Description
COMPOSITION-
| Each ml contains-: | |
| Moxifloxacin hydrochloride | 0.5% |
| Loteprednol Etabonate | 0.5% |
| Sterile aqueous vehicle | q.s. |
Pharmacology:
Category: Antibiotic + Steroid
Mode of Action:
FREDMOX-LP 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. 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.
FREDMOX-LP consists of Loteprednol Etabonate which is a “soft” steroid that belongs to the class of Glucocorticoids.
Being structurally similar to other Glucocorticoids and missing ketone group, prevents formation of proteins, responsible for cataract formation with ketone steroids. Loteprednol Etabonate is highly lipophilic, a characteristic that increases its efficacy by enhancing penetration through biological membranes. Loteprednol Etabonate undergo a predictable transformation to an inactive metabolite. It first binds to the type II Glucocorticoid receptors.
At molecular level, unbound Glucocorticoids readily cross cell membranes and bind with high affinity, to specific Cytoplasmic receptors. This binding induces a response by modifying transcription and, ultimately protein synthesis to achieve the formation of Anti-Inflammatory Protein that inhibits the enzyme Phospholipase A2 which is needed in supply of Arachidonic acid. The latter is responsible for the formation of the mediators of inflammatory response. Thus inhibits the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation with inflammation.
Indications and Usage:
Seasonal allergic Conjunctivitis with Secondary infections, Keratitis, Post-operative ocular inflammation, Iritis, Cyclitis, Steroid responsive ocular infection caused by the 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 |
Warnings & Precautions:
- Use with caution in patients having history of glaucoma.
- It may delay healing and scar formation.
- Contraindicated in Acute untreated purulent ocular infections, fungal or mycobacterial ocular infections, viral conjunctivitis, or keratitis.
- Growth of Resistant Organisms and viral infections (including Herpes Simplex) with Prolonged Use
- Avoidance of Contact Lens Wear
Adverse Effects:
Hypersensitivity towards any of the component in ophthalmic solution. Stinging sensation, blurred vision, swelling, redness, sensitivity to light and pain in eye.
Dosage and Administration:
Instill 1-2 drops of FREDMOX-LP Eye drops 4-8 times a day depending upon the severity of the condition.
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-LP Eye Drops comes in a 5ml vial.
