D. H. E. 45
D.H.E. 45
(dihydroergotamine mesylate) Injection, USP
| WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section) |
DRUG DESCRIPTION
D.H.E. 45® is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45® is known chemically as ergotaman-3',6',18-trione,9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl) (5'a)-, monomethanesulfonate. Its molecular weight is 679. 80 and its empirical formula is C13H37N5O5 · CH4O3S. Its chemical structure is:
D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is a clear, colorless solution supplied in sterile ampuls for I.V., I.M. , or subcutaneous administration containing per mL:
- dihydroergotamine mesylate, USP .................................. 1 mg
- methanesulfonic acid/sodium hydroxide, qs to ..................pH 3.6 ± 0. 4
- alcohol USP ...................................................................6.1 % by vol.
- glycerin, UP ...................................................................15% by wt.
- water for injection, USP , qs to ...................................... 1 ml .
Generic Name: Dihydroergotamine
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D. H. E. 45
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