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Lidocaine and hydrocortisone: Drug information

Lidocaine and hydrocortisone: Drug information
(For additional information see "Lidocaine and hydrocortisone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ana-Lex;
  • Lidocort;
  • Radiaura
Pharmacologic Category
  • Anesthetic/Corticosteroid;
  • Antihemorrhoidal Agent
Dosing: Adult
Anti-inflammatory/anesthetic

Anti-inflammatory/anesthetic:

Topical: Apply twice daily.

Rectal: One applicatorful twice daily.

Hemorrhoids, anorectal pain/itch

Hemorrhoids, anorectal pain/itch:

Note: Combine with dietary modifications, bowel hygiene, and warm sitz baths for best results (Ref). General dosing guidelines provided; refer to specific product labeling for dosing instructions.

Topical, rectal: Apply to anal area or by applicator into rectum, as needed, up to 2 times daily. Some experts recommend limiting use to ≤1 week due to risk of mucosal thinning (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified. Also see individual agents.

Frequency not defined:

Dermatologic: Burning sensation of skin (transient)

Local: Application site erythema, localized blanching (lightening; application site)

Nervous system: Transient stinging of skin

Contraindications

Hypersensitivity to lidocaine, hydrocortisone, local anesthetics of the amide type, corticosteroids, or any component of the formulation; tuberculous or fungal lesions; skin vaccinia, varicella, and acute herpes simplex infections.

Warnings/Precautions

Concerns related to adverse effects:

• Contact dermatitis: Allergic contact dermatitis may occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Hypersensitivity: Allergic and anaphylactic reactions may occur. Patients allergic to paraaminobenzoic acid derivatives (eg, procaine, tetracaine, benzocaine) have not shown cross sensitivity to lidocaine; use with caution in patients with a history of drug sensitivities.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Local effects: Irritation, sensitivity, and/or infection may occur at the site of application; discontinue use and institute appropriate therapy if local effects occur.

• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, lightheadedness, fatigue).

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible), manifestations of Cushing syndrome, hyperglycemia, or glycosuria; HPA axis suppression may lead to adrenal crisis. Absorption is increased by the use of occlusive dressings, application to abraded/fissured/irritated skin, prolonged use, or application to extensive or large surface areas. Patients who are acutely ill, debilitated, and/or elderly patients may be at increased risk of systemic toxicity.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

Special populations:

• Acutely ill patients: Use with caution; acutely ill patients should be given reduced doses commensurate with their age and physical status.

• Older adult: Use with caution in the elderly.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, Rectal:

Ana-Lex: Lidocaine hydrochloride 2% and hydrocortisone acetate 2% (4 g) [contains propylene glycol; kit contains 24 tubes (4 g each), single-use applicators, and wipes]

Lidocort: Lidocaine hydrochloride 3% and hydrocortisone acetate 0.5% (85 g) [contains cetyl alcohol, methylparaben, propylene glycol, polyparaben]

Generic: Lidocaine hydrochloride 2% and hydrocortisone acetate 2% (7 g); Lidocaine hydrochloride 3% and hydrocortisone acetate 0.5% (7 g, 85 g); Lidocaine hydrochloride 3% and hydrocortisone acetate 1% (7 g)

Cream, Topical:

Radiaura: Lidocaine hydrochloride 3% and hydrocortisone acetate 0.5% [contains cetearyl alcohol, cetyl alcohol]

Gel, Rectal:

Generic: Lidocaine hydrochloride 2.8% and hydrocortisone acetate 0.55% (100 g); Lidocaine hydrochloride 3% and hydrocortisone acetate 2.5% (7 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Lidocaine-Hydrocort (Perianal) External)

3-0.5% (per gram): $1.20

Cream (Lidocaine-Hydrocortisone Ace External)

1-1% (per gram): $48.67

Cream (Lidocort External)

3-0.5% (per gram): $6.75

Cream (Radiaura External)

3-0.5% (per gram): $17.63

Gel (Lidocaine-Hydrocortisone Ace Rectal)

2.8-0.55% (per gram): $3.60

Kit (Ana-Lex Rectal)

2-2% (per each): $399.00

Kit (Lidocaine-Hydrocortisone Ace Rectal)

2-2% (per each): $265.44

3-0.5% (per each): $158.64 - $358.70

3-1% (per each): $181.38

3-2.5% (per each): $358.70 - $360.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

For external use only; not for oral, ophthalmic, otic, or nasal use.

