OZANEX Cream (2017)
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Name of the medicinal product
OZANEX Ozenoxacin cream 1% w/w.
Summary product information
Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Topical Ozenoxacin cream 1% w/w None<br />For a complete listing see Dosage Forms, Composition and Packaging section
Indications and clinical use
OZANEX (ozenoxacin) is indicated for the topical treatment of impetigo in patients aged 2 months and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of OZANEX ...
Contraindications
OZANEX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the ...
Warnings and precautions
General Do not ingest. There are very limited efficacy data in subjects with impetigo affecting more than 50 cm² total surface area. Safety and efficacy of OZANEX has not been established in subjects with ...
Adverse reactions
Adverse Drug Reaction Overview OZANEX has been evaluated for safety in 458 patients with superficial skin infections. In these clinical studies, the most frequently reported adverse events were application ...
Drug interactions
Overview OZANEX shows negligible systemic absorption (generally below 0.5 ng/ml) OZANEX does not induce cytochrome P450 enzymes in vitro. Drug-Drug Interactions The effect of concurrent application of ...
Dosage and administration
Dosing Considerations OZANEX is for cutaneous use only. There are very limited efficacy data in subjects with impetigo affecting more than 50 cm² total surface area. Efficacy and safety of OZANEX has not ...
Overdosage
Overdosage with OZANEX has not been reported. Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically and consistent with good clinical practices. ...
Action and clinical pharmacology
Mechanism of Action Ozenoxacin is a non-fluorinated quinolone with dual inhibitory activity against bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. Pharmacokinetics Absorption Healthy ...
Storage and stability
OZANEX should be stored at room temperature (15 to 30°C). Use within 45 days of first opening the tube.
Dosage forms, composition and packaging
OZANEX is a pale yellow cream containing 10 mg/g of ozenoxacin (1% w/w). The nonmedicinal ingredients are benzoic acid (E 210), ethylene glycol monopalmitostearate, octyldodecanol, oleoyl macrogol-6-glycerides, ...
Pharmaceutical information
Common name: ozenoxacin Chemical name: 1-Cyclopropyl-8-methyl-7-(5-methyl-6-methylamino-pyridin3-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid Molecular formula: C<sub>21</sub>H<sub>21</sub>N<sub> ...
Clinical trials
The clinical efficacy of OZANEX (ozenoxacin) was demonstrated in two multicentre, randomized, placebo-controlled pivotal Phase III studies; 362 adult and pediatric subjects ≥2 months of age with impetigo ...
Microbiology
Ozenoxacin is a non-fluorinated quinolone antibacterial. Mechanism of Action The antibacterial action of ozenoxacin is due to the inhibition of both bacterial enzymes, DNA gyrase A and topoisomerase IV. ...
Toxicology
Acute Toxicity The acute toxicity of ozenoxacin was assessed with a single i.v. dose of ozenoxacin 50, 70, 100, 125, 150 and 175 mg/kg in rats. Based on observation for 14 days, the maximum dose without ...
Marketing authorization holder
Manufacturer: Ferrer Internacional, S.A., Gran Via Carlos III, 94, 08028 Barcelona, Spain Imported and Distributed by: Cipher Pharmaceuticals Inc., 2345 Argentia Road, Suite 100A, Mississauga, Ontario, ...
Submission control number
192925
Date of approval
May 1, 2017
References
Gropper S, Albareda N, Chelius K, Kruger D, Mitha I, Vahed Y, Gani M, García-Alonso F; Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical ...