lidocaine hydrochloride 5% and 7.5% Dextrose (FOR SPINAL ANESTHESIA) Principal Display Panel | Pfizer Medical Information - US

PRINCIPAL DISPLAY PANEL - 2 mL Ampul Label

NDC 0409-4712-11
2 mL

5% Lidocaine HCl
and 7.5% Dextrose
Injection, USP
For spinal anesthesia.

RL–5101

Rx only

Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

Principal Display Panel - 2 mL Ampul Label

PRINCIPAL DISPLAY PANEL - 2 mL Ampul Cello Pack Label

NDC 0409-4712-25

2 mL Single-dose 5 Ampuls
Rx only

5% Lidocaine HCl
and 7.5% Dextrose
Injection, USP

Sterile, hyperbaric solution for spinal anesthesia. Each mL
contains lidocaine hydrochloride, anhydrous 50 mg; dextrose
hydrous 75 mg. May contain sodium hydroxide and/or
hydrochloric acid for pH adjustment. pH 6.5 (6.0 to 7.0).
0.75 mOsmol/mL (calc.). Usual dosage: See insert. For spinal
anesthesia. Store at 20 to 25°C (68 to 77°F).
[See USP Controlled Room Temperature.]

Hospira, Inc., Lake Forest, IL 60045 USA

RL - 5341

Hospira

Principal Display Panel - 2 mL Ampul Cello Pack Label

lidocaine hydrochloride 5% and 7.5% Dextrose (FOR SPINAL ANESTHESIA) Quick Finder

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INDICATIONS AND USAGE

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is indicated for the production of spinal anesthesia when the accepted procedures for this technique as described in standard textbooks are...

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DOSAGE AND ADMINISTRATION

Spinal anesthesia with 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP may be induced in the right or left lateral recumbent or the sitting position. Since this is a hyperbaric solution...

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CONTRAINDICATIONS

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

The following conditions preclude the use of spinal anesthesia:

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WARNINGS

5% LIDOCAINE HYDROCHLORIDE AND 7.5% DEXTROSE INJECTION, USP FOR SPINAL ANESTHESIA SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE...

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ADVERSE REACTIONS

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and...

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OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see...

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DESCRIPTION

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is a sterile, nonpyrogenic, hyperbaric solution for use in spinal anesthesia.

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains...

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CLINICAL PHARMACOLOGY

Mechanism of action

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of...

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Lambert DH and Hurley RJ: Cauda Equina syndrome and continuous spinal anesthesia. Anesth and Analg 72:817–9, 1991.
Ready, LB, et al: Neurotoxicity of local anesthetics in rabbits. Anesthesiology 63:364–70, 1985.

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HOW SUPPLIED

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, is supplied in the following:

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Ampul

Single-dose Container

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.