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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/16/2011
 
Trade Name:  Maxalt and Maxalt-MLT
 
Generic Name or Proper Name (*):  rizatriptan
 
Indications Studied:  Treatment of migraine
 
Label Changes Summary:  * Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.* Safety and effectiveness in pediatric patients under 6 years of age have not been established.* Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been established* Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)* The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adults* Hallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial * Information on dosing, adverse reactions, clinical trial, and overdose
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  09/20/2011
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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