Relpax 20 mg/1
eletriptan hydrobromide · TABLET, FILM COATED · ROERIG
Relpax is a tablet, film coated containing eletriptan hydrobromide at 20 mg/1, taken oral. Manufactured by ROERIG.
Key Facts
- Brand Name
- Relpax
- Generic Name
- eletriptan hydrobromide
- NDC Code (Product)
0049-2330- Manufacturer
- ROERIG
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021016
- Marketing Start
- 12/26/2002
Recall History
Pfizer Inc.
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Pfizer Inc.
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
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 RELPAX is 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 RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks. • RELPAX is not intended for the prevention of migraine attacks. • Safety and effectiveness of RELPAX have not been established for cluster headache. RELPAX 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 RELPAX, 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 RELPAX is 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 RELPAX (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9) ]. • Recent use (…
Drug Interactions
7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs Including Other 5-HT 1B/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 RELPAX within 24 hours of each other is contraindicated . Concomitant use of other 5-HT 1 agonists within 24 hours of RELPAX treatment is contraindicated [see Contraindications (4) ] . 7.2 CYP3A4 Inhibitors Potent CYP3A4 inhibitors significantly increase the exposure of RELPAX. RELPAX 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 and 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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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, adv…
Frequently Asked Questions
What is Relpax used for?
Relpax contains eletriptan hydrobromide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Relpax a controlled substance?
Relpax is not classified as a controlled substance by the DEA.
What is the generic name for Relpax?
The generic name for Relpax is eletriptan hydrobromide. There are 10 other brand versions of eletriptan hydrobromide.
What is the NDC code for Relpax 20 mg/1?
The NDC (National Drug Code) for Relpax 20 mg/1 is 0049-2330, listed by ROERIG.
Other Relpax Dosages
Other Eletriptan Brands
See all →- Eletriptan Hydrobromide40 mg/159651-105
- Eletriptan hydrobromide40 mg/131722-444
- Eletriptan Hydrobromide20 mg/159651-104
- Eletriptan Hydrobromide40 mg/180425-0408
- Eletriptan hydrobromide40 mg/168382-923
- Eletriptan Hydrobromide40 mg/10378-4288
- Eletriptan hydrobromide20 mg/170771-1107
- Eletriptan Hydrobromide20 mg/124689-167
- Eletriptan Hydrobromide20 mg/10378-4287
- Eletriptan Hydrobromide20 mg/10093-8310
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)