Lidothol Patch
Generic: LIDOTHOL PATCH
Basic Information
Manufacturer
Direct_Rx
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1987e839-6f4e-8671-e063-6394a90abea6
Indications & Usage
Lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain.
Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains.
It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.
Other uses may be considered if deemed clinically relevant.
Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains.
It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.
Other uses may be considered if deemed clinically relevant.
Warnings
Excessive dosage or short interval between doses can result in high plasma levels and serious adverse effects.
Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label.
The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.
Accidental Exposure in Children Even a used Lidothol patch contains a large amount of Lidocaine.
The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidothol patch, although the risk with this formulation has not been evaluated.
It is important for patients to store and dispose of Lidothol beyond the reach of children, pets and others.
(See HANDLING AND DISPOSAL) Excessive Dosing Excessive dosing by applying Lidothol to larger areas for longer than the recommended wearing time could result in increased absorption of Lidocaine and high blood concentrations, leading to serious adverse effects.
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 patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of Lidocaine.
With recommended dosing of Lidothol, the average blood concentration is about 0.13 µg/mL, but concentration higher than 0.25 µg/mL have been observed in some patients.
Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label.
The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.
Accidental Exposure in Children Even a used Lidothol patch contains a large amount of Lidocaine.
The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidothol patch, although the risk with this formulation has not been evaluated.
It is important for patients to store and dispose of Lidothol beyond the reach of children, pets and others.
(See HANDLING AND DISPOSAL) Excessive Dosing Excessive dosing by applying Lidothol to larger areas for longer than the recommended wearing time could result in increased absorption of Lidocaine and high blood concentrations, leading to serious adverse effects.
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 patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of Lidocaine.
With recommended dosing of Lidothol, the average blood concentration is about 0.13 µg/mL, but concentration higher than 0.25 µg/mL have been observed in some patients.
Adverse Reactions
The most common adverse reactions occur at the application site, including dermatitis, itching or scaling.
These tend to be dose-‐limiting and diminish with time.
Serious adverse experiences following the administration of Lidothol are similar in nature to those observed in other amide anesthetic-‐containing agents.
These adverse experiences are, in general, dose-‐related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature.
During or immediately after treatment with Lidothol, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation.
Allergic Reactions Allergic and anaphylactoid reactions associated with Lidocaine, although rare, can occur.
They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria.
If they occur, consult your doctor.
These tend to be dose-‐limiting and diminish with time.
Serious adverse experiences following the administration of Lidothol are similar in nature to those observed in other amide anesthetic-‐containing agents.
These adverse experiences are, in general, dose-‐related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient.
Serious adverse experiences are generally systemic in nature.
During or immediately after treatment with Lidothol, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation.
Allergic Reactions Allergic and anaphylactoid reactions associated with Lidocaine, although rare, can occur.
They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria.
If they occur, consult your doctor.