IMITREX spray patient counseling information
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events: Inform patients that IMITREX Nasal Spray may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)].
Anaphylactic/Anaphylactoid Reactions: Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving IMITREX Nasal Spray. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) and Warnings and Precautions (5.10)].
Concomitant Use With Other Triptans or Ergot Medications: Inform patients that use of IMITREX Nasal Spray within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) and Drug Interactions (7.1, 7.3)].
Serotonin Syndrome: Caution patients about the risk of serotonin syndrome with the use of IMITREX Nasal Spray or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].
Medication Overuse Headache: Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].
Pregnancy: Inform patients that IMITREX Nasal Spray should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].
Nursing Mothers: Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)]. Ability to Perform Complex Tasks: Treatment with IMITREX Nasal Spray may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX Nasal Spray.
Local Irritation: Inform patents that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.
How to Use IMITREX Nasal Spray: Provide patients instruction on the proper use of IMITREX Nasal Spray. Caution patients to avoid spraying the contents of the device in their eyes. Imitrex is a registered trademark of the GlaxoSmithKline group of companies.[1]
References
Adapted from the FDA Package Insert.