Aetos Montelukast Tablet 10mg

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

MONTELUKAST SODIUM

Tilgjengelig fra:

Hovid Pharmacy Sdn. Bhd.

INN (International Name):

MONTELUKAST SODIUM

Enheter i pakken:

10 x 10'stablet Tablets; 3 x 10'stablet Tablets

Produsert av:

HOVID BERHAD

Preparatomtale

Montelukast and malformations (i.e. limb defects) that have been
rarely
reported in worldwide post marketing experience.
USE DURING LACTATION: It is not known if Montelukast is excreted in
human
milk. Montelukast may be used in nursing mothers only if it is
considered
to be clearly essential.
DRUG INTERACTIONS
•
Montelukast may be administered with other therapies routinely used in
the prophylaxis and chronic treatment of asthma. In drug-interactions
studies, the recommended clinical dose of montelukast did not have
clinically important effects on the pharmacokinetics of theophylline,
prednisone,
prednisolone,
oral
contraceptives
(ethinyl
estradiol/
norethindrone 35/1), terfenadine, digoxin and warfarin.
•
Montelukast is metabolised by CYP 3A4, caution should be exercised,
particularly in children, when montelukast is co-administered with
inducers of CYP 3A4, such as phenytoin, phenobarbital and rifampicin.
•
_In vitro_ studies have shown that montelukast is a potent inhibitor
of
CYP 2C8. However, data from a clinical drug-drug interaction study
involving
montelukast
and
rosiglitazone
(a
probe
substrate
representative
of
drugs
primarily
metabolized
by
CYP
2C8)
demonstrated that montelukast does not inhibit CYP 2C8 in vivo.
Therefore,
montelukast
is
not
anticipated
to
markedly
alter
the
metabolism of drugs metabolised by this enzyme (e.g., paclitaxel,
rosiglitazone, and repaglinide.)
MAIN SIDE/ADVERSE EFFECTS
The following side/adverse effects have been selected on the basis of
their potential clinical significance (possible signs and symptoms in
parentheses where appropriate) - not necessarily inclusive:
THOSE INDICATING FOR MEDICAL ATTENTION:
•
_INCIDENCE LESS FREQUENT:_
Elevated hepatic enzymes (asymptomatic) which include alanine
aminotransferase and aspartate transferase.
•
_INCIDENCE RARE:_
Pyuria (pus in the urine)
THOSE INDICATING NEED FOR MEDICAL ATTENTION ONLY IF THEY CONTINUE OR
ARE BOTHERSOME:
•
_INCIDENCE MORE FREQUENT:_
Headache
•
_INCIDENCE LESS FREQUENT:_
Abdominal or stomach pain, as