DIHYDROERGOTAMINE MESYLATE spray

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Oceanside Pharmaceuticals

INN (الاسم الدولي):

dihydroergotamine mesylate

تركيب:

dihydroergotamine mesylate 4 mg in 1 mL

طريقة التعاطي:

NASAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 ). 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

ملخص المنتج:

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. 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 68682-357-10). Store below 25°C (77°F). Do not refrigerate or freeze. * Trademark of PDR Network, LLC Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Mipharm, S.p.A. Milano, Italy © 2022 Bausch Health Companies Inc. or its affiliates Rev. 09/2022 9606502

الوضع إذن:

New Drug Application Authorized Generic

خصائص المنتج

DIHYDROERGOTAMINE MESYLATE- DIHYDROERGOTAMINE MESYLATE SPRAY
OCEANSIDE PHARMACEUTICALS
----------
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 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
Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10
position as the
mesylate salt. Dihydroergotamine Mesylate Nasal Spray 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:
Dihydroergotamine Mesylate Nasal Spray is provided for intranasal
administration as a
33
37
5
5
4
3
Dihydroergotamine Mesylate Nasal Spray is provided for intranasal
administration as a
clear, colorless to light yellow aqueous 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
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 therapeutic activity of dihydro