Rx Item-Eletriptan 20MG 6 Tab by Teva Pharma USA Gen Relpax

Rx Item-Eletriptan 20MG 6 Tab by Teva Pharma USA , Clinical Information:
Generic Code And Description: 49605 Eletriptan Hydrobromide Oral Tablet 20 Mg
Strength: 20 Mg
Dose Form: Tablet
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 28322800 Selective Serotonin Agonists
Active Ingredients: 9522 Eletriptan Hbr 177834923
Inactive Ingredients: 10143 Yellow Dye
2432 Lactose 64044515
915 Dextrose 5996101 Drug Class: Drug Class: 28322800 Selective Serotonin Agonists , OMP Family: Waiting for Details, Temparature Zone: 10 Room Temperature, Unit Dose Indicator: UD, Item Size: 6 , Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:6 , Item Strength Code:20MG , Item Abbreviation: Eletriptan , Generic Form: TAB

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 tablets are 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 (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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 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 and FDA-approved patient labeling.

Revised: 7/2023

Rx Item-Eletriptan 20MG 6 Tab by Teva Ph
Item No. RX686035, 686035, NDC No.: 00093-8310-18, 00093-310-18, 0009331018, 00093831018, 8310-18, 831018 UPC No. 3-00938-31018-0, 300938-310180, 300938310180

Rx Item-Eletriptan 20MG 6 Tab
Item No. RX686035, 686035, NDC No.: 00093-8310-18, 00093-310-18, 0009331018, 00093831018, 8310-18, 831018 UPC No. 3-00938-31018-0, 300938-310180, 300938310180

Rx Item-Eletriptan 20MG 6 Tab by Teva Ph
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Eletriptan 20MG 6 Tab by Teva Ph
Item No. RX686035, 686035, NDC No.: 00093-8310-18, 00093-310-18, 0009331018, 00093831018, 8310-18, 831018 UPC No. 3-00938-31018-0, 300938-310180, 300938310180