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__NOTOC__
{{DrugProjectFormSinglePage
{{Ergotamine}}
|authorTag={{AP}}
{{CMG}}; {{AE}} {{PB}}
|genericName=Ergotamine tartrate
|aOrAn=an
|drugClass=alpha adrenergic blocking agent
|indicationType=prophylaxis
|indication=[[vascular migraine]]
|hasBlackBoxWarning=Yes
|adverseReactions=[[pruritus]], [[nausea and vomiting]], [[muscle weakness]], [[paresthesia]] and [[visual disturbance]]
|blackBoxWarningTitle=<span style="color:#FF0000;">WARNING</span>
|blackBoxWarningBody=<i><span style="color:#FF0000;"></span></i> 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.
|fdaLIADAdult======Abortion or prevention of vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia"=====
*For best results, dosage should start at the first sign of an attack. Early administration gives maximum effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Sublingual Tablets should not be used for chronic daily administration.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ergotamine in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ergotamine in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ergotamine in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ergotamine in pediatric patients.
|contraindications=*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, 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 [[CYP3A4]] (e.g., [[ketoconazole]], [[itraconazole]]).
*[[Ergomar]] Sublingual Tablets may cause fetal harm when administered to pregnant women. [[Ergomar]] Sublingual Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. [[Peripheral vascular disease]], [[coronary heart]] disease, [[hypertension]], impaired [[hepatic function]] or [[renal function]] and [[sepsis]][[Hypersensitivity]] to any of the components.
|warnings======CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)=====
*Coadministration of ergotamine with potent [[CYP3A4]] inhibitors such as [[protease inhibitors]] or [[macrolide antibiotics]] has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine. While these reactions have not been reported with less potent [[CYP3A4]] inhibitors, there is a potential risk for serious toxicity including [[vasospasm]] when these drugs are used with ergotamine. Examples of less potent [[CYP3A4]] inhibitors include: [[saquinavir]], [[nefazodone]], [[fluconazole]], [[fluoxetine]], grapefruit juice, [[fluvoxamine]], [[zileuton]], [[metronidazole]], and [[clotrimazole]]. These lists are not exhaustive, and the prescriber should consider the effects on [[CYP3A4]] of other agents being considered for concomitant use with ergotamine.


'''''For patient information about Ergotamine, click [[Ergotamine (patient information)|here]].'''''
=====Fibrotic Complications=====
*There have been a few reports of patients on ergotamine tartrate and [[caffeine]] therapy developing [[retroperitoneal]] and/or [[pleuropulmonary fibrosis]]. There have also been rare reports of fibrotic thickening of the [[aortic valve]], [[mitral valve]], [[tricuspid valve]], and/or [[pulmonary valve]] with long-term continuous use of ergotamine tartrate and caffeine. Ergomar Sublingual Tablets should not be used for chronic daily administration
|clinicalTrials=====Cardiovascular Effects====
*[[Vasoconstriction]]
**[[Ischemia]]
**[[Cyanosis]]
**[[Absence of pulse]]
**[[Cold extremities]]
**[[Gangrene]]
**[[Precordial distress]]
**[[Precordial pain]]
**[[EKG]] changes
**[[Muscle pain]]
*[[Transient tachycardia]]
*[[Bradycardia]]
*[[Hypertension]]


{{SB}}
=====Gastrointestinal Effects=====
*[[Nausea and vomiting]]


==Overview==
=====Neurological Effects=====  
{{drugbox |
*[[Paresthesias]]  
| image = Ergotamine.png
*[[Numbness]]  
| IUPAC_name = Ergotaman-3',6',18-trione, 12'-hydroxy-2'-methyl-5'-(phenylmethyl)-, (5'-alpha)- (9CI)
*[[Weakness]]  
| CAS_number = 113-15-5
*[[Vertigo]]
| ATC_prefix = N02
| ATC_suffix = CA02
| C=33 | H=35| N=5| O=5
| molecular_weight = 581.66 g/mol
| elimination_half-life =
| metabolism = hepatic
| excretion = renal
| pregnancy_category =
| PubChem=9787
| pregnancy_AU =
| pregnancy_US =
| legal_AU = Schedule 4
| legal_UK = POM
| legal_US = Rx-only
| legal_status =
| routes_of_administration = [[Wiktionary:oral|Oral]]
}}
'''Ergotamine''' is an [[ergopeptine]] and part of the [[ergot]] family of [[alkaloid]]s; it is structurally and biochemically closely related to [[ergoline]]. It possesses structural similarity to several [[neurotransmitter]]s, and has [[biological activity]] as a [[vasoconstrictor]]. It is used [[Pharmacology|medicinally]] for [[migraine]] prevention (sometimes in combination with [[caffeine]]), and to induce [[childbirth]] and prevent [[post-partum]] [[haemorrhage]].


