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| Product NDC Code | 69557-111 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Ztlido |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 2001434, 2001439 |
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| Application Number | NDA207962 | ||||||
| Labeler Name | Scilex Pharmaceuticals Inc. | ||||||
| Packages |
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Overdosage of Ztlido
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose, check drug blood concentration. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Excessive Dosing/Overexposure to Lidocaine [see Warnings and Precautions (5.2) ] Methemoglobinemia [see Warnings and Precautions (5.3) ] Application Site Reactions [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Eye Irritation [see Warnings and Precautions (5.6) ] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissues : blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erosions, erythema, exfoliation, flushing, irritation, papules, petechia, pruritus, vesicles, and abnormal sensation. Immune system : angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. Central Nervous System : lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, somnolence, respiratory depression and arrest. Cardiovascular : bradycardia, hypotension, and cardiovascular collapse leading to arrest. Other : asthenia, disorientation, headache, hyperesthesia, hypoesthesia, metallic taste, nausea, pain exacerbated, paresthesia, taste alteration, and vomiting. Common adverse reactions are application site reactions such as irritation, erythema, and pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Scilex Pharmaceuticals Inc. at 1-866-SCILEX3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Ztlido Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS Class I Antiarrhythmic Drugs: When ZTLIDO is used in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) the toxic effects are additive and potentially synergistic. Consider risk/benefit before concomitant use. ( 7.2 ) Local Anesthetic Agents: When ZTLIDO is used concomitantly with other products containing local anesthetic agents, the effects are additive. Consider the amount of drug absorbed from all formulations when local anesthetics are administered concomitantly. ( 7.3 ) 7.1 Drugs That May Cause Methemoglobinemia When Used with ZTLIDO Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicyclic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine 7.2 Antiarrhythmic Drugs When ZTLIDO is used in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine), the toxic effects are additive and potentially synergistic. Consider risk/benefit during concomitant use. 7.3 Local Anesthetics When ZTLIDO is used concomitantly with other products containing local anesthetic agents, the effects are additive. Consider the amount of drug absorbed from all formulations when local anesthetic agents are administered concomitantly.
| Class | Examples |
|---|---|
| Nitrates/Nitrites | nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Local anesthetics | articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Antineoplastic agents | cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Antibiotics | dapsone, nitrofurantoin, para-aminosalicyclic acid, sulfonamides |
| Antimalarials | chloroquine, primaquine |
| Anticonvulsants | phenobarbital, phenytoin, sodium valproate |
| Other drugs | acetaminophen, metoclopramide, quinine, sulfasalazine |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lidocaine is an amide local anesthetic. Lidocaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses. 12.2 Pharmacodynamics The penetration of lidocaine into intact skin after application of ZTLIDO is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. 12.3 Pharmacokinetics ZTLIDO has different bioavailability compared to Lidoderm. In a single-dose, crossover study conducted in 53 healthy volunteers, ZTLIDO (lidocaine topical system) 1.8% demonstrated equivalent exposure (AUC) and peak concentration (C max ) of lidocaine to Lidoderm (lidocaine patch 5%). Absorption The amount of lidocaine systemically absorbed from ZTLIDO is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three ZTLIDO topical systems were applied over an area of 420 cm 2 of intact skin on the backs of normal healthy volunteers for 12 hours. Blood samples were drawn for determination of lidocaine concentration during the topical system application and for 12 hours after removal of topical systems. The results are summarized in Table 1 . Table 1 Mean ± SD Absorption of lidocaine from ZTLIDO Healthy Volunteers (n = 54, 12-hour application time) Topical System Application Site Area (cm 2 ) C max (ng/mL) T max (hr) median (min, max) 3 Topical systems of ZTLIDO (108 mg) Back 420 75.1 ± 28.0 13.9 (4.0, 18.0) Repeated application of three Lidoderm patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1 . Figure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three Lidoderm patches simultaneously for 12 hours per day in healthy volunteers (n = 15). The pharmacokinetics of ZTLIDO (n = 3 topical systems) was assessed in 12 healthy volunteers with exposure to external heat source (heating pad at medium setting applied for 20 minutes at Time 0 and 8.5 hours) or undergoing moderate exercise (cycling for 30 minutes at a heart rate of 108 bpm at Time 0, 2.5, 5.5 and 8.5 hours) and compared to pharmacokinetics of ZTLIDO at rest. Exposure to external heat at 0 and 8.5 hours results in increased peak plasma levels of lidocaine with a mean (SD) of 160.3 ± 100.1 ng/mL versus the peak plasma levels observed at rest with a mean (SD) of 97.6 ± 36.9 ng/mL. For this reason, instruct patients not to apply heating pads directly to ZTLIDO. Concentrations returned to normal within 4 hours after the heat was removed. No clinically relevant differences in systemic absorption were observed under exercise conditions with a mean (SD) peak plasma concentration of 90.5 ± 25.4 ng/mL. A separate study in 12 healthy volunteers showed that there was no effect on ZTLIDO pharmacokinetics when the topical system is applied to the administration site after external heat exposure (heating pad at medium setting applied for 15 minutes prior to the topical system application) or after engagement in exercise (walking at a moderate pace on a treadmill for approximately 20 minutes beginning approximately 30 minutes prior to the topical system application). Chemical Structure Distribution When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to 2.7 L/kg (mean 1.5 ± 0.6 SD, n = 15). At concentrations produced by application of ZTLIDO, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 µg/mL of free base), the plasma protein binding of lidocaine is concentration dependent. Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion. Elimination Metabolism: It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. A minor metabolite, 2,6-xylidine, has unknown pharmacologic activity. The blood concentration of this metabolite is negligible following application of ZTLIDO. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively. Excretion: Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/minute (mean 0.64 ± 0.18 SD, n = 15).
| Topical System | Application Site | Area (cm 2) | C max(ng/mL) | T max(hr) |
|---|---|---|---|---|
| 3 Topical systems of ZTLIDO (108 mg) | Back | 420 | 75.1 ± 28.0 | 13.9 (4.0, 18.0) |
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Lidocaine is an amide local anesthetic. Lidocaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics The penetration of lidocaine into intact skin after application of ZTLIDO is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics ZTLIDO has different bioavailability compared to Lidoderm. In a single-dose, crossover study conducted in 53 healthy volunteers, ZTLIDO (lidocaine topical system) 1.8% demonstrated equivalent exposure (AUC) and peak concentration (C max ) of lidocaine to Lidoderm (lidocaine patch 5%). Absorption The amount of lidocaine systemically absorbed from ZTLIDO is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three ZTLIDO topical systems were applied over an area of 420 cm 2 of intact skin on the backs of normal healthy volunteers for 12 hours. Blood samples were drawn for determination of lidocaine concentration during the topical system application and for 12 hours after removal of topical systems. The results are summarized in Table 1 . Table 1 Mean ± SD Absorption of lidocaine from ZTLIDO Healthy Volunteers (n = 54, 12-hour application time) Topical System Application Site Area (cm 2 ) C max (ng/mL) T max (hr) median (min, max) 3 Topical systems of ZTLIDO (108 mg) Back 420 75.1 ± 28.0 13.9 (4.0, 18.0) Repeated application of three Lidoderm patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1 . Figure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three Lidoderm patches simultaneously for 12 hours per day in healthy volunteers (n = 15). The pharmacokinetics of ZTLIDO (n = 3 topical systems) was assessed in 12 healthy volunteers with exposure to external heat source (heating pad at medium setting applied for 20 minutes at Time 0 and 8.5 hours) or undergoing moderate exercise (cycling for 30 minutes at a heart rate of 108 bpm at Time 0, 2.5, 5.5 and 8.5 hours) and compared to pharmacokinetics of ZTLIDO at rest. Exposure to external heat at 0 and 8.5 hours results in increased peak plasma levels of lidocaine with a mean (SD) of 160.3 ± 100.1 ng/mL versus the peak plasma levels observed at rest with a mean (SD) of 97.6 ± 36.9 ng/mL. For this reason, instruct patients not to apply heating pads directly to ZTLIDO. Concentrations returned to normal within 4 hours after the heat was removed. No clinically relevant differences in systemic absorption were observed under exercise conditions with a mean (SD) peak plasma concentration of 90.5 ± 25.4 ng/mL. A separate study in 12 healthy volunteers showed that there was no effect on ZTLIDO pharmacokinetics when the topical system is applied to the administration site after external heat exposure (heating pad at medium setting applied for 15 minutes prior to the topical system application) or after engagement in exercise (walking at a moderate pace on a treadmill for approximately 20 minutes beginning approximately 30 minutes prior to the topical system application). Chemical Structure Distribution When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to 2.7 L/kg (mean 1.5 ± 0.6 SD, n = 15). At concentrations produced by application of ZTLIDO, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 µg/mL of free base), the plasma protein binding of lidocaine is concentration dependent. Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion. Elimination Metabolism: It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. A minor metabolite, 2,6-xylidine, has unknown pharmacologic activity. The blood concentration of this metabolite is negligible following application of ZTLIDO. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively. Excretion: Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/minute (mean 0.64 ± 0.18 SD, n = 15).
