情報リーフレット
MAXALT
®
WAFERS
_Rizatriptan benzoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using MAXALT
Wafers. This leaflet answers some
common questions about MAXALT
Wafers. 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 you taking MAXALT
Wafers against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MAXALT WAFERS
ARE USED FOR
MAXALT Wafers are used to relieve
the headache pain and other
symptoms of migraine attacks.
MAXALT Wafers do not work for
other types of headaches.
Migraine is an intense, throbbing,
typically one-sided headache. It often
includes nausea, vomiting, sensitivity
to light, and sensitivity to sound.
Some people may have visual
symptoms before the headache,
called an aura. An aura can include
flashing lights or wavy lines.
Migraine attacks last anything from
two hours to two days and they can
return frequently. The severity and
frequency of migraine attacks may
vary.
Migraine occurs in about one out of
every 10 people. It is three times
more common in women than men.
Six out of ten migraine sufferers have
their first attack before the age of 20.
There is no single cause of migraine.
It tends to run in families. Certain
things, singly or in combination, can
trigger migraine attacks in some
people. Some of these triggers are:
•
certain foods or drinks, for
example, cheese and other dairy
products, chocolate, citrus fruit,
caffeine, alcohol (especially red
wine)
•
stress, anger, worry
•
changes in routine, for example,
under or over sleeping, missing a
meal, change in diet
•
bright light or loud noises
•
hormonal changes in women, for
example, during menstrual
periods
If you understand what triggers your
attacks, you
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製品の特徴
MAXALT Wafer + Tablet PI A120508 v5 (0462-AUS-2012-004509)
Page 1
PRODUCT INFORMATION
MAXALT
TABLETS / MAXALT
WAFERS
(RIZATRIPTAN BENZOATE, MSD)
NAME OF THE MEDICINE
Rizatriptan benzoate is described
chemically as: _N,N_-dimethyl-5-(1_H_-1,2,4-triazol-1-
ylmethyl)-1_H_-indole-3-ethanamine monobenzoate.
Its empirical formula is C
15
H
19
N
5
•C
7
H
6
O
2
and its structural formula is:
DESCRIPTION
Rizatriptan benzoate is a white to off-white, crystalline solid.
The molecular weight of the
benzoate salt is 391.47; the molecular weight of the free base
is 269.4. Rizatriptan
benzoate is soluble in water at about 42 mg per mL (expressed
as free base) at 25°C.
Each compressed tablet contains either 7.265 mg or 14.53
mg of rizatriptan benzoate
(corresponding to 5 mg or 10
mg of rizatriptan, respectively) and the following inactive
ingredients: lactose, microcrystalline cellulose, pregelatinised
maize starch, iron oxide red
CI77491, and magnesium stearate.
Each lyophilised wafer contains either 7.265 mg or 14.53
mg of rizatriptan benzoate
(corresponding to 5 mg or 10
mg of rizatriptan, respectively) and the following inactive
ingredients: gelatin, mannitol, glycine, aspartame, and
peppermint flavour.
PHARMACOLOGY
MECHANISM OF ACTION_ _
Rizatriptan is a potent, orally active
serotonergic agonist that has been shown in radioligand
binding assays and functional pharmacological bioassays to
act selectively at 5-HT
1B/1D
receptors. Rizatriptan has no
clinically significant activity at 5-HT
2
or 5-HT
3
receptor
subtypes, nor at alpha- and
beta-adrenergic, dopaminergic, histaminergic, muscarinic or
benzodiazepine receptors._ _
Rizatriptan acts at craniovascular 5-HT
1B
receptors to cause selective constriction of the
extracerebral, intracranial arteries that are thought to be
dilated during a
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