==Category==
=====Allergic Effects=====
Anti Migraine Drugs
*Localized [[edema]] and [[itching]].


==FDA Package Insert==
=====Fibrotic Complications=====
==ERGOMAR (ergotamine tartrate) tablet==
*[[Retroperitoneal]]
*[[Pleural]]
|drugInteractions=*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. 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.
|FDAPregCat=X
|useInPregnancyFDA=*There are no studies on the placental transfer or teratogenicity of Ergomar. Ergotamine crosses the [[placenta]] in small amounts, although it does not appear to be [[embryotoxic]] in this quantity. However, prolonged [[vasoconstriction]] of the [[uterine vessels]] and/or increased [[myometrial tone]] leading to reduced myometrial and placental blood flow may have contributed to [[fetal growth retardation]] observed in animals.
|useInLaborDelivery=*Ergomar is contraindicated in pregnancy due to its oxytocic effect which is maximal in the third trimester.
|useInNursing=*Ergot drugs are known to inhibit [[prolactin]] but there are no reports of decreased lactation with Ergomar. Ergotamine is excreted in breast milk and may cause symptoms of [[vomiting]], [[diarrhea]], weak pulse and unstable [[blood pressure]] in nursing infants. Because of the potential for serious adverse reactions in nursing infants from Ergomar, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
|useInPed=*Safety and effectiveness in pediatric patients have not been established.
|administration=*Sublingual tablets
|overdose=*Symptoms include [[vomiting]], [[numbness]], [[tingling]], [[pain]] and [[cyanosis]] of the extremities associated with diminished or absent [[peripheral pulses]]; [[hypertension]] or [[hypotension]]; [[drowsiness]], [[stupor]], [[coma]], [[convulsions]] and [[shock]]. A case has been reported of reversible bilateral [[papillitis]] with ring [[scotomata]] in a patient who received five times the recommended daily adult dose over a period of 14 days. Treatment consists of removal of the offending drug. Maintenance of adequate pulmonary ventilation, correction of [[hypotension]], and control of [[convulsions]] and [[blood pressure]] are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent [[hypotension]].
|drugBox=[[file:ErgotamineDB2.png|thumb|none|600px]]
|mechAction=*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.
|structure=*D.H.E. 45® is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45® is known chemically as ergotaman-3´,6´,18-trione,9,10-dihydro-12´-hydroxy-2´-methyl-5´-(phenylmethyl)-,(5´α)-, monomethanesulfonate. Its molecular weight is 679.80 and its empirical formula is C33H37N5O5•CH4O3S.
*The chemical structure is:


'''  [[ERGOMAR (ergotamine tartrate) tablet indications and usage|Indications and Usage]]'''
[[file:Ergotamine Structure432.png|none|400px]]
'''| [[ERGOMAR (ergotamine tartrate) tablet dosage and administration|Dosage and Administration]]'''
|howSupplied======Ergotamine Tartrate Sublingual Tablets=====
'''| [[ERGOMAR (ergotamine tartrate) tablet dosage forms and strengths|Dosage Forms and Strengths]]'''
*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
'''| [[ERGOMAR (ergotamine tartrate) tablet contraindications|Contraindications]]'''
|storage=*Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.
'''| [[ERGOMAR (ergotamine tartrate) tablet warnings and precautions|Warnings and Precautions]]'''
|packLabel=[[file:FDA label.png|thumb|none|450px]]
'''| [[ERGOMAR (ergotamine tartrate) tablet adverse reactions|Adverse Reactions]]'''
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
'''| [[ERGOMAR (ergotamine tartrate) tablet drug interactions|Drug Interactions]]'''
|alcohol=Alcohol-Ergotamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
'''| [[ERGOMAR (ergotamine tartrate) tablet use in specific populations|Use in Specific Populations]]'''
|brandNames=*Ergomar®<ref>{{Cite web | title = ERGOMAR- ergotamine tartrate tablet, orally disintegrating | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1bfd4827-5123-4dbb-8f94-7b097f5bfd5c}}</ref>
'''| [[ERGOMAR (ergotamine tartrate) tablet overdosage|Overdosage]]'''
}}
'''| [[ERGOMAR (ergotamine tartrate) tablet description|Description]]'''
{{LabelImage
'''| [[ERGOMAR (ergotamine tartrate) tablet clinical pharmacology|Clinical Pharmacology]]'''
|fileName=CP2.png
'''| [[ERGOMAR (ergotamine tartrate) tablet nonclinical toxicology|Nonclinical Toxicology]]'''
}}
'''| [[ERGOMAR (ergotamine tartrate) tablet clinical studies|Clinical Studies]]'''
'''| [[ERGOMAR (ergotamine tartrate) tablet how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[ERGOMAR (ergotamine tartrate) tablet patient counseling information|Patient Counseling Information]]'''
'''| [[ERGOMAR (ergotamine tartrate) tablet labels and packages|Labels and Packages]]'''
 
