INDICATION
Nomi® (Zolmitriptan) is indicated for the acute treatment of migraine with or
without aura.
DOSAGE AND ADMINISTRATION
The recommended dose of Nomi® (Zolmitriptan) to treat a migraine attack
is 2.5 mg. If symptoms persist or return within 24 hours, a second dose has
been shown to be effective. If a second dose is required, it should not be
taken within 2 hours of the initial dose. If a patient does not achieve
satisfactory relief with 2.5mg doses, subsequent attacks can be treated with
5 mg doses of Nomi® (Zolmitriptan). In those patients who respond,
significant efficacy is apparent within 1 hour of dosing,
Nomi® (Zolmitriptan) is equally effective whenever the tablets are taken
during a migraine attack; although it is advisable that Nomi® (Zolmitriptan)
tablets are taken as early as possible after the onset of migraine headache.
In the event of recurrent attacks, it is recommended that the total intake of
Nomi® (Zolmitriptan) in a 24-hour period should not exceed 15 mg.
Nomi® (Zolmitriptan) is not indicated for prophylaxis of migraine.
Use in children: Safety and efficacy of Nomi® (Zolmitriptan) in paediatric
patients have not been established.
Use in patients aged over 65 years: Safety and efficacy of Nomi®
(Zolmitriptan) in individuals aged over 65 years have not been systematically
evaluated.
Patients with hepatic impairment: There is no clinical or pharmacokinetics
experience in patients with hepatic impairment treated with Nomi®
(Zolmitriptan).
Patients with renal impairment: No dosage adjustment required.
CONTRAINDICATION
Zolmitriptan is contraindicated in patients with known hypersensitivity to
any component of the product.
Zolmitriptan must not be given to patients with uncontrolled hypertension.
DRUG INTERACTION
There is no evidence that concomitant use of migraine prophylactic
medications has any effect on the efficacy or unwanted effects of
Zolmitriptan (for example beta blockers, oral dihydroergotamine, pizotifen).
The pharmacokinetics and tolerability of Zolmitriptan were unaffected by
acute symptomatic treatments such as paracetamol, metoclopramide and
ergotamine. However, it is recommended that patients should leave at least
6 hours between taking an ergotamine preparation and starting
Zolmitriptan, and vice versa. Concomitant administration of other 5HT1D
agonists within 12 hours of Zolmitriptan treatment should be avoided.
Following administration of moclobemide, a specific MAO-A inhibitor, there
was a small increase (26%) in AUC for zolmitriptan and a 3-fold increase in
AUC of the active metabolite. Therefore, a maximum intake of 7.5 mg
Zolmitriptan in 24 hours is recommended in patients taking an MAO-A
inhibitor.
SIDE EFFECT
Zolmitriptan is well tolerated. Adverse reactions are typically mild/moderate,
transient, not serious and resolve spontaneously without additional
treatment. Possible adverse reactions tend to occur within 4 hours of dosing
and are no more frequent following repeated dosing.
The following adverse reactions have been the most commonly reported:
nausea; dizziness; somnolence; warm sensation; asthenia; dry mouth.
Abnormalities or disturbances of sensation have been reported; heaviness,
tightness or pressure may occur in the throat, neck, limbs and chest (with
no evidence of ischaemic changes on ECG), as may myalgia, muscle
weakness, paraesthesia and dysaesthesia.
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