United Kingdom - English - eMC (Electronic Medicines Compendium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this
medicine, because it contains important information for you.
The name of your medicine is Maxalt 5mg tablets, and will be referred
to as Maxalt throughout this leaflet. Maxalt Tablets are also available in
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
What is in this leaflet
1) What Maxalt is and what it is used for
2) What you need to know before you take Maxalt
3) How to take Maxalt
4) Possible side effects
5) How to store Maxalt
6) Contents of the pack and other information
1) WHAT MAXALT IS AND WHAT IT IS USED FOR
Maxalt belongs to a class of medicines called selective serotonin
Maxalt is used to treat the headache phase of the migraine attack in
Treatment with Maxalt:
Reduces swelling of blood vessels surrounding the brain. This swelling
results in the headache pain of a migraine attack.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXALT
Do not take Maxalt if:
you are allergic to rizatriptan benzoate or any of the other ingredients
of this medicine (listed in section 6)
you have moderately severe or severe high blood pressure or mild
high blood pressure that is not controlled by medication
you have or have ever had heart problems including heart attack or
pain on the chest (angina) or you have experienced heart disease
you have severe liver or severe kidney problems
you have had a stroke (cerebrovascular accident CVA) or mini stroke
(transient ischaemic attack TIA)
you have blockage problems with your arteries (peripheral vascular
you are taking monoamine oxidase (MAO) inhibitors such as
moclobemide, phenelzine, tranylcypromine, or pargyline (drugs against
depression), or linezolid (an antibiotic), or if it has been less than two
weeks since you stopped taking MAO inhibitors
you are now taking ergotamine-type medications, such as ergotamine
or dihydro-ergotamine to treat your migraine or methysergide to
prevent a migraine attack
you are taking any other drug in the same class, such as sumatriptan,
naratriptan, or zolmitriptan to treat your migraine (see Other
medicines and Maxalt below).
If you are not sure if any of the above apply to you talk to your doctor or
pharmacist before taking Maxalt.
Warnings and precautions
Before you take Maxalt, tell your doctor or pharmacist, if:
you have any of the following risk factors for heart disease: high blood
pressure, diabetes, you smoke or you are using nicotine substitution,
your family has a history of heart disease, you are a man over 40
years of age, or you are a postmenopausal woman
you have kidney or liver problems
you have a particular problem with the way your heart beats (bundle
you have or have had any allergies
your headache is associated with dizziness, difficulty in walking, lack of
co-ordination or weakness in the leg and arm
you use herbal preparation containing St. John's wort
you have had allergic reaction like swelling of face, lips, tongue and/or
throat which may cause difficulty breathing and/or swallowing
you are taking selective serotonin reuptake inhibitors (SSRIs) such as
sertraline, escitalopram oxalate, and fluoxetine or serotonin
norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and
duloxetine for depression
you have had short lived symptoms including chest pain and tightness.
If you take Maxalt too often this may result in you getting a chronic
headache. In such cases you should contact your doctor as you may
have to stop taking Maxalt.
Please tell your doctor or pharmacist about your symptoms. Your doctor
will decide if you have migraine. You should take Maxalt only for a
migraine attack. Maxalt should not be used to treat headaches that might
be caused by other, more serious conditions.
Please tell your doctor if you are taking or have recently taken, or plan to
take, any other medicines including medicines obtained without a
prescription. This includes herbal medicines and those you normally take
for a migraine. This is because Maxalt can affect the way some
medicines work. Also, other medicines can affect Maxalt.
Other medicines and Maxalt
Do not take Maxalt
if you are already taking a 5-HT
agonist (sometimes referred to as
‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
if you are taking a monoamine oxidase (MAO) inhibitor such as
moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if
it has been less than two weeks since you stopped taking an MAO
if you use ergotamine-type medications such as ergotamine or
dihydro-ergotamine to treat your migraine.
if you use methysergide to prevent a migraine attack.
The above listed medicines when taken with Maxalt may increase the
risk of side effects.
You should wait at least 6 hours after taking Maxalt before you take
ergotamine-type medications such as ergotamine or dihydro-ergotamine
You should wait at least 24 hours after taking ergotamine-type
medications before taking Maxalt.
