BONDLIDO
Generic: LIDOCAINE
Basic Information
Manufacturer
MEDRx USA, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
17e69028-d2c2-4080-8090-cb0cab570196
Indications & Usage
1 INDICATIONS AND USAGE BONDLIDO (lidocaine topical system 10%) is indicated in adults for relief of pain associated with post-herpetic neuralgia (PHN).
BONDLIDO contains lidocaine, an amide local anesthetic, and is indicated in adults for relief of pain associated with post-herpetic neuralgia (PHN) ( 1 ).
BONDLIDO contains lidocaine, an amide local anesthetic, and is indicated in adults for relief of pain associated with post-herpetic neuralgia (PHN) ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Accidental Exposure [see Warnings and Precautions (5.1) ] 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 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.
at TELEPHONE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
at TELEPHONE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.