pramoxine/menthol/petrolatum topical (Sarna Ultra)

Dosing and uses of Sarna Ultra (pramoxine/menthol/petrolatum topical)

• Adult
• Pediatric

 

Adult dosage forms and strengths

pramoxine/menthol/petrolatum topicaL

topical lotion

• 1%/0.5%

 

Topical Pain

For temporary relief from dry itching skin and pain due to minor burns, abrasions and other irritated skin conditions

Apply to affected area q6-8hr PRn

 

Administration

Shake well before using

For cleansing of anogenital area, spread on cotton or tissue and wipe affected area

 

Pediatric dosage forms and strengths

pramoxine/menthol/petrolatum topicaL

topical lotion

• 1%/0.5%

 

Topical Pain

For temporary relief from dry itching skin and pain due to minor burns, abrasions and other irritated skin conditions

>2 years: Apply to affected area q6-8hr PRn

<2 years: Safety and efficacy not established

 

Sarna Ultra (pramoxine/menthol/petrolatum topical) adverse (side) effects

Frequency not defined

Irritation

Pruritus

 

Warnings

Contraindications

Hypersensitivity to any product component

 

Cautions

For external use only

Do not use in the eyes

Do not use on blistered or broken skin

If condition worsens, or if symptoms persist for longer than 7 days or clear up and occur again within a few days, discontinue use and consult a physician

 

Pregnancy and lactation

Pregnancy category: Undetermined, caution advised

Lactation: Unknown if excreted in breast milk, caution advised

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 Sarna Ultra (pramoxine/menthol/petrolatum topical)

Mechanism of action

Pramoxine: Local anesthetic due to inhibition of conduction of nerve impulses from sensory nerves, resulting from an alteration of the cell membrane permeability to ions

Menthol: Antiseptic, local anesthetic and analgesic properties

 

Absorption

Onset: 3-5 min