ZONACIP EAR DROPS

Description

PROPERTIES:
ZONACIP otic suspension contains the synthetic broad spectrum antibacterial fluoroquinolone ciprofloxacin combined with the anti-inflammatory fluorinated corticosteroid dexamethasone with high efficacy in the treatment of common ear infections. Ciprofloxacin is active against a wide range of Gram-positive and Gram-negative bacteria. The bactericidal action of ciprofloxacin results from selective inhibition of the enzyme DNA gyrase (topoisomerase II) with subsequent prevention of DNA replication and rapid bacterial cell death. The antibacterial spectrum of ciprofloxacin covers:
– Aerobic and facultative Gram-positive microorganisms (e.g. Staphylococcus aeurus, Streptococcus pneumoniae).
– Aerobic and facultative Gram-negative micro-organisms (e.g. Haemophillus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis).
Dexamethasone, in ZONACIP ear drops, exerts topical anti-inflammatory and antipruritic effects. Thus the use of ZONACIP ear drops provides complete cure of bacterial ear infection with rapid relief of associated inflammatory manifestations such as redness and edema of the affected area, pain and itching.
PHARMACOKINETICS:
Measurable plasma concentrations of ciprofloxacin and dexamethasone where observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients respectively. Peak plasma of both ciprofloxacin and dexamethasone were observed within 15 minutes to 2 hours post dose application.
INDICATIONS:
ZONACIP, as ear drops, is used for the treatment of bacterial ear infection presented as:
– Acute otitis media.
– Acute otitis externa.
USAGE & ADMINISTRATION:
– Acute otitis media: four drops to be instilled into affected ear twice daily for 7 days.
– Acute otitis externa: four drops to be instilled into the affected ear twice daily for 7 days.
CONTRAINDICATIONS:
 Hypersensitivity to any of the components of the preparation.
 Viral infection of the external canal including herpes simplex infections.

SIDE EFFECTS:
ZONACIP, as ear drops, is well tolerated. Ear discomfort, tinnitus and dizziness may follow the use of ear drops.
DRUG INTERACTIONS:
Not reported.
PREGNANCY & LACTATION:
Pregnancy: No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when ZONACIP ear drops is used in pregnant women.
Lactation: It is not known whether topical otic administration of the drug could result in systemtic absorption to produce detectable quantities in human milk. Use of ZONACIP ear drops for nursing mother is not recommended.
PRECAUTIONS:
 ZONACIP ear drops is for otic use only and not for ophthalmic use.
 If ear infection is not improved after one week, bacterial cultures should be obtained to guide further treatment.
 If otorrhea persists after a full course of therapy, further evaluation is recommended.
 Therapy with ear drops should be continued for as long as instructed by the physician.
 ZONACIP ear drops is used for pediatric patients of 6 months and older.
PACKING:
A dropper bottle containing 15 ml.
STORAGE:
Keep at temperature not exceeding 30C.
Keep out of reach of children.
INSTRUCTION TO PATIENTS:
 Shake the dropper bottle of ZONACIP well before use.
 Warm the dropper bottle of ZONACIP in hands prior to use to avoid dizziness.
 Discard the unused portion ZONACIP ear drops after therapy is completed.