CIPRODEX 0.3 % — DIN 02252716

What is CIPRODEX?

CIPRODEX 0.3 % contains CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) : 0.3 % DEXAMETHASONE : 0.1 %. It is listed in the Health Canada Drug Product Database under DIN 02252716, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as SUSPENSION for OTIC administration. Health Canada currently lists it as marketed, status dated 11-Jun-2018. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CIPRODEX used for?

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: Acute Otitis Media with Otorrhea through tympanostomy tubes in pediatric patients ≥ 6 months of age due to: Aerobic, Gram-Positive: Streptococcus pneumoniae Staphylococcus aureus Aerobic, Gram-Negative: Haemophilus influenza Moraxella catarrhalis Pseudomonas aeruginosa Acute Otitis Externa in adults and pediatric patients ≥ 1 year of age due to: Aerobic, Gram-Positive: Staphylococcus aureus Aerobic, Gram-Negative: Pseudomonas aeruginosa To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRODEX and other antibacterial drugs, CIPRODEX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Recommended Dose Acute Otitis Media in pediatric patients (≥ 6 months of age) with tympanostomy tubes: Four drops instilled into the affected ear twice daily for seven days. Acute Otitis Externa in adult patients and pediatric patients (≥ 1 year of age): Four drops instilled into the affected ear twice daily for seven days. Missed Dose If a dose is missed, it should be given as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Administration SHAKE WELL IMMEDIATELY BEFORE USING. Acute Otitis Media in pediatric patients (≥ 6 months of age) with tympanostomy tubes: The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed. Acute Otitis Externa in adult patients and pediatric patients (≥ 1 year of age): The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.

Included because it drives pack selection and wastage. Consult the monograph.

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 Forms, Composition and Packaging section. • Hypersensitivity to other quinolones, including nalidixic acid. • Hypersensitivity to other corticosteroids. • Fungal otic infections. • Viral infections of the external canal, including herpes simplex infections. • Parasitic otic infections.

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 fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticarial and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. Corticosteroids may reduce resistance to and aid in the establishment of non-susceptible bacterial, fungal, parasitic or viral infections and mask the clinical signs of infection. If the infection is not improved after one week of treatment, alternate therapy should be considered. If otorrhea persists after a full course of therapy, or if 2 or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition, such as cholesteatoma, foreign body, or a tumor. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy, including ciprofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore, treatment with CIPRODEX should be discontinued at the first sign of tendon inflammation. CIPRODEX contains the preservative benzalkonium chloride, which may be an irritant and cause skin reactions.