NORITATE

1 Dosing Considerations  NORITATE is for topical use only. NORITATE is not for ophthalmic, oral, or vaginal use.  Avoid contact with eyes.  Significant therapeutic results should be evident within the first month of treatment and controlled clinical studies have demonstrated continuing improvement through 8 weeks of therapy.

The dosage required for long-term administration is uncertain (see 7 WARNINGS AND PRECAUTIONS).  Patients may use cosmetics after application of NORITATE. The medication should have absorbed into the skin (“dry”) before the cosmetics are applied.

1 Pediatrics).  Cleanse all affected areas of the skin.  Squeeze out approximately 1/2 cm of NORITATE cream and apply to the entire affected areas twice daily, morning and evening.  Rub in lightly. 5 Missed Dose If patients miss a dose of NORITATE, they should apply it as soon as possible.

However, if it is almost time for the next dose, they would need to go back to their regular dosing schedule. Patients should not use extra medicine to make up their missed dose.

). 4 Drug-Drug Interactions). 1 Pregnant Women There has been no experience to date with the use of NORITATE in pregnant patients. Systemically administered metronidazole crosses the placental barrier and enters the fetal circulation rapidly.

No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only after careful assessment of the risk/benefit ratio.

2 Breast-feeding Even though metronidazole blood levels are significantly lower after topical than after oral administration, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in plasma. 3 Pediatrics Pediatrics (< 18 years of age): Safety and effectiveness in children have not been established. 1 Pediatrics).

4 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. 1 Adverse Reactions Overview Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug are less likely to occur with NORITATE but the possibility cannot be excluded.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, 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 PrNORITATE ® Metronidazole Cream Product Monograph Page 8 of 20 information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse conditions reported included transient skin irritation, dryness and stinging, as well as 3 cases of possible contact dermatitis.

).  Patients may use cosmetics after application of NORITATE. The medication should have absorbed into the skin (“dry”) before the cosmetics are applied. 1 Pediatrics).  Cleanse all affected areas of the skin.  Squeeze out approximately 1/2 cm of NORITATE cream and apply to the entire affected areas twice daily, morning and evening.

 Rub in lightly. 5 Missed Dose If patients miss a dose of NORITATE, they should apply it as soon as possible. However, if it is almost time for the next dose, they would need to go back to their regular dosing schedule. Patients should not use extra medicine to make up their missed dose.

5 OVERDOSAGE There is no human experience with overdosage of topically applied NORITATE cream. Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects. Do not exceed the recommended dose and duration of treatment.

Symptoms Massive ingestion may produce vomiting and slight disorientation. Treatment There is no specific antidote. Ipecac syrup or gastric lavage; then activated charcoal followed by a saline cathartic is suggested. Treatment should include symptomatic and supportive therapy.

For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging NORITATE is a white to slightly off-white soft cream containing 10 mg metronidazole per gram of cream (1% w/w) and is supplied in aluminum tubes of 45 g.

Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical Metronidazole Topical Cream 1 % w/w Glycerin, Glyceryl Monostearate, Methyl Paraben, Propyl Paraben, Purified Water, Stearic Acid, Triethanolamine.

PrNORITATE ® Metronidazole Cream Product Monograph Page 6 of 20 7 WARNINGS AND PRECAUTIONS General Although rosacea is a chronic disease, data on the long-term use of NORITATE in rosacea are not available. 1 Dosing Considerations). Carcinogenesis and Mutagenesis Studies in rats and mice have provided some evidence that metronidazole may cause tumors in these species when administered orally for a long period at high doses.

 NORITATE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.