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

akorn - gatifloxacin anhydrous (unii: 81485y3a9a) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin anhydrous 5 mg in 1 ml - gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. data animal data oral administration of gatifloxacin to pregnant rats throughout organogenesis produced t

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

sandoz inc - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: * efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. data animal data oral administration of gatifloxacin to pregnant rats throughout organogenesis produ

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

lupin limited - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis * streptococcus pneumoniae aerobic gram-negative bacteria: haemophilus influenzae * efficacy for this organism was studied in fewer than 10 infections. none pregnancy category c teratogenic effects: there were no teratogenic effects observed in rats or rabbits following oral gatifloxacin doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum recommended ophthalmic dose). however, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). in a perinatal/postnatal study, increased late post-implantation loss and neonatal/perinatal m

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

pacific pharma, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: - aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group* streptococcus oralis* streptococcus pneumoniae - aerobic gram-negative bacteria: haemophilus influenzae *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions ( 5.1 )] . risk summary there are no available data on the use of gatifloxacin ophthalmic solution 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of ga

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

lupin pharmaceuticals, inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin 5 mg in 1 ml - gatifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: - aerobic gram-positive bacteria: staphylococcus aureus staphylococcus epidermidis streptococcus mitis group*   streptococcus oralis* streptococcus pneumoniae - aerobic gram-negative bacteria: haemophilus influenzae * efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution, 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution, 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats

Canada - English - Health Canada

apotex inc - gatifloxacin (gatifloxacin hemihydrate) - solution - 0.3% - gatifloxacin (gatifloxacin hemihydrate) 0.3% - antibacterials

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

mylan pharmaceuticals inc. - gatifloxacin (unii: l4618bd7kj) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: * efficacy for these organisms were studied in fewer than ten infections. gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions (5.1)] . there are no available data on the use of gatifloxacin ophthalmic solution in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses. administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat

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

torrent pharmaceuticals limited - gatifloxacin anhydrous (unii: 81485y3a9a) (gatifloxacin anhydrous - unii:81485y3a9a) - gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: •    aerobic gram-positive bacteria:             staphylococcus aureus             staphylococcus epidermidis             streptococcus mitis group *             streptococcus oralis*             streptococcus pneumoniae •    aerobic gram-negative bacteria:             haemophilus influenzae *efficacy for these organisms were studied in fewer than 10 infections. gatifloxacin ophthalmic solution 0.5% is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see warnings and precautions ( 5.1)]. risk summary there are no available data on the use of gatifloxacin ophthalmic solution 0.5% in pregnant women to inform a drug-associated risk. administration of oral gatifloxacin to pregnant rats and rabbits throughout

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

physicians total care, inc. - besifloxacin (unii: bfe2nbz7nx) (besifloxacin - unii:bfe2nbz7nx) - besifloxacin 6 mg in 1 ml - besivance™ (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: cdc coryneform group g corynebacterium pseudodiphtheriticum* corynebacterium striatum* haemophilus influenzae moraxella lacunata* staphylococcus aureus staphylococcus epidermidis staphylococcus hominis* staphylococcus lugdunensis* streptococcus mitis group streptococcus oralis streptococcus pneumoniae streptococcus salivarius* *efficacy for this organism was studied in fewer than 10 infections. none pregnancy category c. oral doses of besifloxacin up to 1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups in a study of embryo-fetal development, although this dose was associated with maternal toxicity (reduced body weight gain and food consumption) and maternal mortality. increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. at this dose, the mean

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

merus labs international inc. - gemifloxacin mesylate (unii: x4s9f8rl01) (gemifloxacin - unii:okr68y0e4t) - gemifloxacin 320 mg - factive is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (see dosage and administration and clinical studies. ) acute bacterial exacerbation of chronic bronchitis (abecb) caused by streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis . because fluoroquinolones, including factive, have been associated with serious adverse reactions (see warnings ) and for some patients abecb is self-limiting, reserve factive for treatment of abecb in patients who have no alternative treatment options. community-acquired pneumonia (of mild to moderate severity) caused by streptococcus pneumoniae (including multi-drug resistant strains [mdrsp])*, haemophilus influenzae, moraxella catarrhalis, mycoplasma pneumoniae, chlamydia pneumoniae, or klebsiella pneumoniae . *mdrsp: multi-drug resistant s