Advice to Patients
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For external use only; avoid contact with the eyes and nose.
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Importance of not using topical skin preparations for vaginal, rectal, or genital itching.
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Importance of using as directed; importance of not applying to extensive areas of skin, open wounds, or damaged or blistered skin; importance of not using for prolonged periods.
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Importance of discontinuing therapy and consulting clinician if dermatologic condition worsens, if symptoms persist for >7 days or clear and occur again within a few days, if rash or irritation develops during therapy, or if rectal bleeding occurs.
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Importance of discontinuing therapy and consulting clinician if condition worsens or if there is no evidence of improvement after 2–3 weeks of using aerosol foam containing pramoxine in fixed combination with hydrocortisone.
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Importance of not inserting the drug preparation into the rectum using fingers or any mechanical device including any part of an aerosol container.
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Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
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Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription OTC drugs as well as any concomitant illnesses.
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Importance of informing patients of other important precautionary information. (See Cautions.)
Uses for Pramoxine Hydrochloride
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 Hydrochloride 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
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.
Cautions for Pramoxine Hydrochloride
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
Allergic reactions may occur.
If allergic reaction occurs, discontinue the drug and consult a clinician.
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
Pediatric Use
Safety and efficacy of topical gel, lotion, ointment, or solution not established in children 100
Safety and efficacy of topical vaginal pledgets, anorectal cream, foam, ointment, or pledgets not established in children 101
Fixed-combination preparations containing hydrocortisone: Limit topical therapy in children to the minimum amount necessary for therapeutic efficacy.
Local burning or stinging.
References
Only references cited for selected revisions after 1984 are available electronically.
100. B.F. Ascher & Co., Inc. Itch-X gel/spray product information. Lenexa, KS; undated.
101. Fleet. Fleet pain-relief pads product information. From the drugstore.com website (http://www.drugstore.com/qxp27194_333181_sespider/fleet/pain_relief_pre_moistened_anorectal_pads.html). Accessed 2005 Jan 6.
102. Ferndale Laboratories, Inc. Prax lotion product information. Ferndale, MI; undated.
103. Pfizer consumer healthcare. Caladryl clear lotion product information. In: Physicians’ desk reference. From the Drugs.com website (//www.drugs.com/PDR/Caladryl_Clear_Lotion.html). Accessed 2005 Jan 6.
104. Pfizer consumer healthcare. Anusol hemorrhoidal ointment product information. Morris Plains, NJ; undated.
105. Pfizer consumer healthcare. Hemorid hemorrhoidal ointment product information. Morris Plains, NJ; 2001.
106. Monticello Companies, Inc. Tronolane hemorrhoidal cream product information. Jacksonville, FL; undated.
107. Schwarz Pharma. Proctofoam non-steroidal hemorrhoidal foam product information. Milwaukee, WI; undated.
108. Blistex Inc. Blistex Pro Relief lip balm product information. Oak Brook, IL; undated.
109. Pfizer consumer healthcare. Neosporin LT lip treatment product information. Morris Plains, NJ; undated.
110. Bayer consumer care. Campho-Phenique cold sore treatment with scab relief product information. Morristown, NJ; undated.
111. Combe Inc. Vagisil anti-itch medicated wipes product information. White Plains, NY; undated.
a. AHFS drug information 2007. McEvoy GK, ed. Pramoxine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3539-40.
b. B.F. Ascher & Co., Inc. Itch-X gel patient information. Lenexa, KS; undated. Available at: http://www.bfascher.com. Accessed 2007 Dec 31.
c. C.B. Fleet Co., Inc. Fleet pain-relief pre-moistened anorectal pads patient information. Lynchberg, VA; undated. Available at: http://www.drugstore.com/products/prod.asp?pid=27194&catid;=102. Accessed 2007 Dec 31.
d. McNeil-PPC, Inc. Tucks hemorrhoidal ointment patient information. Morris Plains, NJ; undated. Available at: https://www.pfizer.com. Accessed 2007 Oct 12.
e. McNeil-PPC, Inc. Hemorid ointment patient information. Morris Plains, NJ; undated. Available at: https://www.pfizer.com. Accessed 2007 Dec 31.
f. McNeil-PPC, Inc. Caladryl clear lotion patient information. Morris Plains, NJ; undated. Available at: https://www.pfizer.com. Accessed 2007 Dec 31.
g. Combe Inc. Vagisil anti-itch medicated wipes patient information. White Plains, NY; undated. Available at: http://www.drugstore.com/products/prod.asp?pid=139769&catid;=33587. Accessed 2007 Dec 31.
h. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Phildelphia, PA: Lippincott Williams & Wilkins; 2005:1330-1.
i. Proctofoam-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol prescribing information. In PDR.net . Montvale, NJ: Thomson Healthcare; 2006. Updated 2004 Aug.
j. Ferndale Laboratories Inc. Pramosone (hydrocortisone acetate and promoxine hydrochloride) cream, lotion, and ointment prescribing information. In PDR.net . Montvale, NJ: Thomson Healthcare; 2006. Updated 2005 May.
