Drug delivery through intact skin has been around for ages,1 but it’s still far from perfect. A myriad of issues continues to compromise treatment, such as adhesion.2 In addition, many pain management patches deliver only a fraction of the medicine allocated to the patch.3
See how we’ve engineered patch systems to efficiently deliver medicine through the skin. Our adhesive and pliable properties are designed to permit reliable skin contact throughout the dosing regimen.
Proprietary patch technologies
SCILEX employs anhydrous, single-layer, drug-in-adhesive, topical delivery system technology to keep its patches thin and drug delivery locally targeted.
Our patch technology utilizes a proprietary single-layer anhydrous system, allowing it to be cut into smaller sizes.
We’ve structured our patches to be flexible to the contours of the human body.
ZTLido® is indicated for relief of pain associated with post-herpetic neuralgia (PNH). Please see ZTLIdo’s Full Prescribing Information here.
ZTLido® Important Safety Information Read More
ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
Accidental exposure can occur even after a ZTLIDO patch has been used. Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used ZTLIDO patch. Store and dispose of patches properly and keep out of reach of children and pets.
Excessive dosing or overexposure to lidocaine can occur. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine. If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.
Cases of methemoglobinemia have been reported with local anesthetic use, although patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, or concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. Signs and symptoms include cyanotic skin discoloration and/or abnormal coloration of the blood and may occur immediately or may be delayed after exposure. Methemoglobin levels may continue to rise leading to more serious central nervous system and cardiovascular adverse effects. Discontinue ZTLIDO and any other oxidizing agents. Depending on severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Application site reactions can occur during or immediately after treatment with ZTLIDO. This may include development of blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Inform patients of these potential reactions and that severe skin irritation may occur with ZTLIDO if applied for a longer period than instructed.
Hypersensitivity cross-reactions may be possible for patients allergic to PABA derivatives. Manage hypersensitivity reactions by conventional means.
Eye exposure with ZTLIDO should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye (eg, eye glasses/eye wear) until sensation returns.
Side effects of ZTLIDO include application site reactions such as, irritation, erythema, and pruritus. These are not all of the adverse reactions that may occur. Please see full Prescribing Information for more information.
Use in Specific Populations
Use of ZTLIDO during lactation should be used with caution as lidocaine is excreted into breast milk. The limited human data with lidocaine in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage.
To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. Banerjee S, Chattopadhyay P, Ghosh A, Datta P, Veer V. Aspect of adhesives in transdermal drug delivery systems. Int J Adhes. 2014;50:70-84. 2. Hughes PJ, Freeman MK, Wensel TM. Appropriate use of transdermal drug delivery systems. J Nurs Educ Pract. 2013;3(10):129-138. 3. Lidoderm [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; 2015.