BONDLIDO

2 DOSAGE AND ADMINISTRATION Due to differences in bioavailability, the efficacy of a lidocaine topical system does not necessarily correlate with dosage strength. Refer to the dosing instructions for the specific product being used ( 2 ).

Apply BONDLIDO to intact skin to cover the most painful area. Apply the prescribed number of topical systems (maximum of two) only once for up to 12 hours in a 24-hour period (2) . Apply firm pressure for 20 seconds to ensure adequate adherence.

, concentration). Comparing different products on a nominal percentage-for-percentage basis may be misleading and the appropriate strength for a given indication may vary by product. Refer to the dosing instructions for the specific product being used.

3) ] . When BONDLIDO is used concomitantly with other products containing local anesthetic agents, the total amount of drug absorbed from all formulations must be considered. 2 Application Instructions Clearly instruct and advise patients: to apply BONDLIDO to intact skin to cover the most painful area.

Apply the prescribed number of topical systems (maximum of 2), only once for up to 12 hours within a 24-hour period. Safety has not been established for application of more than 2 BONDLIDO topical systems per day. to apply firm pressure for 20 seconds to ensure an adequate adherence.

that clothing may be worn over the area of application. to remove BONDLIDO if irritation or a burning sensation occurs during application. Advise patients not to reapply until the irritation subsides. 5) , Patient Counseling Information (17) ].

to not store BONDLIDO outside of the sealed pouch. to apply immediately after removal from the protective pouch. to fold used BONDLIDO so that the adhesive side sticks to itself. to safely discard used BONDLIDO where children and pets cannot get to them.

2) , Patient Counseling Information (17) ]. that BONDLIDO may not stick if it gets wet and to avoid contact with water, such as bathing, swimming, or showering, while a BONDLIDO topical system is applied. If the BONDLIDO topical system comes off completely and will not stick to the skin, advise patients that they may apply a replacement BONDLIDO topical system and take the replacement BONDLIDO topical system off at the usual removal time.

6) ] The following adverse reactions associated with the use of lidocaine were identified in clinical trials or postmarketing reports for 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 MEDRx USA, Inc. gov/medwatch.

5 WARNINGS AND PRECAUTIONS Accidental Exposure : A used BONDLIDO topical system contains residual lidocaine after use. 1). 2 ). 2 ). 2 ). 3 ). 4 ). 5 ). 6 ). 1 Accidental Exposure A used BONDLIDO topical system contains residual lidocaine after use.

The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting new or used BONDLIDO. It is important for patients to store and dispose of BONDLIDO properly, and keep out of the reach of children, pets, and others [see Dosage and Administration (2) ] .

2 Excessive Dosing Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 µg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of BONDLIDO, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine.

If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment [see Overdosage (10) ].

Improper Application and Duration of Use :

Application of more than the recommended number of BONDLIDO or applying BONDLIDO for longer than the recommended wearing time (12 hours of every 24 hours) could result in increased absorption and high blood concentrations of lidocaine, leading to adverse effects.

Advise patients on proper application and duration [see Patient Counseling Information (17) ] .

Hepatic Disease :

Impaired elimination may contribute to increasing blood concentrations of lidocaine. Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine because of their inability to metabolize lidocaine normally.

4 CONTRAINDICATIONS 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 ).