ERGOMAR- ergotamine tartrate tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rosedale Therapeutics

INN (International Name):

Ergotamine Tartrate

Composition:

Ergotamine Tartrate 2 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a 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® Sublingual Tablets are con

Product summary:

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 individual foil strips packaged in a plastic child resistant canister containing 20 tablets (5 – 2 × 2 foil strips) NDC 10802-12020 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOMAR- ERGOTAMINE TARTRATE TABLET, ORALLY DISINTEGRATING
ROSEDALE THERAPEUTICS
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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 a 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 i