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NIX DERMAL is a brand name for Permethrin, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NIX Dermal Cream (Permethrin Cream, 5% w/w) is indicated for: • the treatment of infestation with Sarcoptes scabiei (scabies). 1.1 Pediatrics Pediatrics (< 2 years of age): NIX Dermal Cream is well tolerated and effective in children two years of age and older. Based on the data submitted and reviewed by Health…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • In view of the great individual variability in body area and skin type’s precise recommendations are not possible. As such, dosage information provided below is for guidance purposes only. • It is recommended that family members and close contacts, including sexual partners, be treated with NIX Dermal Cream to reduce the risk of transmission or eliminate reinfestation.
2 Recommended Dose and Dosage Adjustment Adults and Children over 12 years: Approximately 1 (30 g) tube. Usually 30 g is sufficient for an average adult. If more than 30 g is required for full body coverage, not more than 60 g should be used during a single application.
Children 5 to 12 years:
Approximately ½ of a 30 g tube (15g). 5g). Health Canada has not authorized an indication for use in patients under 2 years of age. 3 Administration For external use only.
Adults:
Patients should apply NIX Dermal Cream to clean and dry skin. Patients should not take a hot bath before application. NIX Dermal Cream should be thoroughly massaged into the whole body, excluding the head and face, paying particular attention to the areas between the fingers and toes, wrists, axillae (arm pits), external genitalia (external sexual organs), buttocks and under the finger area and toe nails.
In women, the whole body application should include the breasts. NIX Dermal Cream should not be applied to mucous membranes, head, face, mouth, broken skin or near the eyes. Following application, the patient should put on clean clothes, and hands should be washed before eating.
NIX Dermal Cream should be reapplied to the hands if washed off with soap and water within 8 hours of application. Patients should be instructed that it is not necessary to apply a thick visible layer of cream into the skin as it disappears on application.
Pediatrics (>2 years):
Children should use as directed for adults, and should be supervised by an adult when applying the product to ensure thorough treatment is administered.
Geriatrics:
Scabies rarely infests the scalp of adults, although the hairline, neck, temple, outer ears, and forehead may be infested in geriatric patients. Therefore, elderly patients should use as directed for adults but apply the product to the whole body including the neck, face, ears and scalp, avoiding the area close to the eyes.
1 Adverse Reaction Overview In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after NIX Dermal Cream is applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.
Other transient signs and symptoms of irritation, including erythema, oedema, eczema, rash and pruritus which may follow the treatment of scabies with NIX Dermal Cream are generally considered to be part of the natural history of scabies.
In patients being treated for scabies, the pruritus may persist for up to 4 weeks after treatment. This is generally considered to be an allergic reaction to the dead mites present under the skin and is not necessarily a sign that the treatment has failed.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Ten percent of patients in clinical trials experienced generally mild and transient burning and stinging followed application with permethrin 5%.
This was associated with the severity of infestation. Pruritus and erythema were reported in 6% and 4%, respectively, of patients at various times post-application. Approximately 75% of patients treated with NIX Dermal Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks.
Tingling and rash were reported in up to 2% of patients. 3 Less Common Clinical Trial Adverse Reactions There were isolated reports of skin pain, diarrhea, papules and excoriation observed in clinical trials. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data There were no drug-related laboratory findings observed in the clinical trials.
General Keep out of reach of children. 1%) is added as a preservative. For a complete listing see Dosage Forms, Composition and Packaging section. Page 7 of 20 For external use only. In the event of accidental ingestion of permethrin, patient should seek immediate medical attention.
The product should not be applied to mucous membranes, head, face, near the eyes, nose, mouth or broken skin. Permethrin is not an eye irritant, but contact of NIX Dermal Cream with the eyes should be avoided because the cream itself may cause marked irritation.
If it should get into eyes, rinse them immediately with plenty of water or, if readily available, normal saline. If hypersensitivity to NIX Dermal Cream occurs, patients should discontinue use. Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of NIX Dermal Cream.
If skin irritation occurs patients should stop using NIX Dermal Cream, and consult a doctor if it does not improve. Scabies infestation is often accompanied by pruritus, edema and erythema. Treatment with NIX Dermal Cream may temporarily exacerbate these conditions.
Pruritus caused by an acquired sensitivity to mites and their products frequently persists for one to several weeks following treatment; this reaction does not indicate treatment failure. It is important to ensure that the course of treatment is followed as directed because treatment failure has been reported when this has not occurred.
Carers who routinely apply permethrin may wish to wear gloves to avoid any possible irritation to the hands. 1 Pregnant Women Teratogenic Effects: Reproduction studies have been performed in mice, rats and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin.
Negative in vivo genotoxicity tests (see TOXICOLOGY section of Part II:
NIX Dermal Cream is contraindicated in patients who are hypersensitive to permethrin (including pyrethroids and pyrethrins) or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. • Nix Dermal Cream is also contraindicated in patients who are hypersensitive to chrysanthemums.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Permethrin in Canada.
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NIX Dermal Cream should be removed by washing (shower or bath) after 12 to 14 hours (at a minimum the cream should be left on for 8 hours), and patients should change into clean clothes. In the majority of individuals, the scabies infestation is cleared with a single application of the cream.
If necessary, a second application may be given 7 to 10 days after the first, but only if live mites can be demonstrated or new lesions appear. To prevent reinfestations all clothing and bed linens used within two days prior to treatment should be machine-washed in hot water and dried in the dryer for at least 20 minutes, or dry Page 6 of 20 cleaned.
Mattresses which have been used by an infested person should not be used for 48 hours. Toilet seats should be disinfected. Persistent pruritus after treatment is not an indication of retreatment (see WARNINGS AND PRECAUTIONS: General).
5 Clinical Trial Adverse Reactions (Pediatrics) The evaluation of the safety and efficacy of permethrin 5% cream for the treatment of infants and children with scabies was of particular interest and children aged two months to 5 years were included in three of the pivotal studies.
No age or size-related adverse experiences were observed in any study and there were no meaningful differences in the adverse reactions observed in the pediatrics population. 6 Post-Market Adverse Reactions Nervous system disorders Paraesthesia Skin and subcutaneous tissue disorders Eczema, skin oedema, rash, erythema, pruritus, burning sensation, skin irritation, skin discomfort, smarting, pain of skin.
Skin discomfort occurs in patients with severe scabies, is not usually severe and is of short duration. Other symptoms of irritation are part of the natural development of the infection.
Scientific Information) and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with NIX Dermal Cream is minimal. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy. 2 Breast-feeding It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.
3 Pediatrics Pediatrics (< 2 years of age): NIX Dermal Cream is well tolerated and effective in children two years of age and older. Based on the data submitted and reviewed by Health Canada, the safety and efficacy of NIX Dermal Cream in patients under 2 years of age has not been established; therefore, Health Canada has not authorized an indication for use in children under 2 years of age.
4 Geriatrics Adults over 70 years of age, should be treated under medical supervision before using NIX Dermal Cream.