| Topical System | Application Site | Area (cm 2) | C max(ng/mL) | T max(hr) |
|---|---|---|---|---|
| 3 Topical systems of ZTLIDO (108 mg) | Back | 420 | 75.1 ± 28.0 | 13.9 (4.0, 18.0) |
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS 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. 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. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION 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. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Because of the difference in bioavailability of ZTLIDO compared to Lidoderm®, a different dosage strength is required to be administered to the patient. One ZTLIDO (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm (lidocaine patch 5%). ( 2.1 ) Apply ZTLIDO to intact skin to cover the most painful area. Apply the prescribed number of topical systems (maximum of 3) only once for up to 12 hours in a 24-hour period. ( 2.2 ) ZTLIDO may be cut into smaller sizes prior to removal of the release liner. ( 2.2 ) In patients who are debilitated or have impaired elimination, smaller areas of treatment are recommended. Achieve this by cutting ZTLIDO with scissors into a smaller size prior to removing the release liner. ( 2.2 ) 2.1 Important Dosage and Administration Instructions Because of the difference in bioavailability of ZTLIDO compared to Lidoderm (lidocaine patch 5%), a different dosage strength is required to be administered to the patient. One ZTLIDO (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm (lidocaine patch 5%) [see Clinical Pharmacology (12.3) ]. When ZTLIDO is used concomitantly with other products containing local anesthetic agents, the total amount of drug absorbed from all formulations must be considered. Clearly instruct and advise patients: to wash hands immediately after handling ZTLIDO and to avoid contact with eyes [see Warnings and Precautions (5.6) ] . to store ZTLIDO inside the sealed envelope out of the reach of children, pets, and others and to apply immediately after removal from the envelope. to fold used ZTLIDO so that the adhesive side sticks to itself and to safely discard used ZTLIDO or pieces of cut ZTLIDO where children and pets cannot get to them [see Warnings and Precautions (5.1) ] . to never apply external heat sources, such as heating pads or electric blankets, directly to ZTLIDO, because plasma lidocaine levels are increased. ZTLIDO can be applied, however, to the administration site after moderate heat exposure, such as 15 minutes of heating pad exposure on a medium setting [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ] . that clothing may be worn over the area of application. that ZTLIDO may be used during moderate exercise, such as biking for 30 minutes. that ZTLIDO may be exposed to water, such as showering for 10 minutes or immersion for 15 minutes. to dry the topical system, after water exposure, by gently patting the skin, not by rubbing the skin or topical system. that ZTLIDO topical systems that have lifted at the edges may be reattached by pressing firmly on the edges and that fully detached topical systems may be reapplied as originally directed. that if a ZTLIDO topical system comes off completely and will not stick to patient's skin, to remove and properly dispose of the used ZTLIDO and to apply a new ZTLIDO topical system for a total duration of 12 hours of used and new topical system together. that if irritation or a burning sensation occurs during application, to remove ZTLIDO and to not reapply until the irritation subsides [see Warnings and Precautions (5.4) ] . 2.2 Treatment of Post-Herpetic Neuralgia Advise patients to apply ZTLIDO to intact skin to cover the most painful area and to apply the prescribed number of topical systems (maximum of 3), only once for up to 12 hours within a 24-hour period (12 hours on and 12 hours off) [see Warnings and Precautions (5.2) ] . In patients who are debilitated or have impaired elimination, smaller areas of treatment are recommended. Achieve this by cutting ZTLIDO with scissors into a smaller size prior to removing the release liner.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Topical system: 1.8% packaged in an individual envelope. ZTLIDO 1.8% is available as a single-dose topical system. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults. ZTLIDO contains lidocaine, an amide local anesthetic, and is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults ( 1 ).
