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Drug Details

MAXALT

• Drug Class Description
  5HT1 -agonists.
• Generic Name
  Rizatriptan
• Presentation
  Tablets 5 mg tablets are pale pink, capsule-shaped, coded MSD on one side and 266 on the other. 10 mg tablets are pale pink, capsule-shaped, coded MAXALT on one side and MSD 267 on the other. Oral lyophilisates 10 mg oral lyophilisates are white to off-white, round with a modified square on one side, with a peppermint flavour.
• Description
  Maxalt 5mg Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of the rizatriptan). Excipients: lactose 30.25 mg in the 5 mg tablet. Maxalt 10mg Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan). Excipients: lactose 60.5 mg in the 10 mg tablet. Maxalt Melt 10mg Each oral lyophilisate contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan). Excipients: aspartame 3.75 mg in the 10 mg oral lyophylisate.
• Indications
  

  Acute treatment of the headache phase of migraine attacks, with or without aura.

• Adult Dosage
  

  General

  'Maxalt' should not be used prophylactically.

  The oral tablets should be swallowed whole with liquid.

  Effects of food: The absorption of rizatriptan is delayed by approximately 1 hour when administered together with food. Therefore, onset of effect may be delayed when rizatriptan is administered in the fed state.

  'Maxalt' Melt oral lyophilisates need not be taken with liquid.

  The oral lyophilisate is packaged in a blister within an outer aluminium sachet. Patients should be instructed not to remove the blister from the outer sachet until just prior to dosing. The blister pack should then be peeled open with dry hands and the oral lyophilisate placed on the tongue, where it will dissolve and be swallowed with the saliva.

  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.

  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.

  Some patients should receive the lower (5 mg) dose of 'Maxalt', in particular the following patient groups:

  − patients on propranolol. Administration of rizatriptan should be separated by at least two hours from administration of propranolol. 

  − 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.

  Paediatric patients

  Children (under 12 years of age)

  The use of 'Maxalt' in patients under 12 years of age is not recommended. There are no data available on the use of rizatriptan in children under 12 years of age.

  Tablets: adolescents (12-17 years of age)

  The use of 'Maxalt' Tablets in patients under 18 years of age is not recommended. In a placebo controlled study, the efficacy of 'Maxalt' Tablets (5 mg) was not superior to placebo. The efficacy of 'Maxalt' in patients under 18 years of age has not been established.

  Oral lyophilisates: adolescents (12-17 years of age)

  The use of 'Maxalt' Melt oral lyophilisates in patients under 18 years of age is not recommended. Safety and effectiveness of 'Maxalt' Melt oral lyophilisates in paediatric patients have not been evaluated.

• Child Dosage
  Under 18 years, not recommended.
• Elderly Dosage
  

  Patients older than 65 years

  The safety and effectiveness of rizatriptan in patients older than 65 years have not been systematically evaluated.

• Contra Indications
  

  Hypersensitivity to rizatriptan or to any of the excipients.

  Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation of MAO inhibitor therapy. (See section 4.5)

  'Maxalt' is contra-indicated in patients with severe hepatic or severe renal insufficiency.

  '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_1B/1D receptor agonists. (See section 4.5).

• Special Precautions
  

  '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, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful.

  Rizatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat. 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_1B/1D 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 underlying cardiovascular disease when 5-HT₁ agonists have been administered. Those in whom CAD is established should not be given 'Maxalt'.

  5-HT_1B/1D receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischaemia or infarction have been reported with 5-HT_1B/1D receptor agonists including 'Maxalt'

  Other 5-HT_1B/1D agonists, (e.g. sumatriptan) should not be used concomitantly with 'Maxalt'.

  It is advised to wait at least six hours following use of rizatriptan before administering ergotamine-type medications, (e.g. ergotamine, dihydro-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.

  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.

  Undesirable effects may be more common during concomitant use of triptans (5-HT_1B/1D agonists) and herbal preparations containing St John's wort (Hypericum perforatum).

  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 of drugs.

  The quantity of lactose 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.

  Phenylketonurics: Phenylketonuric patients should be informed that phenylalanine may be harmful. 'Maxalt' Melt oral lyophilisates contain aspartame (which contains phenylalanine). Each 10 mg oral lyophilisate contains 3.75 mg aspartame.

  The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates

  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.

• Interactions
  

  Ergotamine, ergot derivatives (including methysergide), other 5 HT _1B/1D receptor agonists: Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide), or other 5 HT _1B/1D receptor agonists (e.g. sumatriptan, zolmitriptan, naratriptan) increase the risk of coronary artery vasoconstriction and hypertensive effects. This combination is contraindicated.

  Monoamine oxidase inhibitors: Rizatriptan is principally metabolised via monoamine oxidase, 'A' subtype (MAO-A). Plasma concentrations of rizatriptan and its active N-monodesmethyl metabolite were increased by concomitant administration of a selective, reversible MAO-A inhibitor. 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. 

  Beta-blockers: Plasma concentrations of rizatriptan may be increased by 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_max of 70-80%. In patients receiving propranolol, the 5 mg dose of 'Maxalt' should be used.

  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 describing patients with symptoms compatible with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans.

  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 2D6 substrates.

• Adverse Drug Reactions
  

  'Maxalt' (as the tablet and oral lyophilisate formulation) was evaluated in over 3,600 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: [ 1/1000, <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:

  Not known: hypersensitivity reaction, anaphylaxis/anaphylactoid reaction.

  Psychiatric disorders:

  Uncommon: disorientation, insomnia, nervousness.

  Nervous system disorders:

  Common: dizziness, somnolence, paresthesia, headache, hypaesthesia, decreased mental acuity, tremor.

  Uncommon: ataxia, vertigo.

  Rare: syncope, dysgeusia/bad taste, serotonin syndrome.

  Not known: seizure.

  Eye disorders:

  Uncommon: blurred vision.

  Cardiac disorders:

  Common: palpitation, tachycardia.

  Rare: Myocardial ischaemia or infarction, cerebrovascular accident. Most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease.

  Vascular disorders:

  Common: hot flushes/flashes.

  Uncommon: hypertension.

  Not known: peripheral vascular ischaemia.

  Respiratory, thoracic and mediastinal disorders:

  Common: pharyngeal discomfort, dyspnoea.

  Rare: wheezing.

  Gastro-intestinal disorders:

  Common: nausea, dry mouth, vomiting, diarrhoea.

  Uncommon: thirst, dyspepsia.

  Skin and subcutaneous tissue disorders:

  Common: flushing, sweating.

  Uncommon: pruritus, urticaria.

  Rare: angioedema (e.g. facial oedema, tongue swelling, pharyngeal oedema), rash, toxic epidermal necrolysis.

  Musculoskeletal and connective tissue disorders:

  Common: regional heaviness.

  Uncommon: neck pain, regional tightness, stiffness, muscle weakness.

  Rare: facial pain.

  General disorders and administration site conditions:

  Common: asthenia/fatigue, pain in abdomen or chest.