GYRIMOX
How to use MOXIFLOXACIN
PRODUCT INFORMATION
Composition
Moxifloxacin Hydrochloride IP Equivalent to Moxifloxacin……………………………………………. % w/v
Purified Water IP……… q.s.
Preservative : Product is self preserved.
Active Ingredient : Moxifloxacin.
Description :
Moxifloxacin is a fourth-generation 8-methoxy fluoroquinolone antibacterial agent having a broad-spectrum activity with enhanced Gram-positive coverage, maintain Gram-negative activity and also active against a typical microorganisms, Mycobacterium and anaerobes. The bactericidal action of Moxifloxacin results from inhibition of enzymes DNA gyrase and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described below
Aerobic Gram-positive microorganisms :
Corynebacterium species, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Staphylococcus pneumoniae, Staphylococcus viridans group.
Aerobic Gram-Negative microorganisms :
Acinetobacter iwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae.
Other microorganisms :
Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.
Indications :
Moxifloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains and post- operative prophylaxis from susceptible strains.
Dosage And Administration :
Instill one drop in the affected eye 3 times a day for 7 days or as directed by the ophthalmologist.
Contraindications :
Moxifloxacin is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warning And Precautions : NOT FOR INJECTION.
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
Pregnancy Category C : Since there are no adequate and well-controlled studies in pregnant women, moxifloxacin solution 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 solution is administered to nursing mothers.
Paediatric Use :
The safety and effectiveness of Moxifloxacin in infants below 1 year of age have not been established. There is no evidence that the ophthalmic administration of Moxifloxacin has any effect on weight bearing joints.
Geriatric Use :
No overall difference in safety and effectiveness have been observed between elderly and younger patients.
Side Effects :
The most frequently reported ocular side effects 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.
Overdosage :
A topical overdose may be flushed from the eyes with warm tap water.
Packing :
Moxifloxacin Eye Drops are available in 5ml in lyondellbasel Purell low density polyethylene dispensing system consisting of plastic bottle with good flexibility. Tamper evidence ring around the closure and neck area of the bottle.
Storage :
Store in cool & dry place. Protect from light. Use the solution within one month after opening the container. For external use only. Keep out of reach of children.