Spl product data elements
Usually a list of ingredients in a drug product.Ztlido Lidocaine DIPROPYLENE GLYCOL MINERAL OIL ISOSTEARIC ACID POLYISOBUTYLENE (1100000 MW) BUTYLATED HYDROXYTOLUENE POLYISOBUTYLENE (55000 MW) SILICON DIOXIDE LIDOCAINE LIDOCAINE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals specifically designed to evaluate the carcinogenic potential of lidocaine or ZTLIDO have not been conducted. A metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The clinical significance is not known. Mutagenesis Lidocaine HCl was not mutagenic in the in vitro bacterial reverse mutagenicity assay (Ames test). Lidocaine HCl was not clastogenic in the in vitro chromosome aberration assay with human lymphocytes or in the in vivo mouse micronucleus test. Impairment of Fertility In a published study, female Sprague-Dawley rats were treated subcutaneously with lidocaine via osmotic pumps starting two weeks prior to mating, and reproductive effects were assessed. Rats dosed up to the high dose of 500 mg/kg/day (approximately 45 times the MRDD on a mg/m 2 basis) showed no effects on copulatory rate, pregnancy rate, or the numbers of corpora lutea or implantations.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals specifically designed to evaluate the carcinogenic potential of lidocaine or ZTLIDO have not been conducted. A metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The clinical significance is not known. Mutagenesis Lidocaine HCl was not mutagenic in the in vitro bacterial reverse mutagenicity assay (Ames test). Lidocaine HCl was not clastogenic in the in vitro chromosome aberration assay with human lymphocytes or in the in vivo mouse micronucleus test. Impairment of Fertility In a published study, female Sprague-Dawley rats were treated subcutaneously with lidocaine via osmotic pumps starting two weeks prior to mating, and reproductive effects were assessed. Rats dosed up to the high dose of 500 mg/kg/day (approximately 45 times the MRDD on a mg/m 2 basis) showed no effects on copulatory rate, pregnancy rate, or the numbers of corpora lutea or implantations.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - lidocaine patch 1.8% CARTON LABEL NDC 69557-111-30 ZTlido ™ (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 PHARMACEUTICALS Manufactured by: Oishi Koseido Co., Ltd., Tosu, Saga, Japan Manufactured for: SCILEX Pharmaceuticals Inc., San Diego, CA 92121 Active Ingredient Made in Spain Carton
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration ( 2.1 ) 4/2021
| Dosage and Administration ( | 4/2021 |
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufactured for: Scilex Pharmaceuticals Inc. Palo Alto, CA 94303 USA ZTLIDO ® is a trademark owned by Scilex Pharmaceuticals Inc. Patented. See: www.scilexpharma.com/patents © 2021 Scilex Pharmaceuticals Inc. All rights reserved. SCILEX ® PHARMACEUTICALS SCILEX ® and ZTLIDO ® are registered trademarks of Scilex Pharmaceuticals Inc.
Ztlido: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Accidental Exposure and Disposal Advise patients to store ZTLIDO out of the reach of children, pets, and others. Advise patients to dispose of used ZTLIDO by folding used ZTLIDO so that the adhesive side sticks to itself and safely discarding used ZTLIDO or pieces of cut ZTLIDO where children, pets, and others cannot come in contact with them [see Warnings and Precautions (5.1) ] . Proper Application Advise patients: not to apply more than the prescribed number (up to 3 ZTLIDO) [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ]. not to wear ZTLIDO longer than the recommended wearing time (12 hours of every 24 hours) [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ]. to apply ZTLIDO to intact skin [see Warnings and Precautions (5.2) ]. to reattach by pressing firmly on the edges of ZTLIDO that are lifting. If a ZTLIDO topical system comes off completely and will not stick to patient's skin, it should be removed and properly disposed of and a new ZTLIDO topical system should be applied for a total duration of 12 hours of used and new topical system together [see Dosage and Administration (2.1 , 2.2) ] . Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue [see Warnings and Precautions (5.3) ]. Application Site Reactions Inform patients that skin irritation and other skin reactions may occur at the site of ZTLido application. If skin reactions occur during wear, instruct patients to remove ZTLido and not to reapply until the skin reaction subsides [see Warnings and Precautions (5.4) ] Eye Exposure Advise patients to wash hands immediately after handling ZTLIDO and to avoid contact with eyes. Instruct patients to, if eye contact should occur, immediately wash out the eye with water or saline and protect the eye until sensation returns [see Dosage and Administration (2.1) , Warnings and Precautions (5.6) ] .
