PRILOCAINE HYDROCHLORIDE WITH EPINEPHRINE- prilocaine and epinephrine injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

prilocaine hydrochloride (UNII: MJW015BAPH) (prilocaine - UNII:046O35D44R), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Διαθέσιμο από:

Septodont Inc.

INN (Διεθνής Όνομα):

prilocaine hydrochloride

Σύνθεση:

prilocaine hydrochloride 40 mg in 1 mL

Οδός χορήγησης:

SUBCUTANEOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 injection 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.

Περίληψη προϊόντος:

Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection (NDC 0362-9013-50) is dispensed in 1.8 mL cartridges, packed 50 per box. Sterilization, Storage and Technical Procedures:

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRILOCAINE HYDROCHLORIDE WITH EPINEPHRINE - PRILOCAINE AND
EPINEPHRINE INJECTION, SOLUTION
SEPTODONT INC.
----------
PRILOCAINE HCL 4% WITH EPINEPHRINE 1:200,000 INJECTION
For Local Anesthesia in Dentistry
Rx only
DESCRIPTION
Prilocaine Hydrochloride 4% with epinephrine 1:200,000 injection is a
sterile, non pyrogenic isotonic
solution that contains a local anesthetic agent with epinephrine (as
bitartrate) and is administered
parenterally by injection. See INDICATIONS AND USAGE for specific
uses. The quantitative
composition is shown in Table 1.
Prilocaine Hydrochloride 4% with epinephrine 1:200,000 injection
contains prilocaine HCl, which is
chemically designated as propanamide,
N-(2-methyl-phenyl)-2-(propylamino)-,monohydrochloride and
has the following structural formula:
1.jpg
Epinephrine bitartrate is (-)-3,4-Dihydroxy-a-[(methylamino)methyl]
benzyl alcohol and has the
following formula:
2.jpg
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
Ingredients
Prilocaine
Citric
Sodium
Ingredients
HCl
Epinephrine Acid
Metabisulfite pH
Formula
(mg/mL)
40.0
mg/mL
0.005
mg/mL
0.2
mg/mL
0.5
mg/mL
3.3 to
5.5
Note: Sodium hydroxide or hydrochloric acid may be used to adjust the
pH of Prilocaine
Hydrochloride 4% with epinephrine 1:200,000 injection.
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 2.25 hours.
When used for inferior alveolar nerve block, the time of onset
averages less than three minutes with an
average duration of soft tissue anesthesia of approximatelty 3 hours.
HEMODYNAMICS
Excessiv