Class: Antipruritics and Local Anesthetics
ATC Class: D04AB07
VA Class: DE700
CAS Number: 637-58-1
Brands: Analpram, Analpram HC, Blistex Pro Relief, Caladryl, Campho-Phenique Cold Sore, Fleet Pain-Relief, Hemorid, Itch-X, Neosporin, Neosporin LT, Neosporin + Pain Relief, PrameGel, Pramosone, Prax, Preparation H, ProctoFoam, ProctoFoam-HC, Tronolane, Tucks, Vagisil Medicated
Introduction
Local anesthetic.101 105 106 107
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).100 102 103 108 109 110 b f k j
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).101 104 105 106 107 111 c d e g
In fixed combination with hydrocortisone for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.i
Pramoxine Hydrochloride Dosage and Administration
Administration
Topical
Apply topically to the skin as a gel, lotion, ointment, or solution.100 102 103 110 b f
Apply topically to the lip as an ointment.108 109 k
Do not use topical skin preparations for vaginal, genital, or rectal itching.100 b
For external use only; avoid contact with the eyes and nose.100 101 102 103 104 105 106 107 108 109 110 111 b c f Do not apply to extensive areas of skin, open wounds, or damaged or blistered skin; do not use for prolonged periods.100 102 b
Do not use on deep or puncture wounds, animal bites, or serious burns.108 109
Apply to cold sores and fever blisters after blister has dried.k
Shake lotion well before use.102 103 107 f j
Anorectal Topical Administration
Apply externally to the anorectal area as an aerosol foam, cream, ointment, lotion, or pledgets.101 104 105 106 107 c d e Do not insert drug into rectum using fingers or any mechanical device.104 105 106 107 c d e
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.101 104 105 106 107 c d e
Shake aerosol foam before use.i Disperse onto a clean tissue before applying to the affected area.107 i Rub in gently.i Do not insert any part of the aerosol container past anus into the rectum.107 i Clean applicator thoroughly after each use.i
Apply pledget by gently patting the affected area with pledget; use pledget only once, then discard.101 c
Vaginal Topical Administration
Apply externally to vaginal area as vaginal pledgets.111 g
Apply by gently patting or wiping the affected area from front to back;g use pledget only once, then discard.111 g
Anal Administration
Apply topically to anus as an aerosol foam.i
In fixed combination with hydrocortisone: Apply aerosol foam using provided applicator for anal administration.i
Shake aerosol foam before use.i Do not insert any part of the aerosol container past anus into the rectum.107 i Clean applicator thoroughly after each use.i
Dosage
Available as pramoxine hydrochloride; dosage expressed in terms of the salt.a
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.100 102 103 108 109 110 b f k
Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.j Administer the least amount of topical preparations that provides effective therapy.j (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.101 104 105 106 107 c d e
External Vaginal Topical
Children ≥12 years of age (self-medication): Apply as pledget to the affected area up to 3 or 4 times daily.111 g
Anal Topical
Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.i (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.100 102 103 108 109 110 f k
Fixed combination with hydrocortisone: Apply cream, lotion, or ointment to the affected area as a thin film 3 or 4 times daily.j
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.101 104 105 106 107 c d e
External Vaginal Topical As (self-medication)
Apply as pledget to the affected area up to 3 or 4 times daily.111 g
Anal Topical
Fixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily.i
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.i
Cautions for Pramoxine Hydrochloride
Contraindications
Known hypersensitivity to pramoxine or any ingredient in the formulation.a i j
Warnings/Precautions
Warnings
Administration Precautions
For external use only.100 101 102 103 104 105 106 107 108 109 110 111 b c d e f k Avoid contact with the eyes and nose.100 102 103 108 109 110 111 b f i k
Do not use topical skin preparations (intended for skin irritation) for vaginal, genital, or rectal itching.100 b
Do not apply to extensive areas of skin, open wounds, or damaged/blistered skin.100 102 b
Do not use for prolonged periods.100 102
