TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE); CLOTRIMAZOLE

Available from:

TARO PHARMACEUTICALS INC

ATC code:

D01AC20

INN (International Name):

IMIDAZOLES/TRIAZOLES IN COMBINATION WITH CORTICOSTEROIDS

Dosage:

0.05%; 1%

Pharmaceutical form:

CREAM

Composition:

BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%; CLOTRIMAZOLE 1%

Administration route:

TOPICAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0216399001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-02-19

Summary of Product characteristics

_Page 1 of 17_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE
Clotrimazole and Betamethasone Dipropionate Cream, USP
1% w/w clotrimazole / 0.05% w/w betamethasone (as betamethasone
dipropionate)
Topical Antifungal and Corticosteroid Agent
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
March 29, 2021
Brampton, ON
L6T 1C1
Submission
Control Number: 246369
_Page 2 of 17_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
1
INDICATIONS
..................................................................................................................3
1.1
Pediatrics....................................................................................................................3
1.2
Geriatrics
....................................................................................................................3
2
CONTRAINDICATIONS
.................................................................................................3
3
DOSAGE AND ADMINISTRATION
.............................................................................3
3.1
Dosing Considerations
...............................................................................................3
3.2
Recommended Dose and Dosage Adjustment
...........................................................3
3.3
Administration
...........................................................................................................4
4
MISSED DOSE
..................................................................................................................4
5
OVERDOSAGE
.................................................................................................................4
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................5
7
WARNINGS AND PRECAUTIONS
...............................................................................5
7.1
Special Populations
...................................................