PATIENT INFORMATION
ZTLIDO® (ZEE-TEE-LIE-DOH) (lidocaine topical system) |
What is ZTLIDO?
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ZTLIDO is a prescription medicine used for relief of pain from damaged nerves (neuropathic pain) that follows healing of shingles. It is not known if ZTLIDO is safe and effective in children. |
Do not use ZTLIDO if you:
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- have a history of allergic reactions to numbing medicines (anesthetics). Ask your healthcare provider if you are not sure.
- are allergic to any of the ingredients in ZTLIDO. See the end of this leaflet for a complete list of ingredients in ZTLIDO.
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Before using ZTLIDO, tell your healthcare provider about all your medical conditions, including if you:
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- have liver problems
- have heart or lung problems
- are allergic to para-aminobenzoic acid (PABA) medicines such as procaine, tetracaine, or benzocaine
- have been told that you have glucose-6-phosphate dehydrogenase deficiency
- were born with (congenital) methemoglobinemia or have had methemoglobinemia from an unknown cause
- are pregnant or plan to become pregnant. It is not known if ZTLIDO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. ZTLIDO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZTLIDO.
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you are using other lidocaine containing products or anesthetic medicines.
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How should I use ZTLIDO?
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Read the Instructions for Use at the end of this Patient Information leaflet for information about how to apply the ZTLIDO topical system.
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- Use ZTLIDO exactly as your healthcare provider tells you to use it.
- Do not apply more than your prescribed number of ZTLIDO. You may apply up to 3 ZTLIDO topical systems at one time.
- A ZTLIDO may be worn only 1 time for up to 12 hours within a 24-hour period (12 hours on and 12 hours off).
- Apply ZTLIDO to intact skin only. Do not apply ZTLIDO to skin that is not intact, such as skin that is cut, scraped, burned, or irritated.
- ZTLIDO topical systems that come off completely or are lifting at the edges may be reattached by firmly pressing down on the topical system or on the lifted areas.
- If ZTLIDO lifts off the skin or detaches more than 1 time, do not try to reattach it. Throw it away as described below.
- If the ZTLIDO you are wearing comes off completely, and will not stick to your skin, throw it away as described below.
In either of these cases, you may apply a replacement (a new) ZTLIDO topical system. Take off the replacement ZTLIDO at your usual removal time. The total time you may wear the used and replacement ZTLIDO is 12 hours.
- You may wear clothing over the ZTLIDO application site.
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Do not apply external heat sources, such as heating pads or electric blankets, directly on ZTLIDO. This may cause increased levels of lidocaine in your blood. You may apply ZTLIDO to a treatment site after moderate heat exposure, such as after 15 minutes of heating pad use on a medium setting.
- ZTLIDO may be used during moderate exercise, such as biking for 30 minutes.
- ZTLIDO may be worn in water such as showering for 10 minutes or bathing for 15 minutes.
- After ZTLIDO is exposed to water, pat the topical system dry. Do not rub the topical system.
- After using ZTLIDO, fold the used ZTLIDO so that the sticky sides stick together. Safely throw away used ZTLIDO and any pieces of cut ZTLIDO where children and pets cannot get to them.
- Wash your hands right away after handling ZTLIDO (after you apply ZTLIDO, when you try to re-attach it, or when you remove it.)
- If you start feeling irritation or burning when applying ZTLIDO, remove the ZTLIDO. Do not reapply ZTLIDO until the irritation or burning goes away.
- If you apply more than 3 ZTLIDO topical systems or apply ZTLIDO for longer than 12 hours of a 24-hour period, call your healthcare provider.
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What should I avoid while using ZTLIDO?
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- Avoid contact of your hands and fingers with your eyes while handling ZTLIDO. See "Contact of ZTLIDO with your eyes" below.
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What are the possible side effects of ZTLIDO?
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ZTLIDO may cause serious side effects, including:
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Lidocaine overdose can happen if you apply more than the prescribed number of ZTLIDO, applying ZTLIDO for longer than 12 hours, have liver problems, use ZTLIDO on skin that is not intact, or if you apply external heat sources directly on ZTLIDO. This can result in increased levels of lidocaine in your blood.
