Eletriptan Hbr
Generic Name: eletriptan hbr
Brand Names:
Eletriptan Hbr
Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure: [Chemical Structure] The molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43.
Overview
Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure: [Chemical Structure] The molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43.
Uses
Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.
Dosage
The maximum recommended single dose is 40 mg. In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose [see CLINICAL STUDIES (14)]. If the migraine has not resolved by 2 hours after taking eletriptan hydrobromide tablets, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg. The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.
Side Effects
The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial ischemia and myocardial infarction, and Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.2)] Arrhythmias [see WARNINGS AND PRECAUTIONS (5.3)] Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS (5.4)] Cerebrovascular events [see WARNINGS AND PRECAUTIONS (5.4)] Other vasospasm reactions [see WARNINGS AND PRECAUTIONS (5.5)] Medication overuse headache [see WARNINGS AND PRECAUTIONS (5.6)] Serotonin syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Increase in blood pressure [see WARNINGS AND PRECAUTIONS (5.8)] Hypersensitivity reactions [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.9)] 6.1 Clinical Trials Experience Because clinica...
Interactions
7.1 Ergot-Containing Drugs Including Other 5-HT 1B/1D Agonists Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine [DHE] or methysergide) and eletriptan hydrobromide within 24 hours of each other is contraindicated. Concomitant use of other 5-HT1 agonists within 24 hours of eletriptan hydrobromide treatment is contraindicated [see CONTRAINDICATIONS (4)]. 7.2 CYP3A4 Inhibitors Potent CYP3A4 inhibitors significantly increase the exposure of eletriptan hydrobromide. Eletriptan hydrobromide should not be used within at least 72 hours of treatment with potent CYP3A4 inhibitors [see CONTRAINDICATIONS (4) and CLINICAL PHARMACOLOGY (12.3)].
Warnings
Eletriptan hydrobromide should only be used where a clear diagnosis of migraine has been established. 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina Eletriptan hydrobromide is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of eletriptan hydrobromide. Some of these reactions occurred in patients without known CAD. Eletriptan hydrobromide may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Eletriptan hydrobromide tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)].
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Eletriptan Hbr used for?▼
Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.
What are the side effects of Eletriptan Hbr?▼
The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial ischemia and myocardial infarction, and Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.2)] Arrhythmias [see WARNINGS AND PRECAUTIONS (5.3)] Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS (5.4)] Cerebrovascular events [see WARNINGS AND PRECAUTIONS (5.4)] Other vasospasm reactions [see WARNINGS AND PRECAUTIONS (5.5)] Medication overuse headache [see WARNINGS AND PRECAUTIONS (5.6)] Serotonin syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Increase in blood pressure [see WARNINGS AND PRECAUTIONS (5.8)] Hypersensitivity reactions [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.9)] 6.1 Clinical Trials Experience Because clinica...
What are the important warnings for Eletriptan Hbr?▼
Eletriptan hydrobromide should only be used where a clear diagnosis of migraine has been established. 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina Eletriptan hydrobromide is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of eletriptan hydrobromide. Some of these reactions occurred in patients without known CAD. Eletriptan hydrobromide may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Eletriptan hydrobromide tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.