Description
COMPOSITION-
| Each ml contains-: | |
| Moxifloxacin hydrochloride BP eq. to moxifloxacin | 0.5% w/v |
| Dexamethosone Sodium Phosphate IP eq. to Dexamethosone Phosphate | 0.1%w/v |
| Benzalkonium Chloride Solution (As Preservative) | 0.02%w/v |
| Sterile aqueous vehicle | q.s. |
Pharmacology
Mode of Action:
MOXIFLOXIN, in FREDMOX-D works 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. 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.
DEXAMETHASONE- is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone and has anti-inflammatory and immunosuppressant effects. It fulfills it function through multiple pathways, it binds with the corticosteroid receptors and alters the protein synthesis thus prevents the leukocyte infiltration at the site of inflammation, interferes in the function of the mediators responsible for the inflammatory response, suppresses the humoral immune responses and reduction in edema or scar tissue. The anti-inflammatory actions of dexamethasone involve phospholipase A2 inhibitory proteins which control the biosynthesis of potent mediators of inflammation such as prostaglandins.
Indication and Usage:
Bacterial Infection, Inflammation and pain associated with Post Surgery, Lasik and Ocular infections of susceptible strains.
Precautions:
Hypersensitivity towards any of the component in the solution.
Warnings and Precautions:
- Growth of Resistant Organisms with Prolonged Use
- Avoidance of Contact Lens Wear
- if irritations persist, discontinue the use and consult the eye doctor
- Prolonged use may result in glaucoma
- Defects in visual acuity and fields of vision
Contraindicated: In Acute untreated purulent ocular infections, fungal or mycobacterial ocular infections, viral conjunctivitis, or keratitis.
Adverse Effect:
- 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:
One drop in the affected eye(s), within intervals directed by your doctor.
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.
Presentation:
FREDMOX-D Eye Drops comes in a 10ml vial.