Ask your doctor for instructions and the risks about taking Maxalt
if you are taking propranolol (see section 3: How to take Maxalt).
if you are taking SSRIs such as sertraline, escitalopram oxalate, and
fluoxetine or SNRIs such as venlafaxine, and duloxetine for
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Maxalt with food and drink
Maxalt can take longer to work if it is taken after food. Although it is better
to take it on an empty stomach, you can still take it if you have eaten.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is not known whether Maxalt is harmful to an unborn baby when taken
by a pregnant woman. Breastfeeding should be avoided for 24 hours
Children and adolescents
The use of Maxalt tablets in children under 18 years of age is not
Use in patients older than 65 years
There have been no full studies to look at how safe and effective Maxalt
is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking Maxalt. If this happens, do not
drive or use any tools or machines.
Maxalt contains lactose monohydrate
The 5-mg tablet contains 30.25 mg of lactose monohydrate and the
10-mg tablet contains 60.50 mg of lactose monohydrate. If you have
been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3) HOW TO TAKE MAXALT
Maxalt is used to treat migraine attacks. Take Maxalt as soon as
possible after your migraine headache has started. Do not use it to
prevent an attack.
Always take Maxalt exactly as your doctor has told you. You should
check with your doctor or your pharmacist if you are not sure.
The usual dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems
you should use the 5-mg dose of Maxalt. You should leave at least
2 hours between taking propranolol and Maxalt up to a maximum of 2
doses in a 24-hour period.
Maxalt (rizatriptan benzoate) tablets should be taken by mouth and
swallowed whole with liquid.
Maxalt is also available as a 10-mg oral lyophilisate that dissolves in the
mouth. The oral lyophilisate can be used in situations in which liquids are
not available, or to avoid the nausea and vomiting that may accompany
the ingestion of tablets with liquids.
If migraine returns within 24 hours
In some patients, migraine symptoms can return within a 24-hour period.
If your migraine does return you can take an additional dose of Maxalt.
You should always wait at least 2 hours between doses.
If after 2 hours you still have a migraine
If you do not respond to the first dose of Maxalt during an attack, you
should not take a second dose of Maxalt for treatment of the same
attack. It is still likely, however, that you will respond to Maxalt during the
Do not take more than 2 doses of Maxalt in a 24-hour period, (for
example, do not take more than two 10-mg or 5-mg tablets or oral
lyophilisate in a 24-hour period). You should always wait at least 2
hours between doses.
If your condition worsens, seek medical attention.
If you take more Maxalt than you should:
If you take more Maxalt than you should, talk to your doctor or
pharmacist straight away. Take the medicine pack with you.
Signs of overdosage can include dizziness, drowsiness, vomiting, fainting
and slow heart rate.
If you have any further questions on the use of this product ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may happen with this
In adult studies, the most common side effects reported were dizziness,
sleepiness and tiredness.
Common (affects 1 to 10 users in 100)
tingling (paraesthesia), headache, decreased sensitivity of skin
(hypoaesthesia), decreased mental sharpness, insomnia.
fast or irregular heart beat (palpitation).
flushing (redness of the face lasting a short time).
feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion
feeling of heaviness in parts of the body, neck pain, stiffness.
pain in abdomen or chest.
Uncommon (affects 1 to 10 users in 1000)
bad taste in your mouth.
unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,
tremor, fainting (syncope).
high blood pressure (hypertension); thirst, hot flushes, sweating.
rash, itching and lumpy rash (hives); swelling of face, lips, tongue
and/or throat which may cause difficulty breathing and/or swallowing
(angioedema), difficulty breathing (dyspnoea).
feeling of tightness in parts of the body, muscle weakness.
changes in the rhythm or rate of the heartbeat (arrhythmia);
abnormalities of the electrocardiogram (a test that records the
electrical activity of your heart), very fast heartbeat (tachycardia).
facial pain, muscle pain.
Rare (affects 1 to 10 users in 10,000)
allergic reaction (hypersensitivity); sudden life-threatening allergic
stroke (this generally occurs in patients with risk factors for heart and
blood vessel disease (high blood pressure, diabetes, smoking, use of
nicotine substitution, family history of heart disease or stroke, man
over 40 years of age, post-menopausal women, particular problem
with the way your heart beats [bundle branch block])).
slow heartbeat (bradycardia).
Not known (frequency cannot be estimated from the available data):
heart attack, spasm of the blood vessels of the heart (these generally
occur in patients with risk factors for heart and blood vessel disease
(high blood pressure, diabetes, smoking, use of nicotine substitution,
family history of heart disease or stroke, man over 40 years of age,
postmenopausal women, particular problem with the way your heart
beats (bundle branch block)).
a syndrome called “serotonin syndrome” that may cause side effects
like coma, unstable blood pressure, extremely high body temperature,
lack of muscle coordination, agitation, and hallucinations.
severe shedding of the skin with or without fever (toxic epidermal
spasm of blood vessels of the extremities including coldness and
numbness of the hands or feet.
spasm of the blood vessels of the colon (large bowel), which can
cause abdominal pain.
