pramoxine (Fleet Pain Relief, ProctoFoam NS, Tronolane, Tucks Ointment)
Classes: Gastrointestinal Agents, Other; Antipruritics/Non-corticosteroid Topical
Dosing and uses of Fleet Pain Relief, ProctoFoam NS (pramoxine)
Adult dosage forms and 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
Pediatric dosage forms and 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
Fleet Pain Relief, ProctoFoam NS (pramoxine) adverse (side) effects
Frequency not defined
Irritation
Pruritus
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
Pregnancy and 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.
Pharmacology of Fleet Pain Relief, ProctoFoam NS (pramoxine)
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
