#
Ana-Lex Cream
  • Professionals
  • FDA PI

Ana-Lex Cream

Generic name: hydrocortisone acetate and lidocaine hydrochloride
Dosage form: cream
Drug class:Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION: Each gram of Ana-Lex™ contains the active ingredients hydrocortisone acetate 20 mg and lidocaine hydrochloride 20 mg. Also contains a 1% (10 mg per gram) Coleus Forskohlii Base.* The inactive ingredients include aluminum sulfate, calcium acetate, carbomer, cetyl alcohol, citric acid, glycerine, methyl paraben, mineral oil, polycarophil, propyl paraben, propylene glycol, purified water, sodium citrate, sodium hydroxide, sodium lauryl sulfate, sorbitan stearate, stearic acid, stearyl alcohol, trolamine, urea and white petrolatum.

Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11ß)-. It has the following structural formula:

Lidocaine HCl is chemically designated as acetamide, 2(diethylamino)- N-(2,6-dimethylphenyl), and has the following structure:

CLINICAL PHARMACOLOGY:

MECHANISM OF ACTION: Ana-Lex™ releases lidocaine and hydrocortisone from a coleus base to increase the antimicrobial function by inhibiting microbial growth, thereby enhancing the function of the product. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

PHARMACOKINETICS: 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 HCl is metabolized rapidly by the liver, an...