Introduction

Local anesthetic.

Uses for Pramoxine

Dermatologic Conditions

Self-medication for the temporary relief of pain and itching associated with minor lip or skin irritations (e.g., dermatoses, insect bites, minor burns or sunburns, minor cuts or scrapes, cold sores, hives, rashes due to poison ivy, poison oak, or poison sumac).

Anorectal/Anogenital Disorders

Self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort associated with hemorrhoids and other anorectal or anogenital disorders (e.g., inflammation, irritation, fissures, anogenital pruritus).

In fixed combination with hydrocortisone for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

Pramoxine Dosage and Administration

Administration

Topical

Apply topically to the skin as a gel, lotion, ointment, or solution.

Apply topically to the lip as an ointment.

Do not use topical skin preparations for vaginal, genital, or rectal itching.

For external use only; avoid contact with the eyes and nose. Do not apply to extensive areas of skin, open wounds, or damaged or blistered skin; do not use for prolonged periods.

Do not use on deep or puncture wounds, animal bites, or serious burns.

Apply to cold sores and fever blisters after blister has dried.

Shake lotion well before use.

Anorectal Topical Administration

Apply externally to the anorectal area as an aerosol foam, cream, ointment, lotion, or pledgets. Do not insert drug into rectum using fingers or any mechanical device.

Before applying drug, cleanse the affected perianal area with mild soap and warm water and rinse thoroughly whenever practical; dry by patting or blotting with toilet tissue or a soft cloth.

Shake aerosol foam before use. Disperse onto a clean tissue before applying to the affected area. Rub in gently. Do not insert any part of the aerosol container past anus into the rectum. Clean applicator thoroughly after each use.

Apply pledget by gently patting the affected area with pledget; use pledget only once, then discard.

Vaginal Topical Administration

Apply externally to vaginal area as vaginal pledgets.

Apply by gently patting or wiping the affected area from front to back; use pledget only once, then discard.

Anal Administration

Apply topically to anus as an aerosol foam.

In fixed combination with hydrocortisone: Apply aerosol foam using provided applicator for anal administration.

Shake aerosol foam before use. Do not insert any part of the aerosol container past anus into the rectum. Clean applicator thoroughly after each use.

Dosage

Available as pramoxine hydrochloride; dosage expressed in terms of the salt.

Pediatric Patients

Dermatologic Conditions

Topical

Children ≥2 years of age (self-medication): Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily. Administer the least amount of topical preparations that provides effective therapy. (See Pediatric Use under Cautions.)

Anorectal/Anogenital Disorders

External Anorectal Topical

Children ≥12 years of age (self-medication): Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.

External Vaginal Topical

Children ≥12 years of age (self-medication): Apply as pledget to the affected area up to 3 or 4 times daily.

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily. (See Pediatric Use under Cautions.)

Adults

Dermatologic Conditions

Topical

As self-medication: Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.

Anorectal/Anogenital Disorders

External Anorectal Topical As (self-medication)

Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.

External Vaginal Topical As (self-medication)

Apply as pledget to the affected area up to 3 or 4 times daily.

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy; use lowest effective dosage.

Contraindications

• Known hypersensitivity to pramoxine or any ingredient in the formulation.

Warnings/Precautions

Warnings

Administration Precautions

For external use only. Avoid contact with the eyes and nose.

Do not use topical skin preparations (intended for skin irritation) for vaginal, genital, or rectal itching.

Do not apply to extensive areas of skin, open wounds, or damaged/blistered skin.

Do not use for prolonged periods.

Do not use on deep or puncture wounds, animal bites, or serious burns.

Do not insert the drug preparation into the rectum using fingers or any mechanical device. Do not insert any part of an aerosol container into the rectum.

Discontinue and consult a clinician if erythema, irritation, swelling, pain, or other symptoms develop or worsen during therapy, or if pain or itching persists for >7 days, worsens, or resolves and occurs again within a few days, or if rectal bleeding occurs during use.

Discontinue use of fixed-combination pramoxine and hydrocortisone aerosol foam if condition worsens or does not improve in 2–3 weeks.

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions may occur.

If allergic reaction occurs, discontinue the drug and consult a clinician.

Cross-sensitivity

Low index of sensitization; cross-sensitization with other local anesthetics is unlikely.

General Precautions

Use of Fixed Combinations

When used in fixed combinations with allantoin, calamine, dimethicone, hydrocortisone acetate, neomycin, phenylephrine hydrochloride, polymyxin B, or zinc oxide, consider the cautions, precautions, and contraindications associated with the concomitant agent.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical pramoxine is distributed into milk.

Pediatric Use

Safety and efficacy of topical gel, lotion, ointment, or solution not established in children <2 years of age.

Safety and efficacy of topical vaginal pledgets, anorectal cream, foam, ointment, or pledgets not established in children <12 years of age.

Fixed-combination preparations containing hydrocortisone: Limit topical therapy in children to the minimum amount necessary for therapeutic efficacy.

Common Adverse Effects

Local burning or stinging.

Administration

Topical

Apply topically to the skin as a gel, lotion, ointment, or solution.

Apply topically to the lip as an ointment.

Do not use topical skin preparations for vaginal, genital, or rectal itching.

For external use only; avoid contact with the eyes and nose. Do not apply to extensive areas of skin, open wounds, or damaged or blistered skin; do not use for prolonged periods.

Do not use on deep or puncture wounds, animal bites, or serious burns.

Apply to cold sores and fever blisters after blister has dried.

Shake lotion well before use.

Anorectal Topical Administration

Apply externally to the anorectal area as an aerosol foam, cream, ointment, lotion, or pledgets. Do not insert drug into rectum using fingers or any mechanical device.

Before applying drug, cleanse the affected perianal area with mild soap and warm water and rinse thoroughly whenever practical; dry by patting or blotting with toilet tissue or a soft cloth.

Shake aerosol foam before use. Disperse onto a clean tissue before applying to the affected area. Rub in gently. Do not insert any part of the aerosol container past anus into the rectum. Clean applicator thoroughly after each use.

Apply pledget by gently patting the affected area with pledget; use pledget only once, then discard.

Vaginal Topical Administration

Apply externally to vaginal area as vaginal pledgets.

Apply by gently patting or wiping the affected area from front to back; use pledget only once, then discard.

Anal Administration

Apply topically to anus as an aerosol foam.

In fixed combination with hydrocortisone: Apply aerosol foam using provided applicator for anal administration.

Shake aerosol foam before use. Do not insert any part of the aerosol container past anus into the rectum. Clean applicator thoroughly after each use.

Dosage

Available as pramoxine hydrochloride; dosage expressed in terms of the salt.

Pediatric Patients

Dermatologic Conditions

Topical

Children ≥2 years of age (self-medication): Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily. Administer the least amount of topical preparations that provides effective therapy. (See Pediatric Use under Cautions.)

Anorectal/Anogenital Disorders

External Anorectal Topical

Children ≥12 years of age (self-medication): Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.

External Vaginal Topical

Children ≥12 years of age (self-medication): Apply as pledget to the affected area up to 3 or 4 times daily.

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily. (See Pediatric Use under Cautions.)

Adults

Dermatologic Conditions

Topical

As self-medication: Apply gel, lotion, ointment, or solution to the affected area up to 3 or 4 times daily.

Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.

Anorectal/Anogenital Disorders

External Anorectal Topical As (self-medication)

Apply cream, foam, ointment, or pledget to the affected area up to 4 or 5 times daily or after each bowel movement.

External Vaginal Topical As (self-medication)

Apply as pledget to the affected area up to 3 or 4 times daily.

Anal Topical

Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy; use lowest effective dosage.