pramoxine (OTC)

Brand and Other Names:Fleet Pain Relief, ProctoFoam NS, more...Tronolane, Tucks Ointment
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical

  • 1%

Minor Skin Irritation

Apply lotion/cream to affected area up to 3-4 times/day

Vaginal Itching

Apply wipes to external vaginal area up to 3-4 times/day

Hemorrhoid Pain/Itching

Up to 5 times/day in anorectal area AM, PM and after bowel movements, or PRN

Dosage Forms & Strengths

topical

  • 1%

Minor Skin Irritation

< 2 years: Safety and efficacy not established

> 2 years: Apply lotion/cream to affected area up to 3-4 times/day

Hemorrhoidal or Vaginal Itching

< 12 years: Safety and efficacy not established

> 12 years: Apply lotion/cream to affected area up to 3-4 times/day

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Adverse Effects

Frequency Not Defined

Irritation

Pruritus

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Warnings

Contraindications

Hypersensitivity to any ingredients

Cautions

PR not to be used >4 consecutive weeks

Reevaluate if rectal bleeding or condition worsens in 7 days

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Pregnancy & Lactation

Pregnancy Category: NA

Lactation: not known if excreted in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Local anesthetic; inhibits conduction of nerve impulses from sensory nerves by decreasing neuronal membrane's permeability to sodium ions

Pharmacokinetics

Onset: 3-5 min

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Prax topical
-
1 % lotion
pramoxine topical
-
1 % foam
Vagisil Anti-Itch topical
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1 % miscellaneous
Vagisil Anti-Itch topical
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1 % miscellaneous

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
pramoxine topical

PRAMOXINE - TOPICAL

(pram-OX-een)

COMMON BRAND NAME(S): Caladryl, Tronolane

USES: Pramoxine is used to temporarily relieve itching and pain caused by minor skin irritation such as minor burns/cuts/scrapes, sunburn, eczema, insect bites, cold sores, or rashes from poison ivy, poison oak, or poison sumac. Some products containing pramoxine are also used to temporarily relieve the itching and discomfort from hemorrhoids and certain other problems of the genital/anal area (such as anal fissures, itching around the vagina/rectum). Pramoxine belongs to a class of drugs known as local anesthetics. It works by numbing the skin to block the feelings of pain and itching. This product may also contain other ingredients including skin protectants (such as calamine, zinc acetate, zinc oxide). Read the product package for more information.Do not use pramoxine for skin irritation in children younger than 2 years or use pramoxine for hemorrhoids or other genital/anal conditions in children younger than 12 years unless directed by the doctor.If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)

HOW TO USE: This medication is for use only on the skin as directed by your doctor. Do not apply on severely broken skin areas such as open wounds, deep cuts, or serious burns. If you are self-treating, follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.Gently clean and dry the affected area. If you are using a lotion or foam product, shake the container well before using as directed on the label. For skin irritation, apply to the affected area usually up to 3 to 4 times a day or as directed by your doctor. For hemorrhoids or other anal conditions, apply the medication to the affected area usually after each bowel movement or up to 4 to 5 times a day, or as directed by your doctor. Do not use this medication inside the rectum. Spray the foam onto a clean tissue and apply to the affected area. If you are using the hemorrhoidal cream, you may use the applicator that comes with it. Clean the applicator after each use.Wash your hands immediately after use, unless the area being treated includes the hands.Do not use this product on large areas of the body or use it more often than directed. Do not cover the area with waterproof bandages or plastic, or apply heat unless told to do so by your doctor. Your condition will not improve any faster, and your risk of side effects will increase.Do not get the product in your eyes, nose, ears, or mouth. If the medication gets in these areas, wipe it off and rinse right away with water.Stop using this product and tell your doctor if your condition worsens, if symptoms do not improve within 7 days or last after 7 days of treatment, or if symptoms clear up and return in a few days. If you think you may have a serious medical problem, seek immediate medical attention.

SIDE EFFECTS: Burning or stinging may occur. If either of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has directed you to use this product, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to any of the other ingredients listed on the product package; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: deep/open/puncture wounds, broken/damaged/blistered skin, animal bites, serious burns.If you are using this product for hemorrhoids and bleeding from the rectum occurs, stop using it and consult your doctor promptly.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Keep all regular medical and laboratory appointments.

MISSED DOSE: If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Different products have different storage needs. Check the product package for instructions on how to store it, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.