DailyMed Label: Lidotral Two Percent

DailyMed Label: Lidotral Two Percent

2024

DailyMed Prescription

Lidotral Two Percent

Lidocaine Hydrochloride

PureTek Corporation

NDC: 59088-304

NDC: 59088-304

Lidotral® 2% Spray contains 20 mg of Lidocaine HCl per gram in a vehicle of Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aqua (Purified Water), Benzyl Alcohol, Ethyl Alcohol, 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® 2% 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

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Adults & children 4 years of age and older: spray to the affected area(s) two or three times daily or as directed by alicensed healthcare practitioner. Children under 4 years of age: consult a licensed healthcare practitioner. Apply Lidotral® 2% 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® 2% Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

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.

Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Lidotral® 2% 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® 2% 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® 2% Spray is not recommended as this has not been evaluated and may increase plasma lidocaine levels. Eye Exposure: The contact of Lidotral® 2% 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.

Antiarrhythmic Drugs: Lidotral® 2% 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® 2% Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Lidotral® 2% Spray (Lidocaine HCl 2%) is supplied in a 1 fl. oz. (30 mL) amber PET bottle with a screw cap sprayer (NDC 59088-304-03) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Pharmacodynamics Lidocaine is a common local anesthetic that relieves itching, burning, and pain. Topically, it blocks both initiation and conduction or nerve impulses by decreasing ionic flux through the neuronal membrane. Since it penetrates the skin, it creates an anesthetic effect by not just preventing pain signals from propagating to the brain out by stopping them before they begin. Absorption: Lidocaine- Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver. Lidocaine is metabolized rapidly by the liver and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/ toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics, but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity. Excretion: Lidocaine- Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/min (mean 0.64 ± 0.18 SD, n = 15).

Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label