Frovatriptan patient counseling information: Difference between revisions
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===Medication Overuse Headache=== | ===Medication Overuse Headache=== | ||
Inform patients that use of drugs to treat acute | Inform patients that use of drugs to treat acute [[migraine]]s 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=== | ===Serotonin Syndrome=== | ||
Inform patients about the risk of serotonin syndrome with the use of FROVA or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.3)]. | Inform patients about the risk of serotonin syndrome with the use of FROVA or other triptans, particularly during combined use with [[SSRIs]], [[SNRIs]], TCAs, and [[MAO]] inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.3)]. | ||
===Pregnancy=== | ===Pregnancy=== | ||
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Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)]. | Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)]. | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0703630-9ce8-4259-841e-71fd2019fa66 | publisher = | date = | accessdate = 7 February 2014 }}</ref> | <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0703630-9ce8-4259-841e-71fd2019fa66 | publisher = | date = | accessdate = 7 February 2014 }}</ref> | ||
==References== | ==References== | ||
Revision as of 19:04, 7 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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 FROVA 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, and 5.8)].
Anaphylactic/Anaphylactoid Reactions
Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving FROVA. 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)].
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 FROVA or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.3)].
Pregnancy
Inform patients that FROVA 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
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)]. [1]
References
- ↑ "FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]". Retrieved 7 February 2014.