Tell your doctor right away if you have symptoms of allergic
reactions, serotonin syndrome, heart attack or stroke.
In addition, tell your doctor if you experience any symptoms that suggest
an allergic reaction (such as a rash or itching) after taking Maxalt.
Reporting of side effects
If you get any side effects, tell your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme Website:
By reporting side effects you can help provide more information on the
safety of this medicine.
5) HOW TO STORE MAXALT
Keep Maxalt out of the sight and reach of children.
Do not use Maxalt after the expiry date which is stated on the
container after EXP. The expiry date refers to the last day of the
Do not store Maxalt above 30
If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Maxalt contains
The active substance of Maxalt is rizatriptan. Each tablet contains
7.265mg of rizatriptan benzoate, equivalent to 5mg rizatriptan.
The other ingredients of Maxalt tablets are lactose monohydrate,
microcrystalline cellulose, pregelatinised maize starch, red iron oxide
(E172) and magnesium stearate.
What Maxalt looks like and contents of pack
Maxalt 5mg tablets are pale pink, capsule-shaped tablets, coded ‘MSD’
on one side and ‘266’ on the other.
Maxalt is available in packs of 3 or 6 tablets.
Manufactured by Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN,
Haarlem, The Netherlands. Procured from within the EU by the Product
Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7
Tintagel Way, Aldridge, Walsall WS9 8ER, U.K.
Repackaged by XXXXXXXXXXXXXXX
MAXALT 5mg tablets
How can you obtain more information about Maxalt?
This leaflet gives you some of the most important information about
Maxalt. If you have any questions after you have read it, ask your doctor
or pharmacist who can give you further information.
Further information about migraine is available from the following
Migraine Action Association
Floor, 27 East Street
Tel: 0116 275 8317
Fax: 0116 254 2023
The Migraine Trust
52-53 Russell Square
Tel: 020 7631 6970
Fax: 020 7436 2886
(Migraine Action Association and The Migraine Trust are independent
organizations and are not associated with Merck Sharp & Dohme Limited
or MPT Pharma Limited.)
is a registered trademark of Merck & Co. Inc.
Leaflet dated 26
Leaflet coded xxxxxxx
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
5 mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg
of the rizatriptan).
Excipients with known effect: lactose monohydrate 30.25 mg in the 5 mg
For the full list of excipients, see section 6.1.
5 mg tablets are pale pink, capsule-shaped, coded MSD on one side and 266
on the other.
Acute treatment of the headache phase of migraine attacks with or without
aura in adults.
Posology and method of administration
Method of administration
MAXALT should not be used prophylactically.
The oral tablets should be swallowed whole with liquid.
Effect of Food: The absorption of rizatriptan is delayed by approximately 1
hour when administered together with food. Therefore, onset of effect may be
Pharmacokinetic properties, Absorption).
MAXALT is also available as an alternative oral lyophilisate.
Adults 18 years of age and older
The recommended dose is 10 mg.
Redosing: Doses should be separated by at least two hours; no more than two
doses should be taken in any 24-hour period.
for headache recurrence within 24 hours: If headache returns after relief
of the initial attack, one further dose may be taken. The above dosing
limits should be observed.
after non-response: The effectiveness of a second dose for treatment of
the same attack, when an initial dose is ineffective, has not been examined
in controlled trials. Therefore, if a patient does not respond to the first
dose, a second dose should not be taken for the same attack.
Clinical studies have shown that patients who do not respond to treatment of
an attack are still likely to respond to treatment for subsequent attacks.
particular the following patient groups:
patients on propranolol. Administration of rizatriptan should be separated
by at least two hours from administration of propranolol (see section 4.5).
patients with mild or moderate renal insufficiency.
patients with mild to moderate hepatic insufficiency.
Doses should be separated by at least two hours; no more than two doses
should be taken in any 24-hour period.
Children and Adolescents (under 18 years of age)
The safety and efficacy of MAXALT in children and adolescents under 18
years of age has not yet been established.
recommendation on a posology can be made.
The safety and effectiveness of rizatriptan in patients older than 65 years have
not been systematically evaluated.
Hypersensitivity to rizatriptan or to any of the excipients listed in section 6.1.
