Moxifloxacin Ophthalmic Solution 5 mg/mL
Moxifloxacin Ophthalmic · SOLUTION/ DROPS · Gland Pharma Limited
Moxifloxacin ophthalmic solution is an antibiotic eye drop used to treat bacterial eye infections. It works by killing bacteria that cause conditions like conjunctivitis and other eye infections.
Key Facts
- Brand Name
- Moxifloxacin Ophthalmic Solution
- Generic Name
- Moxifloxacin Ophthalmic
- NDC Code (Product)
68083-210- Manufacturer
- Gland Pharma Limited
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA208778
- Marketing Start
- 03/30/2020
Recall History
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Direct Rx
cGMP deviation: discontinue of stability support for product.
Direct Rx
Failed impurities/degradation specifications
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
AuroMedics Pharma LLC
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Promise Pharmacy, LLC
Lack of sterility assurance.
Akorn, Inc.
CGMP Deviations:
Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. MOXIFLOXACIN ophthalmic solution is a topical fluoroquinolone anti- infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis , Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii* , Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. Moxifloxacin ophthalmic solution is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days.
Contraindications
4 CONTRAINDICATIONS Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. MOXIFLOXACIN ophthalmic solution is contraindicated in patients with a history of hypersensitivity to MOXIFLOXACIN, to other quinolones, or to any of the components in this medication.
Drug Interactions
7 DRUG INTERACTIONS Drug-drug interaction studies have not been conducted with moxifloxacin ophthalmic solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients. Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1 to 6% of patients. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is Moxifloxacin Ophthalmic Solution used for?
Moxifloxacin ophthalmic solution is an antibiotic eye drop used to treat bacterial eye infections. It works by killing bacteria that cause conditions like conjunctivitis and other eye infections.
Is Moxifloxacin Ophthalmic Solution a controlled substance?
Moxifloxacin Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Moxifloxacin Ophthalmic Solution?
The generic name for Moxifloxacin Ophthalmic Solution is Moxifloxacin Ophthalmic. There are 4 other brand versions of Moxifloxacin Ophthalmic.
What is the NDC code for Moxifloxacin Ophthalmic Solution 5 mg/mL?
The NDC (National Drug Code) for Moxifloxacin Ophthalmic Solution 5 mg/mL is 68083-210, listed by Gland Pharma Limited.