INDOMETHACIN IV MYLAN indometacin (as sodium trihydrate) 1mg powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
indometacin sodium trihydrate
Available from:
Alphapharm Pty Ltd
INN (International Name):
indometacin sodium trihydrate
Authorization status:
Registered
Patient Information leaflet
INDOMETHACIN IV MYLAN
_Indomethacin sodium trihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Indomethacin IV
Mylan. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of Indomethacin IV Mylan
against the benefits they expect it
will have for your baby.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT INDOMETHACIN IV
MYLAN IS USED FOR
Indomethacin IV Mylan is used in
premature babies to close the patent
ductus arteriosus.
While a baby is inside its mother's
womb it does not need to use its
lungs. An unborn baby has a blood
vessel called a 'ductus arteriosus' near
the heart which allows the baby's
blood to bypass its lungs and
circulate to the rest of its body.
When the baby is born and starts
using its lungs the ductus arteriosus
normally closes up.
However, in some cases this does not
happen. This can cause heart
problems in the baby.
The doctor has prescribed
Indomethacin IV Mylan for your
baby because your baby has a ductus
arteriosus which has not closed
properly. Indomethacin IV Mylan
can help close this blood vessel.
If the ductus arteriosus remains open,
blood intended for the body may be
returned to the lungs, overloading the
lung's blood vessels, making the
lungs and heart work harder to pump
blood to the rest of the body. This
can lead to failure to gain weight,
shortness of breath, a fast heart rate,
frequent chest infections, and
sometimes heart failure.
In premature infants the extra blood
flow to the lungs may interfere with
the functioning of the heart and, even
more significantly, with that of the
lungs which are immature. In these
cases, fluid restriction, Indomethacin
IV Mylan, or surgery may be used to
close the ductus.
Indomethacin IV Mylan belongs to a
group of medicines called Non-
Steroidal Anti-Inflammatory
Read the complete document
Summary of Product characteristics
INDOMETHACIN IV MYLAN_ - _PRODUCT INFORMATION_ _
_ _
_ _
_Doc ID #: 4.AL.P.1.2 _
_ _
_Page 1 of 20 _
_INDOMETHACIN IV MYLAN _
POWDER FOR INJECTION, 1MG
PRODUCT INFORMATION
NAME OF THE MEDICINE
Indomethacin IV Mylan (indomethacin sodium trihydrate) for intravenous
administration is
lyophilised indomethacin sodium trihydrate.
Indomethacin
sodium
trihydrate
is
designated
chemically
as1_H-_Indole-3-acetic
acid,
1-(4-
chlorobenzoyl)-5-methoxy-2-methyl-, sodium salt, trihydrate.
Its molecular weight is 433.82 g/mol.
Its molecular formula is C
19
H
15
ClNNaO
4
.3H
2
O and
Its structural formula is:
CAS Number:
74252-25-8
DESCRIPTION
Each vial contains indomethacin sodium trihydrate equivalent to 1 mg
indomethacin as a sterile
white to yellow lyophilised powder or plug. Variations in the size of
the lyophilised plug and the
intensity of colour have no relationship to the quality or amount of
indomethacin present in the
vial.
pKa value for Indomethacin is 4.5.
Indomethacin IV Mylan contains no other excipients.
PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory agent which inhibits
prostaglandin synthesis.
Although the exact mechanism of action through which indomethacin
causes closure of a patent
ductus arteriosus is not known, it is believed to be through
inhibition of prostaglandin synthesis.
Indomethacin has been shown to be a potent inhibitor of prostaglandin
synthesis, both _in vitro_
and _in vivo._ In human newborns with certain congenital heart
malformations, PGE 1 dilates the
ductus arteriosus. In fetal and newborn lambs, E type prostaglandins
have also been shown to
maintain the patency of the ductus, and as in human newborns,
indomethacin causes its
constriction.
INDOMETHACIN IV MYLAN_ - _PRODUCT INFORMATION_ _
_ _
_ _
_Doc ID #: 4.AL.P.1.2 _
_ _
_Page 2 of 20 _
Studies in premature infants with patent ductus arteriosus indicated
that, after the first dose of
intravenous indomethacin, there was a transient reduction in cerebral
blood flow velocity and
cerebral blood flow. Similar decreases in mesent
Read the complete document
