LIDOCAINE HCL AND EPINEPHRINE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

şimdi satın al

Indir Ürün özellikleri (SPC)
09-09-2021

Aktif bileşen:

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

Mevcut itibaren:

B. Braun Medical Inc.

Uygulama yolu:

EPIDURAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Lidocaine Hydrochloride and Epinephrine Injection is 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.

Ürün özeti:

Lidocaine Hydrochloride and Epinephrine Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution that is supplied in a 5 mL single-dose ampule, packaged within a carton of five as follows. Lidocaine Hydrochloride 1.5% and Epinephrine 1:200,000 1.5% 75 mg/5 mL (15 mg/mL) Discard unused portion. Lidocaine Hydrochloride and Epinephrine Injection, USP solution should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Protect from light.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

                                LIDOCAINE HCL AND EPINEPHRINE- LIDOCAINE HCL AND EPINEPHRINE INJECTION
B. BRAUN MEDICAL INC.
----------
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP
For Infiltration and Nerve Block
Rx only
DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile,
nonpyrogenic,
aqueous solution that contains a local anesthetic agent with
epinephrine and is
administered parenterally by injection. See INDICATIONS AND USAGE
section for
specific uses.
Lidocaine Hydrochloride and Epinephrine Injection, USP solution
contains 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:
Lidocaine Hydrochloride and Epinephrine Injection, USP is a
single-dose solution that is
Methyl Paraben (Preservative) Free (MPF).
Lidocaine Hydrochloride and Epinephrine Injection, USP 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.
The pH of these solutions is adjusted to approximately 4.5 (3.3 to
5.5) with sodium
14
22
2
9
13
3
hydroxide and/or hydrochloric acid. Filled under nitrogen.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for
the initiation and conduction of impulses thereby effecting local
anesthetic action.
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance,
and mean arterial pressure. With central neural blockade these changes
may be
attributable to block of autonomic fibers, a direct depressant effect
of the local
anesthetic agent on various components of the cardiovascular syste
                                
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