Instructions for use
Information about safe handling and use of the drug product.Instructions for Use ZTLIDO ® (ZEE-TEE-LIE-DOH) (lidocaine topical system) Read this Instructions for Use before you start using ZTLIDO and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical treatment or condition. Important information: One ZTLIDO (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm® (lidocaine patch 5%). ZTLIDO is for use on intact skin only. ZTLIDO comes in a child-resistant envelope. Do not open the ZTLIDO envelope until you are ready to use it. Apply the prescribed number of ZTLIDO topical systems at one time. Clothing may be worn over ZTLIDO. You should only use a maximum of 3 ZTLIDO topical systems at a time. Keep your prescribed number of ZTLIDO topical systems on for up to 12 hours within a 24-hour period (12 hours on and 12 hours off). 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 no t rub the topical system. ZTLIDO topical systems that have come off completely or are lifting at the edges may be re-attached to the affected area 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 re-attach it. Throw it away (See Step 6 ). If the ZTLIDO you are wearing comes off completely, and will not stick to your skin, throw it away (see Step 6 ). In either of these cases, you may put on a replacement (a new) ZTLIDO topical system. Take off the replacement ZTLIDO at your usual removal time. The total time that you may wear the used and replacement ZTLIDO is 12 hours. Wash your hands well right away after handling ZTLIDO (when you apply ZTLIDO, when you re-attach it, or when you remove it). Avoid eye contact with your hands and fingers while handling ZTLIDO. Figure A: ZTLIDO Topical System Applying your ZTLIDO topical system: Step 1: Select the application site. ZTLIDO should only be applied to clean, dry, and intact skin to cover the most painful area. Step 2: Using scissors, carefully cut the envelope along the dotted line and open it to remove ZTLIDO. Do not use ZTLIDO if it is damaged. Throw it away and get a new one. ZTLIDO may be cut into smaller sizes with scissors prior to removal of the transparent release liner. Step 3a: Remove the transparent release liner before applying ZTLIDO to the skin. Apply ZTLIDO right away after removing the transparent release liner. Apply ZTLIDO only to intact skin. Step 3b: Place the adhesive side of ZTLIDO to skin, while not touching the sticky side. Smooth the ZTLIDO using your hands and firmly press to make sure it sticks well to skin. Step 4: Wash your hands well right away after applying ZTLIDO. Avoid contact of your hands or fingers with your eyes until after you wash your hands . Removing your ZTLIDO topical system: Step 5: Remove ZTLIDO from your skin after you have worn it for up to 12 hours. Fold the used ZTLIDO so that the sticky sides stick together. Step 6: Throw away the used whole or cut pieces of ZTLIDO where children and pets cannot get to them. Wash your hands well right away after removing ZTLIDO. Avoid contact of your hands and fingers with your eyes until after you wash your hands. How to reattach ZTLIDO or apply a replacement ZTLIDO: If the ZTLIDO you are wearing comes off completely or lifts at the edges, reattach to the affected area by pressing firmly on the edges of the topical system or lifted areas. If ZTLIDO lifts off the skin or comes off completely more than 1 time, do not try to re-attach it. Throw away the used ZTLIDO as instructed above in Step 6 . If the ZTLIDO you are wearing comes off completely and will not stick to your skin, throw away the used ZTLIDO as instructed above in Step 6. Pat dry the area of skin if ZTLIDO came off while swimming or showering. Apply a replacement ZTLIDO the same way you would apply a new ZTLIDO as described above in Steps 1 through 6. Remove the replacement ZTLIDO at your usual removal time as described above in Steps 5 and 6. The total time you may wear the used and replacement ZTLIDO is 12 hours . Manufactured for: Scilex Pharmaceuticals Inc. Palo Alto, CA 94303 USA ZTLIDO ® is a trademark owned by Scilex Pharmaceuticals Inc. © 2021 Scilex Pharmaceuticals Inc. All rights reserved. SCILEX ® PHARMACEUTICALS Revised: 4/2021 Figure A Step 2 Step 2 Step 3a Step 3b Step 4 Step 5 Step 6
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Spl patient package insert
Information necessary for patients to use the drug safely and effectively.This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 4/2021 PATIENT INFORMATION ZTLIDO ® (ZEE-TEE-LIE-DOH) (lidocaine topical system) What is ZTLIDO? 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: 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. Before using ZTLIDO, tell your healthcare provider about all your medical conditions, including if you: 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. 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. How should I use ZTLIDO? Read the Instructions for Use at the end of this Patient Information leaflet for information about how to apply the ZTLIDO topical system. 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. 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. What should I avoid while using ZTLIDO? Avoid contact of your hands and fingers with your eyes while handling ZTLIDO. See " Contact of ZTLIDO with your eyes " below. What are the possible side effects of ZTLIDO? ZTLIDO may cause serious side effects, including: 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. 