==Medihaler ergotamine (ergotamine tartrate)==
 
'''  [[Medihaler ergotamine (ergotamine tartrate) indications and usage|Indications and Usage]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) dosage and administration|Dosage and Administration]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) contraindications|Contraindications]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) warnings and precautions|Warnings and Precautions]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) adverse reactions|Adverse Reactions]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) drug interactions|Drug Interactions]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) use in specific populations|Use in Specific Populations]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) overdosage|Overdosage]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) description|Description]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) clinical studies|Clinical Studies]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) patient counseling information|Patient Counseling Information]]'''
'''| [[Medihaler ergotamine (ergotamine tartrate) labels and packages|Labels and Packages]]'''
 
==Mechanism of action==
The mechanism of action of ergotamine is complex. The molecule shares similarity with neurotransmitters such as [[serotonin]], [[dopamine]], and [[adrenaline]] and can thus bind to several cell [[Receptor (biochemistry)|receptors]] acting both as [[agonist]] and [[Receptor antagonist|antagonist]] in signal transduction within cellular tissues. The anti-migraine effect is due to constriction of the intercranial extracerebral blood vessels through the [[5HT1B|5-HT<sub>1B</sub> receptor]], and by inhibiting trigeminal neurotransmission by [[5HT1D|5-HT<sub>1D</sub> receptor]]s. Ergotamine also has effects on the [[dopamine]] and [[noradrenaline]] receptors. It is its action on the [[D2 receptor|D2 dopamine]] and [[5HT1A|5-HT<sub>1A</sub> receptor]]s that can cause some side effects. <ref name="Tfelt">{{cite journal|author= Tfelt-Hansen P, Saxena PR, Dahlof C, Pascual J, Lainez M, Henry P, Diener H, Schoenen J, Ferrari MD, Goadsby PJ|year=2000|title=Ergotamine in the acute treatment of migraine: a review and European consensus|journal= Brain|volume=123|pages=9-18|id=PMID 10611116}}</ref>
 
==Biosynthesis==
Ergotamine is a [[secondary metabolite]] ([[natural product]]) and the principal alkaloid produced by the ergot fungus, ''Claviceps purpurea'', and related fungi in the family [[Clavicipitaceae]]. Its biosynthesis in these fungi requires the [[amino acid]], L-[[tryptophan]], and [[dimethylallyl diphosphate]]. These precursor compounds are the substrates for the enzyme, ''dimethylally-tryptophan (DMAT) synthase'', catalyzing the first step in ergot alkaloid biosynthesis, i.e., the [[prenylation]] of L-tryptophan. Further reactions, involving [[methyltransferase]] and [[oxygenase]] enzymes, yield the [[ergoline]], [[lysergic acid]]. Lysergic acid (LA) is the substrate of ''lysergyl peptide synthetase'', a [[Nonribosomal peptide|nonribosomal peptide synthetase]], which [[covalent]]ly links LA to the amino acids, L-[[alanine]], L-[[proline]], and L-[[phenylalanine]]. Enzyme-catalyzed or spontaneous cyclizations, [[oxygenation]]s/[[oxidation]]s, and [[isomerization]]s at selected residues precede, and give rise to, formation of ergotamine.<ref name="Schardl">{{cite journal|author=Schardl CL, Panaccione DG, Tudzynski P|year=2006|title=Ergot alkaloids--biology and molecular biology|journal= Alkaloids Chem. Biol.|volume=63|pages=45-86|id=PMID 17133714}}</ref>
 
