Loading…
EMLA is a brand name for Lidocaine (also known as Lignocaine), supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EMLA should only be used for the approved indications because maximum safe doses for other uses are not known. Serious and life-threatening adverse events have occurred when EMLA cream was applied to large areas of skin for topical analgesia during cosmetic procedures (e.g., laser depilation) (see 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
3 Special Populations, Pediatrics). EMLA is contraindicated for use in preterm infants (defined as gestational age less than 37 weeks) (see 2 CONTRAINDICATIONS). 2 Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population may be associated with differences in safety or effectiveness.
4 Special Populations, Geriatrics). 2 CONTRAINDICATIONS EMLA (lidocaine and prilocaine) is contraindicated in: Patients who are hypersensitive to local anesthetics of the amide type or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
). v. catheters or prior to blood sampling vaccination with only the following vaccines, shown not to interact with EMLA in clinical trials: MMR, DPTP; Haemophilus influenzae b and Hepatitis B (see 14 CLINICAL TRIALS, Topical Analgesia in Pediatrics , Vaccination • ).
Since the effect of EMLA on the immune response to any other vaccine is unknown, it cannot be recommended for use with other vaccines. , the removal of necrotic tissue and debris by curettes, scissors, tweezers, etc. v. catheters or prior to blood sampling EMLA® (Lidocaine & Prilocaine) Page 5 of 54 • vaccination with only the following vaccines that have been shown not to interact with EMLA in clinical trials: MMR, DPTP; Haemophilus influenzae b and Hepatitis B (see 14 CLINICAL TRIALS, Topical Analgesia in Pediatrics , Vaccination • Since the effect of EMLA on the immune response to any other vaccine is unknown, it cannot be recommended for use with other vaccines.
1 Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of EMLA in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use.
3 Special Populations, Pediatrics). EMLA is contraindicated for use in preterm infants (defined as gestational age less than 37 weeks) (see 2 CONTRAINDICATIONS). 2 Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population may be associated with differences in safety or effectiveness.
4 Special Populations, Geriatrics). 2 CONTRAINDICATIONS EMLA (lidocaine and prilocaine) is contraindicated in: Patients who are hypersensitive to local anesthetics of the amide type or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , sulfonamides and are 12 months of age or younger (see
1 Pregnant Women 04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES................................................ Error! Bookmark not defined.
TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics (<18 years of age): .............................................................................
2 Geriatrics:.......................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................
4 Administration................................................................................................. 10 5 OVERDOSAGE ...........................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 12 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ..........................................................................................
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
). 2 Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population may be associated with differences in safety or effectiveness. 4 Special Populations, Geriatrics). 2 CONTRAINDICATIONS EMLA (lidocaine and prilocaine) is contraindicated in: Patients who are hypersensitive to local anesthetics of the amide type or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , sulfonamides and are 12 months of age or younger (see 9 DRUG INTERACTIONS) EMLA® (Lidocaine & Prilocaine) Page 6 of 54 Preterm infants (defined as gestational age less than 37 weeks)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lidocaine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4 Geriatrics ................................................................................................... 18 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 2 Clinical Trial Adverse Reactions ........................................................................ 5 Post-Market Adverse Reactions........................................................................
20 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioural Interactions..........................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 22 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics....................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
25 PART II: SCIENTIFIC INFORMATION ...................................................................................... 26 13 PHARMACEUTICAL INFORMATION............................................................................ 26 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 27 15 MICROBIOLOGY ........................................................................................................ 33 16 NON-CLINICAL TOXICOLOGY .....................................................................................
33 PATIENT MEDICATION INFORMATION - EMLA® Patch........................................................... 38 PATIENT MEDICATION INFORMATION - EMLA® Cream ......................................................... 46 EMLA® (Lidocaine & Prilocaine) Page 4 of 54 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS EMLA should only be used for the approved indications because maximum safe doses for other uses are not known.
, laser depilation) (see 7 WARNINGS AND PRECAUTIONS;