MAXATAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rizatriptan benzoate, Quantity: 7.265 mg (Equivalent: rizatriptan, Qty 5 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
rizatriptan benzoate
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: acesulfame potassium; mannitol; sodium stearylfumarate; hypromellose; colloidal anhydrous silica; ethylcellulose; crospovidone; silicon dioxide; Flavour
Administration route:
Sublingual
Units in package:
2, 6, 3
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
for acute treatment of migraine attacks with or without aura.
Product summary:
Visual Identification: White to off-white, round, flat face beveled edge tablets, debossed with 'C6' on one side and 'C' on the other side, having a characteristic flavour; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2015-03-20
Patient Information leaflet
MAXATAN ORALLY DISINTEGRATING TABLETS
1
MAXATAN
ORALLY DISINTEGRATING TABLETS
_Rizatriptan benzoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before
you start using MAXATAN orally
disintegrating tablets. This leaflet
answers some common questions about
MAXATAN orally disintegrating
tablets. 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 MAXATAN orally
disintegrating tablets 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 MAXATAN ORALLY
DISINTEGRATING TABLETS
ARE USED FOR
MAXATAN orally disintegrating
tablets are used to relieve the headache
pain and other symptoms of migraine
attacks. MAXATAN orally
disintegrating tablets 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 slee
Read the complete document
Summary of Product characteristics
Rizatriptan Orally Disintegrating Tablets
Page 1
PRODUCT INFORMATION
MAXATAN
(RIZATRIPTAN BENZOATE)
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:
CAS No. 145202-66-0
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.
Eac
h orally disintegrating 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: silicon dioxide, crospovidone, hypromellose,
ethylcellulose, mannitol, acesulfame
potassium, colloidal anhydrous silica, sodium stearylfumarate,
strawberry 052311 AP 0551
and peppermint Flavor 501500 TP0504.
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.
Rizatr
iptan acts at craniovascular 5-HT
1B
receptors to cause selective constriction of the
extracerebral, intracranial arteries that are thought to be dilated
during a migraine attack.
Vasodilatation of these arteries and stimulation of trigeminal sensory
nervous pain pathways
have
been
postulated
to
be
the
most
important
underlying
mechanisms
in
migraine
pathogenesis. In anaesthetised dogs, rizatriptan reduces carotid
artery blood flow selectively
and has much lesser effects on blood flow in the coronary and
pulmonary ar
ter
y vasculature.
Rizatriptan also inhibits cra
Read the complete document
