Relpax (Eletriptan Hydrobromide) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Ergot-Containing Drugs Including Other 5-HT_B/1D Agonists

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine [DHE] or methysergide) and RELPAX within 24 hours of each other is contraindicated. Concomitant use of other 5-HT₁ agonists within 24 hours of RELPAX treatment is contraindicated [see Contraindications (4) ].

CYP3A4 Inhibitors

Potent CYP3A4 inhibitors significantly increase the exposure of RELPAX. Relpax should not be used within at least 72 hours of treatment with potent CYP3A4 inhibitors [see Contraindications and Clinical Pharmacology].

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs and MAO inhibitors [see Warnings and Precautions].

OVERDOSAGE

The elimination half-life of eletriptan is about 4 hours [see Clinical Pharmacology], therefore monitoring of patients after overdose with eletriptan should continue for at least 20 hours or longer while symptoms or signs persist.

There is no specific antidote to eletriptan.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan.

CONTRAINDICATIONS

RELPAX is contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions].
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions].
• History of stroke, transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions].
• Peripheral vascular disease [see Warnings and Precautions].
• Ischemic bowel disease [see Warnings and Precautions].
• Uncontrolled hypertension [see Warnings and Precautions].
• Recent use (i.e., within 24 hours) of another 5-hydroxytryptamine₁ (5-HT₁) agonist, ergotamine-containing medication, or ergot-type medication such as dihydroergotamine (DHE) or methysergide [see Drug Interactions].
• Hypersensitivity to RELPAX (angioedema and anaphylaxis seen) [see Warnings and Precautions].
• Recent use (i.e., within at least 72 hours) of the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir [see Drug Interactions and Clinical Pharmacology].