Chemical formula: C₁₅H₁₉N₅ Molecular mass: 269.345 g/mol PubChem compound: 5078
Rizatriptan interacts in the following cases:
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.
Patients with mild or moderate renal insufficiency should receive the lower (5 mg) dose.
Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.
Patients with mild to moderate hepatic insufficiency should receive the lower (5 mg) dose.
Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period.
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 Cmax of 70-80%. In patients receiving propranolol, the lower dose (5 mg) should be used.
In a drug interaction study, nadolol and metoprolol did not alter plasma concentrations of rizatriptan.
The safety of rizatriptan for use in human pregnancy has not been established. Animal studies do not indicate harmful effects at dose levels that exceed therapeutic dose levels with respect to the development of the embryo or foetus, or the course of gestation, parturition and post-natal development.
Because animal reproductive and developmental studies are not always predictive of human response, rizatriptan should be used during pregnancy only if clearly needed.
Studies in rats indicated very high milk transfer of rizatriptan occurred. Transient, very slight decreases in pre-weaning pup body weights were observed only when the mother’s systemic exposure was well in excess of the maximum exposure level for humans. No data exist in humans.
Therefore, caution should be exercised when administering rizatriptan to women who are breast-feeding. Infant exposure should be minimised by avoiding breast-feeding for 24 hours after treatment.
Effects on human fertility have not been investigated. Animal studies only revealed minimal effects on fertility at plasma concentrations far in excess of human therapeutic concentrations (more than 500-fold).
Migraine or treatment with rizatriptan may cause somnolence in some patients. Dizziness has also been reported in some patients receiving rizatriptan. Patients should, therefore, evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan.
Rizatriptan (as the tablet and oral lyophilisate formulation) was evaluated in 8630 adult 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]).
Rare: hypersensitivity reaction, anaphylaxis/anaphylactoid reaction.
Common: insomnia
Uncommon: disorientation, nervousness.
Common: dizziness, somnolence, paraesthesia, headache, hypoaesthesia, decreased mental acuity.
Uncommon: ataxia, vertigo, dysgeusia/bad taste, tremor, syncope.
Not known: seizure, serotonin syndrome.
Uncommon: blurred vision.
Common: palpitation.
Uncommon: arrhythmia, ECG abnormalities, tachycardia
Rare: cerebrovascular accident (most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease), bradycardia
Not known: myocardial ischaemia or infarction (most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease).
Uncommon: hypertension, hot flushes/flashes.
Not known: peripheral vascular ischaemia.
Common: pharyngeal discomfort.
Uncommon: dyspnoea.
Rare: wheezing.
Common: nausea, dry mouth, vomiting, diarrhoea, dyspepsia.
Uncommon: thirst.
Not known: ischemic colitis.
Common: flushing.
Uncommon: pruritus, urticaria, angioedema (e.g. facial oedema, tongue swelling, pharyngeal oedema), rash, sweating.
Not known: toxic epidermal necrolysis.
Common: regional heaviness, neck pain, stiffness.
Uncommon: regional tightness, muscle weakness, facial pain, myalgia.
Common: asthenia/fatigue, pain in abdomen or chest.
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