Ofloxacin Otic
Generic Name: ofloxacin otic
Brand Names:
Ofloxacin
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.
Overview
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.
Uses
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 .
Dosage
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.
Side Effects
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).
Interactions
Drug Interactions: Specific drug interaction studies have not been conducted with Ofloxacin Otic Solution 0.3%.
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. 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.
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.
Storage
HOW SUPPLIED Ofloxacin Otic Solution 0.3% is supplied in plastic dropper bottles in the following sizes: NDC: 70518-3984-00 PACKAGING: 5 mL in 1 BOTTLE DROPPER, TYPE 9 Storage: Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature.] Protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Frequently Asked Questions
What is Ofloxacin Otic used for?▼
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 .
What are the side effects of Ofloxacin Otic?▼
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).
Can I take Ofloxacin Otic during 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.
What are the important warnings for Ofloxacin Otic?▼
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. 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.
Related Medications
Ailanthus Glandulosus, Arsenicum Album, Herpes Simplex Virus 1 And 2 Dna, Echinacea (angustifolia), Hepar Sulphuris Calcareum, Herpes Simplex I And Ii Nosode, Herpes Zoster Nosode, Lachesis Mutus, Mercurius Solubilis, Mezereum, Phytolacca Decandra
ailanthus glandulosus, arsenicum album, herpes simplex virus 1 and 2 dna, echinacea (angustifolia), hepar sulphuris calcareum, herpes simplex i and ii nosode, herpes zoster nosode, lachesis mutus, mercurius solubilis, mezereum, phytolacca decandra
PURPOSE Ailanthus Glandulosus – Skin Inflammation, Arsenicum Album - Rash, DNA – Skin Swelling, Echinacea (Angustifolia) - Fever, Hepar Sulphuris Calcareum – Skin Swelling, Herpes Simplex I & II Nosode – Skin Swelling, Herpes Zoster Nosode - Rash, Lachesis Mutus – Skin Inflammation, Mercurius Solubilis - Rash, Mezereum - Fever, Phytolacca Decandra – Skin Swelling
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hcl
dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl
Expectorant [EPC]
Uses: temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold
Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Stillingia Sylvatica, Trifolium Pratense, Ascorbicum Acidum, Cysteinum, L-methionine, Phytolacca Decandra, Thyroidinum (suis), Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Boron, Arsenicum Album, Mercurius Solubilis, Plumbum Metallicum, Lanthanum Metallicum, Niobium Metallicum, Tantalum Metallicum, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum,
allium sativum, berberis vulgaris, glycyrrhiza glabra, lappa major, stillingia sylvatica, trifolium pratense, ascorbicum acidum, cysteinum, l-methionine, phytolacca decandra, thyroidinum (suis), carbolicum acidum, formalinum, lycopodium clavatum, natrum muriaticum, nux vomica, boron, arsenicum album, mercurius solubilis, plumbum metallicum, lanthanum metallicum, niobium metallicum, tantalum metallicum, aluminium metallicum, antimonium crudum, argentum metallicum, arsenicum album, aurum metallicum,
Vitamin C [EPC]
PURPOSE: For temporary relief of symptoms related to heavy metal toxicity including cough, poor concentration, nausea, vomiting, occasional diarrhea, stomach pain, headache, sweating, and a metallic taste in the mouth.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.