{"id":"ofloxacin","rwe":[{"pmid":"41904345","year":"2026","title":"UV-spectrometric study of antibiotic long-term release by different osteoplastic materials used in dentistry.","finding":"","journal":"The Saudi dental journal","studyType":"Clinical Study"},{"pmid":"41893464","year":"2026","title":"Enhanced Toxicity Induced by Combined Exposure to Neonicotinoid Insecticides and Fluoroquinolone Antibiotics in Human Neuroblastoma SK-N-SH Cells.","finding":"","journal":"Toxics","studyType":"Clinical Study"},{"pmid":"41891200","year":"2026","title":"Mechanistic insights into pH-dependent ofloxacin adsorption on nanoporous carbons.","finding":"","journal":"Physical chemistry chemical physics : PCCP","studyType":"Clinical Study"},{"pmid":"41867018","year":"2026","title":"Insights Into the Inhibitory Effect of Ofloxacin on Pepsin Through Peptidomics and Bioinformatics Approaches.","finding":"","journal":"Journal of biochemical and molecular toxicology","studyType":"Clinical Study"},{"pmid":"41862140","year":"2026","title":"Smart Lipid-Based Nanocarrier System for the Topical Delivery of Ocular Therapeutics Bio-Interfacing, Physicochemical Diversity, and Routing Barriers.","finding":"","journal":"European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences","studyType":"Clinical Study"}],"_fda":{"id":"7556cd96-134e-4aaa-bf2d-7b6f9c8133c9","set_id":"0621700e-6315-47ff-a8ed-cccf7d6fc56a","openfda":{"nui":["N0000175937","M0023650"],"upc":["0370756610304","0370756609155"],"unii":["A4P49JAZ9H"],"route":["AURICULAR (OTIC)"],"rxcui":["242446"],"spl_id":["7556cd96-134e-4aaa-bf2d-7b6f9c8133c9"],"brand_name":["ofloxacin"],"spl_set_id":["0621700e-6315-47ff-a8ed-cccf7d6fc56a"],"package_ndc":["70756-609-15","70756-610-30"],"product_ndc":["70756-609","70756-610"],"generic_name":["OFLOXACIN OTIC"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Quinolones [CS]"],"substance_name":["OFLOXACIN"],"pharm_class_epc":["Quinolone Antimicrobial [EPC]"],"manufacturer_name":["Lifestar Pharma LLC"],"application_number":["ANDA216130"],"is_original_packager":[true]},"version":"5","warnings":["WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to ofloxacin is suspected, stop the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation, should be administered as clinically indicated."],"pregnancy":["Pregnancy Teratogenic effects: Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses. Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin Otic Solution 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"description":["DESCRIPTION Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido [1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.38. The structural formula is: Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5. chemstructure.jpg"],"how_supplied":["HOW SUPPLIED Ofloxacin Otic Solution 0.3% is supplied in plastic dropper bottles in the following sizes: NDC 70756-609-15 5 mL NDC 70756-610-30 10 mL Storage: Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature.] Protect from light."],"microbiology":["Microbiology: Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription. Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section. Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus Streptococcus pneumoniae Aerobic and facultative gram-negative microorganisms: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa"],"pediatric_use":["Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications: ■ six months and older: otitis externa with intact tympanic membranes ■ one year and older: acute otitis media with tympanostomy tubes ■ twelve years and older: chronic suppurative otitis media with perforated tympanic membranes Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product. No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% Ofloxacin Otic Solution for one month showed no systemic effects, quinolone-induced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy."],"effective_time":"20230623","nursing_mothers":["Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not known whether ofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from ofloxacin 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."],"pharmacokinetics":["Pharmacokinetics: Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of ofloxacin solution. In two single-dose studies, mean ofloxacin serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively). In adults with perforated tympanic membranes, the maximum serum drug level of ofloxacin detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 of 16 subjects). The variability of ofloxacin concentration in middle ear mucosa was high. The concentrations ranged from 1.2 to 602 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 mcg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of ofloxacin in the otorrhea does not necessarily reflect the exposure of the middle ear to ofloxacin."],"adverse_reactions":["ADVERSE REACTIONS Subjects with Otitis Externa In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacin Otic Solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects: Adverse Event Incidence Rate Studies 002/003† BID (N=229) Studies 016/017† QD (N=310) Study 020† QD (N=489) Application Site Reaction 3% 16.8% 0.6% Pruritus 4% 1.2% 1.0% Earache 1% 0.6% 0.8% Dizziness 1% 0.0% 0.6% Headache 0% 0.3% 0.2% Vertigo 1% 0.0% 0.0% † Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative. An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions. In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection. In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia. Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes: In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice daily with Ofloxacin Otic Solution: Adverse Event Incidence (N=656) Taste Perversion 7% Earache 1% Pruritus 1% Paraesthesia 1% Rash 1% Dizziness 1% Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia. Post-Marketing Adverse Events Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Ofloxacin Otic Solution 0.3% is unknown. To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS Ofloxacin Otic Solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication."],"drug_interactions":["Drug Interactions: Specific drug interaction studies have not been conducted with Ofloxacin Otic Solution 0.3%."],"teratogenic_effects":["Teratogenic effects: Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pharmacokinetics: Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of ofloxacin solution. In two single-dose studies, mean ofloxacin serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively). In adults with perforated tympanic membranes, the maximum serum drug level of ofloxacin detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 of 16 subjects). The variability of ofloxacin concentration in middle ear mucosa was high. The concentrations ranged from 1.2 to 602 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 mcg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of ofloxacin in the otorrhea does not necessarily reflect the exposure of the middle ear to ofloxacin. Microbiology: Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription. Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section. Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus Streptococcus pneumoniae Aerobic and facultative gram-negative microorganisms: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa"],"indications_and_usage":["INDICATIONS AND USAGE Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae , Moraxella catarrhalis , Pseudomonas aeruginosa , Staphylococcus aureus and Streptococcus pneumoniae ."],"nonteratogenic_effects":["Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin Otic Solution 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"adverse_reactions_table":["
Adverse Event Incidence Rate
Studies 002/003† BID (N=229) Studies 016/017† QD (N=310) Study 020† QD (N=489)
Application Site Reaction 3% 16.8% 0.6%
Pruritus 4% 1.2% 1.0%
Earache 1% 0.6% 0.8%
Dizziness 1% 0.0% 0.6%
Headache 0% 0.3% 0.2%
Vertigo 1% 0.0% 0.0%
† Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative.
","
Adverse Event Incidence (N=656)
Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1%
Rash 1%
Dizziness 1%
"],"information_for_patients":["Information for Patients: Avoid contaminating the applicator tip with material from the fingers or other sources. This precaution is necessary if the sterility of the drops is to be preserved. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction. Otitis Externa: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION ). Acute Otitis Media and Chronic Suppurative Otitis Media: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION )."],"spl_unclassified_section":["PRECAUTIONS General: As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor. The systemic administration of quinolones, including ofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Young growing guinea pigs dosed in the middle ear with 0.3% Ofloxacin Otic Solution showed no systemic effects, lesions or erosions of the cartilage in weight-bearing joints, or other signs of arthropathy. No drug-related structural or functional changes of the cochlea and no lesions in the ossicles were noted in the guinea pig following otic administration of 0.3% ofloxacin for one month. No signs of local irritation were found when 0.3% ofloxacin was applied topically in the rabbit eye. Ofloxacin was also shown to lack dermal sensitizing potential in the guinea pig maximization study. Information for Patients: Avoid contaminating the applicator tip with material from the fingers or other sources. This precaution is necessary if the sterility of the drops is to be preserved. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction. Otitis Externa: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION ). Acute Otitis Media and Chronic Suppurative Otitis Media: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION ). Drug Interactions: Specific drug interaction studies have not been conducted with Ofloxacin Otic Solution 0.3%. