MOTRIN TABLETS 300MG

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IBUPROFEN

Available from:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

IBUPROFEN 300MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0108883001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2002-05-15

Summary of Product characteristics

PRODUCT MONOGRAPH
MOTRIN* IB
Tablets, Caplets and Gelcaps, 200mg
Extra Strength MOTRIN*IB
Tablets 300mg
Super Strength MOTRIN*IB
Tablets 400mg
Ibuprofen Tablets USP
Analgesic, Antipyretic Agent
McNeil Consumer Healthcare
Date of Preparation:
890 Woodlawn Road West
May 10, 2002
Guelph, Canada
N1K 1A5
Date of Revision:
August 9, 2003
* Trademark
CTRL#083237
2
PRODUCT MONOGRAPH
NAME OF DRUG
MOTRIN*IB
Ibuprofen Tablets USP
200mg (MOTRIN*IB) tablets, caplets, gelcaps
300mg (Extra Strength MOTRIN*IB) tablets
400mg (Super Strength MOTRIN*IB) tablets
THERAPEUTIC CLASSIFICATION
Analgesic, Antipyretic Agent
CLINICAL PHARMACOLOGY
Ibuprofen is a member of the class of agents commonly known as
non-steroidal
anti-inflammatory drugs (NSAID). Consistent with this classification,
ibuprofen
exhibits anti-inflammatory activity at higher dosage ranges (Brooks
_et al_
.; 1973).
At lower adult single doses relevant to a nonprescription dosage (200
mg to 400
mg) ibuprofen relieves pain of mild to moderate intensity (Cooper
_et al_
.; 1977,
Gallardo & Rossi; 1980, Jain
_et al_
.; 1984, Vecchio
_et al_
.; 1983, Ihles; 1980) and
reduces fever
(Gaitonade
_et al_
.; 1973, Sheth
_et al_
.; 1980, Simila
_et al_
.; 1976).
Analogous to acetylsalicylic acid, the prototype of this class, this
analgesic/antipyretic activity of ibuprofen occurs at lower doses than
necessary
for anti-inflammatory effects which are thought to require sustained
administration of higher individual doses (Flower
_et al_
.; 1985).
Ibuprofen is rapidly absorbed after oral administration, with peak
serum or
plasma levels generally appearing within 1-1/2 to 2 hours. Oral
absorption is
estimated to be 80% of the dose. Both the rate of absorption and peak
plasma
concentrations are reduced when the drug is taken with food, but,
bioavailability
as measured by total area under the concentration-time curve is
minimally
altered. Ibuprofen has an elimination half-life of approximately two
hours. It is
rapidly metabolized through oxidation and glucuronic acid conjugation
with
urinar