NOVO-DIFLUNISAL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIFLUNISAL

Available from:

TEVA CANADA LIMITED

ATC code:

N02BA11

INN (International Name):

DIFLUNISAL

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

DIFLUNISAL 500MG

Administration route:

ORAL

Units in package:

60/100/500

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0113161002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

PRODUCT MONOGRAPH
NOVO-DIFLUNISAL
(diflunisal)
Film-coated Tablets 250 and 500 mg
THERAPEUTIC CLASSIFICATION
Analgesic, Anti-Inflammatory Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
June 19, 2014
Toronto ON
M1B 2K9
Control # 174380
2
NAME OF DRUG
Novo-DIFLUNISAL
(diflunisal tablets, USP)
250 and 500 mg
THERAPEUTIC CLASSIFICATION
Anti-Inflammnatory, Analgesic Agent
ACTION AND CLINICAL PHARMACOLOGY
Diflunisal is a non-steroidal drug with analgesic, anti- inflammatory
and antipyretic
properties. The precise mechanism of the analgesic and
anti-inflammatory actions of
diflunisal is not known, however, it appears to be a
peripherally-acting analgesic drug.
Diflunisal is a prostaglandin synthetase inhibitor. In animals,
prostaglandins sensitize
afferent nerves and potentiate the action of bradykinin in inducing
pain. Since
prostaglandins are known to be among the mediators of pain and
inflammation, the mode
of action of diflunisal may be due in part to a decrease of
prostaglandins in peripheral
tissues.
Pharmacokinetics and Metabolism
Diflunisal is rapidly and completely absorbed following oral
administration with peak
plasma concentrations occurring between 2 to 3 hours. The drug is
excreted in the urine
as two soluble glucuronide conjugates accounting for about 90% of the
administered
dose. Little or no diflunisal is excreted in the feces. Diflunisal
appears in human milk in
concentrations of 2 - 7% of those in plasma. More than 99% of
diflunisal in plasma is
bound to proteins.
As is the case with salicylic acid, concentration-dependent
pharmacokinetics prevail
when diflunisal is administered; a doubling of dosage produces a
greater than doubling of
drug accumulation.
The effect becomes more apparent with repetitive doses. Following
single doses, peak
plasma concentrations of 41 ± 11 µg/mL (mean ± S.D.) were observed
following 250 mg
3
doses 87 ± 17 µg/mL were observed following 500 mg and 124 ± 11
µg/mL following
single 1000 mg doses. However, following administration of 250 mg
b.i.d., a