TARO-CLINDAMYCIN/BENZOYL PEROXIDE GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BENZOYL PEROXIDE; CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Available from:

TARO PHARMACEUTICALS INC

ATC code:

D10AF51

INN (International Name):

CLINDAMYCIN, COMBINATIONS

Dosage:

5%; 1%

Pharmaceutical form:

GEL

Composition:

BENZOYL PEROXIDE 5%; CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 1%

Administration route:

TOPICAL

Units in package:

45G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0242561001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-22

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-CLINDAMYCIN / BENZOYL PEROXIDE GEL
clindamycin and benzoyl peroxide gel, 1%/5%, w/w
(clindamycin as clindamycin phosphate)
Topical Acne Therapy
Professed Standard
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Date of Preparation:
March 4, 2019
Submission Control No: 223918
Page 2 of 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND
PRECAUTIONS..............................................................................
4
ADVERSE REACTIONS
...............................................................................................
6
DRUG INTERACTIONS
................................................................................................
9
DOSAGE AND ADMINISTRATION
..........................................................................
10
OVERDOSAGE
............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 11
STORAGE AND
STABILITY......................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
................................................................... 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 12
PART II: SCIENTIFIC INFORMATION
.............................................................................
14
PHARMACEUTICAL INFORMATION
.....................................................................
14
CLINICAL TRIALS
...................................................