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

sun pharmaceutical industries, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin and dexamethasone otic suspension usp is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: - acute otitis externa (aoe) in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . - ciprofloxacin and dexamethasone otic suspension 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 ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. because of the minimal systemic absorption of ciprofloxacin and dexamethasone following t

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

rebel distributors corp - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin 3 mg in 1 ml - ciprodex® otic 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® otic 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. the safety and efficacy of ciprodex® otic have been established in pediatric patients 6 months and older (937 patients) in adequate and well-controlled clinical trials. although no data are available

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

dr. reddy's laboratories, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 . - ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 ciprofloxacin 0.3% and de

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

northstar rxllc - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 . - ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 ciprofloxacin 0.3% and de

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

sandoz inc - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: risk summary there are no available data on ciprofloxacin and dexamethasone otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal, or fetal outcomes. because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin and dexamethasone otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see clinical pharmacology (12.3)]. animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal mal

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

bryant ranch prepack - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: teratogenic effects. pregnancy category c: no adequate and well controlled studies with ciprofloxacin and dexamethasone otic suspension have been performed in pregnant women. caution should be exercised when ciprofloxacin and dexamethasone otic suspension is used by a pregnant woman. animal reproduction studies have not been conducted with ciprofloxacin and dexamethasone otic suspension. 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. in rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. after iv administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration. dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical otic administration of ciprofloxacin or dexamethasone could result in sufficient systemic absorption to produce detectable quantities in human milk. because of the potential for unwanted effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and efficacy of ciprofloxacin and dexamethasone otic suspension have been established in pediatric patients 6 months and older (937 patients) in adequate and well-controlled clinical trials. no clinically relevant changes in hearing function were observed in 69 pediatric patients (age 4 to 12 years) treated with ciprofloxacin and dexamethasone otic suspension and tested for audiometric parameters. instructions for use ciprofloxacin and dexamethasone otic suspension (sih-proe-flox-ah-sin) and (dex-ah-meth-ah-sone) read this instructions for use that comes with ciprofloxacin and dexamethasone otic suspension before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or treatment. important information about ciprofloxacin and dexamethasone otic suspension: how should i use ciprofloxacin and dexamethasone otic suspension? step 1. wash your hands with soap and water. step 2. warm the bottle of ciprofloxacin and dexamethasone otic suspension by rolling the bottle between your hands for 1 to 2 minutes (see figure a). shake the bottle of ciprofloxacin and dexamethasone otic suspension well. figure a step 3. remove the ciprofloxacin and dexamethasone otic suspension cap. put the cap in a clean and dry area. do not let the tip of the bottle touch your ear, fingers or other surfaces. step 4. lie down on your side so that the affected ear faces upward (see figure b). figure b step 5 . hold the bottle of ciprofloxacin and dexamethasone otic suspension between your thumb and index finger (see figure c) . place the tip of the bottle close to your ear. be careful not to touch your fingers or ear with the tip of the bottle . figure c step 6 . gently squeeze the bottle and let 4 drops of ciprofloxacin and dexamethasone otic suspension fall into the affected ear. if a drop misses your ear, follow the instructions in step 5 again. step 7. stay on your side with the affected ear facing upward (see figure b). it is important that you follow the instructions below for your specific ear infection, to allow ciprofloxacin and dexamethasone otic suspension to enter the affected part of your ear. step 8. if you use ciprofloxacin and dexamethasone otic suspension to treat a middle ear infection, and you have a tube in your eardrum known as a tympanostomy: figure d if you use ciprofloxacin and dexamethasone otic suspension to treat an outer ear canal infection: figure e step 9 . if your doctor has told you to use ciprofloxacin and dexamethasone otic suspension in both ears, repeat steps 5-8 for your other ear. step 10 . put the cap back on the bottle and close it tightly. step 11 . after you have used all of your ciprofloxacin and dexamethasone otic suspension doses, there may be some ciprofloxacin and dexamethasone otic suspension left in the bottle. throw the bottle away. how should i store ciprofloxacin and dexamethasone otic suspension? keep ciprofloxacin and dexamethasone otic suspension and all medicines out of the reach of children. if you would like more information, talk with your doctor. you can ask your pharmacist or doctor for more information about ciprofloxacin and dexamethasone otic suspension that is written for health professionals. distributed by: sandoz inc., princeton, nj 08540 this instructions for use has been approved by the u.s. food and drug administration. revised: february 2019 t2019-76

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

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

alcon laboratories, 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 (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. teratogenic effects. pregnancy category c: no adequate and well controlled studies with ciprodex have been performed in pregnant women. caution should be exercised when

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

physicians total care, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin hydrochloride 3 mg in 1 ml - ciprodex® otic 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® otic 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.

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