNII:046O35D44R), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

Dentsply Pharmaceutical Inc.

INN (International Name):

PRILOCAINE HYDROCHLORIDE

Composition:

PRILOCAINE HYDROCHLORIDE 40 mg in 1 mL

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are 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:

4% Citanest Plain Dental Injection (NDC 66312-520-14 or 66312-520-16) and 4% Citanest Forte Dental Injection with epinephrine 1:200,000 (NDC 66312-540-14 or 66312-540-16) are dispensed in 1.7 mL cartridges, packed 50 or 100 per box. Not all pack sizes may be marketed. Sterilization, Storage and Technical Procedures: Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.7 mL cartridges, and inadvertent freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

CITANEST FORTE- PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
DENTSPLY PHARMACEUTICAL INC.
----------
CITANEST FORTE
(PRILOCAINE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION)
For Local Anesthesia in Dentistry
DESCRIPTION
Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic
isotonic solution that contains a
local anesthetic agent with or without epinephrine (as bitartrate) and
is administered parenterally by
injection. See INDICATIONS AND USAGE for specific uses. The
quantitative composition of each
available injection is shown in Table 1.
Citanest Dental injections contain 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
Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl
alcohol and has the following
structural formula:
C
H
NO
molecular wt = 183.21
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration.
The specific quantitative composition of each available injection is
shown in Table 1.
TABLE 1. COMPOSITION OF AVAILABLE INJECTIONS
PRODUCT
IDENTIFICATION
FORMULA (MG/ML)
PRILOCAINE
HCL
EPINEPHRINE
(AS THE
BITARTRATE)
CITRIC
ACID
SODIUM
METABIS ULFATE
PH
®
13
20
2
9
13
3
Citanest Plain Dental
Injection
40.0
None
None
None
6.0-
7.0
Citanest Forte Dental
Injection with
Epinephrine
40.0
0.005
0.2
0.5
3.3-5.5
Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust
the pH of Citanest Dental
Injections. Filled under nitrogen.
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 with Citanest Plain
Dental Injection and Citanest Forte Dental Injection average