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Ofloxacin
Overview
What is Ofloxacin?
Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
What does Ofloxacin look like?
What are the available doses of Ofloxacin?
Sorry No records found.
What should I talk to my health care provider before I take Ofloxacin?
Sorry No records found
How should I use Ofloxacin?
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
*Efficacy for this organism was studied in fewer than 10 infections
The recommended dosage regimen for the treatment of is:
The recommended dosage regimen for the treatment of
is:
What interacts with Ofloxacin?
Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
What are the warnings of Ofloxacin?
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NOT FOR INJECTION.
Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
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. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
What are the precautions of Ofloxacin?
General
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent to 110 times the maximum recommended daily adult ophthalmic dose) has been associated with these types of effects.
Information for patients
Avoid contaminating the applicator tip with material from the eye, fingers or other source.
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.
Drug interactions
Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
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, in vitro and in vivo cytogenic assay, sister chromatid exchange assay (Chinese hamster and human cell lines), unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or mouse micronucleus assay. Ofloxacin was positive in the UDS test using rat hepatocyte, and in the mouse lymphoma assay.
In fertility studies in rats, ofloxacin did not affect male or female fertility or morphological or reproductive performance at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended daily ophthalmic dose).
Pregnancy
Teratogenic effects
Pregnancy Category C:
Nonteratogenic effects
Additional studies in rats with doses up to 360 mg/kg/day during late gestation showed no adverse effect 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 ophthalmic solution 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 ophthalmic 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 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.
Geriatric use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
What are the side effects of Ofloxacin?
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Ophthalmic Use:
The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received.
What should I look out for while using Ofloxacin?
Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
NOT FOR INJECTION.
Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
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. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
What might happen if I take too much Ofloxacin?
Sorry No Records found
How should I store and handle Ofloxacin?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL10 mLThey are supplied by as follows:Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701This Product was Repackaged By Sandhills Packaging For:Keltman Pharmaceuticals Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days. Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin.
Tear ofloxacin concentrations ranged from 5.7 to 31 µg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 µg/g.
Corneal tissue concentrations of 4.4 µg/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified.
Non-Clinical Toxicology
Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.NOT FOR INJECTION.
Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
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. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent to 110 times the maximum recommended daily adult ophthalmic dose) has been associated with these types of effects.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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