1) The primary adverse effects are burning/stinging, dryness, erythema, rash, itching, local irritation, skin tenderness, and allergic contact dermatitis.

1) No overdose data are available. Toxicity risk from naftifine is extremely low. Nausea, vomiting, and diarrhea may occur primarily due to product emollient base. Refer to LAXATIVE-EMOLLIENT document for more information.

1) Treatment is symptomatic and supportive.

1) Severe toxicity is not expected after overdose of naftifine. Treatment is symptomatic and supportive.

1) PREHOSPITAL: Toxicity after acute ingestion is unlikely. Nausea, vomiting, and diarrhea may occur primarily due to product emollient base. Gastrointestinal decontamination is generally unnecessary.
2) HOSPITAL: Toxicity after acute ingestion is unlikely. Gastrointestinal decontamination is generally unnecessary.

1) Should not be required in these cases.

1) None.

1) Hemodialysis is not recommended given the low toxicity of this drug.

1) HOME CRITERIA: A patient with an inadvertent ingestion, that remains asymptomatic can be managed at home.
2) OBSERVATION CRITERIA: All patients with deliberate self-harm ingestions and any patient with more than mild GI distress after unintentional ingestion should be evaluated in a healthcare facility and monitored until symptoms resolve.
3) ADMISSION CRITERIA: Hospital admission is rarely necessary. Patients should be admitted for severe vomiting, profuse diarrhea, severe abdominal pain, dehydration, and electrolyte abnormalities.
4) CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.

1) If significant toxicity develops the diagnosis should be reconsidered. When managing a suspected naftifine overdose, the possibility of multi-drug involvement should be considered.

1) Bioavailability: (topical), 4.2%. Elimination half-life: approximately 2 days to 3 days.

1) DECONTAMINATION: Remove contaminated clothing and jewelry and irrigate exposed areas with copious amounts of water. A physician may need to examine the area if irritation or pain persists.

1) WITH POISONING/EXPOSURE

1) During clinical trials, burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), and local irritation (2%) were observed with naftifine cream (1%). Burning/stinging (5%), itching (1%), erythema (0.5%), rash (0.5%), and skin tenderness (0.5%) were reported with naftifine gel (1%) (Prod Info Naftin(R) topical cream, gel, 2009; Ganzinger et al, 1986). Both the cream and gel forms are considered to have a low potential for irritation (Maibach, 1987).

1) Allergic contact dermatitis has been reported after use of naftifine ointment (Senff et al, 1989; Kleinhans, 1986; Hoting et al, 1987).
2) LACK OF EFFECT: In a study, 221 patients were tested with a 1% or 3% gel. No reactions were seen in test patients (Maibach, 1987).

1) At the time of this review, no human data were available to assess the teratogenic potential of this agent (Prod Info NAFTIN(R) 2% topical cream, 2012; Prod Info Naftin(R) topical cream, gel, 2009).

1) RATS, RABBITS: There are no adequate or well controlled studies of naftifine use in human pregnancy. Animal studies revealed no evidence of teratogenicity or embryofetal toxicity in pregnant rats administered oral naftifine up to 300 mg/kg/day or subQ naftifine up to 30 mg/kg/day during organogenesis. Pregnant rabbits administered subQ naftifine up to 30 mg/kg/day during organogenesis also showed no signs of embryofetal toxicity or teratogenicity. Peri- and postnatal development studies of pregnant female rats administered oral naftifine doses up to 300 mg/kg/day from gestational day 14 to lactation day 21 resulted in reduced body weight gain. Developmental toxicity was observed with the 100 mg/kg/day dosage (Prod Info NAFTIN(R) 2% topical cream, 2012).
2) RATS, RABBITS: During animal studies, rats and rabbits given oral doses of naftifine 150 times or more than the normal human topical dose, had no trouble with impaired fertility or fetal damage (Prod Info Naftin(R) topical cream, gel, 2009).

1) At the time of this review, no data were available to assess the potential effects of exposure to this agent during pregnancy in humans (Prod Info NAFTIN(R) 2% topical cream, 2012; Prod Info Naftin(R) topical cream, gel, 2009).

1) The manufacturer has classified naftifine as FDA pregnancy category B (Prod Info NAFTIN(R) 2% topical cream, 2012; Prod Info Naftin(R) topical cream, gel, 2009).

1) Based on data indicating the systemic absorption of topical naftifine is between 2.5% to 3.4%, it was suggested that a nursing infant of a mother who is using the drug would be exposed to approximately 0.3 mcg/kg if the drug is excreted in breast milk (Czok, 1987a).

1) At the time of this review, no human data were available to assess the potential effects on fertility from exposure to this agent (Prod Info NAFTIN(R) 2% topical cream, 2012; Prod Info Naftin(R) topical cream, gel, 2009).

1) RATS: Administration of oral naftifine up to 100 mg/kg/day (approximately 6.1 times the maximum recommended human dose) in rats during mating, gestation, parturition, and lactation had no effects on growth, fertility, or reproduction (Prod Info NAFTIN(R) 2% topical cream, 2012).

1) NAFTIFINE

1) NAFTIFINE

A) Hospital admission is rarely necessary. Patients should be admitted for severe vomiting, profuse diarrhea, severe abdominal pain, dehydration, and electrolyte abnormalities.

A) A patient with an inadvertent ingestion, that remains asymptomatic can be managed at home.

A) Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.

A) All patients with deliberate self-harm ingestions and any patient with more than mild GI distress after unintentional ingestion should be evaluated in a healthcare facility and monitored until symptoms resolve.

1) Routine laboratory studies are not likely to be necessary.
2) Monitor serum electrolytes in patients with severe vomiting and/or diarrhea.

1) CREAM (2%): Apply topically to affected areas plus a 0.5 inch margin of healthy surrounding skin once daily for 2 weeks (Prod Info NAFTIN(R) topical cream, 2014).
2) GEL (2%): Apply topically to affected areas plus a 0.5 inch margin of healthy surrounding skin once daily for 2 weeks (Prod Info NAFTIN(R) topical gel, 2014)
3) CREAM (1%): Apply topically once daily in a sufficient quantity with gentle massage to cover the affected area and surrounding skin (Prod Info Naftin(R) topical cream, gel, 2009).
4) GEL (1%): Apply topically twice daily (morning and evening) to affected areas and surrounding healthy skin (Prod Info Naftin(R) topical cream, gel, 2009).

1) 12 YEARS AND OLDER: Apply topically to affected areas plus a 0.5 inch margin of healthy surrounding skin once daily for 2 weeks (Prod Info NAFTIN(R) topical cream, 2014).

1) 12 YEARS AND OLDER: Apply topically to affected areas plus a 0.5 inch margin of healthy surrounding skin once daily for 2 weeks (Prod Info NAFTIN(R) topical gel, 2014).