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: pale, gray, or blue colored skin headache rapid heart beat shortness of breath lightheadedness tiredness 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: blisters bruising burning or abnormal sensation change or loss of color of your skin swelling, redness, and pain of the skin peeling or flaking of skin irritation pimple-like raised skin itching If you develop a skin reaction while wearing ZTLIDO, remove it. Do not reapply ZTLIDO until the site reaction goes away. 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. 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. 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? 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. Keep ZTLIDO and all medicines out of the reach of children, pets, and others. General information about the safe and effective use of ZTLIDO. 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? 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.
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Issued: 4/2021 | |||
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| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||||
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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. | ||||
| 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. | ||||
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES Single-dose treatment with lidocaine patch (currently preferred dosage form term for a patch is topical system) was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidocaine patch performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with lidocaine patch was compared to vehicle patch (without lidocaine) in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of lidocaine patch prior to the study. The constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). Statistically significant differences favoring lidocaine patch were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value <0.001), daily average pain relief, and patient's preference of treatment. About half of the patients also took oral medication commonly used in the treatment of post-herpetic neuralgia. The extent of use of concomitant medication was similar in the two treatment groups. Based on a clinical study in 54 subjects with ZTLIDO, 47 subjects (87%) had adhesion scores of 0 (≥ 90% adhered) for all evaluations performed every 3 hours during the 12 hours of administration, 7 subjects (13%) had adhesion scores of 1 (≥ 75% to < 90% adhered) for at least one evaluation, and no subjects had scores of 2 or greater (< 75% adhered).
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of ZTLIDO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be done with caution, usually starting at the low end of the dosing range (e.g., a single topical system), reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary The limited human data with lidocaine in pregnant woman are not sufficient to inform drug-associated risk for major birth defects and miscarriage. The use of lidocaine for labor neuraxial analgesia has not been associated with an increased incidence of adverse fetal effects either during delivery or during the neonatal period (see Data ) . Should ZTLIDO be used concomitantly with other products containing lidocaine, consider total drug doses contributed by all formulations. In a published animal reproduction study, pregnant rats administered lidocaine by continuous subcutaneous infusion at a dose approximately 45 times the maximum recommended daily dose (MRDD) of 108 mg in ZTLIDO during the period of organogenesis resulted in lower fetal body weights. In a published animal reproduction study, pregnant rats administered lidocaine, containing 1:100,000 epinephrine, injected into the masseter muscle of the jaw or into the gum of the lower jaw at 0.5 times the MRDD on Gestation Day 11 resulted in developmental delays in neonates (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In 22 parturient women given 1.5% lidocaine epidural anesthesia, there were no effects on neonatal behavior, using the early neonatal neurobehavioral scale (ENNS). Neuraxial analgesia also did not affect fetal heart rate, beat-to-beat variability, or uterine activity. Animal Data Reproductive studies with lidocaine have been performed in rats at doses up to 30 mg/kg (2.7 times the maximum recommended daily dose [MRDD] of 108 mg from ZTLIDO on a mg/m 2 basis) subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. In a published study, lidocaine administered to pregnant rats by continuous subcutaneous infusion during the period of organogenesis at 100, 250, and 500 mg/kg/day, did not produce any structural abnormalities, but did result in lower fetal weights at 500 mg/kg/day dose (approximately 45 times the MRDD on a mg/m 2 basis) in the absence of maternal toxicity. In a published study, lidocaine containing 1:100,000 epinephrine at a dose of 6 mg/kg (approximately 0.5 times the MRDD on a mg/m 2 basis) injected into the masseter muscle of the jaw or into the gum of the lower jaw of pregnant Long-Evans hooded rats on Gestation Day 11 resulted in developmental delays in the neonates. