Moxibac XG (Moxifloxacin 0.5%)
Brinzolamide 1% + Brimonidine Tartrate 0.2% Eye Drop
 Moxibac XG (Moxifloxacin 0.5%)

Each ml Moxibac XG eye drops contains :
Active substance: Moxifloxacin Hydrochloride BP equivalent to Moxifloxacin 5 mg
Vehicle: Xanthan Gum BP 0.4%. Preservative Free

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Pharmacology/Description

Moxibac XG is a sterile ophthalmic solution containing Moxifloxacin enriched with Xanthan Gum - a broad spectrum fluoroquinolone derivative for topical administration into the eyes.


Clinical Pharmacology
Moxibac XG (Moxifloxacin) is a 4th generation fluorinated quinolone. It is bactericidal with a broad spectrum of antibacterial activity. The antibacterial action of moxifloxacin results from inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Indications

Moxibac XG is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of following organisms:
Aerobic Gram-positive microorganisms:
Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenzae, Haemophilus parainfluenzae.

Dosage And Administration

Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

Side Effects

The most frequently reported ocular side effects are ocular discomfort, irritation etc. may occur.

Contraindications

Moxibac XG 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

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride. 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 isoenzymes.

Precautions

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi like with other anti-infectives.


Special Populations
Use in Pregnancy:
Pregnancy Category C. Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women.

Use in Lactating Mother:
Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin is administered to a lactating mother.

Pediatric Use:
The safety and effectiveness of Moxifloxacin in infants below four months of age was not proven. However, several clinical studies show that the drug may be used safely in children even younger than one month of age.

Geriatric Use:
No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Pharmaceutical Precautions

Store at room temperature and protect from light and moisture. It is desirable that the contents should not be used more than one month after first opening of the bottle.

Commercial Pack

A sterile ophthalmic solution in 5 ml plastic dropper bottle.