MAXALT® (rizatriptan)
PRESENTATION ‘Maxalt’Tablets: 5 mg and 10 mg tablets each containing either 5 mg or 10 mg of rizatriptan (as benzoate). ‘Maxalt’ Melt oral lyophilisates (wafers): 10 mg oral lyophilisates containing 10 mg of rizatriptan (as benzoate). USES Acute treatment of the headache phase of migraine attacks, with or without aura. DOSAGE AND ADMINISTRATION Do not use prophylactically. Adults 18 years of age and older: 10 mg. Redosing: Separate doses by at least two hours, with no more than two doses to be taken in any 24 hour period. For headache recurrence within 24 hours: one further dose may be taken, observing the above dosing limits. After non-response: Patients not responding to the first dose should not take a second dose for the same attack. Patients not responding to treatment of an attack are still likely to respond to treatment for subsequent attacks. 5 mg of ‘Maxalt’, is recommended for patients on propranolol, with administration separated by at least two hours and for patients with mild or moderate renal insufficiency or with mild to moderate hepatic insufficiency. Children under 18 years: Not recommended. Elderly (over 65 years): Safety and effectiveness have not been evaluated. CONTRA-INDICATIONS Hypersensitivity. Concurrent administration of non-selective reversible (e.g. linezolid) and irreversible MAOIs or use within two weeks of their discontinuation. Severe hepatic or renal insufficiency. 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 with ergotamine, ergot derivatives (including methysergide), or other 5-HT1B/1D receptor agonists. PRECAUTIONS Only use ‘Maxalt’ when there is a clear diagnosis of migraine. Do not use for basilar or hemiplegic migraine, or to treat ‘atypical’ headaches, i.e. those that might be associated with potentially serious medical conditions, (e.g. CVA, ruptured aneurysm). Do not give ‘Maxalt’ without prior evaluation to patients where unrecognised cardiac disease is likely, or patients at risk for coronary artery disease (CAD), [e.g. patients with hypertension, diabetics, smokers, men over 40 years of age, post-menopausal women, patients with bundle branch block, and those with a strong family history for CAD]. Do not use ‘Maxalt’ in those in whom CAD is established. Patients experiencing hypersensitivity, e.g. angioedema, should be placed under medical supervision until symptoms have resolved. Triptan therapy should be promptly discontinued and replaced by an agent belonging to another class of drugs. Chronic daily headache (exacerbation of headache has been reported with overuse). Wait at least six hours following use of rizatriptan before administering ergotamine-type medications, (e.g. ergotamine, dihydro-ergotamine or methysergide). Wait at least 24 hours after administration of an ergotamine-containing preparation before giving rizatriptan. Additive effects are theoretically possible. Phenylketonurics: ‘Maxalt’ Melt oral lyophilisates contain phenylalanine (2.10 mg phenylalanine/10 mg wafer). Interactions: Beta-blockers: plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol, therefore use the 5 mg dose of ‘Maxalt’. CYP 2D6 substrates: the potential for interaction should be considered in patients taking CYP 2D6 substrates. SSRIs: a theoretical possibility of serotonin syndrome occurring with concomitant SSRI use exists. Herbal: Undesirable effects may be more common with concomitant use of triptans (5-HT1B/1D receptor agonists) and herbal preparations containing St. John’s wort (Hypericum perforatum). Food: for ‘Maxalt’ tablets, Tmax is delayed by approximately one hour when given with food. Onset of effect may be delayed if ‘Maxalt’ is administered after meals. Use during pregnancy: use only if clearly needed. Use during lactation: exercise caution in use of ‘Maxalt’ in breast-feeding women. Avoid breast-feeding for 24 hours after taking ‘Maxalt’. SIDE EFFECTS Refer to SPC for complete information on side effects In studies of up to one year, the most common side effects were dizziness, somnolence, and asthenia/fatigue. Additional side effects evaluated in clinical studies and reported in post-marketing experience include: Common: [>1/100, <1/10] Pain in abdomen or chest, palpitation, tachycardia; nausea, vomiting, dry mouth, diarrhoea, regional heaviness, headache, paraesthesia, decreased mental acuity, tremor, hypaesthesia, hot flushes/flashes, pharyngeal discomfort, dyspnoea; flushing, sweating. Uncommon: [>1/1000, <1/100] Dyspepsia, thirst; neck pain, stiffness, regional tightness, muscle weakness, insomnia, ataxia, nervousness, vertigo, disorientation, pruritus, urticaria, blurred vision, hypertension. Rare: [>1/10,000, <1/1,000] Reports of myocardial ischaemia or infarction and CVA, mostly in patients with risk factors for CAD. Angioedema (e.g. facial oedema, tongue swelling, pharyngeal oedema), wheezing, rash, toxic epidermal necrolysis, facial pain and dysgeusia have also been reported. Package Quantities:
Product Licence numbers:
Product Licence holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
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