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Full Prescribing Information: Contents* 1. Indications And 1 HIGHLIGHTS OF PRESCRIBING INFORMATION 41 ----------------------- WARNINGS AND PRECAUTIONS--------------------- 42 • To minimize caloric stimulation that can cause patient dizziness, warm 2 43 TYMBION before administering. (5.1) 3 These highlights do not include all the information needed to use 44 • TYMBION, when used with the Tula Iontophoresis System, does not ™ 4 TYMBION safely and effectively. See full prescribing information for 45 anesthetize the external auditory ear canal. (5.1) 5 TYMBION. 46 6 TYMBION (lidocaine hydrochloride and epinephrine) otic solution 47 Refer to the Tula Iontophoresis System Instructions for Use for additional 7 Initial U.S. Approval: 1948 48 Warnings and Precautions related to the use of the device components of the 49 Tula System. 8 --------------------------- INDICATIONS AND USAGE ------------------------- 9 TYMBION, a combination of an amide local anesthetic and an alpha- and beta- 50 ---------------------------ADVERSE REACTIONS --------------------------------- 10 adrenergic agonist, is indicated for the induction of local anesthesia of the 51 The most common adverse reactions (>2%) occurring in patients treated 11 tympanic membrane via iontophoresis using the Tula® Iontophoresis System in 52 with TYMBION using the Tula Iontophoresis System were inadequate 12 pediatric (aged 6 months and older) and adult patients undergoing 53 anesthesia and vertigo/dizziness. (6) 13 tympanostomy tube placement using the Tula Tube Delivery System. (1) 54 ----------------------USE IN SPECIFIC POPULATIONS------------------------- 14 Limitations of Use 55 The safety and effectiveness of TYMBION has been established in pediatric • TYMBION is for use ONLY with the Tula Iontophoresis System and 15 56 patients aged 6 months and older. The recommended dose for children is the 16 cannot be used with any other iontophoresis device. 57 same as adults, and is controlled by the electrical current delivery of the Tula • 17 TYMBION is not for use alone (i.e., without the Tula Iontophoresis 58 Iontophoresis System. (8.4) 18 System) and is not interchangeable with other lidocaine with epinephrine 19 formulations. 59 20 ----------------------- DOSAGE AND ADMINISTRATION -------------------- 60 To report SUSPECTED ADVERSE REACTIONS, contact Tusker 21 • TYMBION is administered into the external ear canal through the Earset of 61 Medical Inc at 1-650-223-6900 or FDA at 1-800-FDA-1088 or 22 the Tula Iontophoresis System. A low level of electrical current supplied 62 www.fda.gov/medwatch 23 by the Iontophoresis System results in penetration of lidocaine and 63 See 17 for PATIENT COUNSELING INFORMATION 24 epinephrine into the tympanic membrane. Once the iontophoresis process is 64 25 complete, TYMBION is removed from the external ear canal by gravity or 26 wicking. (2.2) 65 27 • TYMBION is to be used by healthcare professionals familiar with the 66 Revised: 11/2019 28 administration of local anesthetics. (2.2) 29 ----------------------- DOSAGE FORM AND STRENGTH -------------------- 30 • Otic Solution. Each mL of TYMBION contains 20 mg of lidocaine HCl 31 and 10 mcg of epinephrine. (3) 32 ------------------------------ CONTRAINDICATIONS --------------------------- 33 • Patients presenting with tympanic membrane perforation(s) or lacerations / 34 abrasions to the external auditory canal. (4) 35 • Patients with a history of sensitivity or allergic reaction to lidocaine HCl, 36 tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the 37 amide type, or any component of the anesthetic drug formulation. (4) 38 • Patients with a familial history of insensitivity to lidocaine or other local 39 anesthetics. (4) 40 FULL PRESCRIBING INFORMATION: CONTENTS* 8.6. Hepatic Impairment 8.7. Renal Impairment 1. INDICATIONS AND USAGE 10. OVERDOSAGE 2. DOSAGE AND ADMINISTRATION 11. DESCRIPTION 2.1. Dosing 12. CLINICAL PHARMACOLOGY 2.2. General Instructions 12.1. Mechanism of Action 2.3. Repeat Administration 12.2. Pharmacodynamics 3. DOSAGE FORM AND STRENGTH 12.3. Pharmacokinetics 4. CONTRAINDICATIONS 13. NONCLINICAL TOXICOLOGY 5. WARNINGS AND PRECAUTIONS 13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility 5.1. Local Effects 13.2. Animal Toxicity and/or Pharmacology 5.2. Middle Ear Effects 14. CLINICAL STUDIES 5.3. Allergic Reactions 16. HOW SUPPLIED/STORAGE AND HANDLING 5.4. Systemic Reactions 17. PATIENT COUNSELING INFORMATION 5.5. Methemoglobinemia 17.1. Risks Relating to the Iontophoresis Process 6. ADVERSE REACTIONS 17.2. Local Effects 6.1. Clinical Trials Experience 6.2. Post-Marketing Experience * Sections or subsections omitted from the full prescribing 7. DRUG INTERACTIONS information are not listed. 