sumatriptan transdermal (Discontinued)

Brand and Other Names:Zecuity
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Dosing & Uses

AdultPediatric

transdermal patch (iontophoretic transdermal system)

6.5mg/4hr

Migraine Headache

October 2017: Manufacturer has discontinued the product and it is no longer available

NOTE (June 2016): Transdermal patch sales and distribution temporarily suspended to investigate the cause of burns and scars associated with the patch

Indicated for acute treatment of migraine with or without aura

Apply one 6.5 mg transdermal patch to dry, intact, non-irritated skin of upper arm or thigh at onset of migraine (see Administration section for instruction on how to activate iontophoretic system within the patch)

May apply a second patch if inadequate migraine relief after 2 hr; not to exceed 2 patches in 24 hr

Patch should not be applied to a previous application site until that site remains erythema free for at least 3 days

Do not cut the patch

Safety of using more than 4 patches in 1 month has not been established

Also see Administration

Safety and efficacy not established

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Interactions

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and sumatriptan transdermal

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    Contraindicated

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            Adverse Effects

            >10%

            Application site pain (4-26%)

            1-10%

            Application site paresthesia (9%)

            Application site pruritus (8%)

            Application site warmth (6%)

            Application site discomfort (6%)

            Skin discoloration (3-5%)

            Contact dermatitis (4%)

            Application site irritation (4%)

            Vesicles (3%)

            Bruising (2%)

            <1%

            Skin erosion (0.4%)

            Frequency Not Defined

            Myocardial ischemia

            Arrhythmias

            Pain/tightness/pressure of chest, throat, neck and/or jaw

            Cerebral hemorrhage, subarachnoid hemorrhage, and stroke

            Noncoronary vasospastic reactions (eg, peripheral vascular ischemia, GI vascular ischemia and infarction)

            Medication overuse headache

            Serotonin syndrome Increased blood pressure

            Anaphylaxis

            Seizures

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            Warnings

            Contraindications

            Ischemic coronary artery disease (CAD) or coronary artery vasospasm; includes angina pectoris, MI, documented silent ischemia, Prinzmetal’s angina

            Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders

            History of stroke, TIA, hemiplegic or basilar migraine (higher stroke risk)

            Peripheral vascular disease

            Ischemic bowel disease

            Uncontrolled hypertension

            Use within 24 hr of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist

            Coadministration of an MAO-A inhibitor or use of MAO-A inhibitor within 2 weeks

            Hypersensitivity

            Severe hepatic impairment

            Allergic contact dermatitis

            Cautions

            Clear diagnosis of migraine headache has been established

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)

            Risk of injury during MRI; patch must be removed before MRI procedure

            Allergic contact dermatitis reported; discontinue patch if suspected

            Cardiovascular evaluation should be performed in triptan-naïve patients who have multiple cardiovascular risk factors (increased age, diabetes, hypertension, smoking, obesity, family history)

            Arrhythmias reported, including ventricular tachycardia and ventricular fibrillation

            Tightness, pain, pressure, and heaviness in the chest, throat, neck and jaw reported

            Cerebral hemorrhage, subarachnoid hemorrhage, and stroke reported

            Noncoronary vasospasm reactions reported, including peripheral vascular ischemia, gastrointestinal vascular ischemia and infarct, splenic infarction, and Raynaud’s syndrome

            Significant partial vision loss, and transient and permanent blindness reported; causal relationship not clearly established since visual disorders may be part of migraines

            Serotonin syndrome may occur, particularly when coadministered with SSRIs, SNRIs, TCAs, and MAOIs; symptoms include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms

            Increased blood pressure, including hypertensive crisis reported (rare)

            Anaphylactic/anaphylactoid reactions reported

            Seizures reported; use with caution in patients with history of epilepsy or conditions associated with a lowered seizure threshold

            Should not be applied in areas near or over electrically-active implantable or body-worn medical devices (eg, cardiac pacemaker, insulin pump, deep brain stimulator)

            Advise patients not to bathe, shower, or swim while wearing sumatriptan patch

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            Pregnancy & Lactation

            Pregnancy Category: C

            Reproductive toxicity studies for sumatriptan by transdermal route have not been conducted; embryolethality and blood vessel abnormalities observed with PO or IV doses in pregnant rabbits during organogenesis

            Lactation: Excreted in breast milk in very low levels (NLM Toxnet); minimize infant to potential exposure by avoiding breastfeeding for 8-12 hr after administration

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Selective 5-HT1 receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache; agonist effects specifically at the 5-HT 1B/1D receptors on intracranial blood vessels and trigeminal nerves result in cranial vessel constrictions and inhibition of pro-inflammatory neuropeptide release (substance P and calcitonin gene-related peptide)

            Other pharmacodynamic actions include increased blood pressure and increased peripheral resistance

            Absorption

            Peak plasma time: 1.1 hr

            Peak plasma concentration: 22 ng/mL

            AUC: 110 hr•ng/mL

            Cmax and AUC of transdermal application ~37% and 45% the values measured following sumatriptan 100 mg PO

            Distribution

            Protein bound: 14-21%

            Vd: 2.4 L/kg

            Metabolism

            Metabolized by monamine oxidase (predominantly MAO-A)

            Metabolites (inactive): Indole acetic acid (IAA) or the IAA glucuronide

            Elimination

            Half-life: 3.1 hr

            Excretion: 11% urine (unchanged); 69% urine (IAA metabolite)

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            Administration

            Transdermal Administration

            Disposable, single use transdermal system designed to deliver sumatriptan through the skin using iontophoresis (noninvasive method of delivering a drug through the skin using a low electrical current); patch powered by 2 coin cell lithium batteries

            Apply patch to dry, intact, nonirritated skin of upper arm or thigh; may secure with medical tape if needed

            Within 15 minutes of applying the patch, push the application button to activate the iontophoretic transdermal system (red light will turn on)

            When dosing is completed at 4 hr, the system stops operating (red light turns off) and the patch may be removed; system cannot be reactivated If the light turns off before 4 hr, dosing has stopped and the patch may be removed

            Fold the adhesive sides together for disposal; patch contains lithium-manganese dioxide batteries and should be disposed in accordance with state and local regulations

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