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic in the Ames test, the sister chromatid exchange assay (Chinese hamster and human cell lines), the unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or the mouse micronucleus assay. Ofloxacin was positive in the rat hepatocyte UDS assay, and in the mouse lymphoma assay. In rats, ofloxacin did not affect male or female reproductive performance at oral doses up to 360 mg/kg/day. This would be over 1000 times the maximum recommended clinical dose, based upon body surface area, assuming total absorption of ofloxacin from the ear of a patient treated with Ofloxacin Otic Solution 0.3% twice per day. Pregnancy Teratogenic effects: Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses. Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin Otic Solution 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not known whether ofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from ofloxacin 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. Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications: ■ six months and older: otitis externa with intact tympanic membranes ■ one year and older: acute otitis media with tympanostomy tubes ■ twelve years and older: chronic suppurative otitis media with perforated tympanic membranes Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product. No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% Ofloxacin Otic Solution for one month showed no systemic effects, quinolone-induced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.","Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Spain Revised: March 2023, V-04","PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT Patient Information IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. Ofloxacin Otic Solution 0.3% (Sterile) What is Ofloxacin Otic Solution 0.3%? Ofloxacin Otic Solution 0.3% is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in: ■ patients (12 years and older) who have a middle ear infection and have a hole in the eardrum ■ pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum ■ patients (6 months and older) who have an infection in the ear canal. Middle Ear Infection: A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) from the ear canal. Ear Canal Infection: An ear canal infection (also known as \"Swimmer's Ear\") is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal. Who should NOT use Ofloxacin Otic Solution 0.3%? ■ Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics. ■ Do not give this product to pediatric patients who: have an ear canal infection and are less than 6 months of age because no data were collected from this population have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population have a middle ear infection and have a hole in the eardrum and are less than twelve years of age because no data were collected from this population How should Ofloxacin Otic Solution 0.3% be given? 1. Wash hands The person giving Ofloxacin Otic Solution 0.3% should wash his/her hands with soap and water. 2. Clean ear and warm bottle Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL. Hold the bottle of Ofloxacin Otic Solution 0.3% in the hand for one or two minutes to warm the solution. 3. Add drops For a Middle Ear Infection : The person receiving Ofloxacin Otic Solution 0.3% should lie on his/her side with the infected ear up. Patients (12 and older) should have 10 drops of Ofloxacin Otic Solution 0.3% put into the infected ear. Pediatric patients under 12 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. For an Ear Canal Infection (\"Swimmer's Ear\"): The person receiving ofloxacin otic should lie on his/her side with the infected ear up. Patients (13 and older) should have 10 drops of ofloxacin otic put into the infected ear. Pediatric patients under 13 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT'S SPECIFIC EAR INFECTION. 4. Press ear or pull ear For a Middle Ear Infection: While the person receiving Ofloxacin Otic Solution 0.3% lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear. For an Ear Canal Infection (\"Swimmer's Ear\"): While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear upward and backward. This will allow the ear drops to flow down into the ear canal. 5. Stay on side The person who received the ear drops should remain on his/her side for at least 5 minutes. Repeat Steps 2-5 for the other ear if both ears are infected . How often should Ofloxacin Otic Solution 0.3% be given? In patients with an Ear Canal Infection (\"Swimmer's Ear\"), ofloxacin otic ear drops should be given once daily at about the same time each day (for example, 8 AM or 8 PM) in each infected ear unless the doctor has instructed otherwise. In patients with a Middle Ear infection, Ofloxacin Otic Solution 0.3% ear drops should be given 2 times each day (about 12 hours apart, for example, 8 AM and 8 PM) in each infected ear unless the doctor has instructed otherwise. The best times to use the ear drops are in the morning and at night. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve . If Ofloxacin Otic Solution 0.3% ear drops are not used for as long as the doctor has instructed, the infection may be more likely to return. What if a dose is missed? In patients with an Ear Canal Infection (\"Swimmer's Ear\"), it is important that you take the drops every day. If you miss a dose which may have been scheduled for earlier in the day, (for example, 8 AM), you should take that day's dose as soon as possible and then go back to your regular daily dosing schedule. In patients with a Middle Ear Infection, if a dose of Ofloxacin Otic Solution 0.3% is missed, it should be given as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not use a double dose unless the doctor has instructed you to do so. If the infection is not improved after one week, you should consult your doctor. If you have two or more episodes of drainage within six months, it is recommended you see your doctor for further evaluation. What activities should be avoided while using Ofloxacin Otic Solution 0.3%? It is important that the infected ear(s) remain clean and dry. When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless the doctor has instructed otherwise. What are some of the possible side effects of Ofloxacin Otic Solution 0.3%? During the testing of ofloxacin otic in external ear infections, the most common side effect was discomfort upon application which happened in 7% of patients. If the pain is severe, the medication should be stopped and you should contact your doctor. Other side effects were: itching (1%), earache (0.8%), and dizziness (0.4%). During testing in middle ear infections, the most common side effect was a bitter taste which happened in 7% of patients with a middle ear infection. This may occur when some of the drops pass from the middle ear to the back of the mouth. This side effect is not serious and there is no need to stop the medicine if this should happen. Other side effects which were found in 1% of the patients were: earache, itching, abnormal sensation, rash, and dizziness. Call your doctor about these or other side effects if they occur. If a rash or an allergic reaction to Ofloxacin Otic Solution 0.3% occurs, stop using the product and contact your doctor. DO NOT TAKE Ofloxacin Otic Solution 0.3% BY MOUTH. If Ofloxacin Otic Solution 0.3% is accidentally swallowed or overdose occurs, call the doctor immediately. This medicine is available only with a doctor's prescription. Use only as directed. Do not use this medicine if outdated. If you wish to learn more about Ofloxacin Otic Solution 0.3% ask the doctor or pharmacist. See complete Prescribing Information . HOW SUPPLIED Ofloxacin Otic Solution 0.3% is supplied in plastic dropper bottles in 5 mL and 10 mL sizes. Storage: Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Spain This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: March 2023, V-04 washhands.jpg wipeear.jpg dropsinear.jpg pushear.jpg tragus.jpg restingear.jpg"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness that may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear. Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear."],"spl_product_data_elements":["ofloxacin ofloxacin otic OFLOXACIN OFLOXACIN BENZALKONIUM CHLORIDE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER ofloxacin ofloxacin otic OFLOXACIN OFLOXACIN BENZALKONIUM CHLORIDE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-609-15 Ofloxacin Otic Solution 0.3% FOR USE IN EARS ONLY Sterile Rx only 5 mL NDC 70756-609-15 Ofloxacin Otic Solution 0.3% Sterile FOR USE IN EARS ONLY 5 mL Rx only NDC 70756-610-30 Ofloxacin Otic Solution 0.3% FOR USE IN EARS ONLY Sterile Rx only 10 mL NDC 70756-610-30 Ofloxacin Otic Solution 0.3% 10 mL Sterile FOR USE IN EARS ONLY Rx only label 5 ml.jpg 5 mL carton 10 mL label 10 mL carton"]},"tags":[{"label":"Quinolone Antimicrobial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H3 receptor","category":"target"},{"label":"HRH3","category":"gene"},{"label":"SLC6A4","category":"gene"},{"label":"CHRM1","category":"gene"},{"label":"J01MA01","category":"atc"},{"label":"Auricular (Otic)","category":"route"},{"label":"Ophthalmic","category":"route"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Abdominal abscess","category":"indication"},{"label":"Acute Moraxella catarrhalis bronchitis","category":"indication"},{"label":"Acute bacterial bronchitis","category":"indication"},{"label":"Acute bacterial peritonitis","category":"indication"},{"label":"Acute bacterial sinusitis","category":"indication"},{"label":"Acute exacerbation of chronic bronchitis","category":"indication"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Urinary","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Cytochrome P-450 CYP1A2 Inhibitors","category":"pharmacology"},{"label":"Cytochrome P-450 Enzyme Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Metabolic