7.1. Monoamine Oxidase Inhibitors 7.2. Drugs Associated with Methemoglobinemia 8. USE IN SPECIFIC POPULATIONS 8.1. Pregnancy 8.2. Lactation 8.4. Pediatric Use 8.5. Geriatric Use FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System. Limitations of Use • TYMBION is for use ONLY with the Tula Iontophoresis System and cannot be used with any other iontophoresis device. • TYMBION is not for use alone (i.e., without the Tula Iontophoresis System) and is not interchangeable with other lidocaine with epinephrine formulations. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Each mL of TYMBION contains 20 mg lidocaine HCl, equivalent to 16.2 mg lidocaine, and 10 mcg of epinephrine. The typical volume of the external ear canal for children ages 6 months to 12 years is approximately 0.4 mL to 0.8 mL. The Tula Iontophoresis System tubing and reservoir accommodates approximately 0.6 mL. 2.2 General Instructions Use TYMBION only in conjunction with the Tula Iontophoresis System. Full instructions for use of the Tula Iontophoresis System are provided with the Iontophoresis System. In brief, instill TYMBION into the external ear canal via Earsets connected to fitted Earplugs. The Tula Iontophoresis System applies an electrical current to the solution, which causes lidocaine and epinephrine to penetrate the tympanic membrane. After approximately 10 minutes, iontophoresis is complete and TYMBION is drained from the external ear canal by gravity or wicking. Iontophoresis can extend beyond 10 minutes if the program is paused or current is reduced per the Tula Iontophoresis System instructions for use. Assess adequate local anesthesia by lightly tapping the tympanic membrane with a dull otologic probe or the tip of the Tube Delivery System. • Warm TYMBION to approximately body temperature prior to instilling in the external ear canal [see Warnings and Precautions (5.1)]. • Avoid touching the ear canal wall with otologic instruments [see Warnings and Precautions (5.1)] 2.3 Repeat Administration The safety of repeat iontophoretic administration of TYMBION has not been evaluated in humans, and repeat administration (to the same ear) is not recommended. [see Nonclinical Toxicology (13.2)]. A nonclinical repeat dose study showed mild residual shifts in auditory brainstem response at 28 days after the final repeated dose, likely related to external ear canal debris or inflammation in the external ear canal or tympanic membrane. There was no adverse impact of the repeat TYMBION dosing on ossicular structures, ossicular mobility, cochlear hair cells, or on microscopic inner ear findings. 3 DOSAGE FORMS AND STRENGTH Otic Solution for iontophoretic delivery using only the Tula Iontophoresis System: TYMBION is a sterile, nonpyrogenic solution of lidocaine hydrochloride 2% (20 mg/mL, equivalent to lidocaine 16.2 mg/mL) and epinephrine 1:100,000 (0.01 mg/mL) in water; provided in 20 mL single-patient-use vials for iontophoretic administration using the Tula Iontophoresis System. 4 CONTRAINDICATIONS • Iontophoretic administration of TYMBION is contraindicated in patients with tympanic membrane (TM) perforation(s), or lacerations or abrasions to the external auditory canal. • Iontophoretic administration of TYMBION is contraindicated in patients with a history of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation. • Iontophoretic administration of TYMBION is contraindicated in patients with a familial history of insensitivity to lidocaine or other local anesthetics (e.g., history of inadequate anesthesia with dental local anesthetic agents). 5 WARNINGS AND PRECAUTIONS 5.1 Local (External Ear Canal and Tympanic Membrane) Effects Although not noted during clinical trials, local edema and erythema was noted during preclinical animal studies upon iontophoretic administration of TYMBION. These effects were temporary in nature and generally resolved within 14 days of the procedure. TYMBION should be warmed to approximately body temperature prior to instilling in the external ear canal. Cool drug placed into the ear canal may cause dizziness due to caloric stimulation. TYMBION, when administered with the Tula Iontophoresis System, provides local anesthesia of the tympanic membrane, and not the external ear canal. Avoid impacting the ear canal wall with otologic instruments. 5.2 Middle Ear Effects Iontophoretic administration of TYMBION is contraindicated in patients with perforation
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