What are some other side effects of Acticin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Itching. Talk to the doctor about what to do.
- Irritation where Acticin is used.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Acticin (permethrin) Cream 5% (wt./ wt.) is supplied in 60g tubes.
Store at room temperature 15°- 25° C (59°- 77° F).
CAUTION: Federal (USA) law prohibits dispensing without prescription.
Permethrin topical Pregnancy Warnings
Permethrin topical has been assigned to pregnancy category B by the FDA. Animal studies have revealed no evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy. Permethrin topical is only recommended for use during pregnancy when benefit outweighs risk.
Permethrin Levels and Effects while Breastfeeding
Summary of Use during Lactation
Because less than 2% is absorbed after topical application, rapid metabolism to inactive metabolites and safe application directly on infants' skin, topical permethrin products are acceptable in nursing mothers. Extensive exposure, such as from agricultural use or malaria control might have long-term health concerns because residues can be found in breastmilk. Only water-miscible cream, gel or liquid products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
Maternal Levels. Permethrin was measured in 53 breastmilk samples from 29 mothers collected 1998 to 1999 in Basel Switzerland. Permethrin was detected in 25 milk samples, even in mothers from households that reported no permethrin use. The average permethrin concentration was 74 mcg/kg of fat (range undetectable [<60 mcg/kg] to 152 mcg/kg fat).
Permethrin was found in the breastmilk of nursing mothers in 3 South African towns. Average levels in breastmilk ranged from 8.3 to 48.4 mcg/L in the 3 towns. The source was thought to be from a dusting powder widely available and used in gardening. The dosage and route of exposure (i.e., topical, inhalation, oral) could not be determined. All milk levels were below the allowable daily limit for permethrin.
Samples of mature milk were collected in 2002 from 22 mothers in Mozambique where pyrethrins were used for mosquito control in the thatching of homes from 1993 to 2000 and continued to be used in bed netting after this period. The average permethrin concentration in the milk samples was 79 mcg/kg of lipid; the median concentration was 55 mcg/kg of lipid (range 10 to 230 mcg/kg of lipid). The milk permethrin levels in all mothers were below the allowable daily limit for permethrin.
Breastmilk samples from mothers in Brazil, Colombia and Spain were analyzed for pyrethroids. Permethrin was detected in all samples, regardless of reported household usage. Samples from rural Brazil (n = 9) contained a mean permethrin concentration of 3.57 ng/gram of lipid. Samples from Sao Paulo (n = 8) contained a mean permethrin concentration of 0.36 ng/gram of lipid. Samples from Santiago de Cali, Colombia (n = 27) contained a mean permethrin concentration of 0.91 ng/gram of lipid. Samples from Barcelona, Spain (n = 6) contained a mean permethrin concentration of 2.2 ng/gram of lipid. Other pyrethroids were also detected, but estimated daily intakes by breastfed infants were all below acceptable daily intake limits.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
In a telephone follow-up study, 5 mothers who used permethrin during breastfeeding reported no adverse reactions in their breastfed infants.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
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