Myguard Nasal Spray(Zolmitriptan)

Therapeutic Group: Antimigraine

Presentation

Myguard Nasal Spray: Each spray delivers Zolmitriptan USP 5 mg.

Description

Zolmitriptan is an antimigraine agent. It binds with high affinity to 5-HT1B/1D receptors. The therapeutic activity of Zolmitriptan for the treatment of migraine headache can most likely be attributed to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system which results in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Indications

Zolmitriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.

Dosage & Administration

The maximum recommended single dose is 1 spray (5 mg) in one nostril. The maximum daily dose should not exceed 2 sprays (10 mg) in any 24-hour period.

Side Effects

Sore or irritated nose, sensitive skin, especially around the nose, dry mouth, unusual taste in the mouth, nausea, tiredness, dizziness, weakness, burning or tingling feeling, pain, tightness, pressure, or heaviness in the chest, throat, neck, or jaw, slow or difficult speech, faintness, breaking out in a cold sweat, problems with vision, weakness or numbness of an arm or leg, fast, pounding, or irregular heartbeat, bloody diarrhea, vomiting, sudden or severe stomach pain, sudden weight loss, paleness or blue color of the fingers and toes, shortness of breath, swelling of the eyes, face, lips, tongue, or throat, difficulty breathing or swallowing, rash, hoarseness, pain.

Precautions

• Myocardial Ischemia, Myocardial Infarction and Prinzmetal’s Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors.
• Arrhythmias: Discontinue dosing if occurs.
• Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs.
• Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs.
• Medication Overuse Headache: Detoxification may be necessary.
• Serotonin syndrome: Discontinue dosing if occurs.
• Increase in blood pressure: very rarely associated with significant events.

Use in Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women and lactating mother.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Geriatric patients: Safety and effectiveness in aged 65 and over have not been established.

Drug Interaction

Zolmitriptan nasal spray is contraindicated with Ergot containing drugs, Monoamine Oxidase-A Inhibitors, Other 5-HT1 Agonists, Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors.

Over Dose

There is no experience with acute overdose.

Storage

Do not store above 30 ºC. Keep away from light and out of the reach of children.

Commercial Pack

Myguard Nasal Spray: Each bottle contains Zolmitriptan clear solution adequate for 60 metered doses.