DIHYDROERGOTAMINE MESYLATE spray

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Advagen Pharma Ltd

Stjórnsýsluleið:

NASAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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 72888-096-19) Dihydroergotamine mesylate Nasal Spray is provided as a package of 1 unit, administration instruction sheet, and one package insert. Each unit consists of one vial and one sprayer. (NDC 72888-096-34) Store below 25°C (77°F). Do not refrigerate or freeze. Manufactured by: Mipharm, S.p.A. Milano, Italy Distributed by: Advagen Pharma Ltd., 666 Plainsboro Road, Suite 605 Plainsboro, NJ 08536, USA. Rev. 11/2022

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DIHYDROERGOTAMINE MESYLATE- DIHYDROERGOTAMINE MESYLATE SPRAY
ADVAGEN PHARMA LTD
----------
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 ALSO CONTRAINDICATIONSAND WARNINGSSECTION)_
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 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