Ofloxacin Ophth Soln 3 mg/mL
Ofloxacin Ophth Soln · SOLUTION/ DROPS · Direct_Rx
Ofloxacin Ophth Soln is a solution/ drops containing ofloxacin ophth soln at 3 mg/mL, taken ophthalmic. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Ofloxacin Ophth Soln
- Generic Name
- Ofloxacin Ophth Soln
- NDC Code (Product)
72189-472- Manufacturer
- Direct_Rx
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA215886
- Drug Class
- Quinolone Antimicrobial [EPC]
- Marketing Start
- 05/22/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes
Dosage & Administration
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 through treatment completion Instill one to two drops, four times daily.
Warnings
NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, 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.
Contraindications
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 (see Warnings).
Adverse Reactions
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. Refer to Warnings for additional adverse reactions. 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.
Frequently Asked Questions
What is Ofloxacin Ophth Soln used for?
Ofloxacin Ophth Soln contains Ofloxacin Ophth Soln. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Ofloxacin Ophth Soln a controlled substance?
Ofloxacin Ophth Soln is not classified as a controlled substance by the DEA.
What is the generic name for Ofloxacin Ophth Soln?
The generic name for Ofloxacin Ophth Soln is Ofloxacin Ophth Soln. There are no other listed brand versions of Ofloxacin Ophth Soln.
What is the NDC code for Ofloxacin Ophth Soln 3 mg/mL?
The NDC (National Drug Code) for Ofloxacin Ophth Soln 3 mg/mL is 72189-472, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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