Drugplain

Trilocaine 41.2 mg/g

Lidocaine Hydrochloride · CREAM · Trifluent Pharma LLC

No Recall HistoryCurrently in Shortage
Plain English

Trilocaine is a cream containing lidocaine hydrochloride at 41.2 mg/g, taken topical. Manufactured by Trifluent Pharma LLC.

Key Facts

Brand Name
Trilocaine
Generic Name
Lidocaine Hydrochloride
NDC Code (Product)
73352-610
Manufacturer
Trifluent Pharma LLC
Strength
41.2 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
06/24/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

infusion site pain682 reports
nausea471 reports
drug ineffective435 reports
infusion site erythema422 reports
headache415 reports
dyspnoea409 reports
off label use400 reports
diarrhoea398 reports
fatigue350 reports
pain331 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

Dosage & Administration

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

Warnings

WARNINGS For external use only. Not for ophthalmic use. Keep out of reach of children. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue [the use of this product] and any other oxidizing agents. Depending on the severit

Contraindications

CONTRAINDICATIONS 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.

Drug Interactions

DRUG INTERACTIONS 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)

Adverse Reactions

ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma at (210) 944-6920 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Frequently Asked Questions

What is Trilocaine used for?

Trilocaine contains Lidocaine Hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.

Is Trilocaine a controlled substance?

Trilocaine is not classified as a controlled substance by the DEA.

What is the generic name for Trilocaine?

The generic name for Trilocaine is Lidocaine Hydrochloride. There are 12 other brand versions of Lidocaine Hydrochloride.

What is the NDC code for Trilocaine 41.2 mg/g?

The NDC (National Drug Code) for Trilocaine 41.2 mg/g is 73352-610, listed by Trifluent Pharma LLC.