sumatriptan intranasal (Rx)

Brand and Other Names:Imitrex Intranasal, Onzetra Xsail
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal spray (Imitrex Intranasal)

  • 5 mg/actuation
  • 20 mg/actuation

intranasal powder (Onzetra Xsail)

  • 11mg/capsule in disposable nosepiece
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Migraine Headache

Indicated for acute treatment of migraine headache with or without aura

Imitrex Intranasal

  • Individualized dose of 5 mg, 10 mg, or 20 mg intranasally once
  • Administer 5 mg or 20 mg dose into 1 nostril; 10 mg dose achieved by administering 5 mg in each nostril
  • If headache returns, may repeat dose once after 2 hr; not to exceed 40 mg/day

Onzetra Xsail intranasal powder

  • 22 mg (2 nosepieces) administered using the Xsail breath-powered delivery device (see Administration)
  • A second 22-mg dose may be administered if the migraine has not resolved by 2 hr after taking the first dose, or returns after a transient improvement
  • Not to exceed 2 doses in 24 hr (ie, 44 mg/4 nosepieces) or 1 dose of Onzetra Xsail and 1 dose of another sumatriptan product, separated by at least 2 hr

Dosing Considerations

Safety not established for treating >4 headaches/30 days

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and sumatriptan intranasal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Bad/unusual taste (13.5-24.5%)

            Gastrointestinal: nausea/vomiting (11-13.5%)

            1-10%

            Disorder/discomfort of nasal cavity/sinuses (2.5-3.8%)

            Throat discomfort (0.8-2.4%)

            Dizziness/vertigo (1-1.7%)

            Burning sensation (0.4-1.4%)

            Frequency Not Defined

            Atypical Sensations: Tingling, numbness, pressure sensation, cold sensation, feeling of tightness

            Cardiovascular: Flushing, hypertension, palpations, tachycardia, arrhythmia, edema

            Chest tightness/discomfort, chest pressure/heaviness

            Disturbance of hearing, ear infections

            Eye irritation and visual disturbances

            Gastrointestinal: Abdominal discomfort, diarrhea, dysphagia, GERD, dry mouth, thirst

            Musculoskeletal: Neck pain/stiffness, backache, weakness, joint symptoms, arthritis, myalgia, muscle cramps

            Neurological: Drowsiness/sedation, anxiety, sleep disturbances, tremors, syncope, chills, depression, agitation, confusion

            Respiratory: Dyspnea, lower respiratory infection

            Skin: Rash/skin eruption, pruritus, erythema

            Urogenital: Dysuria, dysmenorrhea

            Postmarketing Reports

            Blood: Hemolytic anemia, pancytopenia, thrombocytopenia

            Cardiovascular: Atrial fibrillation, cardiomyopathy, colonic ischemia, Prinzmetal variant angina, pulmonary embolism, shock, thrombophlebitis

            Ear, nose, throat: Deafness

            Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision

            Gastrointestinal: Ischemic colitis, dry mouth

            Hepatic: Elevated LFTs

            Neurological: CNS vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage

            Psychiatric: Panic disorder

            Respiratory: bronchospasm in patients with or without a history of asthma

            Skin: exacerbation of sunburn, hypersensitivity reactions (erythema, pruritus, rash), photosensitivity

            Urogenital: acute renal failure

            Nonspecific: Angioneurotic edema, cyanosis, death, temporal arteritis

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            Warnings

            Contraindications

            Current/history of: ischemic cardiac, cerebrovascular, or peripheral vascular syndromes (angina, MI, stroke, TIA, ischemic bowel disease)

            Uncontrolled hypertension

            Coadministration of MAO-A inhibitors or use within 2 weeks after discontinuing MAO-A inhibitors

            Use within 24 hr of any ergotamine-containing or ergot-type medication (eg, dihydroergotamine or methysergide)

            Use within 24 hr of other 5-HT1 agonists

            Hypersensitivity

            Severe hepatic impairment

            Not indicated for basilar or hemiplegic migraine

            Cautions

            Clear diagnosis of migraine headache has been established

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)

            Serious cardiac and cerebrovascular events, including cerebral hemorrhage, subarachnoid hemorrhage, stroke, acute MI, arrhythmias, and death reported within a few hours after administration

            Chest discomfort and jaw or neck tightness reported infrequently following intranasal administration (relatively common following SC injection)

            Not for use with unrecognized CAD as predicted by risk factors (eg, hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, male aged >40 yr)

            Serotonin syndrome may occur, particularly when coadministered with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (eg, venlafaxine, duloxetine) Increased blood pressure, including hypertensive crisis reported (rare)

            Local irritation of nose and throat reported

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            Pregnancy & Lactation

            Pregnancy Category: C

            Reproductive toxicity studies for sumatriptan by intranasal route have not been conducted; embryolethality and blood vessel abnormalities observed with PO or IV doses in pregnant rabbits during organogenesis

            Lactation: Excreted in human breast milk in very low levels (NLM Toxnet); minimize infant to potential exposure by avoiding breastfeeding for 8-12 hr after administration

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Selective 5-HT1 receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache

            Absorption

            Bioavailability: 80-100%

            Onset: 30 min

            Peak Plasma Concentration: 5-16 ng/mL (dose dependent)

            Distribution

            Protein Bound: 14-21%

            Metabolism

            Metabolized by MAO-A

            Metabolites: indole acetic acid analogue of sumatriptan

            Elimination

            Half-life: 2 hr

            Total body clearance: 1,200 mL/min

            Excretion: urine (3% unchanged, 42% as major metabolite)

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            Administration

            Intranasal Administration

            Imitrex Intranasal

            • Administer 5 mg or 20 mg metered-spray dose into 1 nostril
            • 10 mg dose achieved by administering 5 mg in each nostril

            Onzetra Xsail

            • Remove the clear device cap from the reusable delivery device, then remove a disposable nosepiece from its foil pouch and click the nosepiece into the device body
            • Fully press and promptly release the white piercing button on the device body to pierce the capsule inside the nosepiece; the white piercing button should only be pressed once and released prior to administration to each nostril
            • Insert the nosepiece is then inserted into the nostril so that it makes a tight seal; keeping the nosepiece in the nose, rotate the device to place the mouthpiece into the mouth
            • The patient blows forcefully through the mouthpiece to deliver the sumatriptan powder into the nasal cavity
            • Vibration (eg, a rattling noise) may occur, and indicates that the patient is blowing forcefully, as directed
            • Once the medication in the first nosepiece has been administered, remove and discard the nosepiece
            • The same process must then be repeated using a second 11 mg nosepiece into the other nostril to administer the remainder of the total recommended 22 mg dose

            Storage

            Imitrex Intranasal

            • Store between 36-86°F (2-30°C)
            • Protect from light

            Onzetra Xsail

            • Store at room temperature between 20-25°C (68-77°F), with excursions permitted between 15-30°C (59-86°F)
            • Do not store in the refrigerator or freezer
            • Use nosepiece immediately after removing from foil pouch
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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