DailyMed Label: Trilocaine

DailyMed Label: Trilocaine

2024

DailyMed Prescription

Trilocaine

Lidocaine Hydrochloride

Trifluent Pharma LLC

NDC: 73352-610

NDC: 73352-610

Lidocaine hydrochloride has a chemical name of 2-(diethylamino)- N -(2,6-dimethylphenyl)acetamide;hydrochloride and has the molecular weight 270.8. Lidocaine hydrocholoride (C 14 H 22 N 2 O ∙ HCL) has the following structural formula: Ingredients: Each gram of Trilocaine™ 4.12% Cream contains 41.2 mg Lidocaine HCl, USP. Inactive Ingredients include: Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydroxypropyl cellulose, isobutylparaben, Lavandula angustifolia (lavender) oil, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, xanthan gum. Chemical Structure

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

Apply a thin film to the affected area two or three times daily or as directed by a physician.

Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with "caine" ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex.

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Trilocaine™ 4.12% Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine. Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman. Safety and efficacy in children have not been established.

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics Articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfa drugs (i.e., sulfasalazine)

Trilocaine™4.12% Cream: 1 oz. (28.3 g) tube - NDC 73352-610-01 KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Trilocaine™ 4.12% Cream releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. 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 of 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 glycinexlidide. 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 concentration 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 18-21g/mL have been shown to be threshold for convulsive activity.

NDC: 73352-610-01 Rx only TRIFLUENT PHARMA™ Trilocaine™ (4.12% Lidocaine HCl Cream) Topical Anesthetic Net Wt. 1 oz. (28.3 g) Active ingredient: Lidocaine HCl, USP 4.12% Inactive ingredients: Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydroxypropyl cellulose, isobutylparaben, Lavandula angustifolia (lavender) oil, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, xanthan gum. Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN Usual Adult Dosage: Apply a thin film to the affected area two or three times daily or as directed by a physician. Additional Product Information Enclosed. Caution: For external use only. Not for ophthalmic use. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Distributed By: Trifulent Pharma San Antonio, TX 78213 610-01 Rev. 03/2024 FPO Data Matrix PRINCIPAL DISPLAY PANEL - 28.3 g Tube Pouch Label