Zecuity
Loading...Zecuity Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
ZECUITY (sumatriptan iontophoretic transdermal system) is a disposable, single use system designed to deliver sumatriptan through the skin using iontophoresis. Iontophoresis is a non-invasive method of delivering a drug through the skin using a low electrical current. The ZECUITY electronics, powered by two coin cell lithium batteries, control the amount of current applied and the rate and amount of sumatriptan delivered.
Sumatriptan succinate, the active component of ZECUITY, is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT1) agonist (triptan). Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and has the following structure:
The empirical formula is C14H21N3O2S•C4H6O4 representing a molecular weight of 413.5.
Sumatriptan succinate is a white to off-white powder that is freely soluble in water. Each ZECUITY iontophoretic transdermal system contains 86 mg sumatriptan (base) as the succinate salt in an aqueous formulation. ZECUITY, upon activation, delivers 6.5 mg of sumatriptan through the skin over 4 hours [see Dosage and Administration (2)].
ZECUITY iontophoretic transdermal system is composed of an iontophoretic device and a drug reservoir card. The reservoir card contains 2 non-woven pads and 2 different gel formulations; one a sumatriptan succinate formulation and the other a sodium salt formulation. The sumatriptan succinate formulation and pad contains the following inactive ingredients: purified water, basic butylated methacrylate copolymer (polyamine), lauric acid, adipic acid, methylparaben and a non-woven viscose pad. The salt formulation and pad contains: purified water, hydroxypropylcellulose, sodium chloride, methylparaben and a non-woven viscose pad. ZECUITY is a non-sterile product.
The iontophoretic device consists of medical grade adhesive fabric and foam and a plastic dome that contains an activation button, batteries, and electronics (see Figure 2).
Figure 2: Iontophoretic Device
The sumatriptan and salt pads are housed in individual reservoirs. Each reservoir is sealed by a foil strip that is removed prior to transfer of the pads to the iontophoretic device (see Figure 3). The iontophoretic device and foil reservoirs are co-packaged in a single unit pouch [see Patient Counseling Information (17)].
Figure 3: Reservoir Card
For ZECUITY to function, the pads must completely cover the electrodes [see Patient Counseling Information (17)].
Sources
Zecuity Manufacturers
-
Nupathe Inc.
![Zecuity (Sumatriptan Succinate) Patch, Extended Release, Electrically Controlled [Nupathe Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zecuity | Nupathe Inc.
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.
Figure 1: Applied Transdermal System
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.
Login To Your Free Account