Sumatriptan (transdermal)

Sumatriptan (transdermal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Sumatriptan (transdermal) is a serotonin (5HT) 1b/1d receptor agonist that is FDA approved for the treatment of migraine with or without aura in adults. Common adverse reactions include application site pain, paresthesia, pruritus, warmth, and discomfort.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• ZECUITY is indicated for the acute treatment of migraine with or without aura in adults.

• Limitations of Use:

• Use only if a clear diagnosis of migraine has been established.
• If a patient has no response to the first migraine attack treated with ZECUITY reconsider the diagnosis of migraine before ZECUITY is administered to treat any subsequent attacks.
• ZECUITY is not intended for the prevention of migraine attacks.

Dosage

ZECUITY is for transdermal use only and is designed for patient self-administration to the upper arm or thigh (see Figure 1). ZECUITY should not be applied to other areas of the body. ZECUITY should not be cut.

The maximum recommended single dose is one ZECUITY iontophoretic transdermal system (TDS). No more than two ZECUITY TDS should be used in any 24 hour period, and the second ZECUITY TDS should be applied no sooner than 2 hours after activation of the first ZECUITY TDS. There is no evidence of benefit for the use of a second ZECUITY TDS to treat headache recurrence or incomplete headache relief during a migraine attack.

ZECUITY should be applied to dry intact, non-irritated skin on the upper arm or thigh on a site that is relatively hair free and is without scars, tattoos, abrasions, or other skin conditions (i.e., generalized skin irritation or disease including eczema, psoriasis, melanoma, contact dermatitis). ZECUITY should not be applied to a previous application site until the site remains erythema free for at least 3 days.

File:ZECUITY1.jpeg.png

This image is provided by the National Library of Medicine.

ZECUITY delivers 6.5 mg of sumatriptan over 4 hours. Once applied, the activation button must be pushed, and the red light emitting diode (LED) will turn on. ZECUITY TDS must be applied and activated within 15 minutes of initiation of assembly. When dosing is completed, the system stops operating and the activation light turns off, signaling that the system can be removed. Once dosing is completed, the system cannot be reactivated. If the light turns off before 4 hours, dosing has stopped and ZECUITY can be removed. If headache relief is incomplete, a second ZECUITY TDS can be applied to a different site. [see Patient Counseling Information (17)].

The ZECUITY TDS should remain in place for 4 hours or until the red LED light goes off. The iontophoretic device can be secured with medical tape if needed.

The safety of using more than 4 ZECUITY in one month has not been established.

ZECUITY is for single use only. After use, the TDS should be folded so the adhesive side sticks to itself and safely discarded away from children and pets. ZECUITY contains lithium-manganese dioxide batteries; it should be disposed in accordance with state and local regulations.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sumatriptan (transdermal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sumatriptan (transdermal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sumatriptan (transdermal) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sumatriptan (transdermal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sumatriptan (transdermal) in pediatric patients.

Contraindications

ZECUITY is contraindicated in patients with:

Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.3)]. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.4)]. History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.6)]. Peripheral vascular disease [see Warnings and Precautions (5.7)]. Ischemic bowel disease [see Warnings and Precautions (5.7)]. Uncontrolled hypertension [see Warnings and Precautions (5.10)]. Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions (7.1, 7.3)]. Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of a MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Known hypersensitivity to sumatriptan or components of ZECUITY [see Warnings and Precautions (5.2, 5.11)]. Severe hepatic impairment [see Clinical Pharmacology (12.3)]. Allergic contact dermatitis to ZECUITY [see Warnings and Precautions (5.2)].

Warnings

There is limited information regarding Sumatriptan (transdermal) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sumatriptan (transdermal) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sumatriptan (transdermal) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sumatriptan (transdermal) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sumatriptan (transdermal) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sumatriptan (transdermal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sumatriptan (transdermal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sumatriptan (transdermal) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sumatriptan (transdermal) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sumatriptan (transdermal) in geriatric settings.

Gender

There is no FDA guidance on the use of Sumatriptan (transdermal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sumatriptan (transdermal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sumatriptan (transdermal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sumatriptan (transdermal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sumatriptan (transdermal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sumatriptan (transdermal) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sumatriptan (transdermal) Administration in the drug label.

Monitoring

There is limited information regarding Sumatriptan (transdermal) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sumatriptan (transdermal) and IV administrations.

Overdosage

There is limited information regarding Sumatriptan (transdermal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sumatriptan (transdermal) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sumatriptan (transdermal) Mechanism of Action in the drug label.

Structure

There is limited information regarding Sumatriptan (transdermal) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sumatriptan (transdermal) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sumatriptan (transdermal) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sumatriptan (transdermal) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sumatriptan (transdermal) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sumatriptan (transdermal) How Supplied in the drug label.

Storage

There is limited information regarding Sumatriptan (transdermal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sumatriptan (transdermal) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sumatriptan (transdermal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sumatriptan (transdermal) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sumatriptan (transdermal) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.