MOXI DROP

  • Therapeutic Category
    • ANTI-INFECTIVE AGENTS
    • OPHTHALMOLOGICAL DRUGS
  • Pharmaceutical Form : Eye Drops
  • Composition : Moxifloxacin Hcl 5.45 mg Eq. to Moxifloxacin 5 mg / 1 ml
  • Active Substance : Moxifloxacin Hcl

MECHANISM OF ACTION:

Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The antibacterial action of moxifloxacin results from inhibition of the 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.

The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.

PHARMACODYNAMICS 

Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of MOXI DROP solution 3 times a day. The mean steady-state Cmax (2.7 ng/mL) and estimated daily exposure AUC (45 ng•hr/mL) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours

INDICATIONS:

MOXI DROP solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the 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 lwoffi

Haemophilus influenzae

Haemophilus parainfluenzae

-Other microorganisms :

Chlamydia trachomatis

CONTRA INDICATIONS

MOXI DROP solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

SIDE EFFECTS

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.

PRECAUTIONS

General: As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.

WARNINGS

Not for injection.

MOXI DROP solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Pregnancy Category C:

Since there are no adequate and well-controlled studies in pregnant women, MOXI DROP solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when MOXI DROP solution is administered to a nursing mother.

Pediatric Use: The safety and effectiveness of MOXI DROP solution in infants below 1 year of age have not been established. There is no evidence that the ophthalmic administration of MOXI DROP solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

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

DRUG INTERACTIONS

Drug-drug interaction studies have not been conducted with MOXI DROP 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 this cytochrome P450 isozymes.

DOSAGE

Instill one drop in the affected eye 3 times a day for 7 days.

STORAGE CONDITIONS

Store below 25°C

PACKING:

Plastic bottle 5 mL