Use in Adults
Ergotamines
THIS GUIDE PROVIDES A PARTIAL LISTING OF PRESCRIBING INFORMATION FOR THIS MEDICATION. FOR A FULL LISTING OF PRESCRIBING INFORMATION PLEASE REFER TO THE PACKAGE INSERT. CLICK ON THE BRAND NAME® TO VIEW THE LINK TO THE PACKAGE INSERT.
Dihydroergotamine mesylate Nasal spray (Migranal®) Click Here to Expand
Brands:
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
Counseling Tips:
- Migranal® (dihydroergotamine mesylate) For complete prescribing information click here for the PACKAGE INSERT
- 2 mg, given as 4 sprays
- Migranal comes in individual nasal spray vials; each vial contains enough medication to treat a single migraine attack
- 1 spray (0.5 mg per spray) in each nostril for a total of 2 sprays, after 15 minutes, an additional one spray should be administered in each nostril for a total dosage of 4 sprays (2mg)
- 2 mg (4 sprays) in 24 hours
- 4 mg (8 sprays) in a 7-day period
- Nausea and vomiting, nasal congestion, nasal irritation, altered sense of taste, sore throat, dizziness, fatigue
- Dihydroergotamine has been used for decades to treat severe and refractory attacks of migraine. It can be administered either as a subcutaneous or intramuscular injection or a nasal spray.
- The main side effects of intranasal DHE are nasal burning, nausea, vomiting and dysgeusia.
- DHE may be considered as primary therapy for migraine attacks, particularly in patients with a history of long duration attacks or in those that have failed 1-2 triptans or gepants or ditans, or who cannot tolerate those agents.
- Consider use in patients who experience migraine recurrence but who require a non-oral option.
- Consider use in persons with chronic migraine that have medication overuse headaches as DHE is not thought to cause medication overuse headaches.
- DHE should not be used in those with known cardiovascular disease (CAD, stroke, Prinzmetal’s angina, peripheral vascular disease, mesenteric ischemia), hemiplegic migraine and basilar type migraine. DHE should be used with caution in those with two or more cardiovascular risk factors. In fact, some clinicians recommend a cardiac evaluation to exclude unrecognized cardiovascular disease prior to their use in those with two or more cardiovascular risk factors without known cardiovascular disease.
- Its main advantage is good efficacy, long safety record when used correctly, in addition to not being felt to cause medication overuse headaches.
- Main disadvantages include side effects of nausea/vomiting and the need to screen for cardiovascular disease prior to its use.
- Many insurance plans require a prior authorization and failure of 1-2 triptans before approval will be granted.
- Rare reports of heart attack, stroke and cardiac arrhythmias have been reported after administration of dihydroergotamine
- With frequent use over a prolonged time period there have been rare reports of pleural and retro-peritoneal fibrosis
- Coadministration with potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole)
- Coadministration with peripheral or central vasoconstrictors
- Concomitant use or use within 24 hours of triptans, other ergotamine containing or ergot type medications, or methysergide
- Following vascular surgery
- Hemiplegic or basilar type migraine
- Hypersensitivity to ergot alkaloids
- Ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or symptoms consistent with coronary artery vasospasm, including Prinzmetal’s variant angina
- Nursing mothers
- Peripheral arterial disease
- Pregnancy
- Sepsis
- Severe hepatic impairment
- Severe renal impairment
- Uncontrolled hypertension
- Click Migranal® and navigate to PRECAUTIONS
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
- Should not be administered with other vasoconstrictors
- Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.
- Propranolol: can potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
- Nicotine: vasoconstriction in some patients, predisposing to a greater ischemic response
- Triptans: avoid within 24 hours of use of the triptans or other ergot medications
Counseling Tips:
- Each vial contains enough medication to treat one migraine attack. Before using each nasal spray vial, the patient should be instructed to prime the pump by spraying 4 times into the air, away from the face.
DIHYDROERGOTAMINE MESYLATE NAsal SPRAY (Trudhesa®) Click Here to Expand
Brands:
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
- Trudhesa® (dihydroergotamine mesylate) For complete prescribing information click here for the PACKAGE INSERT
- 0.725 mg in each spray for a total initial dose of 1.45mg
- One dosage (one spray into each nostril) as needed at the onset of a migraine attack; may repeat a second dosage (1 spray in each nostril), if needed, a minimum of 1 hour after the first dose.
- No more than 2 doses (each dose is 2 sprays; no more than 4 sprays within a 24-hour period) or 3 doses (no more than 6 sprays) within 7 days.
