DIHYDROERGOTAMINE MESYLATE- dihydroergotamine spray

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DIHYDROERGOTAMINE MESYLATE (UNII: 81AXN7R2QT) (DIHYDROERGOTAMINE - UNII:436O5HM03C)

Boleh didapati daripada:

Amneal Pharmaceuticals NY LLC

Laluan pentadbiran:

NASAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. 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 co-administration 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). 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 patients who have clinical symptoms or

Ringkasan produk:

Dihydroergotamine mesylate nasal spray is available (as a clear, colorless to faintly yellow solution) in 3.5 mL amber glass vials containing 4 mg of dihydroergotamine mesylate, USP. Dihydroergotamine mesylate nasal spray is provided as a package of 8 units, administration instruction sheet, and one package insert (NDC 69238-1606-8). Each individual unit (NDC 69238-1606-1) consists of one vial and one sprayer. Store below 25°C (77°F). Do not refrigerate or freeze. *Trademark of PDR Network, LLC Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 10-2022-02

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DIHYDROERGOTAMINE MESYLATE- DIHYDROERGOTAMINE SPRAY
AMNEAL PHARMACEUTICALS NY LLC
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DIHYDROERGOTAMINE MESYLATE NASAL SPRAY
THE SOLUTION USED IN DIHYDROERGOTAMINE MESYLATE NASAL SPRAY (4 MG/ML)
IS
INTENDED FOR INTRANASAL USE AND MUST NOT BE INJECTED.
RX ONLY
WARNING: PERIPHERAL ISCHEMIA FOLLOWING CO-ADMINISTRATION
WITH POTENT CYP3A4 INHIBITORS
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN
ASSOCIATED
WITH THE CO-ADMINISTRATION 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).
DESCRIPTION
Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10
position as the
mesylate salt. Dihydroergotamine mesylate 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
Dihydroergotamine mesylate nasal spray is provided for intranasal
administration as a
clear, colorless to faintly yellow solution in an amber glass vial
containing:
dihydroergotamine mesylate ……….. 4 mg
caffeine, anhydrous ………………… 10 mg
dextrose, anhydrous ………………… 50 mg
carbon dioxide ………………..……… qs
purified water ………………………. qs 1 mL
Each milliliter contains
Dihydroergotamine mesylate, USP ………. 4 mg
(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 therapeut