United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin 3 mg in 1 ml - ciprodex is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: - acute otitis media in pediatric patients (age 6 months and older) with tympanostomy tubes due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . - acute otitis externa in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . - ciprodex is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. - use of this product is contraindicated in viral infections of the external canal including herpes simplex infections and fungal otic infections. teratogenic effects. pregnancy category c: no adequate and well controlled studies with ciprodex have been performed in pregnant women. caution should be exercised when ciprodex

Canada - English - Health Canada

taro pharmaceuticals inc - ciprofloxacin (ciprofloxacin hydrochloride); dexamethasone - suspension - 0.3%; 0.1% - ciprofloxacin (ciprofloxacin hydrochloride) 0.3%; dexamethasone 0.1% - antibacterials

Canada - English - Health Canada

sandoz canada incorporated - ciprofloxacin (ciprofloxacin hydrochloride); dexamethasone - suspension - 0.3%; 0.1% - ciprofloxacin (ciprofloxacin hydrochloride) 0.3%; dexamethasone 0.1% - antibacterials

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - dexamethasone; ciprofloxacin hydrochloride - ear drops - 1mg/1ml ; 3mg/1ml

United States - English - NLM (National Library of Medicine)

proficient rx lp - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprodex is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: acute otitis media (aom) in pediatric patients (age 6 months and older) with tympanostomy tubes due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . acute otitis externa (aoe) in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . teratogenic effects. pregnancy category c: no adequate and well controlled studies with ciprodex have been performed in pregnant women. caution should be exercised when ciprodex is used by a pregnant woman. animal reproduction studies have not been conducted with ciprodex. reproduction studies with ciprofloxacin have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (iv) doses up to 30 mg/kg, and have revealed no evidence of harm to the fetus.

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprodex® is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: - acute otitis media (aom) in pediatric patients (age 6 months and older) with tympanostomy tubes due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . - acute otitis externa (aoe) in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . - ciprodex is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. - use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. risk summary there are no available data on ciprodex use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse ma

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - ciprofloxacin hydrochloride 0.33%{relative} equivalent to 0.3% ciprofloxacin; dexamethasone 1%{relative};   - ear drops - 0.33%/1% - active: ciprofloxacin hydrochloride 0.33%{relative} equivalent to 0.3% ciprofloxacin dexamethasone 1%{relative}   excipient: acetic acid benzalkonium chloride boric acid disodium edetate hydrochloric acid hyetellose purified water sodium acetate trihydrate sodium chloride sodium hydroxide tyloxapol - cilodex is indicated for the topical treatment of acute otitis media in patients with tympanostomy tubes and acute otitis externa in patients caused by strains of bacteria susceptible to ciprofloxacin.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - ciprofloxacin (ciprofloxacin hydrochloride); dexamethasone - suspension - 0.3%; 0.1% - ciprofloxacin (ciprofloxacin hydrochloride) 0.3%; dexamethasone 0.1% - antibacterials

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

cst pharma ltd - dexamethasone; ciprofloxacin hydrochloride - ear drops - 1mg/1ml ; 3mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - dexamethasone; ciprofloxacin hydrochloride - ear drops - 1mg/1ml ; 3mg/1ml