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SUMAVEL DOSEPRO to:
Generic Name for SUMAVEL DOSEPRO
Sumatriptan (as succinate) 6mg/0.5mL; needle-free delivery system; soln for SC inj.
Legal Classification:
Rx
Pharmacological Class for SUMAVEL DOSEPRO
Selective 5-HT1B/1D receptor agonist.
Manufacturer of SUMAVEL DOSEPRO
Zogenix, Inc.
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Indications for SUMAVEL DOSEPRO
Acute treatment of migraine or cluster headaches.
Adult dose for SUMAVEL DOSEPRO
≥18yrs: one DosePro (6mg) SC to the abdomen or thigh only. Reevaluate if no response. May repeat after 1 hour; max two DosePro (6mg) doses in 24 hours.
Children's dosing for SUMAVEL DOSEPRO
<18yrs: not recommended.
Contraindications for SUMAVEL DOSEPRO
Do not give intravenously. History, symptoms, or signs of ischemic cardiac (eg, MI, angina pectoris, silent myocardial ischemia), cerebrovascular (eg, stroke, TIA), or peripheral vascular (eg, ischemic bowel disease) syndromes. Vasospastic coronary artery disease (CAD). Uncontrolled hypertension (HTN). Significant underlying cardiovascular disease. Basilar or hemiplegic migraine. Within 24hrs of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within 2 weeks after discontinuing MAO-type A inhibitors.
Warnings/Precautions for SUMAVEL DOSEPRO
Confirm diagnosis. Avoid excessive use. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary artery disease (eg, postmenopausal women, hypercholesterolemia, men over age 40, hypertension, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Peripheral vascular or colonic ischemia following other 5-HT1 agonists. Seizure risk. Instruct patient on use of DosePro. Elderly: not recommended. Pregnancy (Cat.C). Nursing mothers.
Interactions for SUMAVEL DOSEPRO
Ergotamines, other 5-HT1 agonists, MAOIs: see Contraindications. Serotonin syndrome with SSRIs (eg, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) or SNRIs (eg, duloxetine, venlafaxine).
Adverse Reactions for SUMAVEL DOSEPRO
Inj site reactions, tingling, warm/hot or burning sensation, feeling of heaviness or tightness, pressure sensation, numbness, tight feeling in head, flushing, chest or jaw/nasal cavity/sinuses discomfort, dizziness/vertigo, drowsiness/sedation, headache; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss.
How is SUMAVEL DOSEPRO supplied?
Single-dose units (prefilled)—6