Pramoxine
Drug class: Antineoplastic Agents
Usage of 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.
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How to use Pramoxine
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 TopicalChildren ≥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 TopicalChildren ≥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 TopicalChildren ≥12 years of age (self-medication): Apply as pledget to the affected area up to 3 or 4 times daily.
Anal TopicalFixed combination with hydrocortisone: Apply foam to the affected area 3 or 4 times daily. (See Pediatric Use under Cautions.)
Adults
Dermatologic Conditions TopicalAs 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 TopicalFixed 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.
Warnings
Contraindications
Warnings/Precautions
Warnings
Administration PrecautionsFor 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 ReactionsAllergic reactions may occur.
If allergic reaction occurs, discontinue the drug and consult a clinician.
Cross-sensitivityLow index of sensitization; cross-sensitization with other local anesthetics is unlikely.
General Precautions
Use of Fixed CombinationsWhen 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
PregnancyCategory C.
LactationNot known whether topical pramoxine is distributed into milk.
Pediatric UseSafety 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.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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