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition. The developmental delays of the neonatal animals were transient, with responses becoming comparable to untreated animals later in life. The clinical relevance of these animal data is uncertain.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS Lactation : Lidocaine is excreted into human milk. Caution should be exercised when ZTLIDO is administered to a nursing mother, especially when administered with other local anesthetics. ( 8.2 ) 8.1 Pregnancy Risk Summary The limited human data with lidocaine in pregnant woman are not sufficient to inform drug-associated risk for major birth defects and miscarriage. The use of lidocaine for labor neuraxial analgesia has not been associated with an increased incidence of adverse fetal effects either during delivery or during the neonatal period (see Data ) . Should ZTLIDO be used concomitantly with other products containing lidocaine, consider total drug doses contributed by all formulations. In a published animal reproduction study, pregnant rats administered lidocaine by continuous subcutaneous infusion at a dose approximately 45 times the maximum recommended daily dose (MRDD) of 108 mg in ZTLIDO during the period of organogenesis resulted in lower fetal body weights. In a published animal reproduction study, pregnant rats administered lidocaine, containing 1:100,000 epinephrine, injected into the masseter muscle of the jaw or into the gum of the lower jaw at 0.5 times the MRDD on Gestation Day 11 resulted in developmental delays in neonates (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In 22 parturient women given 1.5% lidocaine epidural anesthesia, there were no effects on neonatal behavior, using the early neonatal neurobehavioral scale (ENNS). Neuraxial analgesia also did not affect fetal heart rate, beat-to-beat variability, or uterine activity. Animal Data Reproductive studies with lidocaine have been performed in rats at doses up to 30 mg/kg (2.7 times the maximum recommended daily dose [MRDD] of 108 mg from ZTLIDO on a mg/m 2 basis) subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. In a published study, lidocaine administered to pregnant rats by continuous subcutaneous infusion during the period of organogenesis at 100, 250, and 500 mg/kg/day, did not produce any structural abnormalities, but did result in lower fetal weights at 500 mg/kg/day dose (approximately 45 times the MRDD on a mg/m 2 basis) in the absence of maternal toxicity. In a published study, lidocaine containing 1:100,000 epinephrine at a dose of 6 mg/kg (approximately 0.5 times the MRDD on a mg/m 2 basis) injected into the masseter muscle of the jaw or into the gum of the lower jaw of pregnant Long-Evans hooded rats on Gestation Day 11 resulted in developmental delays in the neonates. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition. The developmental delays of the neonatal animals were transient, with responses becoming comparable to untreated animals later in life. The clinical relevance of these animal data is uncertain. 8.2 Lactation Risk Summary Lidocaine is excreted into human milk. When lidocaine was used as an epidural anesthetic for cesarean section in 27 women, a milk:plasma ratio of 1.07 was observed using AUC values. Lactating women undergoing a dental procedure had a 0.4 milk:plasma ratio. In another dental procedure study, a single patient was administered 20 mg of lidocaine and the milk:plasma ratio was reported as 1.1 at five to six hours after injection. These data, and the low concentrations of lidocaine in the plasma after topical administration of ZTLIDO in recommended doses, suggest that a small amount of lidocaine would be ingested orally by a suckling infant. However, caution should be exercised when ZTLIDO is administered to a nursing mother, especially when administered with other local anesthetics. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of ZTLIDO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be done with caution, usually starting at the low end of the dosing range (e.g., a single topical system), reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING ZTLIDO (lidocaine topical system) 1.8% is available as the following: Carton of 30 topical systems, packaged into individual child-resistant envelopes. NDC 69557-111-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Wash hands thoroughly immediately after handling the topical system. Upon removal, fold the topical system in half so that the adhesive side sticks to itself. Discard used ZTLIDO and pieces of cut ZTLIDO in a manner that prevents accidental contact or ingestion by children, pets or others [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] .
Storage and handling
Information about safe storage and handling of the drug product.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Wash hands thoroughly immediately after handling the topical system. Upon removal, fold the topical system in half so that the adhesive side sticks to itself. Discard used ZTLIDO and pieces of cut ZTLIDO in a manner that prevents accidental contact or ingestion by children, pets or others [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] .
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API