, Pregnant Women and 7 WARNINGS AND PRECAUTIONS, Breast-feeding ). Patients allergic to any of the ingredients, synthetic pyrethroids or pyrethrin, or chrysanthemums should not use the drug (see 7 WARNINGS AND PRECAUTIONS, General).
1 Dosing Considerations A single application is usually sufficient to eliminate a head lice infestation. The active ingredient in NIX® CRÈME RINSE persists on the hair for 10 days, even after subsequent washing with a conditioner-free shampoo.
If you see live lice or nits after the first application, the residual effect should kill these. If you still see live lice or nits on the 7th day (or after) following the first application, NIX® CRÈME RINSE should be applied a second time.
Product Monograph <NIX® CRÈME RINSE ><Permethrin cream 1%> Page 5 of 16 Cleaning of personal articles is also an important part of head lice management and may help prevent reinfestation. Personal belonging including recently worn clothing, towels and bed linens should be machine washed in hot water and dried using the hot cycle of the dryer for at least 20 minutes.
Personal articles of clothing or bedding that cannot be washed may be dry cleaned or sealed in a plastic bag for a period of two weeks. Combs and brushes should be disinfected by soaking in hot water (above 130 °F/54 °C) for 5 to 10 minutes.
Children should be advised not to use any borrowed combs or brushes, nor wear anyone else’s clothes, especially hats. Inspect all family members from time to time for any new lice infestation. If a new infestation is found treat with NIX® CRÈME RINSE.
1 Dosing Considerations. 3 Reconstitution Not applicable. 4 Administration Directions Adults and children 2 years of age and over: 1. Wash the hair with conditioner-free shampoo. Do not use conditioner. Rinse with water and towel dry thoroughly.
2. Shake NIX® CRÈME RINSE bottle well. Apply a sufficient amount of NIX® CRÈME RINSE (1/2 to 1 bottle) to thoroughly saturate the hair and scalp, especially behind the ears and at the base of the neck. 3. Leave NIX® CRÈME RINSE on the hair for 10 minutes.
4. Rinse NIX® CRÈME RINSE off hair with water. 5. Towel dry hair. 6. Comb hair with regular comb to remove tangles. 7.
Remove nits:
Part hair into sections; starting as close to the scalp as possible, remove the nits using the nit removal comb provided. Be sure to comb to the end of the hair shaft. The nit comb should be disinfected by soaking in hot water after each use.
Inspect full head of hair thoroughly for any stray nits. The nit removal procedure should be repeated daily for the 7 days following treatment. Product Monograph <NIX® CRÈME RINSE ><Permethrin cream 1%> Page 6 of 16 5 OVERDOSAGE In the event of accidental ingestion of permethrin, please seek immediate medical attention.
Symptoms of overdose may include dizziness, loss of appetite, nausea, vomiting, headache, weakness, seizures, and loss of consciousness. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging NIX® CRÈME RINSE is packaged in a 59 mL HDPE bottle (inner (primary) package) and cardboard carton (outer (secondary) package).
Each carton contains 2 bottles and 2 nit combs. 7 WARNINGS AND PRECAUTIONS General Do not use if allergic to any of the ingredients, synthetic pyrethroids or pyrethrin, or chrysanthemums. Discontinue use if reaction occurs (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
NIX® CRÈME RINSE is for use when live lice or their eggs are present. It is not for prophylactic/regular use to prevent head lice. NIX® CRÈME RINSE should be discontinued if hypersensitivity occurs. Keep out of reach of children. For external use only.
To prevent accidental ingestion by children, the remaining contents of NIX® CRÈME RINSE should be discarded after use. In case of swallowing, consult your doctor or Poison Control Centre immediately. 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.
Ophthalmologic Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical Cream 1% Balsam Canada, Cetyl Alcohol, Citric Acid, FD&C Yellow No. 6, Hydrolyzed Animal Protein, Hydroxyethyl Cellulose, Isopropyl Alcohol, Methylparaben, Poloxyethylene 10 Cetyl Ether, Propylene Glycol, Propylparaben, Stearalkonium Chloride, Water Product Monograph <NIX® CRÈME RINSE ><Permethrin cream 1%> Page 7 of 16 Permethrin is not irritating to eyes, but contact with the eyes should be avoided because other components of the product may cause marked irritation.
If NIX® CRÈME RINSE comes in contact with the eyes, rinse eyes immediately with water. Skin Head lice infestation is often accompanied by itching, redness, and swelling. Treatment with NIX® CRÈME RINSE may temporarily worsen these conditions.
If skin irritation occurs and does not improve, consult a doctor. 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women. Consult a doctor before using this drug (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
2 Breast-feeding There are no adequate or well-controlled studies in breast-feeding women. Consult a doctor before using this drug (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). 3 Pediatrics Pediatrics (two years and older): Health Canada has authorized an indication for pediatric use (two years and older).
Safety and effectiveness in children less than two years of age have not been established. Do not use on children under 2 years of age. 4 Geriatrics Geriatrics (> 65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.