- Do not apply more than the prescribed number of ZTLIDO.
- Do not wear ZTLIDO longer than 12 hours.
- Do not apply ZTLIDO on skin that is not intact, such as skin that is cut, scraped, burned, or irritated.
- Do not apply external heat sources directly to ZTLIDO. See "
How should I use ZTLIDO?
" for more information about how to properly use external heat sources when using ZTLIDO.
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A serious blood problem called methemoglobinemia. Methemoglobinemia is a serious blood problem where to much methemoglobin is produced in the blood. Methemoglobinemia can happen with the use of local anesthetics and may not let enough oxygen reach the organs and tissues in your body. Anyone who uses or receives local anesthetics is at risk for methemoglobinemia, but certain people are more likely to have serious medical problems and need to be closely monitored by their healthcare provider during treatment with ZTLIDO, including:
- people with glucose-6-phosphate dehydrogenase deficiency
- people with heart of lung problems
- babies under 6 months of age
- people who were born with (congenital) or who have had methemoglobinemia from an unknown cause
- people exposed to certain chemicals at the same time that they use or receive a local anesthetic
Signs of methemoglobinemia can happen right away or they may not happen for some hours after your have used or received a local anesthetic. It is important to get medical treatment right away to help prevent more serious side effects including seizures, coma, abnormal heart rhythms, and death.
You or your caregiver should stop using ZTLIDO and get medical help right away if you develop any of the following signs or symptoms:
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- pale, gray, or blue colored skin
- headache
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- rapid heart beat
- shortness of breath
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- lightheadedness
- tiredness
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Application site reactions. Skin irritation and other skin reactions at the ZTLIDO application site are common and are usually mild. These reactions can happen during or right after treatment with ZTLIDO. Application site reactions will usually go away within a few minutes to hours. Symptoms of application site reactions may include:
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- blisters
- bruising
- burning or abnormal sensation
- change or loss of color of your skin
- swelling, redness, and pain of the skin
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- peeling or flaking of skin
- irritation
- pimple-like raised skin
- itching
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If you develop a skin reaction while wearing ZTLIDO, remove it. Do not reapply ZTLIDO until the site reaction goes away. |
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Allergic reactions can happen if you have a history of allergic reactions to numbing medicines (anesthetics). Tell your healthcare provider right away if you have any symptoms of an allergic reaction such as swelling or shortness of breath.
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Contact of ZTLIDO with your eyes can happen if you touch your eyes while handling the topical system and can cause severe eye irritation. Avoid eye contact with your hands and fingers while handling ZTLIDO. Wash your hands right away after handling ZTLIDO. If the medicine in ZTLIDO comes in contact with your eye, wash out your eye with water or saline right away. Protect the eye (for example eye glasses or eye wear) until the numbness goes away.
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These are not all the possible side effects of ZTLIDO. |
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store ZTLIDO?
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- Store ZTLIDO at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ZTLIDO topical system in the original packaging unit until ready for use.
- Each ZTLIDO topical system comes in a child-resistant envelope.
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Keep ZTLIDO and all medicines out of the reach of children, pets, and others.
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General information about the safe and effective use of ZTLIDO.
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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZTLIDO for a condition for which it was not prescribed. Do not give ZTLIDO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZTLIDO that is written for health professionals. |
What are the ingredients in ZTLIDO?
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Active ingredient: lidocaine |
Inactive ingredients: butylated hydroxytoluene, dipropylene glycol, isostearic acid, mineral oil, polyisobutylene, silicone dioxide, styrene/isoprene/styrene block copolymer, and terpene resin. |
Manufactured for: Scilex Pharmaceuticals Inc., Palo Alto, CA 94303 |
ZTLIDO® is a trademark owned by Scilex Pharmaceuticals Inc. © 2021 Scilex Pharmaceuticals Inc. All rights reserved. |
SCILEX®
PHARMACEUTICALS |
For more information call [1-844-SCILEX1] or visit www.ZTLIDO.com. |