ERGOMAR (ergotamine tartrate)
Ergomar (ergotamine tartrate) is indicated for the abortion or prevention of vascular headaches, such as migraine, migraine variants, or "histaminic cephalalgia" (cluster headaches). It is intended for the management of acute headache symptoms and is not indicated for long-term prophylactic administration.
How ERGOMAR Works
Ergotamine is an alpha-adrenergic antagonist that exerts a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels, resulting in vasoconstriction. It also acts as an agonist at 5-HT1B and 5-HT1D serotonin receptors. Its therapeutic efficacy in treating vascular headaches is attributed to the constriction of dilated cranial extracerebral blood vessels and the potential inhibition of pro-inflammatory neuropeptide release.
Details
- Status
- Prescription
- First Approved
- 1985-04-18
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
ERGOMAR Approval History
What ERGOMAR Treats
3 indicationsERGOMAR is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vascular Headache
- Migraine
- Histaminic Cephalalgia
ERGOMAR Boxed Warning
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, 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 CONTR...
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, 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)
ERGOMAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ERGOMAR FDA Label Details
Indications & Usage
ERGOMAR is indicated for the treatment of Vascular Headache; Migraine; Histaminic Cephalalgia.
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tar...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.