PROTOPIC OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TACROLIMUS

Available from:

LEO PHARMA INC

ATC code:

D11AH01

INN (International Name):

TACROLIMUS

Dosage:

0.1%

Pharmaceutical form:

OINTMENT

Composition:

TACROLIMUS 0.1%

Administration route:

TOPICAL

Units in package:

30/60/100G

Prescription type:

Prescription

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

Active ingredient group (AIG) number: 0127857004; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-04-12

Summary of Product characteristics

_Protopic_
_®_
_ Product Monograph, v.3.0 _
_Template Date: June 2017 _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROTOPIC
®
tacrolimus ointment
0.03% and 0.1% (w/w)
Topical Calcineurin Inhibitor
ATC Code: D11AH01
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.ca
Date of Revision:
AUGUST 13, 2021
Submission Control No: 243249
® Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
_ _
_Protopic_
_®_
_ Product Monograph, v.3.0 _
_Template Date: June 2017 _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
3. SERIOUS WARNINGS AND PRECAUTIONS BOX 08/2021
7. WARNING AND PRECAUTIONS 08/2021
TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatr
ics.............................................................................................................4
2
CONTRAINDICATIONS ...........................................................................................
4
3
DOSAGE AND ADMINISTRATION .........................................................................
4
3.1
Dosing Considerations
.........................................................................................4
3.2
Recommended Dose and Dosage Adjustment
.......................................................5
3.3
Administration.....................................................................................................5
3.4
Missed Dose
........................................................................................................5
4
OVERDOSAGE .........................................................................................................
6
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 6
6
WARNINGS AND PRECAUTIONS
......................