Side Effects of Drugs and Substances","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":243.66,"date":"","count":148,"signal":"Drug reaction with eosinophilia and systemic symptoms","source":"DrugCentral FAERS","actionTaken":"Reported 148 times (LLR=244)"},{"llr":202.954,"date":"","count":70,"signal":"Endophthalmitis","source":"DrugCentral FAERS","actionTaken":"Reported 70 times (LLR=203)"},{"llr":139.58,"date":"","count":97,"signal":"Cholestasis","source":"DrugCentral FAERS","actionTaken":"Reported 97 times (LLR=140)"},{"llr":130.506,"date":"","count":295,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 295 times (LLR=131)"},{"llr":123.523,"date":"","count":93,"signal":"Rash maculo-papular","source":"DrugCentral FAERS","actionTaken":"Reported 93 times (LLR=124)"},{"llr":114.476,"date":"","count":82,"signal":"Eosinophilia","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=114)"},{"llr":112.531,"date":"","count":35,"signal":"Corneal oedema","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=113)"},{"llr":110.838,"date":"","count":66,"signal":"Tendonitis","source":"DrugCentral FAERS","actionTaken":"Reported 66 times (LLR=111)"},{"llr":103.202,"date":"","count":77,"signal":"Hepatocellular injury","source":"DrugCentral FAERS","actionTaken":"Reported 77 times (LLR=103)"},{"llr":102.022,"date":"","count":33,"signal":"Toxic anterior segment syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=102)"},{"llr":100.017,"date":"","count":75,"signal":"Agranulocytosis","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=100)"},{"llr":98.118,"date":"","count":19,"signal":"Type 2 lepra reaction","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=98)"},{"llr":95.837,"date":"","count":73,"signal":"Toxic epidermal necrolysis","source":"DrugCentral FAERS","actionTaken":"Reported 73 times (LLR=96)"},{"llr":93.936,"date":"","count":25,"signal":"Hypopyon","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=94)"},{"llr":90.195,"date":"","count":36,"signal":"Tendon pain","source":"DrugCentral FAERS","actionTaken":"Reported 36 times (LLR=90)"}],"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"},{"url":"/drug/dronedarone","drug":"dronedarone","action":"Monitor closely","effect":"May interact with Dronedarone","source":"DrugCentral","drugSlug":"dronedarone"},{"url":"/drug/prednisolone","drug":"prednisolone","action":"Monitor closely","effect":"May interact with Prednisolone","source":"DrugCentral","drugSlug":"prednisolone"},{"url":"/drug/prednisone","drug":"prednisone","action":"Monitor closely","effect":"May interact with Prednisone","source":"DrugCentral","drugSlug":"prednisone"},{"url":"/drug/sucralfate","drug":"sucralfate","action":"Monitor closely","effect":"May interact with Sucralfate","source":"DrugCentral","drugSlug":"sucralfate"},{"url":"/drug/tizanidine","drug":"tizanidine","action":"Avoid combination","effect":"May interact with Tizanidine","source":"DrugCentral","drugSlug":"tizanidine"},{"url":"/drug/tolbutamide","drug":"tolbutamide","action":"Monitor closely","effect":"May interact with Tolbutamide","source":"DrugCentral","drugSlug":"tolbutamide"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Application Site Reaction","drugRate":"16.8%","severity":"common","_validated":true},{"effect":"Taste Perversion","drugRate":"7%","severity":"common","_validated":true},{"effect":"Pruritus","drugRate":"4%","severity":"common","_validated":true},{"effect":"Earache","drugRate":"1%","severity":"mild","_validated":true},{"effect":"Dizziness","drugRate":"1%","severity":"mild","_validated":true},{"effect":"Paraesthesia","drugRate":"1%","severity":"mild","_validated":true},{"effect":"Rash","drugRate":"1%","severity":"mild","_validated":true},{"effect":"Headache","drugRate":"0.2%","severity":"mild","_validated":true},{"effect":"Vertigo","drugRate":"0.0%","severity":"mild","_validated":true},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Seborrhea","drugRate":"reported","severity":"unknown"},{"effect":"Transient loss of hearing","drugRate":"reported","severity":"unknown"},{"effect":"Tinnitus","drugRate":"reported","severity":"unknown"},{"effect":"Otitis externa","drugRate":"reported","severity":"unknown"},{"effect":"Otitis media","drugRate":"reported","severity":"unknown"},{"effect":"Tremor","drugRate":"reported","severity":"unknown"},{"effect":"Hypertension","drugRate":"reported","severity":"unknown"},{"effect":"Fungal infection","drugRate":"reported","severity":"unknown"},{"effect":"Dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Eczema","drugRate":"reported","severity":"unknown"},{"effect":"Hypoaesthesia","drugRate":"reported","severity":"unknown"},{"effect":"Dyspepsia","drugRate":"reported","severity":"unknown"},{"effect":"Hot flushes","drugRate":"reported","severity":"unknown"},{"effect":"Flushing","drugRate":"reported","severity":"unknown"},{"effect":"Otorrhagia","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"0.6%","severity":"mild","_validated":true},{"effect":"Vomiting","drugRate":"0.3%","severity":"mild","_validated":true},{"effect":"Dry