Concurrent administration of monoamine oxidase (MAO) inhibitors or use
within two weeks of discontinuation of MAO inhibitor therapy. (see section
MAXALT is contra-indicated in patients with severe hepatic or severe renal
MAXALT is contra-indicated in patients with a previous cerebrovascular
accident (CVA) or transient ischaemic attack (TIA).
Moderately severe or severe hypertension or untreated mild hypertension.
Established coronary artery disease, including ischaemic heart disease (angina
pectoris, history of myocardial infarction, or documented silent ischaemia),
signs and symptoms of ischaemic heart disease, or Prinzmetal’s angina.
Peripheral vascular disease.
Concomitant use of rizatriptan and ergotamine, ergot derivatives (including
methysergide), or other 5-HT
receptor agonists. (See section 4.5).
Special warnings and precautions for use
MAXALT should only be administered to patients in whom a clear diagnosis
of migraine has been established. MAXALT should not be administered to
patients with basilar or hemiplegic migraine.
MAXALT should not be used to treat ‘atypical’ headaches, i.e. those that
might be associated with potentially serious medical conditions, (e.g. CVA,
Rizatriptan can be associated with transient symptoms including chest pain
and tightness which may be intense and involve the throat (see section 4.8).
Where such symptoms are thought to indicate ischaemic heart disease, no
further dose should be taken and appropriate evaluation should be carried out.
As with other 5-HT
receptor agonists, rizatriptan should not be given,
without prior evaluation, to patients in whom unrecognised cardiac disease is
likely or to patients at risk for coronary artery disease (CAD) [e.g. patients
with hypertension, diabetics, smokers or users of nicotine substitution therapy,
men over 40 years of age, post-menopausal women, patients with bundle
branch block, and those with strong family history for CAD]. Cardiac
evaluations may not identify every patient who has cardiac disease and, in
very rare cases, serious cardiac events have occurred in patients without
administered. Those in whom CAD is established should not be given
MAXALT. (See section 4.3)
receptor agonists have been associated with coronary vasospasm. In
rare cases, myocardial ischaemia or infarction have been reported with 5-
receptor agonists including MAXALT (see section 4.8)
agonists, (e.g. sumatriptan) should not be used concomitantly
with MAXALT. (See section 4.5).
It is advised to wait at least six hours following use of rizatriptan before
ergotamine or methysergide). At least 24 hours should elapse after the
administration of an ergotamine-containing preparation before rizatriptan is
given. Although additive vasospastic effects were not observed in a clinical
pharmacology study in which 16 healthy males received oral rizatriptan and
parenteral ergotamine, such additive effects are theoretically possible, (see
Serotonin syndrome (including altered mental status, autonomic instability and
neuromuscular abnormalities) has been reported following concomitant
treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or
serotonin noradrenaline reuptake inhibitors (SNRIs). These reactions can be
severe. If concomitant treatment with rizatriptan and an SSRI or SNRI is
clinically warranted, appropriate observation of the patient is advised,
particularly during treatment initiation, with dose increases, or with addition of
another serotonergic medication (see section 4.5).
Undesirable effects may be more common during concomitant use of triptans
Angioedema (e.g. facial oedema, tongue swelling and pharyngeal oedema)
may occur in patients treated with triptans, among which rizatriptan. If
angioedema of the tongue or pharynx occurs, the patient should be placed
under medical supervision until symptoms have resolved. Treatment should
promptly be discontinued and replaced by an agent belonging to another class
The quantity of lactose monohydrate in each tablet is as follows: 30.25 mg in
the 5 mg tablet and 60.50 mg in the 10 mg tablet. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
administered to patients taking CYP 2D6 substrates (see section 4.5)
Medication overuse headache (MOH)
Prolonged use of any painkiller for headaches can make them worse. If this
situation is experienced or suspected, medical advice should be obtained and
treatment should be discontinued. The diagnosis of MOH should be suspected
in patients who have frequent or daily headaches despite (or because of) the
regular use of headache medications.
Interaction with other medicinal products and other forms of interaction
Ergotamine, ergot derivatives
(including methysergide), other 5 HT
receptor agonists: Due to an additive effect, the concomitant use of rizatriptan
and ergotamine, ergot derivatives (including methysergide), or other 5 HT
receptor agonists (e.g. sumatriptan, zolmitriptan, naratriptan) increase the
combination is contraindicated (see section 4.3).
