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

Rx Item-Eletriptan 20MG 6 Tab by Mylan 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
13405 Soy
2432 Lactose 64044515 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 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 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)

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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: 4/2020
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Rx Item-Eletriptan 20MG 6 Tab by Mylan P
Item No. RX691752, 691752, NDC No.: 00378-4287-85, 00378-287-85, 0037828785, 00378428785, 4287-85, 428785 UPC No. 3-03784-28785-9, 303784-287859, 303784287859

Rx Item-Eletriptan 20MG 6 Tab
Item No. RX691752, 691752, NDC No.: 00378-4287-85, 00378-287-85, 0037828785, 00378428785, 4287-85, 428785 UPC No. 3-03784-28785-9, 303784-287859, 303784287859

Rx Item-Eletriptan 20MG 6 Tab by Mylan P
Item No. RX691752, 691752, NDC No.: 00378-4287-85, 00378-287-85, 0037828785, 00378428785, 4287-85, 428785 UPC No. 3-03784-28785-9, 303784-287859, 303784287859

Rx Item-Eletriptan 20MG 6 Tab by Mylan P
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