Eletriptan Hydrobromide 40 mg/1
Eletriptan Hydrobromide · TABLET, FILM COATED · Advanced Rx of Tennessee, LLC
Eletriptan Hydrobromide is a tablet, film coated containing eletriptan hydrobromide at 40 mg/1, taken oral. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- Eletriptan Hydrobromide
- Generic Name
- Eletriptan Hydrobromide
- NDC Code (Product)
80425-0408- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 40 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210708
- Marketing Start
- 06/25/2024
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. Eletriptan hydrobromide tablets is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use: Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. Single dose: 20 mg or 40 mg ( 2 ) Maximum single dose: 40 mg ( 2 ) May repeat dose after 2 hours if needed; not to exceed 80 mg in any 24-hour period ( 2 )
Contraindications
4 CONTRAINDICATIONS 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 )] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )] . History of stroke, transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 )] . Peripheral vascular disease [see Warnings and Precautions ( 5.5 )] . Ischemic bowel disease [see Warnings and Precautions ( 5.5 )] . Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )] . Recent use (i.e., within 24 hours) of another 5-hydroxytryptamine 1 (5-HT 1 ) agonist, ergotamine-containing medication, or ergot-type medication such as dihydroergotamine (DHE) or methysergide [see Drug Interactions ( 7.1 )] . Hypersensitivity to eletriptan hydrobromide tablets (angioedema and anaphylaxis seen) [see …
Drug Interactions
7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs and Other 5-HT1B/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 tablets within 24 hours of each other is contraindicated . Concomitant use of other 5-HT 1 agonists within 24 hours of eletriptan hydrobromide tablets treatment is contraindicated [see Contraindications ( 4 )] . 7.2 CYP3A4 Inhibitors Potent CYP3A4 inhibitors significantly increase the exposure of eletriptan hydrobromide tablets. Eletriptan hydrobromide tablets should not be used within at least 72 hours of treatment with potent CYP3A4 inhibitors [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.3 )] . 7.3 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs and MAO inhibitors [see Warnings and Precautions ( 5.7 )].
Adverse Reactions
6 ADVERSE REACTIONS 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 )] Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reacti…
Frequently Asked Questions
What is Eletriptan Hydrobromide used for?
Eletriptan Hydrobromide contains Eletriptan Hydrobromide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Eletriptan Hydrobromide a controlled substance?
Eletriptan Hydrobromide is not classified as a controlled substance by the DEA.
What is the generic name for Eletriptan Hydrobromide?
The generic name for Eletriptan Hydrobromide is Eletriptan Hydrobromide. There are 5 other brand versions of Eletriptan Hydrobromide.
What is the NDC code for Eletriptan Hydrobromide 40 mg/1?
The NDC (National Drug Code) for Eletriptan Hydrobromide 40 mg/1 is 80425-0408, listed by Advanced Rx of Tennessee, LLC.