Drugplain

Onzetra Xsail 11 mg/1

sumatriptan succinate · CAPSULE · Currax Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage
Plain English

Onzetra Xsail is a capsule containing sumatriptan succinate at 11 mg/1, taken nasal. Manufactured by Currax Pharmaceuticals LLC.

Key Facts

Brand Name
Onzetra Xsail
Generic Name
sumatriptan succinate
NDC Code (Product)
42847-311
Manufacturer
Currax Pharmaceuticals LLC
Strength
11 mg/1
Dosage Form
CAPSULE
Route
NASAL
Marketing Status
Application #
NDA206099
Marketing Start
10/01/2015

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ONZETRA ® Xsail ® is indicated for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail 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 if a clear diagnosis of migraine headache has been established ( 1 ) Not indicated for the prophylactic therapy of migraine attacks ( 1 ) Not indicated for the treatment of cluster headache ( 1 ) 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 ONZETRA Xsail, reconsider the diagnosis of migraine before treatment of subsequent attacks with ONZETRA Xsail. ONZETRA Xsail is not indicated for the prevention of migraine attacks. Safety and effectiveness of ONZETRA Xsail have not been established for the treatment of cluster headache.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended dose: 22 mg, administered by use of one nosepiece (11 mg) in each nostril ( 2.1 ) Maximum dose in a 24-hour period should not exceed two doses (44 mg) separated by at least 2 hours ( 2.1 ) 2.1 Dosing Information The recommended dosage of ONZETRA is 22 mg of sumatriptan nasal powder (2 nosepieces), administered using the Xsail breath-powered delivery device. If the migraine has not resolved by 2 hours after taking ONZETRA Xsail, or returns after a transient improvement, a second dose of 22 mg may be administered at least 2 hours after the first dose. The maximum recommended dose that may be given in 24 hours is two doses of ONZETRA Xsail (44 mg/4 nosepieces) or one dose of ONZETRA Xsail and one dose of another sumatriptan product, separated by at least 2 hours. The safety of treating an average of more than 4 headaches in a 30 day period has not been established. 2.2 Administration Instructions The recommended dose of 22 mg is administered by using one 11 mg nosepiece in each nostril [see Patient Counseling Information (17) ] . For administration of ONZETRA Xsail, the patient removes the clear device cap from the reusable delivery device, then…

Contraindications

4 CONTRAINDICATIONS ONZETRA Xsail is contraindicated in patients with: Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina or in patients with other significant underlying cardiovascular diseases [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 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 ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7.1 and 7.3) ]. Concurrent administration of an MAO-A inhibitor or recent use (within 2 …

Drug Interactions

7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs 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 or methysergide) and ONZETRA Xsail within 24 hours of each other is contraindicated . 7.2 Monoamine Oxidase Inhibitors MAO-A inhibitors increase systemic exposure by up to 7-fold. Therefore, the use of ONZETRA Xsail in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of ONZETRA Xsail and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin 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 serious adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, throat, neck and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] 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) ] Seizures [see Warnings and Precautions (5.10) ] In controlled studies with ONZETRA Xsail, the most common adverse reactions (incidence of ≥ 2% and greater than placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Currax Pharmaceuticals LLC at 1-800-793-2145 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Exper…

Frequently Asked Questions

What is Onzetra Xsail used for?

Onzetra Xsail contains sumatriptan succinate. It is a capsule taken nasal. Consult your doctor for specific uses.

Is Onzetra Xsail a controlled substance?

Onzetra Xsail is not classified as a controlled substance by the DEA.

What is the generic name for Onzetra Xsail?

The generic name for Onzetra Xsail is sumatriptan succinate. There are 11 other brand versions of sumatriptan succinate.

What is the NDC code for Onzetra Xsail 11 mg/1?

The NDC (National Drug Code) for Onzetra Xsail 11 mg/1 is 42847-311, listed by Currax Pharmaceuticals LLC.

Product NDC

42847-311

Package NDC

42847-311-08

Other Sumatriptan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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