ERGOMAR SUBLINGUAL- ergotamine tartrate tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Ergotamine Tartrate (UNII: MRU5XH3B48) (ERGOTAMINE - UNII:PR834Q503T)

제공처:

TerSera Therapeutics, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia". Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (See PRECAUTIONS: Drug Interactions ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (See WARNINGS: CYP 3A4 Inhibitors ). Ergomar® Sublingual Tablets may cause fetal harm when administered to pregnant women. Ergomar® Subli

제품 요약:

Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets USP) Ergomar® Sublingual Tablets are round, green tablets each containing 2 mg of ergotamine tartrate. They are debossed with the product identification code "LB2" on one side, and are supplied in unit-dose cartons of 20 tablets (10 tablets x 2 cards), NDC 70720-120-20. Store at 20°- 25°C (68° - 77°F) [see USP Controlled Room Temperature]; excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ERGOMAR SUBLINGUAL- ERGOTAMINE TARTRATE TABLET
TERSERA THERAPEUTICS, LLC
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ERGOMAR SUBLINGUAL TABLETS, 2 MG
(ERGOTAMINE TARTRATE SUBLINGUAL TABLETS, USP)
Rx Only
WARNING
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN
ASSOCIATED
WITH THE COADMINISTRATION OF ERGOTAMINE TARTRATE WITH POTENT CYP 3A4
INHIBITORS INCLUDING PROTEASE INHIBITORS AND MACROLIDE ANTIBIOTICS.
BECAUSE CYP 3A4 INHIBITION ELEVATES THE SERUM LEVELS OF ERGOTAMINE
TARTRATE, 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:
ERGOMAR SUBLINGUAL TABLETS
Ergotamine Tartrate Sublingual Tablets USP ... 2 mg
_Inactive Ingredients:_ Microcrystalline Cellulose NF, Natural
Peppermint Flavor Powder,
Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake,
Magnesium
Stearate NF, FD&C Blue #1 Aluminum Lake.
CLINICAL PHARMACOLOGY:
Ergotamine is an alpha adrenergic blocking agent with a direct
stimulating effect on the
smooth muscle of peripheral and cranial blood vessels and produces
depression of
central vasomotor centers. The compound also has the properties of
serotonin
antagonism. In comparison to hydrogenated ergotamine, the adrenergic
blocking
actions are less pronounced and vasoconstrictive actions are greater.
PHARMACOKINETICS: INTERACTIONS
Pharmacokinetic interactions (increased blood levels of ergotamine)
have been reported
in patients treated orally with ergotamine and macrolide antibiotics
(e.g., troleandomycin,
clarithromycin, erythromycin), and in patients treated orally with
ergotamine and
protease inhibitors (e.g., ritonavir) presumably due to inhibition of
cytochrome P450 3A
metabolism of ergotamine (_See _CONTRAINDICATIONS). Ergotamine has
also been
shown to be an inhibitor of cytochrome P450 3A catalyzed reactions. No
pharmacokinetic interactions involving other cytochrome P450
isoenzymes are known.
®
®
INDICATIONS AND USAGE
Ergomar
is