Monoamine oxidase inhibitors: Rizatriptan is principally metabolised via
rizatriptan and its active N-monodesmethyl metabolite were increased by
Similar or greater effects are expected with non-selective, reversible (e.g.
linezolid) and irreversible MAO inhibitors. Due to a risk of coronary artery
vasoconstriction and hypertensive episodes, administration of MAXALT to
patients taking inhibitors of MAO is contraindicated (see section 4.3).
concomitant administration of propranolol. This increase is most probably due
to first-pass metabolic interaction between the two drugs, since MAO-A plays
a role in the metabolism of both rizatriptan and propranolol. This interaction
leads to a mean increase in AUC and C
of 70-80%. In patients receiving
propranolol, the 5 mg dose of MAXALT should be used (see section 4.2).
In a drug interaction study, nadolol and metoprolol did not alter plasma
concentrations of rizatriptan.
Selective Serotonin Reuptake Inhibitors (SSRIs) /Serotonin Norepinephrine
Reuptake Inhibitors (SNRIs) and Serotonin Syndrome: There have been reports
(including altered mental status, autonomic instability
abnormalities) following the use of selective serotonin reuptake inhibitors
(SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans
(see section 4.4).
In vitro studies indicate that rizatriptan inhibits cytochrome P450 2D6 (CYP
2D6). Clinical interaction data are not available. The potential for interaction
should be considered when rizatriptan is administered to patients taking CYP
Fertility, pregnancy and lactation
Effects on human fertility have not been investigated. Animal studies only
revealed minimal effects on fertility at plasma concentrations far in excess of
human therapeutic concentrations (more than 500-fold).
The safety of rizatriptan for use in human pregnancy has not been established.
Animal studies do not indicate harmful effects at dose levels that exceed
therapeutic dose levels with respect to the development of the embryo or
foetus, or the course of gestation, parturition and post-natal development.
predictive of human response, MAXALT should be used during pregnancy
only if clearly needed.
Studies in rats indicated very high milk transfer of rizatriptan occurred.
observed only when the mother’s systemic exposure was well in excess of the
maximum exposure levels for humans. No data exist in humans.
Therefore, caution should be exercised when administering rizatriptan to
women who are breast-feeding. Infant exposure should be minimised by
avoiding breast-feeding for 24 hours after treatment.
Effects on Ability to Drive and Use Machines
Migraine or treatment with ‘Maxalt’ may cause somnolence in some patients.
Dizziness has also been reported in some patients receiving ‘Maxalt’. Patients
should, therefore, evaluate their ability to perform complex tasks during
migraine attacks and after administration of ‘Maxalt’.
MAXALT (as the tablet and oral lyophilisate formulation) was evaluated in
8630 adult patients for up to one year in controlled clinical studies. The most
common side effects evaluated in clinical studies were dizziness, somnolence,
and asthenia/fatigue. The following side effects have been evaluated in clinical
studies and/or reported in post-marketing experience:
(Very common [
1/10]; Common [
1/100, <1/10]; Uncommon [
<1/100]; Rare [
1/10,000 <1/1,000]; Very rare [
1/10000], not known
[cannot be estimated from the available data]).
Immune system disorders:
Rare: hypersensitivity reaction, anaphylaxis/anaphylactoid reaction.
Uncommon: disorientation, nervousness.
Nervous system disorders:
decreased mental acuity.
Uncommon: ataxia, vertigo, dysgeusia/bad taste, tremor, syncope
Not known: seizure, serotonin syndrome.
Uncommon: blurred vision.
Uncommon: arrhythmia, ECG abnormalities, tachycardia
Rare: cerebrovascular accident (most of these adverse reactions have been
reported in patients with risk factors predictive of coronary artery disease),
coronary artery disease)
Uncommon: hypertension, hot flushes/flashes
Not known: peripheral vascular ischaemia.
Respiratory, thoracic and mediastinal disorders:
Common: pharyngeal discomfort
Common: nausea, dry mouth, vomiting, diarrhoea, dyspepsia
Not known: ischemic colitis.
Skin and subcutaneous tissue disorders:
swelling, pharyngeal oedema) (for angioedema see also section 4.4), rash,
Not known: toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders:
Common: regional heaviness, neck pain, stiffness
Uncommon: regional tightness, muscle weakness, facial pain, myalgia.