==Illegal uses==
Ergotamine is also a precursor of [[LSD]], lysergic acid diethylamide.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = MEDIHALER ERGOTAMINE (ERGOTAMINE TARTRATE) AEROSOL, METERED [3M RIKER] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e713859d-f454-4f7e-a535-868b8d5f2c88 | publisher =  | date =  | accessdate = }}</ref>
 
==See also==
 
* [[Cafergot]], a preventative migraine treatment with ergotamine and <ref name="dailymed.nlm.nih.gov">[[caffeine]].{{Cite web | last =  | first =  | title = ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1bfd4827-5123-4dbb-8f94-7b097f5bfd5c | publisher =  | date =  | accessdate = }}</ref>
 
==References==
{{reflist|2}}
 
{{Antimigraine preparations}}
 
[[Category:Antimigraine drugs]]
[[Category:DEA List I chemicals]]
 
[[da:Ergotamin]]
[[de:Ergotamin]]
[[fr:Ergotamine]]
[[nl:Ergotamine]]
[[pl:Ergotamina]]
[[sv:Ergotamin]]
 
{{WikiDoc Help Menu}}
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Latest revision as of 15:53, 14 May 2015

Ergotamine tartrate (sublingual tablet)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

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Black Box Warning

WARNING
See full prescribing information for complete Boxed 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.

Overview

Ergotamine tartrate (sublingual tablet) is an alpha adrenergic blocking agent that is FDA approved for the prophylaxis of vascular migraine. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pruritus, nausea and vomiting, muscle weakness, paresthesia and visual disturbance.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Abortion or prevention of vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia"
  • For best results, dosage should start at the first sign of an attack. Early administration gives maximum effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Sublingual Tablets should not be used for chronic daily administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergotamine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergotamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ergotamine tartrate (sublingual tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergotamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergotamine in pediatric patients.

Contraindications

Warnings

WARNING
See full prescribing information for complete Boxed 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.
CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)
Fibrotic Complications

Adverse Reactions

Clinical Trials Experience

Cardiovascular Effects

Gastrointestinal Effects
Neurological Effects
Allergic Effects
Fibrotic Complications

Postmarketing Experience

There is limited information regarding Ergotamine tartrate (sublingual tablet) Postmarketing Experience in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ergotamine tartrate (sublingual tablet) in women who are pregnant.

Labor and Delivery

  • Ergomar is contraindicated in pregnancy due to its oxytocic effect which is maximal in the third trimester.

Nursing Mothers

  • Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with Ergomar. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from Ergomar, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in geriatric settings.

Gender

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ergotamine tartrate (sublingual tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Sublingual tablets

Monitoring

There is limited information regarding Ergotamine tartrate (sublingual tablet) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ergotamine tartrate (sublingual tablet) and IV administrations.

Overdosage

Pharmacology

Mechanism of Action

  • 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.

Structure

  • D.H.E. 45® is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45® is known chemically as ergotaman-3´,6´,18-trione,9,10-dihydro-12´-hydroxy-2´-methyl-5´-(phenylmethyl)-,(5´α)-, monomethanesulfonate. Its molecular weight is 679.80 and its empirical formula is C33H37N5O5•CH4O3S.
  • The chemical structure is:

Pharmacodynamics

There is limited information regarding Ergotamine tartrate (sublingual tablet) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ergotamine tartrate (sublingual tablet) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ergotamine tartrate (sublingual tablet) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ergotamine tartrate (sublingual tablet) Clinical Studies in the drug label.

How Supplied

Ergotamine Tartrate Sublingual Tablets
  • 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

Storage

  • Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.

Images

Drug Images

{{#ask: Page Name::Ergotamine tartrate (sublingual tablet) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ergotamine tartrate (sublingual tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ergotamine tartrate (sublingual tablet) in the drug label.

Precautions with Alcohol

Alcohol-Ergotamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Ergotamine tartrate (sublingual tablet) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "ERGOMAR- ergotamine tartrate tablet, orally disintegrating".

{{#subobject: 

 |Label Page=Ergotamine tartrate (sublingual tablet)
 |Label Name=CP2.png

}}

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