Zomig Rapimelt

/ Astra Zeneca

The recommended dose of ‘Zomig Rapimelt’ to treat a migraine attack is 2.5 mg. ‘Zomig Rapimelt’ rapidly dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking ‘Zomig Rapimelt’. ‘Zomig Rapimelt’ can be taken when water is not available thus allowing early administration of treatment for a migraine attack. This formulation may also be beneficial for patients who suffer from nausea and are unable to drink during a migraine attack, or for patients who do not like swallowing conventional tablets. If symptoms persist or return within 24 hours, a second dose of zolmitriptan 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 Rapimelt’. In those patients who respond, significant efficacy is apparent within 1 hour of dosing with zolmitriptan. Zolmitriptan is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that ‘Zomig Rapimelt’ is 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 Rapimelt’ in a 24 hour period should not exceed 10 mg. ‘Zomig Rapimelt’ is not indicated for prophylaxis of migraine.
Use in Children (under 12 year of age): Safety and efficacy of ‘Zomig Rapimelt’ in paediatric patients have not been evaluated. Use of Zomig Rapimelt tablets in childrens 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 Rapimelt tablets in adolescents is therefore not recommended.
Use in Patients Aged Over 65 years: Safety and efficacy of ‘Zomig Rapimelt’ in individuals aged over 65 years have not been established.
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.
For full details see prescribing information.

Acute migraine with/without aura.

‘Zomig Rapimelt’ is contraindicated in patients with:
– Known hypersensitivity to any component of the product.
– Uncontrolled hypertension.
– Ischaemic heart disease.
– Coronary vasospasm/Prinzmetal’s angina.
– A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
– Concomitant administration of Zomig with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.

‘‘Zomig Rapimelt’ should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of ‘Zomig Rapimelt’ in hemiplegic or basilar migraine. Migraneurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. ‘Zomig Rapimelt’ should not be given to patients with symptomatic WolffParkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways. In very rare cases, as with other 5HT1B/1D agonists, coronary vasospasm, angina pectoris, and myocardial infarction have been reported. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compounds, including ‘Zomig Rapimelt’, is recommended. These evaluations, however, may not identify every patient who has cardiac disease, and in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease. As with other 5HT1B/1D agonists, atypical sensations over the precordium have been reported after the administration of zolmitriptan. If chest pain or symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be taken until after appropriate medical evaluation had been carried out. As with other 5HT1B/1D agonists, transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events. As with other 5HT1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving Zomig Patients with phenylketonuria should be informed that ‘Zomig Rapimelt’ contains phenylalanine (a component of aspartame). Each 2.5 mg orally dispersible tablet contains 2.81 mg of phenylalanine. Excessive use of an acute anti-migraine medicinal product may lead to an increased frequency of headache, potentially requiring withdrawal of treatment. Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability, (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI is clinically warranted, particularly during treatment initiation and dosage increases.

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.

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 ‘Zomig’, when administered as the conventional tablet, were unaffected by acute symptomatic treatments such as paracetamol, metoclopramide and ergotamine. Concomitant administration of other 5HT1B/1D agonists within 24 hours of ‘Zomig Rapimelt’ treatment should be avoided. Data from healthy subjects suggest there are no pharmacokinetic or clinically significant interactions between Zomig and ergotamine, however, the increased risk of coronary vasospasm is a theoretical possibility. Therefore, it is advised to wait at least 24 hours following the use of ergotamine containing preparations before administering Zomig . . Conversely it is advised to wait at least six hours following use of Zomig before administering any ergotamine-containing preparation. 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 5 mg ‘Zomig Rapimelt’ in 24 hours is recommended in patients taking an MAO-A inhibitor. Following the administration of cimetidine, a general P450 inhibitor, the half life of zolmitriptan was increased by 44% and the AUC increased by 48%. In addition the half life and AUC of the active N-desmethylated metabolite (183C91) were doubled. A maximum dose of 5 mg ‘Zomig Rapimelt’ in 24 hours is recommended in patients taking cimetidine. Based on the overall interaction profile, an interaction with inhibitors of the cytochrome P450 isoenzyme CYP1A2 cannot be excluded. Therefore, the same dosage reduction is recommended with compounds of this type, such as fluvoxamine and the quinolone antibiotics (eg ciprofloxacin). Fluoxetine does not affect the pharmacokinetic parameters of zolmitriptan. Therapeutic doses of the specific serotonin reuptake inhibitors, fluoxetine, sertraline, paroxetine and citalopram do not inhibit CYP1A2. However, Serotonin Syndrome has been reported during combined use of triptans, and SSRIs (e.g. fluxetine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine, duloxetine).4 As with other 5HT1B/1D agonists, there is the potential for dynamic interactions with the herbal remedy St John’s wort (Hypericum perforatum) which may result in an increase in undesirable effects.
For full details see prescribing information.

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 is 2.5 to 3 hours, and therefore monitoring of patients after overdose with ‘Zomig Rapimelt’ 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.