PRESCRIBING INFORMATION

XYLOCAINE® PARENTERAL SOLUTIONS Lidocaine Hydrochloride Injection USP 0.5% lidocaine hydrochloride (5 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) 2% lidocaine hydrochloride (20 mg/mL)

Lidocaine Hydrochloride and Epinephrine Bitartrate Injection USP 1% lidocaine hydrochloride (10 mg/mL) with 1:200,000 epinephrine (0.005 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) with 1:100,000 epinephrine (0.010 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) with 1:200,000 epinephrine (0.005 mg/mL) Local Anesthetic

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca

Date of Revision: April 18, 2016

Submission Control No: 176093

XYLOCAINE® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

COPYRIGHT 1954-2016 ASTRAZENECA CANADA INC.

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TABLE OF CONTENTS

PART I: HEALTH PROFESSIONAL INFORMATION ........................................................3 SUMMARY PRODUCT INFORMATION......................................................................3 INDICATIONS AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS.................................................................................................4 WARNINGS AND PRECAUTIONS ...............................................................................5 ADVERSE REACTIONS ...............................................................................................12 DRUG INTERACTIONS ...............................................................................................14 DOSAGE AND ADMINISTRATION ...........................................................................16 OVERDOSAGE..............................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY..........................................................22 STORAGE AND STABILITY .......................................................................................24 SPECIAL HANDLING INSTRUCTIONS.....................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING...........................................25 PART II: SCIENTIFIC INFORMATION.............................................................................27 PHARMACEUTICAL INFORMATION .......................................................................27 REFERENCES................................................................................................................28 PART III: CONSUMER INFORMATION............................................................................29

COPYRIGHT 1954-2016 ASTRAZENECA CANADA INC.

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XYLOCAINE® PARENTERAL SOLUTIONS Lidocaine Hydrochloride Injection USP 0.5% lidocaine hydrochloride (5 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) Lidocaine Hydrochloride and Epinephrine Bitartrate Injection USP 1% lidocaine hydrochloride (10 mg/mL) with 1:200,000 epinephrine (0.005 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) with 1:100,000 epinephrine (0.010 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) with 1:200,000 epinephrine (0.005 mg/mL)

PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration

Dosage Form / Strength

Nonmedicinal Ingredients

Parenteral

Sterile solutions of 0.5%, 1% and 2% lidocaine hydrochloride contain 5, 10 or 20 mg/mL lidocaine hydrochloride.

Multidose vials: All multidose vials of lidocaine hydrochloride and lidocaine hydrochloride with epinephrine contain methylparaben Solutions with Epinephrine: sodium metabisulfite and citric acid (certain vial presentations, please refer to the product label) For a complete listing see Dosage Forms, Composition and Packaging section.

Sterile solutions of 1% and 2% lidocaine hydrochloride with epinephrine contain 10 or 20 mg/mL lidocaine hydrochloride with 0.010 mg/mL (1:100,000) or 0.005 mg/mL (1:200,000) epinephrine base, as epinephrine bitartrate.

INDICATIONS AND CLINICAL USE Adults (>18 years of age): XYLOCAINE Parenteral Solutions (lidocaine hydrochloride) are indicated for production of local or regional anesthesia by: 

infiltration techniques including percutaneous injection,



peripheral nerve block techniques such as brachial plexus and intercostal blocks, and

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

central neural techniques including epidural and caudal blocks,

when the accepted procedures for these techniques, as described in standard textbooks, are observed. Geriatrics (> 65 years of age): Elderly patients should be given reduced doses commensurate with their age and physical condition (see DOSAGE AND ADMINISTRATION-Special Populations). Pediatrics (