General disorders and administration site conditions:
Common: asthenia/fatigue, pain in abdomen or chest.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme, website
Rizatriptan 40 mg (administered as either a single dose or as two doses with a
two-hour interdose interval) was generally well tolerated in over 300 adult
rizatriptan, at total cumulative doses of 80 mg (given within four hours), two
subjects experienced syncope and/or bradycardia. One subject, a female aged
29 years, developed vomiting, bradycardia, and dizziness beginning three
hours after receiving a total of 80 mg rizatriptan (administered over two
hours). A third degree AV block, responsive to atropine, was observed an
hour after the onset of the other symptoms. The second subject, a 25 year old
venipuncture. The venipuncture occurred two hours after the subject had
received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other
more serious cardiovascular symptoms could occur after overdosage. Gastro-
intestinal decontamination, (e.g. gastric lavage followed by activated charcoal)
should be considered in patients suspected of an overdose with MAXALT.
Clinical and electrocardiographic monitoring should be continued for at least
12 hours, even if clinical symptoms are not observed.
The effects of haemo- or peritoneal dialysis on serum concentrations of
rizatriptan are unknown.
(5HT1) agonist, ATC-code: N02C C04.
Mechanism of action: Selective Serotonin (5-HT
Rizatriptan binds selectively with high affinity to human 5-HT
receptors and has little or no effect or pharmacological activity at 5-HT
or beta; D
, dopaminergic, histaminic H
muscarinic; or benzodiazepine receptors.
The therapeutic activity of rizatriptan in treating migraine headache may be
extracerebral intracranial blood vessels that are thought to become dilated
during an attack and on the trigeminal sensory nerves that innervate them.
Activation of these 5-HT
receptors may result in constriction of
release that leads to decreased inflammation in sensitive tissues and reduced
central trigeminal pain signal transmission.
The efficacy of MAXALT Tablets in the acute treatment of migraine attacks
was established in four multicentre, placebo-controlled trials that included
over 2,000 patients who received MAXALT 5 or 10 mg for up to one year.
response rates (i.e. reduction of moderate or severe headache pain to no or
mild pain) two hours after treatment were 67-77% with the 10-mg tablet,
60-63% with the 5-mg tablet, and 23-40% with placebo. Although patients
who did not respond to initial treatment with MAXALT were not redosed for
the same attack, they were still likely to respond to treatment for a subsequent
attack. MAXALT reduced the functional disability and relieved the nausea,
photophobia, and phonophobia associated with migraine attacks.
MAXALT remains effective in treating menstrual migraine, i.e. migraine that
occurs within 3 days before or after the onset of menses.
The European Medicines Agency has waived the obligation to submit the
results of studies with MAXALT tablets in all subsets of the paediatric
population in the treatment of migraine. See section 4.2 for information on
Adolescents (12-17 years of age)
The efficacy of MAXALT oral lyophilisates in paediatric patients (12 to
17 years of age) was evaluated in a multicenter, randomized, double-blind,
placebo-controlled, parallel group study (n=570). The patient population was
required to be historically non-responsive to NSAIDs and acetaminophen
therapy. Patients with a qualifying migraine headache initially administered
placebo or rizatriptan within 30 minutes of onset. Following the 15 minute
placebo run-in, subjects who did not respond to placebo then treated a single
migraine attack with placebo or rizatriptan. Using a weight-based dosing
strategy, patients 20 kg to <40 kg received 5mg rizatriptan and patients
received 10mg rizatriptan.
In this enriched population study, a difference of 9% between active treatment
and placebo was observed for the primary efficacy endpoint of pain freedom
(reduction from moderate or severe pain to no pain) 2 hours after treatment
difference for the secondary endpoint of pain relief (reduction from moderate
or severe pain to mild or no pain) was found.
Children (6-11 years of age)
The efficacy of MAXALT oral lyophilisates was also evaluated in paediatric
patients 6 to 11 years of age in the same acute placebo-controlled clinical trial
(n=200). The percentage of patients achieving pain freedom 2 hours after
treatment was not statistically significantly different in patients who received
MAXALT oral lyophilisates 5 and 10 mg, compared with those who received
placebo (39.8% vs. 30.4%, p=0.269).
Rizatriptan is rapidly and completely absorbed following oral administration.
The mean oral bioavailability of the tablet is approximately 40-45%, and mean
peak plasma concentrations (C
) are reached in approximately 1-1.5 hours
). Administration of an oral tablet dose with a high-fat breakfast had no
effect on the extent of rizatriptan absorption, but absorption was delayed for
approximately one hour.
Effect of Food: The effect of food on the absorption of rizatriptan from the oral
lyophilisate has not been studied. For the rizatriptan tablets, T
is delayed by
approximately 1 hour when the tablets are administered in the fed state. A
lyophilisate is administered after meals (see section 4.2).