Clinical Information
Gen. Code and Des.
65944 cream base no.32 MISCELL CREAM (G)
GCN and Des.
28082 cream base no.32 MISCELL CREAM (G)
Strength
Dose Form
CREAM (GRAM)
Product Category
OT Over the Counter
Fine Line Class
790079407948 Miscellaneous Compounding Supplies
DEA Class
NC
OMP Family
AHFS Class
96000000 PHARMACEUTICAL AIDS
Active Ingredients
13346 cream base no.32
These highlights do not include all the information needed to use ELETRIPTAN HYDROBROMIDE TABLETS safely and effectively. See full prescribing information for ELETRIPTAN HYDROBROMIDE TABLETS.
ELETRIPTAN HYDROBROMIDE tablets, for oral use
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
Eletriptan hydrobromide is a serotonin (5-HT1B/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 AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg and 40 mg (3)
CONTRAINDICATIONS
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-HT1 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)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue eletriptan hydrobromide 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 if occurs (5.4)
Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue eletriptan hydrobromide if occurs (5.5)
Medication overuse headache: Detoxification may be necessary (5.6)
Serotonin syndrome: Discontinue eletriptan hydrobromide if occurs (5.7, 7.3)
ADVERSE REACTIONS
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2020
