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

a a h pharmaceuticals ltd - dexamethasone; ciprofloxacin hydrochloride - ear drops - 1mg/1ml ; 3mg/1ml

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

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

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)

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)

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

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace

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)

armas pharmaceuticals inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprofloxacin 0.3% and dexamethasone 0.1% 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 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 dexamethasone 0.1% 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 ci

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone as sodium phosphate - solution for injection - dexamethasone as sodium phosphate 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematologica