Zolmitriptan patient counseling information: Difference between revisions
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== | ==Patient Counseling Information== | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK GENERICS INC.,USA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a734b368-6008-441c-ab44-5634e46be9a4 | publisher = | date = | accessdate = }}</ref> | See FDA Approved Patient Labeling (Patient Information). | ||
====Myocardial Ischemia and/or Infarction, Prinzmetal’s angina, Other Vasospastic Reactions, and Cerebrovascular Events==== | |||
Inform patients that zolmitriptan may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. | |||
====Medication Overuse Headache==== | |||
Inform patients that use of drugs to treat acute migraines 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)]. | |||
====Serotonin Syndrome==== | |||
Inform patients about the risk of serotonin syndrome with the use of zolmitriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7)]. | |||
====Pregnancy==== | |||
Inform patients that zolmitriptan 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)]. | |||
====Handling of Zolmitriptan Orally Disintegrating Tablets==== | |||
Inform patients not to break zolmitriptan orally disintegrating tablets. Inform patients that the orally disintegrating tablet is packaged in a blister. Instruct patients not to remove the orally disintegrating tablet from the blister until just prior to dosing. Instruct patients that prior to dosing, peel open the blister pack and place the orally disintegrating tablet on the tongue, where it will dissolve and be swallowed with the saliva [see Dosage and Administration (2.2)]. | |||
====Patients with Phenylketonuria==== | |||
Inform patients with phenylketonuria (PKU) that zolmitriptan orally disintegrating tablets contain phenylalanine (a component of aspartame) [see Warnings and Precautions (5.9)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK GENERICS INC.,USA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a734b368-6008-441c-ab44-5634e46be9a4 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 03:35, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Patient Counseling Information
See FDA Approved Patient Labeling (Patient Information).
Myocardial Ischemia and/or Infarction, Prinzmetal’s angina, Other Vasospastic Reactions, and Cerebrovascular Events
Inform patients that zolmitriptan may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)].
Medication Overuse Headache
Inform patients that use of drugs to treat acute migraines 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)].
Serotonin Syndrome
Inform patients about the risk of serotonin syndrome with the use of zolmitriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7)].
Pregnancy
Inform patients that zolmitriptan 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)].
Handling of Zolmitriptan Orally Disintegrating Tablets
Inform patients not to break zolmitriptan orally disintegrating tablets. Inform patients that the orally disintegrating tablet is packaged in a blister. Instruct patients not to remove the orally disintegrating tablet from the blister until just prior to dosing. Instruct patients that prior to dosing, peel open the blister pack and place the orally disintegrating tablet on the tongue, where it will dissolve and be swallowed with the saliva [see Dosage and Administration (2.2)].
Patients with Phenylketonuria
Inform patients with phenylketonuria (PKU) that zolmitriptan orally disintegrating tablets contain phenylalanine (a component of aspartame) [see Warnings and Precautions (5.9)].[1]
References
Adapted from the FDA Package Insert.