Lidotral Five Percent 50 mg/mL
Lidocaine Hydrochloride · SPRAY · PureTek Corporation
Lidotral Five Percent is a spray containing lidocaine hydrochloride at 50 mg/mL, taken topical. Manufactured by PureTek Corporation.
Key Facts
- Brand Name
- Lidotral Five Percent
- Generic Name
- Lidocaine Hydrochloride
- NDC Code (Product)
59088-350- Manufacturer
- PureTek Corporation
- Strength
- 50 mg/mL
- Dosage Form
- SPRAY
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 06/04/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation. This formulation can be 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 musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. If consulted by your physician, it may be used for other conditions as well. If consulted by your physician, it may be used for other conditions as well.
Dosage & Administration
DOSAGE AND ADMINISTRATION Spray to the affected area two or three times daily or as directed by a physician. Apply Lidotral™ 5% with Menthol Spray to intact skin to cover the most painful area. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. When Lidotral™ 5% with Menthol Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Warnings
WARNINGS For external use only. Not for ophthalmic use. EXCESSIVE DOSING Excessive dosing by applying Lidotral™ 5% with Menthol Spray to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/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, the average peak blood concentration is about 0.13 mcg/ mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.
Contraindications
CONTRAINDICATIONS Lidotral™ 5% with Menthol Spray 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.
Drug Interactions
Drug Interactions Antiarrhythmic Drugs: Lidotral™ 5% with Menthol Spray should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Lidotral™ 5% with Menthol Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Adverse Reactions
ADVERSE REACTIONS ADVERSE REACTIONS Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. It is advisable to apply a small amount on the forearm prior to first use. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch. 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, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Other Adverse Events Due to the nature and limitation of spontaneous reports …
Frequently Asked Questions
What is Lidotral Five Percent used for?
Lidotral Five Percent contains Lidocaine Hydrochloride. It is a spray taken topical. Consult your doctor for specific uses.
Is Lidotral Five Percent a controlled substance?
Lidotral Five Percent is not classified as a controlled substance by the DEA.
What is the generic name for Lidotral Five Percent?
The generic name for Lidotral Five Percent is Lidocaine Hydrochloride. There are 12 other brand versions of Lidocaine Hydrochloride.
What is the NDC code for Lidotral Five Percent 50 mg/mL?
The NDC (National Drug Code) for Lidotral Five Percent 50 mg/mL is 59088-350, listed by PureTek Corporation.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)