Moxifloxan

The mechanism of action

Moxifloxacin is the 4^th generation fluoroquinolone. Like other fluoroquinolones, it stops the duplication of bacterial DNA, besides suppressing the production of DNA-gyrase and topoisomerase IV necessary for recombination and repair.

Antimicrobial spectrum

Gram positive aerobic microorganisms:

Corinebacteria types
Corinebacterium diphtheriae
Staphylococcus aureus (methicillin sensitive)
Pneumococcus

Gram negative aerobic microorganisms:

Neisseria gonorheae

Auxiliary substances:

Boric acid
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Distilled water

Ocular moxifloxacin is moderately absorbed. As a result of four-day triple administration of 2 eyes under stationary conditions, Cmax is 2.7 ng/ml, and AUC is 41.9 ng, respectively. These values were 1600- and 1200-fold lower than at the therapeutic (400 mg) dose of moxifloxacin administered orally.

Method of administration and dosage

Use from 2 years of age. Intended for local use only. Those over the age of 65 are not allowed. Not intended for injection. The solution cannot be introduced subconjunctivally or directly into the anterior chamber of the eye.

3 times a day, one drop in each eye. Usually, within 5 days, the lesion passes. The duration of the treatment depends on the degree of the lesion, the course, the clinical and bacteriological state of the infection.

In pediatrics, it is used in the same doses and method.

Contraindications

Hypersensitivity to moxifloxacin and any of the excipients.

Serious, sometimes fatal, hypersensitivity (anaphylactic) reactions may occur during regular use of quinolones. In case of allergic reactions, Moxifloxacin should be stopped immediately and a doctor should be consulted. Long-term use of moxifloxacin can lead to overgrowth of certain microorganisms, including fungi. This drug is not recommended for use in the treatment of pyelonephritis in infants. Moxifloxacin should not be used for the prevention of gonococcal infections, including neonatal eye infections caused by fluoroquinolone-resistant Neisseria gonorheae. Moxifloxacin should not be used in children under 2 years of age for Chlamydia trachomatis strep throat due to a lack of evidence on the drug’s efficacy and safety. Pregnancy and breastfeeding

Moxifloxacin can be used during pregnancy.
It is believed that the use of Moxifloxacin does not cause any side effects on the breastfed baby.

Side effects

No serious ocular or systemic adverse reactions were reported during clinical trials. The main side effects observed were eye irritation and pain (in 1-2% of clinical trial participants), which did not cause discontinuation of treatment.

Blood and lymphatic system disorders: rarely – decrease in hemoglobin
Cardiovascular disorders: no side effect was registered
Immune system disorders: not found: hypersensitivity
Nervous system disorders: rarely – headaches, not often – paranesthesia, dizziness was not registered
Respiratory disorders: rarely discomfort in the nasal cavity, sore throat, foreign body sensation in the throat, cough was not registered
Gastrointestinal disorders: not often ageusia (loss of taste), rarely: vomiting, nausea was not registered
Hepato-biliary system disorder: rarely elevation of GGT (Gamma-Glutamyl transferase) and AAT (Alanine Aminotransferase)
Skin և subcutaneous disorders: not registered erythema, rash, itching, or rash
Visual system disorders: often there were registered eye pain, irritation of the eyes, dryness, redness, itching, discomfort, spotted corneas, retinal hemorrhage, swelling of the eyelids. Rare: inflammation of the eyelids, erythema of the eyelids, defects of the corneal epithelium, inflammation of the larynx, swelling of the larynx, swelling of the eyes, asthenopia, decreased visual acuity. Not registered: corneal infiltration, erosion, edema, blur vision, ulcerative keratitis, ocular hypertension, endophthalmitis, photophobia, tearing, feeling of a foreign body in the eye.

Official representative: Demi Pharm LLC, Nairi Zaryan 22, Yerevan

Manufacturer: Balkanpharm a-Razgrad, