sumatriptan [Transdermal]

Adult Dosing

Acute migraine attacks with or without aura

6.5mg/4hr
No more than two transdermal systems should be used in any 24 hour period; second transdermal system should be used no sooner than 2 hours after activation of first.

Pediatric Dosing

Safety and effectiveness in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Acute migraine attacks with or without aura

Hypersensitivity to any of the ingredients of the product
Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
Hx of stroke
Hx of transient ischemic attack
Hx of hemiplegic or basilar migraine
Peripheral vascular disease
Ischemic bowel disease
Uncontrolled hypertension
Concurrent (or within 24 hr) use of other 5-HT1 agonists, ergotamine, or ergot-type medications
Concurrent (or within 2 wk) use of MAO inhibitors
Severe hepatic impairment
Allergic contact dermatitis

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Mild-moderate hepatic impairment: Dose adjustments not defined
Severe hepatic impairment: Use contraindicated

Transdermal patch contains metal parts which may cause injury during magnetic resonance imaging (MRI) procedure; hence must be removed before an MRI procedure
Therapy may lead to allergic contact dermatitis (ACD). If ACD is suspected, therapy should be discontinued
Erythema, erythematous plaque and/or erythemato-vesicular or erythemato-bullous eruptions may develop during therapy
Patients sensitized from use of patch may develop systemic sensitization or other systemic reactions if sumatriptan-containing products are taken via other routes, e.g., orally or subcutaneously
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Use is contraindicated in patients with ischemic or vasospastic CAD
Before initiating therapy in triptan-naive patients who have multiple cardiovascular risk factors such as increased age, diabetes, hypertension, smoking, obesity, or strong family history of CAD, a cardiovascular evaluation should be performed
Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists
Sensations of tightness, pain, pressure, and heaviness in the chest, throat, neck, and jaw commonly occur after treatment with sumatriptan
5-HT1 agonists have been associated with cerebral hemorrhage, subarachnoid hemorrhage, and stroke
5-HT1 agonists, including sumatriptan, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome
5-HT1 agonists may lead to transient and permanent blindness and significant partial vision loss
Overuse may lead to exacerbation of headache
During coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors, serotonin syndrome characterized by symptoms such as mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) may occur
Rarely, 5-HT1 agonists have been associated with significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems. Closely monitor blood pressure
Anaphylactic/anaphylactoid fatal and life threatening reactions have occurred in patients receiving sumatriptan
Seizures have been reported following administration of sumatriptan. Use cautiously in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
Patch should not be applied in areas near or over electrically-active implantable or body-worn medical devices (e.g., implantable cardiac pacemaker, body-worn insulin pump, implantable deep brain stimulator)

Pregnancy Category:C

Breastfeeding: It is not known whether sumatriptan is excreted in human milk following transdermal administration. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

NEURO: Cerebrovascular events, paresthesia
DERM: Allergic contact dermatitis, pruritus
CV: Increase in blood pressure, myocardial ischemia, myocardial infarction, and Prinzmetal’s angina, arrhythmias
EENT: Chest, throat, neck, and/or jaw pain/tightness/pressure
HYPERSENSITIVITY: Application site pain, anaphylactic/anaphylactoid reactions

5-HT1B/1D receptor agonist; binds to 5-HT1B/1D receptors located on intracranial blood vessels and activates vascular serotonin receptors; produces vasoconstriction
Metabolized by MAO to inactive metabolites: indole acetic acid (IAA) or the IAA glucuronide
Excretion: Urine (11%) and 69% in urine (IAA metabolite)
Half-life: 3.1 hours