Lidotral Five Percent
Lidocaine Hydrochloride · Spray · Topical
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
Dosage and administration
Spray to the affected area(s) two or three times daily or as directed by a licensed healthcare practitioner. Apply Lidotral® 5% 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% Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Contraindications
Tuberculosis or fungal lesions of the skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Warnings
For external use only. Not for ophthalmic use. EXCESSIVE DOSING Excessive dosing by applying Lidotral® 5% 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.
Precautions
General Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Lidotral® 5% Spray should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Lidotral® 5% Spray is only recommended for use on intact skin. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over Lidotral® 5% Spray is not recommended as this has not been evaluated and may increase plasma lidocaine levels. Eye Exposure: The contact of Lidotral® 5% Spray with eyes, although not studied, should be avoided based on thefindings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Side effects
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 in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of lidocaine is unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Drug interactions
Drug Interactions Antiarrhythmic Drugs: Lidotral® 5% 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% Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Pregnancy
Pregnancy Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed. Labor and Delivery Lidocaine has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
Pediatric use
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Overdosage
Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or over dosage from other sources of lidocaine or other local anesthetics. The oral LD50 of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.
Description
Lidotral® 5% Spray contains 50 mg of Lidocaine HCl per gram in a vehicle of Aminomethyl Propanol, Aqua (Purified Water), Benzyl Alcohol, Ethyl Alcohol, DL-Panthenol, PEG-8, Rosmarinus Officinalis (Rosemary) Leaf Oil, Fragrance. Lidocaine HCI is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Lidotral® 5% Spray is a combination of ingredients with analgesics and anesthetic properties used in a unique way to maximize its pain-relieving effects to aid in addition to other therapies. This offers long lasting relief for a variety of pain conditions. Drug
How supplied
Lidotral® 5% Spray (Lidocaine HCl 5%) is supplied in a 1 fl. oz. (30 mL) amber PET bottle with a screw cap sprayer (NDC 59088-350-03) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Label text from the FDA structured product label by PureTek Corporation (revised Jun 4, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Lidocaine Hydrochloride in 1 product
Lidotral Five Percent NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59088-350 | Lidocaine Hydrochloride 50 mg/mL Spray | PureTek Corporation | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Lidotral Five Percent used for?
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
What are the side effects of Lidotral Five Percent?
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… See the full label for the complete list.
Who makes Lidotral Five Percent?
Lidotral Five Percent is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.