What is the maximum dose of RELPAX® that may be taken to treat a migraine?
First migraine attack treated with RELPAX.
The recommended initial dose is 40 mg, taken as early as possible after the onset of a migraine headache.
If the initial dose is ineffective, controlled clinical trials have not shown a benefit of a second dose to treat the same attack.
However, if the headache returns following initial improvement, there is evidence to suggest that a repeat 40 mg dose may be beneficial. If a second dose is required, it should not be taken within 2 hours of the initial dose.
Subsequent migraine attacks.
If the 40 mg dose is tolerated but ineffective, a maximum single dose of 80 mg may be taken to treat a subsequent migraine. A second dose of 80 mg may be taken 2 hours after the first dose if required.
The maximum single dose of RELPAX is 80 mg. The maximum daily dose should not exceed 160 mg.
Should the dose of RELPAX® be modified in patients with renal impairment?
A two-fold increase in maximum plasma concentration and elevations in blood pressure have been observed in patients with renal impairment who received RELPAX.
A dose of greater than 40 mg should be administered with caution in patients with renal impairment.
Should the dose of RELPAX® be modified in patients with hepatic impairment?
No dose adjustment is required in patients with mild or moderate hepatic impairment.
RELPAX has not been studied in patients with severe hepatic impairment and is therefore contraindicated in these patients.
How frequently can a patient take RELPAX®?
In controlled clinical trials of adult patients (18-65 years of age), single doses of 20 mg, 40 mg and 80 mg were effective for the acute treatment of migraine. A greater proportion of patients had a response following a 40 mg or 80 mg dose than following a 20 mg dose. The recommended initial dose is 40 mg. The maximum single dose is 80 mg.
If the initial dose is ineffective, controlled clinical trials have not shown a benefit of a second dose to treat the same attack. However, if the headache returns following initial improvement, there is evidence to suggest that a repeat dose may be beneficial. If a second dose is required, it should not be taken within 2 hours of the initial dose.
The maximum daily dose should not exceed 160 mg. No information is available on the maximum weekly or monthly usage of Relpax.
Excessive use of any anti-migraine medicinal product can lead to daily chronic headaches.
Many experts limit acute therapy to two headache days per week on a regular basis. The German Migraine and Headache Society (DMKG) guideline recommends that triptans are not to be used more than ten days per month, and/or more than on 3 consecutive days. Various other guidelines on the management of migraine have been published.
2. Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000;55(6):754-62.
3. DMKG Therapy recommendations available at http://www.dmkg.de.
4. Olesen J, Bousser MG, Diener HC, et al on behalf of the International Headache Society. The International Classification of Headache Disorders, 3rd Edition (beta version) of criteria for 8.2 Medication-overuse headache. Cephalalgia. 2013;33(9):733-5.
5. British Association for the Study of Headache (BASH) Management Guidelines 2010. Available at http://www.bash.org.uk/.
6. Agence Nationale d’Accréditation et d’Evaluation en Santé (ANAES) Chronic Daily Headache Guidelines 2004. Available at http://www.has-sante.fr/portail/upload/docs/application/pdf/CCQ_guidelines.pdf.
Has the use of RELPAX® been associated with rebound headache?
Overuse of all triptans has been reported primarily in patients with chronic daily headache.1
The diagnostic criteria for triptan-overuse headache according to the International Headache Society (IHS), which can accessed at www.ihs-headache.org are as follows:
- Headache present on ≥15 days/month, which developed or markedly worsened during medication overuse and which resolves or reverts to its previous pattern within 2 months after discontinuation of overused medication.2
- Triptan intake (any formulation) on ≥10 days/month on a regular basis for > 3 months.2
- Relpax®(eletriptan hydrobromide) Product Information
- Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013; 33(9) 629–808. www.ihs-headache.org/ichd-guidelines.
Is RELPAX® effective in the management of menstrual migraine?
RELPAX is indicated for the acute treatment of migraine headache with or without aura.
RELPAX has been shown to be effective in treating migraines that occur between one day before and four days after the onset of menses.
Can RELPAX® be used in the management of migraine in patients with cardiovascular disorders?
Treatment with any triptan has a potential risk for coronary vasoconstriction.
Cardiovascular evaluation prior to commencement of treatment with RELPAX is recommended for patients in whom cardiovascular disease is likely, or in patients at risk of cardiovascular disease.
RELPAX is contraindicated in patients with:
- uncontrolled hypertension
- confirmed coronary heart disease
- ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia)
- coronary artery vasospasm, objective or subjective symptoms of ischaemic heart disease or Prinzmetal’s angina
- peripheral vascular disease
- history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA)
RELPAX is not recommended in patients with:
- heart failure
Can RELPAX® be used in combination with antidepressants?
Co-administration of serotonin (5-HT) agonists, including RELPAX, with drugs having serotonergic activity, such as serotonin noradrenaline reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), may increase the risk of serotonin syndrome.
If concomitant treatment with RELPAX and a serotonergic active drug is clinically warranted, caution is advised. Careful observation of the patient is warranted particularly during treatment initiation or dose increase of either agent.
Concomitant use of the herbal remedy St John’s Wort (Hypericum perforatum) in patients receiving triptans should be avoided since there is a possibility of serotonergic potentiation.
Tips and Tricks
Contact Pfizer Medical Information
Monday to Friday 9am – 5pm EST