Svoz Ophthalmic Solution

Moxifloxacin hydrochloride.

Each 1 ml contains Moxifloxacin Hydrochloride 5.45 mg is equivalent to Moxifloxacin 5 mg.

Pharmacology: Pharmacodynamics: Moxifloxacin is a Fluoroquinolone anti-infective agent. Like other commercially available fluoroquinolones, Moxifloxacin contains a fluorine at the C-6 position of the quinolone nucleus. Moxifloxacin, like gatifloxacin, contains an 8-methoxy group and has been termed an 8-methoxy fluoroquinolone. Moxifloxacin inhibits DNA synthesis in susceptible organisms via inhibition of type II topoisomerases (DNA gyrase and topoisomerase IV). DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA.
Pharmacokinetics: Following topical application to both eyes of Moxifloxacin 0.5% ophthalmic solution 3 times daily for 5 days in healthy adults, mean steady-state peak, plasma concentrations and estimated daily exposure, as determined by area under the plasma concentration-time curve (AUC), reportedly were 1600 and 1000 times lower, respectively, than values attained following oral administration of therapeutic (400 mg daily for 10 days) doses of the drug.

1. For the treatment of conjunctivitis or keratitis (including corneal ulcer).
2. For aseptic treatment during a perioperative period for ocular surgery.
3. For the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria: Corynebacterium species*; Microbacterium species; Micrococcus luteus* [including erythromycin, gentamicin, tetracycline and/or trimethoprim resistant strains]; Staphylococcus aureus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains]; Staphylococcus epidermidis [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains]; Staphylococcus haemolyticus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains]; Staphylococcus hominis* [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains]; Staphylococcus warneri* [including erythromycin resistant strains]; Streptococcus mitis* [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant strains]; Streptococcus pneumoniae [including penicillin, erythromycin, gentamicin, tetracycline and/or trimethoprim resistant strains]; Streptococcus viridans [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant strains].
Gram-negative bacteria: Acinetobacter species; Haemophilus "alconae" [including ampicillin resistant strains]; Haemophilus influenzae [including ampicillin resistant strains]; Klebsiella pneumoniae*; Moraxella catarrhalis*; Pseudomonas aeruginosa*.
Other Organisms: Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10 infections.

Adult: Bacterial conjunctivitis: Instill 1 drop into affected eye(s) 3 times daily for 4 days.
Keratitis (including corneal ulcer): Instill 1 drop into affected eye(s) 3 times daily for 7-14 days, up to 8 times daily. The dosage may be adjusted according to the patient's symptoms.
Prevent infection before and after the ocular surgery: Instill 1 drop into affected eye(s) 5 times daily before the ocular surgery 2 days and 3 times daily on the surgery day until the day 14^th after the surgery.
Pediatric: Safety and efficacy not establish in children younger than 1 year of age.
Geriatic: No substantial differences in safety and efficacy relative to younger adults.
Renal impairment: There are no dosage adjustments. However, dosage adjustment unlikely due to low systemic absorption.
Hepatic impairment: There are no dosage adjustments. However, dosage adjustment unlikely due to low systemic absorption.

Overdose and Treatment: The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product. The total amount of Moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.

This product is contraindicated in patients who are hypersensitive to Moxifloxacin, the ingredient of this product or any quinolone antibiotics.

1. Do not use this product if you are hypersensitive to Moxifloxacin or other quinolones.
2. If any symptoms such as eye redness/swelling, rash, muscle pain, tendinopathy are observed, administration should be discontinued and consult a doctor immediately.
3. Moxifloxacin may cause hepatotoxicity or renal toxicity.

Route of administration: Ophthalmic use only. Not for injection or subconjunctival injection or introduction directly into the anterior chamber.
As with other anti-infective agents, prolonged use of Moxifloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Moxifloxacin should be discontinued and other appropriate therapy instituted.

Pregnancy Category: C.
The safety of this product during pregnancy has not been established. Should be used in pregnant women if the expected therapeutic benefits are judged to outweigh the possible risks associated with treatment. Distribution of Moxifloxacin into milk following ophthalmic administration has not been studied, it is presumed that Moxifloxacin is distributed into milk. Caution is advised if ophthalmic Moxifloxacin is administered in nursing women.

See table.

Click on icon to see table/diagram/image

No formal drug interaction studies have been performed with Moxifloxacin ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit cytochrome P-450 (CYP) isoenzymes 3A4, 2D6, 2C9, 2C19 or 1A2.

Store below 30°C and protect from light.

Eye Anti-Infectives & Antiseptics

S01AE07 - moxifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.

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