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Dihydroergotamine Brand Names
DHE 45 | Migranal
What is Dihydroergotamine
Dihydroergotamine (DHE) is a semisynthetic ergot alkaloid administered parenterally or intranasally to treat migraine.
Although DHE injection has been used for many years in the treatment of migraine, it is now considered more appropriate for treating severe cases since less toxic agents, such as naproxen, are more efficacious for moderate cases.
Intranasal dihydroergotamine was successful in 47—70% of patients with migraine headache pain (assessed four hours after treatment) compared with placebo response rates of 22—35%.
Similar to other ergot alkaloids used for acute migraine relief, the administration of dihydroergotamine injection or nasal spray should not exceed the daily and weekly dosing guidelines; the products should not be used for chronic daily administration.
Dihydroergotamine was approved by the FDA in 1946. The nasal spray dosage form (e.g., Migranal(R) by Novartis) was approved for acute treatment of migraine with or without aura on December 10, 1997. In October 2003, the FDA issued a not-approvable letter for MT-300™, an injectable formulation of dihydroergotamine mesylate under investigation for severe migraine treatment.
The FDA concluded that while MT-300™ achieved its primary endpoint of pain relief at 2 hours that was sustained for 72 hours, it failed to achieve statistical significance versus placebo for the relief at two hours of the secondary symptoms of migraine (nausea, sensitivity to light, and sensitivity to sound). No clinical safety issues were identified in the letter.
The manufacturer (Pozen) is expected to continue to seek NDA approval for MT-300™.
Indications
- cluster headache
- migraine
- orthostatic hypotension
- orthostatic hypotension prophylaxis
For the acute treatment of migraine with or without aura and the acute treatment of cluster headache episodes
Side Effects
- abdominal pain
- angina
- anorexia
- anxiety
- arthralgia
- asthenia
- bowel ischemia
- bronchospasm
- cardiac valvulopathy
- chest pain (unspecified)
- chills
- colitis
- confusion
- conjunctivitis
- coronary vasospasm
- cyanosis
- cystitis
- depression
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dysgeusia
- dysosmia
- dyspepsia
- dysphagia
- dyspnea
- dystonic reaction
- ecchymosis
- edema
- epistaxis
- euphoria
- fatigue
- fetal death
- fever
- flushing
- hematoma
- hiccups
- hot flashes
- hyperkinesis
- hypersalivation
- hypertension
- hypoesthesia
- hypotension
- injection site reaction
- insomnia
- intracranial bleeding
- lacrimation
- laryngitis
- maculopapular rash
- malaise
- migraine
- muscle cramps
- myalgia
- myocardial infarction
- myoclonia
- nasal congestion
- nasal dryness
- nasal irritation
- nausea
- ocular pain
- otalgia
- palpitations
- paresthesias
- peripheral vasoconstriction
- petechiae
- pharyngitis
- photophobia
- polyuria
- pruritus
- pulmonary fibrosis
- rash
- retroperitoneal fibrosis
- rhinitis
- sinus tachycardia
- sinusitis
- spontaneous fetal abortion
- stroke
- throat irritation
- tinnitus
- tissue necrosis
- tremor
- urticaria
- uterine contractions
- vaginitis
- ventricular fibrillation
- ventricular tachycardia
- vertigo
- visual impairment
- vomiting
- weakness
- xerostomia
- yawning
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- angina
- arteriosclerosis
- basilar/hemiplegic migraine
- biliary tract disease
- breast-feeding
- cardiac disease
- children
- cholestasis
- coronary artery disease
- diabetes mellitus
- ergot alkaloid hypersensitivity
- geriatric
- hepatic disease
- hypercholesterolemia
- hypertension
- infants
- intramuscular administration
- myocardial infarction
- obesity
- peripheral vascular disease
- peripheral vasoconstriction or ischemia
- pregnancy
- pulmonary disease
- pulmonary fibrosis
- Raynaud’s phenomenon
- renal disease
- renal failure
- renal impairment
- retroperitoneal fibrosis
- sepsis
- stroke
- surgery
- thromboangiitis obliterans (Buerger’s disease)
- thrombophlebitis
- tobacco smoking
- valvular heart disease
Interactions
- Acebutolol
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Pseudoephedrine
