Eletriptan Hydrobromide
PrescriptionNoms de marque : eletriptan hydrobromide
About This Medication
11 DESCRIPTION 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: The molecular formula is C 22 H 26 N 2 O 2 S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide, hypromellose, triacetin, FD&C Yellow No. 6 aluminum lake. str
Principes Actifs
| Ingrédient | Dosage |
|---|---|
| Eletriptan Hydrobromide | - |
Indications et Utilisation
Comment ça marche
Posologie et Administration
Side Effects Overview
Mises en Garde et Précautions
5 WARNINGS AND PRECAUTIONS Eletriptan hydrobromide tablets should only be used where a clear diagnosis of migraine has been established. Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue eletriptan hydrobromide tablets if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia; evaluate high risk patients for CAD ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue eletriptan hydrobromide tablets if occurs ( 5.4 ) Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue eletriptan hydrobromide tablets if occurs ( 5.5 ) Medication overuse headache: Detoxification may be necessary ( 5.6 ) Serotonin syndrome: Discontinue eletriptan hydrobromide tablets if occurs ( 5.7 , 7.3 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Eletriptan hydrobromide tablets are 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 tablets. Some of these reactions occurred in patients without known CAD. Eletriptan hydrobromide tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving eletriptan hydrobromide tablets. Do not use eletriptan hydrobromide tablets if there is evidence of CAD or coronary artery vasospasm [see Contraindications ( 4 )]. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first eletriptan hydrobromide tablets dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration of eletriptan hydrobromide tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of eletriptan hydrobromide tablets. 5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue eletriptan hydrobromide tablets if these disturbances occur. Eletriptan hydrobromide tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Contraindications ( 4 )]. 5.3 Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with eletriptan hydrobromide tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. Eletriptan hydrobromide tablets are contraindicated in patients with CAD or Prinzmetal’s variant angina [see Contraindications ( 4 )]. 5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical of migraine, other potentially serious neurological conditions need to be excluded. Eletriptan hydrobromide tablets are contraindicated in patients with a history of stroke or TIA [see Contraindications ( 4 )]. 5.5 Other Vasospasm Reactions Eletriptan hydrobromide tablets may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional eletriptan hydrobromide tablets doses [see Contraindications ( 4 )]. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g. ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused acute migraine drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Serotonin Syndrome Serotonin syndrome may occur with eletriptan hydrobromide tablets, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors [see Drug Interactions ( 7.3 )]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue eletriptan hydrobromide tablets if serotonin syndrome is suspected. 5.8 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with eletriptan hydrobromide tablets. Eletriptan hydrobromide tablets are contraindicated in patients with uncontrolled hypertension [see Contraindications ( 4 )]. 5.9 Anaphylactic/Anaphylactoid Reactions There have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving eletriptan hydrobromide tablets. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Eletriptan hydrobromide tablets are contraindicated in patients with a history of hypersensitivity reaction to eletriptan hydrobromide tablets [see Contraindications ( 4 )].
Contre-indications
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 Warnings and Precautions ( 5.9 )] . Recent use (i.e., within at least 72 hours) of the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 )] . History of coronary artery disease (CAD) or coronary artery vasospasm ( 4 ) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Within 24 hours of treatment with another 5-HT 1 agonist, or an ergotamine containing medication ( 4 ) Hypersensitivity to eletriptan hydrobromide tablets (angioedema and anaphylaxis seen) ( 4 ) Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir ( 4 )
Pharmacocinétique
Frequently Asked Questions
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 …
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 …
5 WARNINGS AND PRECAUTIONS Eletriptan hydrobromide tablets should only be used where a clear diagnosis of migraine has been established. Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue eletriptan hydrobromide tablets if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia; evaluate high risk patients for CAD ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue eletriptan hydrobromide tablets if occurs ( …
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 …
Eletriptan Hydrobromide is a prescription medication. You will need a valid prescription from a licensed healthcare provider.
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Browse all Tablet products →References & Data Sources
- • DailyMed — Eletriptan Hydrobromide drug label (National Library of Medicine)
- • openFDA — Eletriptan Hydrobromide label data (U.S. Food & Drug Administration)
- • RxNorm — RXCUI 359494 (NLM Normalized Drug Names)
- • NDC Directory — Eletriptan Hydrobromide (FDA National Drug Code)
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Sources des données : DailyMed (NLM), openFDA, MFDS