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BONDLIDO 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. BONDLIDO 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 ).

Warnhinweise und Vorsichtsmaßnahmen

Accidental Exposure : A used BONDLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of BONDLIDO out of the reach of children, pets, and others (5.1). Excessive Dosing : Applying BONDLIDO to larger surface areas or for a longer duration than recommended could result in increased absorption and high blood concentrations of lidocaine, leading to serious adverse effects ( 5.2 ).

Non-Intact Skin : May result in higher blood concentrations of lidocaine from increased absorption ( 5.2 ). External Heat Sources : External heat sources may increase drug exposure, leading to overexposure of lidocaine ( 5.2 ). Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.3 ). Application Site Reactions : Severe skin irritation may occur with BONDLIDO if applied for a longer period than instructed ( 5.4 ).

Hypersensitivity Reactions : Patients with an allergy to PABA derivatives may have cross-sensitivity to BONDLIDO( 5.5 ). Eye Exposure : If eye contact occurs, immediately wash out the eye with water or saline and protect the eye using, for example, eyeglasses/eye wear, until sensation returns ( 5.6 ).

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Warnhinweise und Vorsichtsmaßnahmen

Schwangerschaft und Stillzeit

8.1Pregnancy 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 BONDLIDO 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 12 times the maximum recommended daily dose (MRDD) of 400 mg in BONDLIDO 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 approximately 0.14 times the MRDD on Gestation Day 11 resulted in developmental delays in neonates [see Data ].

The 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 (0.73 times the maximum recommended daily dose [MRDD] of 400 mg from BONDLIDO 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 12 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 0.14 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.

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Warnhinweise und Vorsichtsmaßnahmen

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5.1Accidental Exposure

5.2Excessive Dosing

5.3Methemoglobinemia Cases

5.5Hypersensitivity Reactions

5.6Eye Exposure

Wechselwirkungen

7.1Antiarrhythmic Drugs When

7.2Local Anesthetics When

7.3Drugs That May Cause Methemoglobinemia When Used with

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

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