Do not use on deep or puncture wounds, animal bites, or serious burns.108 109 b
Do not insert the drug preparation into the rectum using fingers or any mechanical device.104 105 106 107 c d e Do not insert any part of an aerosol container into the rectum.107 i
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.100 101 102 103 104 105 106 107 108 109 110 111 c d e f k
Discontinue use of fixed-combination pramoxine and hydrocortisone aerosol foam if condition worsens or does not improve in 2–3 weeks.i
Sensitivity Reactions
Hypersensitivity Reactions
Allergic reactions may occur.101 106 107 c d e
If allergic reaction occurs, discontinue the drug and consult a clinician.104 105 d e
Cross-sensitivity
Low index of sensitization; cross-sensitization with other local anesthetics is unlikely.a
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.h
Lactation
Not known whether topical pramoxine is distributed into milk.h
Pediatric Use
Safety and efficacy of topical gel, lotion, ointment, or solution not established in children <2 years of age.100 102 103 108 109 110 b f k
Safety and efficacy of topical vaginal pledgets, anorectal cream, foam, ointment, or pledgets not established in children <12 years of age.101 104 106 107 c d e g
Fixed-combination preparations containing hydrocortisone: Limit topical therapy in children to the minimum amount necessary for therapeutic efficacy.i j
Common Adverse Effects
Local burning or stinging.a
Pramoxine Hydrochloride Pharmacokinetics
Absorption
Bioavailability
Minimally absorbed following topical application.h
Distribution
Extent
Not known whether pramoxine crosses the placenta or is distributed into milk.h
Stability
Storage
Topical
Aerosol
Upright at 20–25°C; i do not refrigerate.107 i Do not puncture, burn, or expose to temperatures >49°C.107 i
Cream
Tight container at 15–30°C.100 103 104 105 j
Lotion
15–25°C.f
Ointment
Tight container at 15–30°C;e j some preparations 20–25°C.d
ActionsActions
Structurally similar to dyclonine; does not contain the usual ester or amide linkage of the procaine-type drugs.a
Stabilizes neuronal membrane of nerve endings with which it comes into contact.j
Temporarily forms a protective coating over inflamed tissues to help prevent drying.c d
Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.f
Advice to Patients
For external use only; avoid contact with the eyes and nose.100 101 102 103 104 105 106 107 108 109 110 111 b c d e f i k
Importance of not using topical skin preparations for vaginal, rectal, or genital itching.100 b
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.100 102 b
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.100 101 102 103 104 105 106 107 108 109 110 111 c d e f k
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. i
Importance of not inserting the drug preparation into the rectum using fingers or any mechanical device including any part of an aerosol container.104 105 106 107 c d e
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.100 105 106 107 e
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription OTC drugs as well as any concomitant illnesses.a e
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Aerosol, foam suspension | 1%* | ProctoFoam (with parabens) | Schwarz |
Pramoxine Hydrochloride Foam (with parabens and propylene glycol) | URL | |||
Cream | 1% | Hemorrhoidal Anesthetic Cream | Clay-Park | |
Gel | 1% | Itch-X (with SD alcohol 40, benzyl alcohol 10%, parabens, and propylene glycol) | Ascher | |
PrameGel (with benzyl alcohol, menthol 0.5%, and SD alcohol 40) | Doak | |||
Lotion | 1% | Prax Lotion | Ferndale | |
Ointment | 1% | Campho-Phenique Cold Sore Treatment for Scab Relief (with parabens) | Bayer | |
Pledgets (saturated with solution) | 1% | Fleet Pain-Relief Pads (with glycerin 12%) | Fleet | |
Vagisil Anti-itch Medicated Wipes (with parabens) | Combe | |||
Solution | 1% | Itch-X Spray (with benzyl alcohol 10% and SD alcohol 40) | Ascher |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Aerosol, foam suspension | 1% with Hydrocortisone Acetate 1% | ProctoFoam-HC (with parabens and propylene glycol) | Schwarz |
Cream | 1% with Hydrocortisone Acetate 1% | Analpram HC (with propylene glycol) | Ferndale | |
Pramosone (with propylene glycol) | Ferndale | |||
1% with Hydrocortisone Acetate 2.5% | Analpram HC (with propylparaben) | Ferndale | ||
