"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
No overdoses of MAXALT were reported during clinical trials in adults.
Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence.
In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.
In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea.
In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
MAXALT is contraindicated in patients with:
- Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see WARNINGS AND PRECAUTIONS].
- Coronary artery vasospasm including Prinzmetal's angina [see WARNINGS AND PRECAUTIONS].
- History of stroke or transient ischemic attack (TIA) [see WARNINGS AND PRECAUTIONS].
- Peripheral vascular disease (PVD) [see WARNINGS AND PRECAUTIONS].
- Ischemic bowel disease [see WARNINGS AND PRECAUTIONS].
- Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS].
- Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see DRUG INTERACTIONS].
- Hemiplegic or basilar migraine.
- Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
- Hypersensitivity to MAXALT or MAXALT-MLT (angioedema and anaphylaxis seen) [see ADVERSE REACTIONS].
Last reviewed on RxList: 1/5/2012
This monograph has been modified to include the generic and brand name in many instances.
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