Zomig

/ Astra Zeneca

The recommended dose of ‘Zomig’ 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 2.5 mg doses, subsequent
attacks can be treated with 5 mg doses of ‘Zomig’.
In those patients who respond, significant efficacy is apparent within 1 hour of
dosing.
‘Zomig’ is equally effective whenever the tablets are taken during a migraine
attack; although it is advisable that ‘Zomig’ 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
‘Zomig’ in a 24 hour period should not exceed 10 mg.
‘Zomig’ is not indicated for prophylaxis of migraine.
Use in Children (under 12 years of age): Safety and efficacy of ‘Zomig’ in paediatric patients have not been evaluated. Use of Zomig in children is therefore not recommended.
Adolescents (12-17 years of age): The efficacy of Zomig tablets was not demonstrated in placebo controlled clinical trial for patients ages 12 to 17 years. Use of Zomig tablets in adolescents is therefore not recommended.
Use in Patients Aged Over 65 years: Safety and efficacy of ‘Zomig’ in individuals aged over 65 years have not been systematically evaluated.
Patients with Hepatic Impairment: Metabolism is reduced in patients with hepatic impairment. Therefore for patients with moderate or severe
hepatic impairment a maximum dose of 5 mg in 24 hours is recommended.
Patients with Renal Impairment: No dosage adjustment required.

Acute migraine with/without aura.

– Known hypersensitivity to any component of the product (angioedema and
anaphylaxis seen)
– Uncontrolled hypertension
– Ischaemic heart disease, Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina.
– Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
– Peripheral vascular disease (PVD)
– A history of cerebrovascular accident (CVA), History of stroke or transient ischaemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke.
– Concomitant administration of Zomig with ergotamine or ergotamine
derivatives or other 5-HT1 receptor agonists.
– Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or
recent use of a MAO-A inhinitor (that is within 2 weeks)
– Ischemic bowel disease

See prescribing information for full details.

Nervous system disorder: Common: Abnormalities or disturbances of sensation, Dizziness, Headache, Hyperaesthesia, Paraesthesia, Somnolence, Warm sensation.
Cardiac disorders: Common: Palpitations.
Gastrointestinal disorders: Common: Abdominal pain, Dry mouth, Nausea, Vomiting.
Musculoskeletal and connective tissue disorders: Common: Muscle weakness, Myalgia.
General disorders: Common: Asthenia, Heaviness, tightness, pain or pressure in throat, neck, limbs or chest.
For full details see prescribing information.

See prescribing information for full details.

Pregnancy: ‘Zomig’ should be used in pregnancy only if the benefits to the mother justify potential risk to the foetus. There are no studies in pregnant women, but there is no evidence of teratogenicity in animal studies.
Lactation: Studies have shown that zolmitriptan passes into the milk of lactating animals. No data exist for passage of zolmitriptan into human breast milk. Therefore, caution should be exercised when administering ‘Zomig’ to women who are breast-feeding.

Volunteers receiving single oral doses of 50 mg commonly experienced
sedation.
The elimination half-life of zolmitriptan tablets is 2.5 to 3 hours, and therefore monitoring of patients after overdose with ‘Zomig’ tablets should continue for at least 15 hours or while symptoms or signs persist.
There is no specific antidote to zolmitriptan. In cases of severe intoxication,
intensive care procedures are recommended, including establishing and
maintaining a patent airway, ensuring adequate oxygenation and ventilation,
and monitoring and support of the cardiovascular system.
It is unknown what effect haemodialysis or peritoneal dialysis has on the
serum concentrations of zolmitriptan.