ZOMIG NASAL SPRAY

Zomig is a brand name of a generic medicine: Zolmitriptan. It is a prescription nasal spray that got FDA approval in 2003 for the acute treatment of migraines that have already been set about in adults and children aged above 12 years. However, it is not indicated for preventing headaches and reducing the number of migraine attacks.

Zomig is a registered trademark of Grunenthal GmbH developed by AstraZeneca Canada Inc. It contains Zolmitriptan as its active ingredient. Zolmitriptan is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor. It’s a white to off-white powder with the chemical name: (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl] methyl]-2-oxazolidinone.

Zomig nasal spray is clear to the pale yellow hypertonic solution of Zolmitriptan in an aqueous buffered solution (pH 5) containing the following ingredients: disodium phosphate dodecahydrate USP, citric acid, purified water USP, and anhydrous, USP. Zolmitriptan is readily soluble in water. Its active ingredient is Zolmitriptan, which belongs to a class of drugs known as triptans. Triptans work by narrowing blood vessels in the brain and reducing the release of certain chemicals that are believed to trigger migraines.

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Zomig Nasal Spray belongs to the pharmacological class Antimigraine agents, Serotonin 5 HT- Receptor Agonists.

Serotonin 5 HT- Receptor Agonists are abortive anti-migraine agents that can terminate established moderately severe to severe migraine attacks. These agents bind to 5-HT receptors in the brain and stimulate them to constrict the blood vessels and prevent inflammation. They inhibit the release of serotonin- a chemical messenger that is known for triggering headache pain, sensitivity to sound and light, nausea, and other migraine symptoms.

Zomig nasal spray comes in two strengths:

• 2.5 mg of Zolmitriptan in a 100µL unit dose aqueous buffered solution.
• 5 mg of Zolmitriptan in a 100µL unit dose aqueous buffered solution.

Both strengths of Zomig nasal spray are intended for nasal administration and are available as a ready-to-use unit dose. The nasal spray is designed to provide quick relief from migraine symptoms, such as headache, nausea, and sensitivity to light and sound.

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Zomig nasal spray is taken only to treat migraines with or without aura that has been diagnosed by a doctor:

• Migraine is a severe headache believed to be the result of the widening of blood vessels around the brain. Initially, a migraine headache starts as a dull ache around the temple or eye.
• The headache may grow in intensity on body movements and may increase to the point that it interferes with daily activities. Migraine headaches occur as pulsing, throbbing, or pounding pain in one or both sides of the head. They may be associated with nausea and vomiting or/and sensitivity to light, smell, or loud sound.

Dosing information for Adults with Major Depressive Disorder:

• The suggested initial dose of Zomig Nasal Spray for adults or children aged above 12 years is 2.5mg.
• The prescribed maximum dose is 10 mg in any 24 hours. This means using 5mg nasal spray twice a day.
• If symptoms of migraine persist or return after a transient improvement, the recommended dose can be repeated after every 2 hours.
• If using Zomig Nasal Spray along with Cimetidine, the suggested maximum dose is 5mg in a day.

Zomig is a nasal spray so the medication (Zolmitriptan) is administered through the nose by spraying only one nostril. While using Zomig nasal spray, the head must be kept slightly tilted back and after spraying nasal breathing should be gentle for 5-10 seconds.

To use Zomig nasal spray:

• Remove the cap and prime the bottle.
• Tilt your head slightly back.
• Close one nostril and insert the nozzle into the other nostril.
• Point the nozzle back and press down to release one spray.
• Keep your head tilted back and breathe gently for 5-10 seconds.

Repeat if instructed, following dosage guidelines.

The commonly reported side effects of using Zomig nasal spray include:

• Unpleasant or unusual taste.
• Tiredness
• Weakness
• Vomiting
• Dizziness or Drowsiness
• A sick feeling
• Dry mouth
• Stomach ache
• Headache
• The discomfort felt inside the nose or throat.
• Muscular aches
• Troubled swallowing
• Bleeding nose
• Increase in urine production and frequency of urination.

Zomig nasal spray may rarely result in serious side effects. Some of these are:

• Spasms of the blood vessels of the heart, gastrointestinal tract, or spleen with or without infarctions.
• Signs of heart attack.
• Severe sudden abdominal pain or bloody diarrhea.
• Irregular or fast heartbeat.
• Signs of stroke
• Signs of high serotonin levels in the body.
• Pain sensation in the chest, jaw, throat, neck, arms, or legs.
• Allergic reactions.

Some drugs, herbal products, supplements, or substances known to interact with Zomig nasal spray include:

• Opioids- a narcotic drug
• Medications for a psychiatric disorder
• Anti-depressants
• Medications to treat vomiting and nausea
• Other 5 HT1 agonist migraine medications
• Medications to treat stomach ulcers or upset stomach such as cimetidine
• Herbal remedies having St. John’s Wort
• Antibiotics belonging to the Quinolone family such as Ciprofloxacin.

Zomig Nasal Spray is not safe for use by patients who:

• Are allergic to Zolmitriptan or any other ingredient of Zomig Nasal Spray
• Have uncontrolled or severe hypertension
• Have a common tension headache, a headache that paralyzes one side of the body, or any headache that is different from usual migraine headaches
• Have a heart problem- like myocardial infarction and angina pectoris
• Have earlier experienced transient ischemic attack or stroke
• Suffers from chest pain due to exertion or has Prinzmetal’s Angina condition
• Suffers from ischemic bowel disease, peripheral vascular disease, or Wolff-Parkinson-white syndrome
• Suffers from moderate to severe hepatic impairment
• Have recently used or concurrently use another serotonin 5-HT- Receptor Antagonists or MAO inhibitors are children aged below 12 years

• Before using Zomig nasal spray, ask a doctor if it’s safe to use during your pregnancy or breastfeeding.
• Inform the doctor before starting to use Zomig nasal spray, about your current intake of medications, and your illnesses (if any) or allergies. Confirm its safety before use.
• Do not use Zomig nasal spray within 24 hours before or after using any other migraine medication.
• Avoid driving or doing any activity that requires an alert mind as the drug can cause drowsiness.
• Follow the doctor’s instructions and prescription while using Zomig nasal spray.

• Store the nasal spray at controlled room temperature (between 15-30 ℃) away from direct heat and moisture.
• Keep it safe from small children and pets.

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