MIGRANAL- dihydroergotamine mesylate spray

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

dihydroergotamine mesylate (UNII: 81AXN7R2QT) (dihydroergotamine - UNII:436O5HM03C)

Verfügbar ab:

Bausch Health US, LLC

INN (Internationale Bezeichnung):

dihydroergotamine mesylate

Zusammensetzung:

dihydroergotamine mesylate 4 mg in 1 mL

Verabreichungsweg:

NASAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine. There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated (see WARNINGS, CYP 3A4 Inhibitors ). MIGRANAL (dihydroergotamine mesylate) Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to p

Produktbesonderheiten:

MIGRANAL (dihydroergotamine mesylate) Nasal Spray is available (as a clear, colorless to light yellow aqueous solution) in 3.5 mL amber glass vials containing 4 mg of dihydroergotamine mesylate. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided as a package of 8 units, administration instruction sheet, and one package insert. Each unit consists of one vial and one sprayer (NDC 0187-0245-03). Store below 25°C (77°F). Do not refrigerate or freeze. * Trademark of PDR Network, LLC Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Mipharm, S.p.A. Milano, Italy www.migranal.com MIGRANAL is a trademark of Bausch Health Companies Inc. or its affiliates. All other product/brand names and/or logos are trademarks of the respective owners. © 2022 Bausch Health Companies Inc. or its affiliates Rev. 09/2022 9603503

Berechtigungsstatus:

New Drug Application

Fachinformation

MIGRANAL- DIHYDROERGOTAMINE MESYLATE SPRAY
BAUSCH HEALTH US, LLC
----------
MIGRANAL
_(DIHYDROERGOTAMINE MESYLATE)_
NASAL SPRAY
THE SOLUTION USED IN MIGRANAL (DIHYDROERGOTAMINE MESYLATE) NASAL SPRAY
(4
MG/ML) IS INTENDED FOR INTRANASAL USE AND MUST NOT BE INJECTED.
Rx Only
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION
WITH POTENT CYP3A4 INHIBITORS
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 _CONTRAINDICATIONS_AND_WARNINGS_).
DESCRIPTION
MIGRANAL is ergotamine hydrogenated in the 9,10 position as the
mesylate salt.
MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione,
9,10-dihydro-12’-
hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-,
monomethane-sulfonate. Its molecular
weight is 679.78 and its empirical formula is C
H
N O •CH O S.
The chemical structure is:
®
33
37
5
5
4
3
MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for
intranasal
administration as a clear, colorless to light yellow aqueous solution
in an amber glass vial
containing:
Each milliliter contains
(equivalent to 3.43 mg dihydroergotamine)
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Dihydroergotamine binds with high affinity to 5-HT
and 5-HT
receptors. It also
binds with high affinity to serotonin 5-HT
, 5-HT
, and 5-HT
receptors,
noradrenaline α
, α
and α receptors, and dopamine D and D receptors.
The therapeutic activity of dihydroergotamine in migraine is generally
attributed to the
agonist effect at 5-HT
receptors. Two current theories have been proposed to explain
the efficacy of 5-HT
receptor agonists in migraine. One theory suggests that
activation of 5-HT
receptors located on intracranial blood ve