Pramosone (with propylparaben) | Ferndale | |||
Preparation H Maximum Strength (with glycerin 14.4%) | Wyeth | |||
1% with Neomycin 0.35% and Polymyxin B 10,000 units/g | Neosporin + Pain Relief (with propylene glycol and parabens) | Pfizer | ||
1% with Phenylephrine Hydrochloride 0.25% | Hemorid Creme (with parabens) | McNeil | ||
1% with Zinc Oxide 5% | Tronolane (with parabens) | Monticello | ||
Lotion | 1% with Calamine 8% | Caladryl Lotion (with alcohol SD 38B, parabens, and propylene glycol) | McNeil | |
1% with Hydrocortisone Acetate 1% | Pramosone | Ferndale | ||
1% with Hydrocortisone Acetate 2.5% | Analpram HC | Ferndale | ||
Pramosone | Ferndale | |||
1% with Zinc Acetate 0.1% | Caladryl Clear (with alcohol SD 38B 2.5%, parabens, and propylene glycol) | McNeil | ||
Ointment | 1% with Allantoin 1.5% | Neosporin LT Lip Treatment (with propylparaben) | Blistex | |
1% with Dimethicone 2% | Blistex Pro Relief (with parabens) | Blistex | ||
1% with Hydrocortisone Acetate 1% | Pramosone | Ferndale | ||
1% with Hydrocortisone Acetate 2.5% | Pramosone | Ferndale | ||
1% with Neomycin 0.35% and Polymyxin B 10,000 units/g | Neosporin + Pain Relief | Pfizer | ||
1% with Phenylephrine Hydrochloride 0.25% | Hemorid | McNeil | ||
1% with Zinc Oxide 12.5% | Tucks Hemorrhoidal | McNeil |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Analpram-HC 1-1% Cream (FERNDALE LAB): 30/$91.99 or 90/$255.96
Analpram-HC 1-2.5% Cream (FERNDALE LAB): 30/$91.41 or 90/$261
Analpram-HC 1-2.5% Lotion (FERNDALE LAB): 59/$105.99 or 177/$295.98
Analpram-HC Singles 1-2.5% Cream (FERNDALE LAB): 120/$219 or 360/$615.98
Pramosone 1-1% Cream (FERNDALE LAB): 28/$82.76 or 85/$213.11
Pramosone 1-1% Lotion (FERNDALE LAB): 59/$85.99 or 118/$159.98
Pramosone 1-1% Ointment (FERNDALE LAB): 28/$80.04 or 85/$215.97
Pramosone 1-2.5% Cream (FERNDALE LAB): 28/$80.47 or 56/$150.62
Pramosone 1-2.5% Lotion (FERNDALE LAB): 118/$148.22 or 354/$431.59
Pramosone 1-2.5% Lotion (FERNDALE LAB): 59/$99.16 or 177/$278.98
Pramosone 1-2.5% Ointment (FERNDALE LAB): 28/$81.73 or 85/$217.94
Proctofoam 1% Foam (ALAVEN PHARMACEUTICAL LLC): 15/$45.13 or 45/$133.2
Proctofoam HC 1-1% Foam (ALAVEN PHARMACEUTICAL LLC): 10/$88.45 or 30/$256.29
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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 (). 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 (). 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: . Accessed 2007 Dec 31.
c. C.B. Fleet Co., Inc. Fleet pain-relief pre-moistened anorectal pads patient information. Lynchberg, VA; undated. Available at: . Accessed 2007 Dec 31.
d. McNeil-PPC, Inc. Tucks hemorrhoidal ointment patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Oct 12.
e. McNeil-PPC, Inc. Hemorid ointment patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Dec 31.
f. McNeil-PPC, Inc. Caladryl clear lotion patient information. Morris Plains, NJ; undated. Available at: . Accessed 2007 Dec 31.
g. Combe Inc. Vagisil anti-itch medicated wipes patient information. White Plains, NY; undated. Available at: . 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 [database online]. 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 [database online]. Montvale, NJ: Thomson Healthcare; 2006. Updated 2005 May.
k. Bayer HealthCare LLC. Campho-phenique (pramoxine HCl 1% and white petrolatum 30%) cold sore treatment for scab relief patient information. 2007; Available at: . Accessed 2007 Dec 31.
More Pramoxine Hydrochloride resources
- Pramoxine Hydrochloride Side Effects (in more detail)
- Pramoxine Hydrochloride Use in Pregnancy & Breastfeeding
- Pramoxine Hydrochloride Support Group
- 9 Reviews for Pramoxine Hydrochloride - Add your own review/rating
- Anest Hemor Concise Consumer Information (Cerner Multum)
- Caladryl Clear MedFacts Consumer Leaflet (Wolters Kluwer)
- Itch-X Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- PrameGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Prax Lotion MedFacts Consumer Leaflet (Wolters Kluwer)
- Proctofoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Sarna Sensitive Lotion MedFacts Consumer Leaflet (Wolters Kluwer)
- Tronolane Cream MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Pramoxine Hydrochloride with other medications
- Anal Itching
- Atopic Dermatitis
- Hemorrhoids
- Pain
- Pruritus
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