- Nausea and vomiting, nasal congestion, nasal irritation, altered sense of taste, sore throat, dizziness, fatigue
- Dihydroergotamine has been used for decades to treat severe and refractory attacks of migraine. It can be administered either a subcutaneous or intramuscular injection or a nasal spray.
- The main side effects of intranasal DHE are nasal burning, nausea, vomiting and dysgeusia.
- DHE may be considered as primary therapy for migraine attacks, particularly in patients with a history of long duration attacks or in those that have failed 1-2 triptans.
- Consider use in patients who experience migraine recurrence but who require a non-oral option.
- Also, might be used in persons with chronic migraine who have medication overuse headache as DHE is not thought to cause medication overuse headaches.
- DHE should not be used in those with known cardiovascular disease (CAD, stroke, Prinzmetal’s angina, peripheral vascular disease, mesenteric ischemia), hemiplegic migraine and basilar type migraine. DHE should be used with caution in those with two or more cardiovascular risk factors. In fact, some clinicians recommend a cardiac evaluation to exclude unrecognized cardiovascular disease prior to their use in those with two or more cardiovascular risk factors without known cardiovascular disease.
- DHE’s main advantage is good efficacy, long safety record when used correctly, in addition to not being felt to cause medication overuse headaches.
- Main disadvantages include side effects of nausea/vomiting and the need to screen for cardiovascular disease prior to its use.
- Rare reports of heart attack, stroke and cardiac arrhythmias have been reported after administration of dihydroergotamine
- With frequent use over a prolonged time period there have been rare reports of pleural and retro-peritoneal fibrosis
- Coadministration with potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole)
- Coadministration with peripheral or central vasoconstrictors
- Concomitant use or use within 24 hours of triptans, other ergotamine containing or ergot type medications, or methysergide
- Following vascular surgery
- Hemiplegic or basilar type migraine
- Hypersensitivity to ergot alkaloids
- Ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or symptoms consistent with coronary artery vasospasm, including Prinzmetal’s variant angina
- Nursing mothers
- Peripheral arterial disease
- Pregnancy
- Sepsis
- Severe hepatic impairment
- Severe renal impairment
- Uncontrolled hypertension
- Click Trudhesa® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
- Should not be administered with other vasoconstrictors
- Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.
- Propranolol: can potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
- Nicotine: vasoconstriction in some patients, predisposing to a greater ischemic response
- Triptans: avoid within 24 hours of use of the triptans or other ergot medications
- Each device must be assembled before use
- The device is primed by releasing 4 sprays, and then should be used immediately after priming.
- Each device contains one complete dose which is 1 spray in each nostril followed in 15 minutes by an additional spray in each nostril, for a total of 4 sprays.
- This device helps decrease side effects by propelling the medication to the targeted area in the nose (delivers dose to upper nasal space).
- Patients should open and prepare a new POD if an additional dose is needed
DIHYDROERGOTAMINE MESYLATE SQ OR IM (Dihydroergotamine®) Click Here to Expand
Brands:
Dihydroergotamine For complete prescribing information click here for the PACKAGE INSERT
Initial Dose:
Precautions and Risk:
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
Dihydroergotamine For complete prescribing information click here for the PACKAGE INSERT
Initial Dose:
- 1 mg intravenously, intramuscularly or subcutaneously is the most common initial dosage.
- 1 mg dosage is given intravenously, intramuscularly or subcutaneously as needed for treatment of an acute migraine attack
- The dose can be repeated, as needed at 1 hour intervals to a total dose of 3mg per 24 hour period for im or sc delivery or 2 mg for iv delivery per 24 hour period.
- If given intravenously, it may be initiated as a test dose of 0.5 mg, and if tolerated, the remaining 0.5mg of the first dose may be administered in 15 minutes.
- 3mg for IM/SC delivery; 2mg for IV delivery
- Nausea and vomiting, diarrhea, muscle cramps, dizziness, drowsiness
- Dihydroergotamine has been used for decades to treat severe and refractory attacks of migraine. It can be administered either a subcutaneous or intramuscular injection or a nasal spray.
- The main side effects intranasal DHE are nasal burning, nausea, vomiting and dysgeusia.
- DHE may be considered as primary therapy for migraine attacks, particularly in patients with a history of long duration attacks or in those that have failed 1-2 triptans.
- Consider use in patients who experience migraine recurrence but who require a non-oral option.
- Also, might be used in persons with chronic migraine that have medication overuse headaches as DHE is not thought to cause medication overuse headaches.
