Rizatriptan patient counseling information: Difference between revisions
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== | ==Patient Counseling Information== | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d93286f5-99f7-4dc5-aa9d-ad73ab8490db | publisher = | date = | accessdate = }}</ref> | See FDA-Approved Patient Labeling (Patient Information). | ||
Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events | |||
Inform patients that MAXALT 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, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)]. | |||
====Serotonin Syndrome==== | |||
Patients should be cautioned about the risk of serotonin syndrome with the use of MAXALT 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), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. | |||
====Pregnancy==== | |||
Inform patients that MAXALT 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==== | |||
Since migraines or treatment with MAXALT may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of MAXALT. | |||
====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)]. | |||
====Handling of Orally Disintegrating Tablets Packages==== | |||
Instruct patients not to remove the blister from the outer aluminum pouch until ready to use the orally disintegrating tablet inside [see Dosage and Administration (2.3)]. | |||
====Patients with Phenylketonuria==== | |||
Inform phenylketonuric patients that MAXALT-MLT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 1.1 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 2.1 mg phenylalanine [see Use in Specific Populations (8.6)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d93286f5-99f7-4dc5-aa9d-ad73ab8490db | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 07:27, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Patient Counseling Information
See FDA-Approved Patient Labeling (Patient Information).
Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events Inform patients that MAXALT 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, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)].
Serotonin Syndrome
Patients should be cautioned about the risk of serotonin syndrome with the use of MAXALT 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), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].
Pregnancy
Inform patients that MAXALT 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
Since migraines or treatment with MAXALT may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of MAXALT.
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)].
Handling of Orally Disintegrating Tablets Packages
Instruct patients not to remove the blister from the outer aluminum pouch until ready to use the orally disintegrating tablet inside [see Dosage and Administration (2.3)].
Patients with Phenylketonuria
Inform phenylketonuric patients that MAXALT-MLT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 1.1 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 2.1 mg phenylalanine [see Use in Specific Populations (8.6)].[1]
References
Adapted from the FDA Package Insert.