XYLOCAINE MPF- lidocaine hydrochloride,epinephrine bitartrate injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

Dostupné z:

A-S Medication Solutions

Spôsob podávania:

INFILTRATION

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Prehľad produktov:

Product: 50090-3321 NDC: 50090-3321-1 20 mL in a VIAL, SINGLE-DOSE

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
XYLOCAINE®
(LIDOCAINE HCL INJECTION, USP)
XYLOCAINE®
(LIDOCAINE HCL AND EPINEPHRINE INJECTION, USP)
For Infiltration and Nerve Block
Rx only
DESCRIPTION
Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic,
aqueous solutions that contain a local
anesthetic agent with or without epinephrine and are administered
parenterally by injection. See
INDICATIONS AND USAGE section for specific uses.
Xylocaine solutions contain lidocaine HCl, which is chemically
designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the
molecular wt. 270.8.
Lidocaine HCl (C
H
N
O • HCl) has the following structural formula:
Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl
alcohol and has the molecular wt.
183.21. Epinephrine (C
H
NO
) has the following structural formula:
Dosage forms listed as Xylocaine-MPF indicate single dose solutions
that are Methyl Paraben Free
(MPF).
Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing
sodium chloride. Xylocaine in
multiple dose vials: Each mL also contains 1 mg methylparaben as
antiseptic preservative. The pH of
these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with
sodium hydroxide and/or hydrochloric
acid.
Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic
solution containing sodium
chloride. Each mL contains lidocaine hydrochloride and epinephrine,
with 0.5 mg sodium metabisulfite
as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine
with Epinephrine in multiple dose
14
22
2
9
13
3
as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine
with Epinephrine in multiple dose
vials: Each mL also contains 1 mg methylparaben as antiseptic
preservative. The pH of these solutions
is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide
and/or hydrochloric acid. Filled
under nitrogen.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine HCl