| Title | A pharmacokinetic interaction study between butorphanol and sumatriptan nasal sprays in healthy subjects: importance of the timing of butorphanol administration. | | Author(s) | Vachharajani NN, Shyu WC, Nichola PS, Boulton DW | | Institution | Clinical Discovery, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ 08543-4000, USA. | | Source | Cephalalgia 2002 May; 22(4):282-7. | | MeSH | Administration, Intranasal
Adult
Aerosols
Analgesics, Opioid
Area Under Curve
Butorphanol
Cross-Over Studies
Drug Administration Schedule
Drug Interactions
Female
Humans
Male
Safety
Serotonin Agonists
Sumatriptan
Vasoconstrictor Agents
| | Abstract | Sumatriptan and butorphanol nasal sprays are commonly used agents for the management of migraine headaches. Under certain circumstances, these two agents may be administered closely in time. However, the possibility of a pharmacokinetic interaction and the safety of this regime have not been examined. In this crossover design study, 24 healthy subjects received the following four treatments, each separated by at least 7 days: 1 mg butorphanol (Stadol NS7); 20 mg sumatriptan (Imitrex Nasal Spray); or both formulations together with butorphanol administered either 1 or 30 min after sumatriptan. Serial plasma samples were collected for 24 h post-dose and analysed for butorphanol and/or sumatriptan by HPLC-MS/MS. Butorphanol plasma concentrations were reduced when it was administered 1 min (mean 28.6% decrease in AUC(0-infinity)), but not 30 min, after sumatriptan. The pharmacokinetics of sumatriptan were not substantially altered by butorphanol. The combination of nasally administered sumatriptan and butorphanol appeared safe. However, if butorphanol nasal spray is administered <30 min after sumatriptan nasal spray, the analgesic effect of butorphanol may be diminished due to reduced nasal absorption resulting from probable transient vasoconstriction of nasal blood vessels by sumatriptan. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 12100090 |
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