CIPRODEX Otic suspension (2017)
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Περιεχόμενα
Name of the medicinal product
CIPRODEX Ciprofloxacin/Dexamethasone Otic Suspension.
Summary product information
Route of<br>Administration Dosage Form / Strength Clinically Relevant<br>Nonmedicinal Ingredients Otic Suspension/0.3% ciprofloxacin (as ciprofloxacin hydrochloride) and 0.1% dexamethasone Benzalkonium ...
Indications and clinical use
CIPRODEX (ciprofloxacin/dexamethasone otic suspension) is indicated for the treatment of infections caused by most strains of the designated microorganisms in the specific conditions listed below: <b> ...
Contraindications
CIPRODEX is contraindicated in patients with: Hypersensitivity to ciprofloxacin, dexamethasone or to any ingredient in the formulation or component of the container. For a complete listing, see Dosage ...
Warnings and precautions
FOR TOPICAL OTIC USE ONLY. NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. General CIPRODEX should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally ...
Adverse reactions
Clinical Trial Adverse Drug 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 ...
Drug interactions
Specific drug interaction studies have not been conducted with CIPRODEX administered in the ear.
Dosage and administration
Recommended Dose <u>Acute Otitis Media in pediatric patients (≥6 months of age) with tympanostomy tubes:</u> Four drops instilled into the affected ear twice daily for seven days. <u>Acute Otitis Externa ...
Overdosage
There is no known treatment of overdosage since overdosage in the use of topical otic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected. For management ...
Action and clinical pharmacology
Mechanism of Action Ciprofloxacin, a fluoroquinolone antibiotic, has in vitro activity against a wide range of grampositive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results ...
Storage and stability
Store at room temperature (15°C to 30°C). Avoid freezing. Protect from light. Keep out of reach and sight of children.
Dosage forms, composition and packaging
Each mL of CIPRODEX contains: <u>Medicinal Ingredients:</u> Ciprofloxacin Hydrochloride (equivalent to 3 mg ciprofloxacin base) and 1 mg Dexamethasone. <u>Preservative:</u> 0.1 mg benzalkonium chloride. ...
Pharmaceutical information
Drug Substance Proper name: Ciprofloxacin Hydrochloride Chemical name: 1 cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid, hydrochloride monohydrate Molecular formula ...
Clinical trials
In a randomized, multicenter, controlled clinical trial, CIPRODEX dosed 2 times per day for 7 days demonstrated clinical cures in the per protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin ...
Microbiology
Ciprofloxacin has <em>in vitro</em> activity against a wide range of gram-positive and gram-negative microorganisms. The bactericidal action of ciprofloxacin results from interference with the enzyme, ...
Toxicology
Single-Dose Toxicity The single-dose toxicity of ciprofloxacin has been established in several species. The oral LD<sub>50</sub> in rats and mice is >5000 mg/kg, and about 2500 mg/kg in rabbits. Emesis ...
Marketing authorization holder
Novartis Pharmaceuticals Canada Inc., 385 Bouchard Blvd., Dorval, Quebec, H9S 1A9
Submission control number
206140
Date of revision
September 27, 2017
References
Campoli-Richards DM, Monk JP, Price A, Benfield P, Todd PA, Ward A. Ciprofloxacin: A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs 1988; 35:373-447. Loew D, ...
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