mouth","drugRate":"0.5%","severity":"mild","_validated":true}],"contraindications":["Achilles tendinitis","Agranulocytosis","Anemia","Bradycardia","Congenital long QT syndrome","Dehydration","Diabetes mellitus","Disease of liver","Drug-induced hepatitis","Epilepsy","Hallucinations","Hepatic failure","Hypokalemia","Impaired renal function disorder","Kidney disease","Leukopenia","Lowered convulsive threshold","Myasthenia gravis","Myocardial ischemia","Pancytopenia","Peripheral nerve disease","Prolonged QT interval","Pseudomembranous enterocolitis","Rhabdomyolysis","Severe Cerebral Arteriosclerosis"],"specialPopulations":{"Pregnancy":"Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving dose","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in infants below the age of one year have not been established.Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints."}},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.6366/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$589","description":"OFLOXACIN 0.3% EAR DROPS","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OFLOXACIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:44:12.507036+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ofloxacin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:44:20.551075+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:44:19.170830+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OFLOXACIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:44:19.482523+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:11.405589+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:11.405640+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:11.405647+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial DNA gyrase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:44:20.551018+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:44:20.204622+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA216130","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:11.405651+00:00"}},"allNames":"floxin","offLabel":[],"synonyms":["gailuoxian","ofloxacine","oxaldin","prifloxcin","prifloxin","ofloxacin","ofloxacin hydrochloride","ofloxacin HCl"],"timeline":[{"date":"1990-12-28","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1992-03-31","type":"positive","source":"FDA Orange Book","milestone":"Floxin approved — 20MG/ML"},{"date":"1993-07-30","type":"positive","source":"FDA Orange Book","milestone":"Ocuflox approved — 0.3%"},{"date":"2024-04-12","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 18 manufacturers approved"}],"aiSummary":"Floxin (Ofloxacin) is a quinolone antimicrobial drug developed by Hoechst Marion Roussel, currently owned by Daiichi. It targets bacterial DNA replication by inhibiting the enzyme DNA gyrase, leading to bacterial cell death. Floxin is approved to treat various bacterial infections, including respiratory, urinary, and skin infections. The drug is available as a generic medication, with over 20 manufacturers, and is no longer protected by patents. Key safety considerations include potential central nervous system effects, such as dizziness and confusion, and the risk of tendon rupture.","approvals":[{"date":"1990-12-28","orphan":true,"company":"","regulator":"FDA"}],"brandName":"Floxin","ecosystem":[{"indication":"Abdominal abscess","otherDrugs":[{"name":"cefoxitin","slug":"cefoxitin","company":""},{"name":"ceftolozane","slug":"ceftolozane","company":"Cubist Pharms"},{"name":"cilastatin","slug":"cilastatin","company":"Merck"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":89000},{"indication":"Acute Moraxella catarrhalis bronchitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefdinir","slug":"cefdinir","company":""},{"name":"cefpodoxime proxetil","slug":"cefpodoxime-proxetil","company":""}],"globalPrevalence":null},{"indication":"Acute bacterial bronchitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefixime","slug":"cefixime","company":""}],"globalPrevalence":null},{"indication":"Acute bacterial peritonitis","otherDrugs":[{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"ertapenem","slug":"ertapenem","company":"Merck Sharp Dohme"},{"name":"norfloxacin","slug":"norfloxacin","company":""},{"name":"trovafloxacin","slug":"trovafloxacin","company":""}],"globalPrevalence":null},{"indication":"Acute bacterial sinusitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Acute exacerbation of chronic bronchitis","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefditoren pivoxil","slug":"cefditoren-pivoxil","company":"Vansen Pharma"}],"globalPrevalence":null},{"indication":"Acute gonococcal cervicitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Acute gonococcal endometritis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"cefotetan","slug":"cefotetan","company":""},{"name":"cefoxitin","slug":"cefoxitin","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H3 receptor","novelty":"Follow-on","targets":[{"gene":"HRH3","source":"DrugCentral","target":"Histamine H3 receptor","protein":"Histamine H3 receptor"},{"gene":"SLC6A4","source":"DrugCentral","target":"Sodium-dependent serotonin transporter","protein":"Sodium-dependent serotonin transporter"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"GABRA2","source":"DrugCentral","target":"Gamma-aminobutyric acid receptor subunit alpha-2","protein":"Gamma-aminobutyric acid receptor subunit alpha-2"}],"modality":"Small Molecule","drugClass":"Quinolone Antimicrobial [EPC]","explanation":"","oneSentence":"","technicalDetail":"Floxin (Ofloxacin) is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (GyrA subunit) and topoisomerase IV (ParC subunit), enzymes critical for bacterial DNA replication and transcription."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ofloxacin","title":"Ofloxacin","extract":"Ofloxacin is a quinolone antibiotic useful for the treatment of a number of bacterial infections. When taken by mouth or injection into a vein, these include pneumonia, cellulitis, urinary tract infections, prostatitis, plague, and certain types of infectious diarrhea. Other uses, along with other medications, include treating multidrug resistant tuberculosis. An eye drop may be used for a superficial bacterial infection of the eye and an ear drop may be used for otitis media when a hole in the ear drum is present.","wiki_history":"==History==\nOfloxacin is a second-generation fluoroquinolone, being a broader-spectrum analog of norfloxacin, and was synthesized and developed by scientists at Daiichi Seiyaku.\n\nIt was first approved for marketing in Japan in 1985, for oral administration, and Daiichi marketed it there under the brand name Tarvid. Daiichi, working with Johnson & Johnson, obtained FDA approval in December 1990, under the brand name Floxin, labelled for use in adults with lower respiratory tract infections, skin and skin structure infections, urinary tract infections, prostatitis, and sexually transmitted diseases. By 1991, it was also marketed as Tarvid by Hoechst in the UK, Germany, Belgium, and Portugal; as Oflocet in France, Portugal, Tunisia, and several African countries by Roussel-Uclaf, as Oflocin by Glaxo in Italy, and as Flobacin by Sigma-Tau in Italy.\n\nIn 1997, an indication for pelvic inflammatory disease was approved by the U.S. Food and Drug Administration (FDA) for the oral formulation, and in the same year, a solution for ear infections was approved under the brand \n\nDaiichi and J&J also cannibalized its own market by introducing levofloxacin, the levo-enantiomer of ofloxacin, in 1996; Johnson & Johnson withdrew the marketing application in 2009.","wiki_society_and_culture":"==Society and culture==\n\n===Available forms===\nOfloxacin for systemic use is available in multiple strengths as a tablet, an oral suspension, and an injectable solution. It is also used as eye drops and ear drops and is available in combination with ornidazole.\n\n===Antibiotic use and bacterial resistance===\n\nResistance to ofloxacin and other fluoroquinolones may evolve rapidly, even during a course of treatment. Numerous pathogens, including Staphylococcus aureus, enterococci, and Streptococcus pyogenes now exhibit resistance worldwide.\n\nFloxacin and other fluoroquinolones had become the most commonly prescribed class of antibiotics to adults in 2002. Nearly half (42%) of these prescriptions were for conditions not approved by the US Food and Drug Administration (FDA), such as acute bronchitis, otitis media, and acute upper respiratory tract infection."},"commercial":{"launchDate":"1990","_launchSource":"DrugCentral (FDA 1990-12-28, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1981","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=OFLOXACIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OFLOXACIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ofloxacin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T13:11:41.756912","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:44:25.692250+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ciprofloxacin","drugSlug":"ciprofloxacin","fdaApproval":"1987-10-22","patentExpiry":"Nov 27, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"enoxacin","drugSlug":"enoxacin","fdaApproval":"1991-12-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"norfloxacin","drugSlug":"norfloxacin","fdaApproval":"1986-10-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"lomefloxacin","drugSlug":"lomefloxacin","fdaApproval":"1992-02-21","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"sparfloxacin","drugSlug":"sparfloxacin","fdaApproval":"1996-12-19","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"grepafloxacin","drugSlug":"grepafloxacin","fdaApproval":"1997-11-06","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"levofloxacin","drugSlug":"levofloxacin","fdaApproval":"1996-12-20","genericCount":36,"patentStatus":"Off-patent — generic 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