Your activity: 25375 p.v.
your limit has been reached. plz Donate us to allow your ip full access, Email: [email protected]

Pramoxine: Drug information

Pramoxine: Drug information
(For additional information see "Pramoxine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Calaclear [OTC];
  • Caladryl Clear [OTC];
  • Caldyphen Clear [OTC];
  • Callergy Clear [OTC];
  • CeraVe Itch Relief [OTC] [DSC];
  • DerMend Moisturizing Anti-Itch [OTC];
  • GoodSense Clear Anti-Itch [OTC];
  • Itch-X [OTC];
  • Ivy Wash Poison Ivy Cleanser [OTC];
  • PrameGel [OTC];
  • Pramox;
  • Prax [OTC];
  • Proctofoam [OTC];
  • Sarna Sensitive [OTC]
Pharmacologic Category
  • Antihemorrhoidal Agent;
  • Local Anesthetic
Dosing: Adult

Anorectal cleansing: Wipes: Topical: Cleanse area up to 5 times daily.

Hemorrhoidal irritations/perianal itching:

Gel (PrameGel): Topical: Apply to affected area 3 to 4 times daily.

Foam, wipes (Prax), and lotion (Prax): Topical: Apply to affected area up to 5 times daily.

Minor skin irritation: Cream, gel, lotion, and spray: Topical: Apply to affected area up to 3 to 4 times daily

Mouth irritations: Liquid (Curasore): Topical: Apply to affected area not more than 3 to 4 times daily; begin at the first sign of a fever blister or cold sore.

Vaginal irritations:

Luvena: Topical: Apply to external vaginal area daily as needed.

Vagisil: Topical: Apply to affected area not more than 3 to 4 times daily.

Dosing: Pediatric

Minor skin irritation: Children ≥2 years: Refer to adult dosing.

Hemorrhoidal itching: Children ≥12 years: Refer to adult dosing.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as hydrochloride:

CeraVe Itch Relief: 1% (340 g [DSC]) [contains cetyl alcohol, disodium edta]

Foam, External, as hydrochloride:

Proctofoam: 1% (15 g) [steroid free; contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Generic: 1% (15 g)

Gel, External, as hydrochloride:

Itch-X: 1% (35.4 g)

PrameGel: 1% (118 mL)

Pramox: 1% (113 g) [contains methylparaben, propylene glycol, propylparaben]

Lotion, External, as hydrochloride:

Calaclear: Pramoxine hydrochloride 1% and zinc acetate 0.1% (177 mL) [contains alcohol, usp, methylparaben, polysorbate 80, propylene glycol, propylparaben]

Caladryl Clear: Pramoxine hydrochloride 1% and zinc acetate 0.1% (177 mL) [contains methylparaben, propylene glycol, propylparaben, sd alcohol]

Caldyphen Clear: Pramoxine hydrochloride 1% and zinc acetate 0.1% (177 mL) [contains alcohol, usp, methylparaben, polysorbate 80, propylene glycol, propylparaben]

Callergy Clear: Pramoxine hydrochloride 1% and zinc acetate 0.1% (177 mL) [contains alcohol, usp, methylparaben, propylene glycol, propylparaben]

DerMend Moisturizing Anti-Itch: 1% (237 mL) [fragrance free, paraben free, steroid free; contains cetyl alcohol, coconut oil (copra/cocos nucifera oil), trolamine (triethanolamine)]

GoodSense Clear Anti-Itch: Pramoxine hydrochloride 1% and zinc acetate 0.1% (177 mL) [contains alcohol, usp, methylparaben, propylene glycol, propylparaben]

Ivy Wash Poison Ivy Cleanser: 1% (177 mL) [contains disodium edta, methylparaben, propylene glycol, propylparaben]

Prax: 1% (118 mL, 237 mL) [contains cetyl alcohol, trolamine (triethanolamine)]

Sarna Sensitive: 1% (222 mL [DSC]) [fragrance free, steroid free]

Sarna Sensitive: 1% (222 mL) [fragrance free, steroid free; contains benzyl alcohol, cetyl alcohol]

Miscellaneous, External, as hydrochloride:

Prax: 1% (1 ea [DSC], 12 ea [DSC])

Generic Equivalent Available: US

May be product dependent

Administration: Adult

Topical:

Anorectal products: Do not put product into the rectum using fingers or any mechanical device or applicator. When practicable, cleanse the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before application.

Foam: Shake well before use. Dispense pramoxine foam onto a clean tissue or pad and apply externally to the affected area. Do not insert any part of the aerosol container into the rectum.

Lotion (Prax): Shake well before use.

Wipes (Prax): Gently apply wipe to the affected area by patting and then discard after single use.

Cream, gel, lotion, and spray: For topical use only. Avoid contact with eyes or nose. Do not use in large quantities. Do not apply over raw surfaces, blistered areas, deep or puncture wounds, animal bites, or serious burns. These topical products are not for vaginal, genital, or rectal use.

Lotion (Caladryl Clear): Shake well before use.

Liquid (Curasore): For external use only; do not swallow. Avoid contact with eyes or nose. Do not moisten area for 2 to 3 minutes following application.

Vaginal wipes (Luvena, Vagisil): For external use only. Unfold and gently apply wipe by patting or wiping the vaginal area from front to back; discard wipe after single use.