- DHE should not be used in those with known cardiovascular disease (CAD, stroke, Prinzmetal’s angina, peripheral vascular disease, mesenteric ischemia), hemiplegic migraine and basilar type migraine. They should be used with caution in those with two or more cardiovascular risk factors. In fact, some clinicians recommend a cardiac evaluation to exclude unrecognized cardiovascular disease prior to their use in those with two or more cardiovascular risk factors without known cardiovascular disease.
- Its main advantage is good efficacy, long safety record when used correctly, in addition to not being felt to cause medication overuse headaches.
- Main disadvantages include side effects of nausea/vomiting and the need to screen for cardiovascular disease prior to its use.
- Many insurance plans require a prior authorization and failure of 1-2 triptans before approval will be granted.
Precautions and Risk:
- Rare reports of heart attack, stroke and cardiac arrhythmias have been reported after administration of dihydroergotamine
- With frequent use over a prolonged time period there have been rare reports of pleural and retro-peritoneal fibrosis
- Coadministration with potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole)
- Coadministration with peripheral or central vasoconstrictors
- Concomitant use or use within 24 hours of triptans, ditans and other ergotamine containing or ergot type medications, or methysergide
- Following vascular surgery
- Hemiplegic or basilar type migraine
- Hypersensitivity to ergot alkaloids
- Ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or symptoms consistent with coronary artery vasospasm, including Prinzmetal’s variant angina
- Nursing mothers
- Peripheral arterial disease
- Pregnancy
- Sepsis
- Severe hepatic impairment
- Severe renal impairment
- Uncontrolled hypertension
- Click Dihydroergotamine and navigate to PRECAUTIONS
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics and protease inhibitors)
- Should not be administered with other vasoconstrictors
- Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.
- Propranolol: can potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
- Nicotine: vasoconstriction in some patients, predisposing to a greater ischemic response
- Triptans: avoid within 24 hours of use of the triptans or other ergot medications
- May need to give an anti-emetic such as promethazine, metoclopramide, or ondansetron thirty minutes prior to use of DHE.
Ergotamine Tablet (Ergomar®) Click Here to Expand
Brands:
Precautions and Risk:
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics, antifungals, calcium channel blockers and protease inhibitors)
- Ergomar® (ergotamine tartrate) For complete prescribing information click here for the PACKAGE INSERT
- 2 mg
- 2 mg under the tongue every 30 minutes as needed for treatment of an acute migraine attack
- 6 mg
- Nausea and vomiting, myalgias, numbness, cold extremities.
- This medication has been used as an acute medication for migraine for the last 40-50 years. Its main advantages include long track record, good efficacy and oral route of administration.
- Its main disadvantage is that it can be difficult to obtain from local pharmacies and can lead to medication overuse headaches if used more than 2 days per week.
- Main side effects are nausea and vomiting.
- It should not be used in those with known cardiovascular disease (CAD, stroke, Prinzmetal’s angina, peripheral vascular disease, mesenteric ischemia), hemiplegic migraine and basilar type migraine. They should be used with caution in those with two mor more cardiovascular risk factors.
Precautions and Risk:
- Rare reports of heart attack, stroke and cardiac arrhythmias have been reported after administration of dihydroergotamine
- With frequent use over a prolonged time period there have been rare reports of pleural and retro-peritoneal fibrosis
- Rare cases of ergotism have been reported with use of ergotamine in which there is intense vasospasm of peripheral arteries with rare reports of gangrene.
- Rare cases of mesenteric ischemia have been reported in the literature
- Retroperitoneal fibrosis and pleural fibrosis can occur with frequent dosing.
- Limit use to 2 or fewer days per week to decrease risk of medication overuse headaches.
- Concomitant use with potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole, protease inhibitors, macrolide antibiotics)
- Coronary heart disease, peripheral vascular disease, or hypertension
- Hypersensitivity to ergotamine tartrate or to any component of the product
- Impaired hepatic or renal function
- Pregnant or may become pregnant
- Sepsis
- Click Ergomar® and navigate to PRECAUTIONS
● CYP 3A4 Inhibitors (e.g., macrolide antibiotics, antifungals, calcium channel blockers and protease inhibitors)
- Should not be administered with other vasoconstrictors
- Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.
- Propranolol: can potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
- Nicotine: vasoconstriction in some patients, predisposing to a greater ischemic response
- Triptans: avoid within 24 hours of use of the triptans or other ergot medications
- No more than 3 tablets per day.