Topical: Apply thin film to affected area.

Rectal: Gently clean affected area (use cleansing wipe if provided). Attach applicator and gently squeeze tube until applicator is full and a small amount of cream comes out of the applicator opening. Applicator tip should be gently inserted into the anal area and squeeze tube until empty; an adequate amount to anal and peri-anal area will be applied via application tip by gently squeezing during application. Do not completely insert applicator and tube; do not insert deep in the anus or rectum.

Use: Labeled Indications

Anti-inflammatory/anesthetic: Topical relief of pruritus, pruritic eczemas, abrasions, minor burns, radiation burns, inflammatory skin conditions, sun exposure, insect bites; pain, itching, soreness, and discomfort due to anal fissures, pruritus ani, pruritus vulvae, and similar conditions of the skin and mucous membranes.

Hemorrhoids, anorectal pain/itch: Itching, pain, soreness, and discomfort due to hemorrhoids.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Antiarrhythmic Agents (Class IB): Lidocaine (Topical) may enhance the adverse/toxic effect of Antiarrhythmic Agents (Class IB). Risk C: Monitor therapy

Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Cimetidine: May increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

Breastfeeding Considerations

It is not known if lidocaine or hydrocortisone is present in breast milk following use of this preparation. The manufacturer recommends that caution be exercised when administering lidocaine/hydrocortisone to breastfeeding women. See individual agents.

Mechanism of Action

Lidocaine: Blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.

Hydrocortisone: Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BD) Bangladesh: Anacaine hc;
  • (BE) Belgium: Dolanal;
  • (GR) Greece: Forproct;
  • (IT) Italy: Emorril | Lidocaina cloridrato e idrocortisone acetato;
  • (NZ) New Zealand: Ego soov it;
  • (PR) Puerto Rico: Anamantle hydrocortisone | Lidamantle hc | Lidazone | Lidocaine hcl hydrocortisone acetate | Lidocaine Hcl-Hydrocortisone Acetate | Lidocaine hydrocortisone | Lidocort | Peranex HC | Xyralid | Xyralid LP | Xyralid Rc;
  • (PY) Paraguay: Ferziman hemorroidal;
  • (QA) Qatar: Xyloproct
  1. Ana-Lex (hydrocortisone acetate and lidocaine hydrochloride) [prescribing information]. Alpharetta, GA: Avion Pharmaceuticals, LLC; October 2014.
  2. Bleday R, Breen E. Home and office treatment of symptomatic hemorrhoids. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 20, 2022.
  3. Brown S, Girling C, Thapa Magar H, et al. Guidelines, guidelines and more guidelines for haemorrhoid treatment: a review to sort the wheat from the chaff. Colorectal Dis. 2022;24(6):764-772. doi:10.1111/codi.16078 [PubMed 35119707]
  4. Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the management of hemorrhoids. Dis Colon Rectum. 2018;61(3):284-292. doi:10.1097/DCR.0000000000001030 [PubMed 29420423]
  5. Goedert JJ, Vitale F, Lauria C, et al, “Risk Factors for Classical Kaposi's Sarcoma,” J Natl Cancer Inst, 2002, 94(22):1712-8. [PubMed 12441327]
  6. Hydrocortisone acetate 0.55% and lidocaine hydrochloride 2.8% gel [prescribing information]. San Fernando, CA: PureTek Corporation; December 2018.
  7. Hydrocortisone acetate 2.5% and lidocaine hydrochloride 3% gel [prescribing information]. Manasquan, NJ: Seton Pharmaceuticals; February 2022.
  8. Hydrocortisone acetate 3% and lidocaine hydrochloride 1% cream [prescribing information]. San Fernando, CA: PureTek Corporation; December 2018.
  9. Lidocort (lidocaine and hydrocortisone) cream [prescribing information]. Panorama City, CA: PureTek Corporation; August 2020.
  10. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  11. Radiaura (hydrocortisone and lidocaine) [prescribing information]. San Fernando, CA: PureTek Corporation; received September 2021.
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