- Acrivastine; Pseudoephedrine
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Almotriptan
- Amiodarone
- Amlodipine
- Amlodipine; Atorvastatin
- Amlodipine; Benazepril
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amphetamine; Dextroamphetamine Salts
- Aprepitant, Fosaprepitant
- Articaine; Epinephrine
- Atazanavir; Cobicistat
- Atenolol
- Atenolol; Chlorthalidone
- Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Azithromycin
- Bendroflumethiazide; Nadolol
- Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Benzphetamine
- Beta-blockers
- Betaxolol
- Bisoprolol
- Bisoprolol; Hydrochlorothiazide, HCTZ
- Boceprevir
- Bosentan
- Brimonidine; Timolol
- Bromocriptine
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Brompheniramine; Pseudoephedrine
- Bupivacaine
- Bupivacaine Liposomal
- Bupivacaine; Lidocaine
- Cabergoline
- Canakinumab
- Carbetapentane; Pseudoephedrine
- Carbinoxamine; Dextromethorphan; Pseudoephedrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Carbinoxamine; Pseudoephedrine
- Carteolol
- Carvedilol
- Ceritinib
- Cetirizine; Pseudoephedrine
- Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
- Chloroprocaine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Pseudoephedrine
- Cimetidine
- Citalopram
- Clarithromycin
- Clofazimine
- Cobicistat
- Cocaine
- Conivaptan
- Crizotinib
- Danazol
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Delavirdine
- Desloratadine; Pseudoephedrine
- Desvenlafaxine
- Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
- Dextromethorphan; Guaifenesin; Pseudoephedrine
- Diazoxide
- Dihydrocodeine; Guaifenesin; Pseudoephedrine
- Diltiazem
- Dirithromycin
- Dobutamine
- Dorzolamide; Timolol
- Dronedarone
- Duloxetine
- Elbasvir; Grazoprevir
- Eletriptan
- Elexacaftor; tezacaftor; ivacaftor
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Emapalumab
- Enzalutamide
- Epinephrine
- Epoprostenol
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Esmolol
- Everolimus
- Fedratinib
- Fenoldopam
- Fexofenadine; Pseudoephedrine
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluvoxamine
- Fostamatinib
- Frovatriptan
- Glycerol Phenylbutyrate
- grapefruit juice
- Green Tea
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Guaifenesin; Pseudoephedrine
- Hydralazine
- Hydralazine; Hydrochlorothiazide, HCTZ
- Hydralazine; Isosorbide Dinitrate, ISDN
- Hydrochlorothiazide, HCTZ; Metoprolol
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
- Ibuprofen; Pseudoephedrine
- Idelalisib
- Iloprost
- Imatinib
- Isavuconazonium
- Isoproterenol
- Istradefylline
- Itraconazole
- Ivacaftor
- Ketoconazole
- Labetalol
- Lanreotide
- Lapatinib
- Larotrectinib
- Lefamulin
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Levobetaxolol
- Levobunolol
- Levomilnacipran
- Lidocaine; Prilocaine
- Linezolid
- Lisdexamfetamine
- Loratadine; Pseudoephedrine
- Lorcaserin
- Lumacaftor; Ivacaftor
- Lumacaftor; Ivacaftor
- Mepivacaine
- Mepivacaine; Levonordefrin
- Methamphetamine
- Methenamine; Sodium Acid Phosphate; Methylene Blue; Hyoscyamine
- Methylene Blue
- Metoprolol
- Metreleptin
- Miconazole
- Mifepristone
- Milnacipran
- Minoxidil
- Mirtazapine
- Mitotane
- Nadolol
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Naratriptan
- Nebivolol
- Nebivolol; Valsartan
- Nefazodone
- Nicardipine
- Nicotine
- Nilotinib
- Nitrates
- Nitroprusside
- Norfloxacin
- Oritavancin
- Palbociclib
- Paroxetine
- Penbutolol
- Perindopril; Amlodipine
- Phentermine
- Phentermine; Topiramate
- Pindolol
- Posaconazole
- Prilocaine
- Prilocaine; Epinephrine
- Procaine
- Propranolol
- Protease inhibitors
- Pseudoephedrine
- Quinine
- Ranolazine
- Ribociclib
- Ribociclib; Letrozole
- Rizatriptan
- Rucaparib
- Rufinamide
- Sarilumab
- Serotonin norepinephrine reuptake inhibitors
- Serotonin-Receptor Agonists
- Sertraline
- Sibutramine
- Siltuximab
- Simeprevir
- Sotalol
- Streptogramins
- Sumatriptan
- Tedizolid
- Telaprevir
- Telithromycin
- Telotristat Ethyl
- Tezacaftor; Ivacaftor
- Timolol
- tobacco
- Tocilizumab
- Trandolapril; Verapamil
- Treprostinil
- Tucatinib
- Vasopressors
- Vemurafenib
- Venlafaxine
- Verapamil
- Vilazodone
- Voriconazole
- Vortioxetine
- Zafirlukast
- Zileuton
- Zolmitriptan
