IBUPROFEN MENSTRUAL PAIN RELIEF TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

IBUPROFEN

Pieejams no:

APOTEX INC

ATĶ kods:

M01AE01

SNN (starptautisko nepatentēto nosaukumu):

IBUPROFEN

Deva:

400MG

Zāļu forma:

TABLET

Kompozīcija:

IBUPROFEN 400MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

16

Receptes veids:

OTC

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0108883002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2008-10-16

Produkta apraksts

0
PRODUCT MONOGRAPH
IBUPROFEN MENSTRUAL PAIN RELIEF
IBUPROFEN TABLETS USP
400 MG
ANALGESIC, ANTIPYRETIC AGENT
APOTEX INC.
DATE OF PREPARATION:
150 Signet Drive
October 14, 2008
Weston, Ontario
M9L 1T9
_ _
SUBMISSION CONTROL NUMBER: 124479_ _
_ _
1
PRODUCT MONOGRAPH
IBUPROFEN MENSTRUAL PAIN RELIEF
Ibuprofen Tablets USP
400 mg
THERAPEUTIC CLASSIFICATION
Analgesic, Antipyretic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Ibuprofen is a member of the class of agents commonly known as
nonsteroidal anti-inflammatory
drugs (NSAID). Consistent with this classification, ibuprofen exhibits
anti-inflammatory activity at
higher dosage ranges. At lower adult single doses relevant to a
nonprescription dosage strength
(200 mg to 400 mg) ibuprofen relieves pain of mild to moderate
intensity and reduces fever.
Analogous to ASA, 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.
Ibuprofen is rapidly absorbed after oral administration, with peak
serum or plasma levels
generally appearing within 1½ 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 2 hours. It is rapidly
metabolized through oxidation and glucuronic acid conjugation with
urinary excretion of the
inactive metaboIites usually complete within 24 hours. Less than 10%
is excreted unchanged in
the urine. Clinical studies indicate a duration of clinical effect for
up to 8 hours for fever and 6+
hours for pain.
2
Studies demonstrate no significant alterations in ibuprofen
pharmacokinetics in the elderly.
Ibuprofen pharmacokinetics has also been studied in patients with
alcoholic liver disease who
have been assessed to have fair to po