Administration: Pediatric

Topical: For external use only; avoid contact with eyes.

Cream: Do not apply in or around the eyes.

Lotion: Apply sparingly, use the minimal effective dose.

Foam: Shake well. Cleanse and dry area prior to use. Dispense foam onto a clean tissue and apply externally. Do not insert into rectum.

Ointment: Do not insert into rectum.

Wipes: Cleanse and rinse area prior to use. Gently pat perianal area with wipe; discard wipe after single use.

Use: Labeled Indications

Hemorrhoidal irritations/perianal itching/anorectal cleansing:

Foam: Temporary relief of pain and itching associated with hemorrhoids.

Gel (PrameGel), lotion (Prax), and wipes (Prax): Temporary relief of itching and discomfort in the perianal area. Also, wipes may be used in anorectal cleansing.

Minor skin irritations: Cream, gel, lotion, and spray: Temporary relief of pain and itching associated with minor skin irritations (eg, rashes, sunburn, hives, minor burns, minor cuts and scrapes, insect bites, poison ivy, poison oak, poison sumac).

Mouth irritations: Liquid (Curasore): Temporary relief of pain and itching associated with fever blisters and cold sores.

Vaginal irritations (Luvena, Vagisil): Temporary relief of itching and burning due to minor vaginal skin irritations.

Medication Safety Issues
Sound-alike/look-alike issues:

Pramoxine may be confused with pralidoxime

Warnings/Precautions

Other warnings/precautions:

• Self-medication (OTC use): For external use only. When used for self-medication, notify health care provider if condition worsens or does not improve within 7 days; clears up and occurs again within a few days; or if accompanied by additional symptoms (eg, swelling, rash, irritation). Do not use topical products on open wounds or large areas of the body; avoid contact with the eyes and nose. Do not put foam or gel anorectal products into the rectum by using fingers or any mechanical device or applicator and do not insert any part of the foam aerosol container into the rectum.

Metabolism/Transport Effects

None known.

Drug Interactions

Bupivacaine: Local Anesthetics may enhance the adverse/toxic effect of Bupivacaine. Management: Avoid using any additional local anesthetics within 96 hours after insertion of the bupivacaine implant (Xaracoll) or bupivacaine and meloxicam periarticular solution (Zynrelef) or within 168 hours after subacromial infiltration (Posimir brand). Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Mechanism of Action

Pramoxine, like other anesthetics, decreases the neuronal membrane's permeability to sodium ions; both initiation and conduction of nerve impulses are blocked, thus depolarization of the neuron is inhibited

Pharmacokinetics

Onset of action: 3-5 minutes

Pricing: US

Foam (Pramoxine HCl (Perianal) External)

1% (per gram): $3.50

Foam (Proctofoam External)

1% (per gram): $6.49

Gel (Itch-X External)

1-10% (per gram): $0.10

Gel (Pramox External)

1% (per gram): $0.13

Lotion (Calaclear External)

1-0.1% (per mL): $0.03

Lotion (Caladryl Clear External)

1-0.1% (per mL): $0.03

Lotion (DerMend Moisturizing Anti-Itch External)

1% (per mL): $0.08

Lotion (Prax External)

1% (per mL): $0.17

Lotion (Sarna Sensitive External)

1% (per mL): $0.04

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Anugesic (ZA);
  • Nestosyl (NL);
  • Pramax Cream (KR);
  • Primoly Gel (TH);
  • Sarmed (IL);
  • Tronolane (LK);
  • Tronotene (IT);
  • Tronothane (FR)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Caladryl (pramoxine) lotion [prescribing information]. Bridgewater, NJ: Bausch Health US LLC; January 2020.
  2. Cereve (pramoxine) cream [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2015.
  3. Curasore (pramoxine) [prescribing information]. Atlanta, GA: SSS Co; received November 2020.
  4. Dermarest (pramoxine) cream [prescribing information]. Langhorne, PA: Insight Pharmaceuticals LLC; 2012.
  5. Dermend (pramoxine) [prescribing information]. Ferndale, MI: Ferndale Healthcare Inc; November 2016.
  6. Itch-X (pramoxine) gel [prescribing information]. Lenexa, KS: B F Ascher and Co Inc; received September 2014.
  7. Itch-X (pramoxine) spray [prescribing information]. Lenexa, KS: B F Ascher and Co Inc; received October 2016.
  8. Luvena (pramoxine) [prescribing information]. Rancho Dominguez, CA: Laclede Inc; received June 2014.
  9. PrameGel (pramoxine) [prescribing information]. Melville, NY: Fougera Pharmaceuticals Inc; November 2011.
  10. Prax (pramoxine) lotion [prescribing information]. Ferndale, MI: Ferndale Healthcare Inc; January 2012.
  11. Prax (pramoxine) wipes [prescribing information]. Ferndale, MI: Ferndale Healthcare Inc; September 2015.
  12. Proctofoam (pramoxine) [prescribing information]. Somerset, NJ: Meda Pharmaceuticals Inc; 2017.
  13. Sarna (pramoxine) [prescribing information]. Research Trangle Park, NC: Stiefel Laboratories Inc; received January 2016.
  14. Vagisil (pramoxine) [prescribing information]. White Plains, NY: Combe Laboratories Inc; August 2014.
Topic 10226 Version 158.0