TM Owner Amneal Pharmaceuticals
Zomig Nasal 5mg Nasal Spray
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Indications & Clinical Uses
- Zomig Nasal 5mg is a single-use nasal spray device containing zolmitriptan, a triptan (5-HT1B/1D receptor agonist), used for the acute treatment of migraine with or without aura in adults and in children and adolescents aged 12 years and older (US label, Amneal Pharmaceuticals).
- It treats an attack that has begun and does not prevent migraine.
- The spray is given into one nostril only and is supplied in cartons of 6 single-use units, in 2.5 mg and 5 mg strengths.
- The nasal spray is a different product from Zomig tablets and Zomig-ZMT orally disintegrating tablets, with its own dosing, so do not swap between forms without advice.
- The usual starting dose is 2.5 mg and the maximum single dose is 5 mg.
- The US label does not carry a boxed warning.
Side Effects
- The most common reactions in adults are an unusual taste (about 17 to 21 in 100 people), tingling or numbness (paraesthesia, 5 to 10 in 100), dizziness (3 to 6 in 100) and increased or altered sensitivity to touch (hyperaesthesia, about 5 in 100).
- In children and adolescents, unusual taste was the most common effect, followed by nasal discomfort.
- Serious effects that need urgent help include chest pain or tightness, a fast or irregular heartbeat, symptoms of stroke such as sudden weakness or trouble speaking, high blood pressure, and serotonin syndrome (agitation, sweating, fever, tremor, diarrhoea).
- Frequent use can cause medication overuse headache.
- There is no boxed warning.
- If you have chest pain or stroke symptoms, seek emergency care.
Precautions & Warnings
- Zolmitriptan must not be used if you have ischaemic heart disease, coronary vasospasm, a history of stroke or transient ischaemic attack (TIA), hemiplegic or basilar migraine, peripheral vascular disease, ischaemic bowel disease or uncontrolled high blood pressure, or if you have taken another triptan or an ergot-type medicine within 24 hours or a monoamine oxidase-A (MAO-A) inhibitor within 2 weeks.
- The label warns of myocardial ischaemia or infarction, arrhythmias, cerebrovascular events, blood pressure elevation, medication overuse headache and serotonin syndrome.
- Use one 2.5 mg or 5 mg unit at a time; a further dose may be used after 2 hours, and the total must not exceed 10 mg in 24 hours.
- Do not prime the device or press the plunger before placing the nozzle in the nostril; each unit is single-use and must be thrown away after use.
- Animal studies showed embryolethality and fetal abnormalities at clinically relevant exposures, so discuss pregnancy with your healthcare provider.
- Dizziness can affect driving.
- Store at room temperature, 20 to 25 degrees C.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you use.
- Medicines that increase the effect or toxicity: cimetidine, after which the maximum single dose is limited to 2.5 mg; MAO-A inhibitors, which are contraindicated within 2 weeks; and SSRIs and SNRIs, which raise the risk of serotonin syndrome.
- Do not use Zomig nasal spray within 24 hours of another 5-HT1 agonist (triptan) or an ergot-type medicine such as ergotamine, because their vessel-narrowing effects can add together.
- The label reviewed lists no medicines or foods that reduce its effect, but tell your prescriber about all your medicines and supplements, including St John's wort.
References
Frequently Asked Questions
Zomig Nasal (zolmitriptan nasal spray) treats an acute migraine attack, with or without aura, in adults and in children aged 12 and over (US label). Use it once the headache starts; it does not prevent migraine attacks. Each spray device is for one use only and is placed in one nostril.
Zomig Nasal (zolmitriptan) is sprayed into one nostril from a single-use device. Do not prime it or press the plunger before use. The usual start is 2.5 mg, with a maximum single dose of 5 mg. Repeat after 2 hours if needed, up to 10 mg in 24 hours.
Common Zomig Nasal side effects are an unusual taste, tingling or numbness, dizziness and increased sensitivity to touch. Get emergency help for chest pain, irregular heartbeat, signs of stroke or serotonin syndrome such as agitation, sweating, fever and tremor. Frequent use may also cause medication overuse headache.
Avoid Zomig Nasal (zolmitriptan) within 24 hours of another triptan or an ergot medicine, and within 2 weeks of an MAO-A inhibitor. With cimetidine, the maximum single dose is 2.5 mg. Do not use it with heart disease, stroke history or uncontrolled high blood pressure.
Use no more than 10 mg of Zomig Nasal (zolmitriptan) in 24 hours, and wait at least 2 hours between doses. Each spray unit is single-use, so throw it away after use. Frequent use can cause medication overuse headache, so tell your healthcare provider if you need it often.
In the US, Zomig Nasal (zolmitriptan) is approved for children aged 12 to 17 as well as adults, and unusual taste and nasal discomfort were the most common effects. Safety and effectiveness are not established in younger children. Your healthcare provider decides whether it is right for you.
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