Generic name: Lidocaine Topical System
Drug class: Topical anesthetics
Medically reviewed by A Ras MD.
What is ZTlido?
ZTlido is a prescription medicine that is used to ease pain caused by shingles. ZTlido may be given to you for other reasons.
ZTLIDO (lidocaine topical system) 1.8% is a single-layer, drug-in-adhesive topical delivery system comprised of an adhesive material containing 36 mg lidocaine, which is applied to a pliable nonwoven cloth backing and covered with a polyethylene terephthalate film release liner. The release liner is removed prior to application to the skin. The size of ZTLIDO is 10 cm × 14 cm × 0.08 cm.
Lidocaine, an amide local anesthetic, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:
Each ZTLIDO contains 36 mg of lidocaine (18 mg per gram adhesive) in a non-aqueous base and also contains the following inactive ingredients: butylated hydroxytoluene, dipropylene glycol, isostearic acid, mineral oil, polyisobutylene, silicone dioxide, styrene/isoprene/styrene block copolymer, and terpene resin.
Mechanism of Action
Lidocaine is an amide local anesthetic. Lidocaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses.
Before taking ZTlido, tell your doctor:
- If you are allergic to ZTlido; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If there is an infection where ZTlido will be used.
- If you have broken skin or open wounds where the drug will be used.
- If you have swollen skin, numbness, or are not able to feel pain where the drug will be used.
- If a large area needs to be treated.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ZTlido with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take ZTlido?
- Tell all of your health care providers that you take ZTlido. This includes your doctors, nurses, pharmacists, and dentists.
- A severe blood problem called methemoglobinemia has happened with drugs like this one. The risk may be raised in people who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be raised while taking certain other drugs and in infants younger than 6 months of age. Tell your doctor if you have ever had methemoglobinemia.
- Talk with your doctor before you use other drugs or products on your skin.
- Do not use ZTlido for longer than you were told by your doctor.
- Do not scratch or rub the skin while it is numb. Do not let it get very hot or very cold.
- Do not put on cuts, scrapes, or damaged skin unless the doctor tells you to.
- Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
- Do not get ZTlido wet. It may not stick. Do not bathe, swim, or shower while you are wearing ZTlido.
- It is common to have skin reactions where ZTlido is put on during or right after treatment. This includes blisters, bruising, burning or abnormal feeling, change in color, swelling, redness, pain, itching, peeling, flaking, or pimples. Most of the time, these skin reactions go away within a few minutes to hours. Call your doctor if any of these effects are very bad, bother you, or do not go away.
- This medicine may cause harm if chewed or swallowed. This includes used patches. If ZTlido has been put in the mouth, call a doctor or poison control center right away.
- This medicine may be put on after use of moderate heat like after 15 minutes of using a heating pad on a medium setting. This medicine may also be used during moderate exercise like biking for 30 minutes.
- If you are 65 or older, use ZTlido with care. You could have more side effects.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is ZTlido best taken?
Use ZTlido as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Do not take ZTlido by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
- If you get ZTlido in any of these areas, rinse well with water.
- Clean affected part before use. Make sure to dry well.
- Put on clean, dry, healthy skin.
- Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
- Wash your hands before and after use.
- Put on the most painful parts of the skin.
- Trim to cover the affected skin.
- Put on at the same time of day.
- Leave on for up to 12 hours.
- After you take ZTlido off, do not put another one on that area of skin for 12 hours.
- Take off ZTlido right away if it burns.
- After you take off a skin patch or system, be sure to fold the sticky sides to each other. Throw away used patches, used systems, and pieces that were cut where children and pets cannot get to them.
What do I do if I miss a dose?
- If you use ZTlido on a regular basis, use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not put on 2 doses at the same time or extra doses.
- Many times ZTlido is used on an as needed basis. Do not use more often than told by the doctor.
What are the side effects of ZTlido that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
- Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
- Trouble breathing, slow breathing, or shallow breathing.
- Very bad numbness and tingling.
- Feeling lightheaded, sleepy, confused, or having blurred eyesight.
- Change in eyesight.
- Feeling nervous and excitable.
- Dizziness or passing out.
- Ringing in ears.
- Upset stomach or throwing up.
- Feeling hot or cold.
- Slow heartbeat.
- Chest pain.
What are some other side effects of ZTlido?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where ZTlido is used.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out ZTlido?
- Store at room temperature.
- Store in the envelope that ZTlido comes in to help keep away from children. Do not open the envelope until you are ready to use ZTlido.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
LabelPRINCIPAL DISPLAY PANEL – lidocaine patch 1.8% CARTON LABEL
- NDC 69557-111-30
- (lidocaine topical system) 1.8%*
- For topical use only.
- *One ZTlido™ (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm® (lidocaine patch 5%).
- Inactive ingredients: butylated hydroxytoluene, dipropylene glycol, isostearic acid, mineral oil, polyisobutylene, silicone dioxide, styrene/isoprene/styrene block copolymer, and terpene resin.
- DOSAGE: For dosage and full prescribing information, please read accompanying product information.
- Store at 68-77°F (20-25°C). [See USP Controlled Room Temperature].
- WARNING: Store and dispose of ZTlido™ out of the reach of children, pets, and others.
- 30 TOPICAL SYSTEMS
- 30 Envelopes Containing 1 Topical System Each
- SCILEX ™ Rx Only
- Manufactured by: Oishi Koseido Co., Ltd., Tosu, Saga, Japan
Manufactured for: SCILEX Pharmaceuticals Inc., San Diego, CA 92121
Active Ingredient Made in Spain