Description
COMPOSITION-
| Each ml contains-: | |
| Moxifloxacin hydrochloride BP eq. to moxifloxacin | 0.5% |
| Sterile aqueous vehicle | q.s. |
Pharmacology:
Category: Moxifloxacin as antibiotic.
Mode of Action:
FREDMOX constitutes 4th generation Fluoro-Quinolones, Moxifloxacin as an anti-bacterial agent. Floro-Quinolones exert their antibacterial effect by preventing bacterial DNA from unwinding and duplicating. Moxifloxacin hydrochloride is a synthetic 8-methoxyfluoroquinolone with a broad spectrum anti-bacterial effect on gram positive, gram negative and other anaerobic micro-organism.
DMF: Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API). The DMF contains factual and complete information on a drug product’s chemistry, manufacture, stability and purity. Thus ensuring the best quality formulations approved by USFDA.
It is “PRESERVATIVE FREE” providing freedom from hypersensitivity or allergic reactions associated with the preservatives. Well tolerated with minimal ocular side effects and provides increased penetration into ocular tissues and fluids with improved activity against Streptococci and Staphylococci species. It has a moderate to excellent activity against clinically relevant, gram-negative ocular pathogens.
Indications and Usage: Bacterial Conjunctivitis (pink eye), Bacterial Corneal Ulcer Infection, caused by the following susceptible strains-
| Corynebacterium species | |
| Micrococcus luteus | Staphylococcus warneri |
| Staphylococcus aureus | Streptococcus pneumoniae |
| Staphylococcus epidermidis | Streptococcus viridans group |
| Staphylococcus haemolyticus | Acinetobacter Iwoffii |
| Staphylococcus hominis | Haemophilus influenzae |
| Haemophilus parainfluenzae | Chlamydia trachomatis |
Precautions:
Hypersensitivity towards any of the component in the solution.
Warnings:
- Growth of Resistant Organisms with Prolonged Use
- Avoidance of Contact Lens Wear
- If irritations persist, discontinue the use and consult the eye doctor.
Adverse Effects:
- Nausea, Diarrhea, Dizziness, blurred vision that does not go away, burning, stinging, or itching of the eyes or eyelids.
- Ocular hyperemia, Ocular pain and Ocular pruritus
Dosage and Administration:
A drop in the affected eyes twice a day or as directed by your Physician.
Information to Patient:
Follow the instructions that are provided by your doctor and if the adverse effect persists, discontinue the usage and contact your doctor immediately.
