Source: Health Products and Food Branch (CA) Revision Year: 2017
CIPRODEX – Ciprofloxacin/Dexamethasone Otic Suspension.
| Route of Administration | Dosage Form / Strength | Clinically Relevant Nonmedicinal Ingredients |
|---|---|---|
| Otic | Suspension/0.3% ciprofloxacin (as ciprofloxacin hydrochloride) and 0.1% dexamethasone | Benzalkonium chloride as preservative. For a complete listing see Dosage Forms, Composition and Packaging section. |
Each mL of CIPRODEX contains:
Medicinal Ingredients: Ciprofloxacin Hydrochloride (equivalent to 3 mg ciprofloxacin base) and 1 mg Dexamethasone.
Preservative: 0.1 mg benzalkonium chloride.
Non-medicinal Ingredients: boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium and purified water. Sodium hydroxide and/or hydrochloric acid may be added for adjustment of pH.
CIPRODEX has a pH of approximately 5 and an osmolality of approximately300 mOsm/kg.
CIPRODEX is supplied as follows: 7.5 mL fill in a DROP-TAINER* system. The DROP-TAINER* system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Novartis Pharmaceuticals Canada Inc., 385 Bouchard Blvd., Dorval, Quebec, H9S 1A9 206140 |
Date of revision:
September 27, 2017 |
| Drug | Countries | |
|---|---|---|
| CIPRODEX | Canada, Ecuador, United States |
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