COACTIFED TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE

Available from:

GLAXOSMITHKLINE INC

ATC code:

R05DA20

INN (International Name):

COMBINATIONS

Dosage:

4MG; 60MG; 20MG

Pharmaceutical form:

TABLET

Composition:

TRIPROLIDINE HYDROCHLORIDE 4MG; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG; CODEINE PHOSPHATE 20MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

PROPYLAMINE DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0304415001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-03-03

Summary of Product characteristics

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_Page 1 of 22 _
PRESCRIBING INFORMATION
N
COACTIFED
®
SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Codeine phosphate)
TABLETS
(Triprolidine HCl – Pseudoephedrine HCl – Codeine phosphate)
EXPECTORANT SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Guaifenesin – Codeine
phosphate)
ANTIHISTAMINE – ANTITUSSIVE DECONGESTANT
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Date of Revision:
December 19, 2013
SUBMISSION CONTROL # 170056
©
2013 GlaxoSmithKline Inc. All rights reserved.
®
COACTIFED is a registered trademark, used under license by
GlaxoSmithKline Inc.
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_Page 2 of 22 _
PRESCRIBING INFORMATION
N
COACTIFED
®
SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Codeine Phosphate)
TABLETS
(Triprolidine HCl – Pseudoephedrine HCl – Codeine Phosphate)
EXPECTORANT SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Guaifenesin – Codeine
phosphate)
INDICATIONS
COACTIFED
® (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL, GUAIFENESIN AND CODEINE
PHOSPHATE) EXPECTORANT SYRUP
COACTIFED
® (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE) SYRUP
COACTIFED
® (TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE) TABLETS
The temporary relief of coughs associated with allergy or the common
cold.
Regardless of the clinical setting, codeine, including COACTIFED
®
, must not be used in
patients below the age of 18 years due to increased safety concerns
(See Warnings and
Precautions/ Special Populations/Children)
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_Page 3 of 22 _
CONTRAINDICATIONS
COACTIFED
®
Tablets and Syrup are contraindicated in:
Newborn or premature infants.
Patients under the age of 18 years.
Women who are breastfeeding (see Lactation)
Women who are pregnant, or during labor and delivery.
Patients who are known to be CYP2D6 extensive or ultra-rapid
metabolisers for
whom there is an increased risk of developing symptoms of opioid
toxicity, even at
commonly prescribed doses (see Pharmacology). General symptoms of
opioid
toxicity include confusion, somnole