DIHYDROERGOTAMINE MESYLATE NASAL spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Cipla USA Inc.

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina (see WARNINGS). Because dihydroergotamine mesylate nasal spray may increase blood pressure, it should not be given to patients with uncontrolled hypertension. Dihydroergotamine mesylate nasal spray , 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other. Dihydroergotamine mesylate nasal spray should not be administered to patients with hemiplegic or basilar migraine. In addition to those conditions mentioned above, dihydroergotamine mesylate nasal spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Dihydroergotamine mesylate nasal spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids. Dihydroergotamine mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure. Currently available data have not demonstrated drug abuse or psychological dependence with dihydroergotamine. However, cases of drug abuse and psychological dependence in patients on other forms of ergot therapy have been reported. Thus, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.

제품 요약:

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. 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 69097-503-31). Each carton contains eight such units. (NDC 69097-503-27). Store below 25°C (77°F). Do not refrigerate or freeze.             Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited. Manufactured by: Mipharm, S.p.A. Milan, Italy Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 5/2022

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DIHYDROERGOTAMINE MESYLATE NASAL- DIHYDROERGOTAMINE MESYLATE
NASAL SPRAY, METERED
CIPLA USA INC.
----------
DIHYDROERTOTAMINE MESYLATE NASAL SPRAY, 4 MG/ML
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_ 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……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