Imox

Light yellow clear solution filled in polypropylene container and free from any foreign particles.
Each mL contains: Moxifloxacin (as hydrochloride) BP 5 mg.

Anti-infective.
Pharmacology: Pharmacodynamics: Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The bacterial 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. In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10 to less than 1 x 10 for gram-positive bacteria.
Pharmacokinetics: Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady-state C (2.7 ng/mL) and AUC (41.9 ng·hr/mL) values were 1,600 and 1,100 times lower than the mean C and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Moxifloxacin (Imox) is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of Aerobic Gram-positive microorganisms, Aerobic Gram-negative microorganisms and other microorganisms (Chlamydia trachomatis).

Instill one drop in the affected eye 3 times a day for 7 days or as directed by the physician.

No information is available on overdose of Moxifloxacin eye drop in humans. An overdose of Moxifloxacin eye drops is not expected to be dangerous.

Moxifloxacin (Imox) Eye drops is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible 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.

Pregnancy: Moxifloxacin (Imox) Eye drops is categorized with Pregnancy Category C. However, since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: 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 Eye Drops is administered to a nursing mother.

Blood and lymphatic system disorders: Rare: Hemoglobin decreased.
Immune system disorders: Not known: Hypersensitivity.
Nervous system disorders: Uncommon: Headache.
Rare: Paresthesia.
Not known: Dizziness.
Eye disorders: Common: Eye pain, eye irritation.
Uncommon: Punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort.
Rare: Corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid.
Not known: Endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes.
Cardiac disorders: Not known: Palpitations.
Gastrointestinal disorders: Uncommon: Dysgeusia.
Rare: Vomiting.
Not known: Nausea.
Hepatobiliary disorders: Rare: Alanine aminotransferase increased, gamma-glutamyltransferase increased.
Skin and subcutaneous tissue disorders: Not known: Erythema, rash, pruritus, urticaria.

Drug-drug interaction studies have not been conducted with Moxifloxacin. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C6, CYP2C19, CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

Special Precautions for Handling and Disposal: Any unused medicine should be disposed of properly. Consult the pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.

Store at temperatures not exceeding 30°C.
Storage condition after opening: Store IMOX Eye Drops in a cold, dry place where the temperature stays below 30°C. It is not necessary to store IMOX Eye Drops in the refrigerator. Do not freeze.

Eye Anti-Infectives & Antiseptics

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

Rx