Dihydergot 1mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Dihydroergotamine mesylate

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

ATC code:

N02CA01

Dosage:

1mg/1mL

Pharmaceutical form:

injection ampoule

Class:

Medicine Registered

Therapeutic area:

antimigraine preparations

Patient Information leaflet

DIHYDERGOT
®
_dihydroergotamine mesylate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dihydergot injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Dihydergot
against the benefits it can provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DIHYDERGOT IS
USED FOR
Dihydergot is used to treat attacks of
migraine, "cluster" headaches and
other similar types of headache.
These headaches are thought to be
caused by temporary changes in the
size of small blood vessels in the
brain. These blood vessels swell,
causing the pain and visual
disturbances that often happen during
an attack. Dihydergot stops the attack
by causing the blood vessels to
constrict (shrink) back to normal
size.
Dihydergot is only used to treat
migraine attacks. It is not used to
prevent attacks from happening.
There are some types of headaches
which must not be treated with
Dihydergot. Your doctor will
determine the best treatment for your
headache.
Dihydergot is also used in adults to
prevent a large drop in blood
pressure that happens in some people
when they stand up from a sitting or
lying position. This condition, called
orthostatic hypotension, can cause
severe, disabling attacks of dizziness
and lightheadedness, sometimes with
fainting.
Dihydergot contains the active
ingred

Summary of Product characteristics

1
DIHYDERGOT
®
(DIHYDROERGOTAMINE MESYLATE)
NAME OF THE MEDICINE
Active ingredient
dihydroergotamine mesylate
Chemical name
ergotaman-3’,6’,18-trione,9,10-dihydro-12’-hydroxy-2’-
methyl-5’-(phenylmethyl)-,(5’α)-,monomethanesulfonate
CAS number
6190-39-2
Molecular weight
679.8
Molecular formula
C
34
H
41
N
5
O
8
S
Chemical structure
DESCRIPTION
Dihydroergotamine mesylate is structurally and pharmacologically
related to the other
hydrogenated ergot alkaloids of the peptide type. The mesylate is a
white to slightly
yellowish or grey to pink-tinged powder soluble 0.85% in water, > 2%
in methanol and
approximately 1 % in chloroform.
Dihydergot injection is a clear, colourless solution, pH 3.9-4.9.
EXCIPIENTS
Tablets: tartaric acid, gelatin, magnesium stearate, stearic acid,
talc-purified, starch-maize,
lactose.
Ampoules: ethanol 5 %, glycerol 15 %, and water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: antimigraine preparations
ATC code: N02CA01
Dihydroergotamine has complex pharmacological effects. It possesses
affinity for both
alpha-adrenergic and serotoninergic receptors with both stimulating
and blocking properties.
2
Dihydergot
exerts
its
effect
in
orthostatic
hypotension
by
selective
constriction
of
capacitance vessels with no significant effect on resistance vessels.
This increase in venous
tone leads to a redistribution of blood, preventing excessive venous
pooling.
In migraine attacks dihydroergotamine acts primarily by compensating
for the decreased
5-HT plasma level. Simulating the effect of 5-HT, it counteracts the
loss of tone of the
extracranial vasculature.
The uterotonic activity of dihydroergotamine is much weaker than that
of ergotamine.
PHARMACOKINETICS
ABSORPTION:
Dihydroergotamine is incompletely and variably absorbed after oral
administration (20 – 50
%). Peak plasma levels are attained in 1-2 hours and are linear over
the range 10 - 30 mg.
The absolute oral bioavailability is low (approx. 1 % when unchanged
drug measured) due
to a 98 % first pass extr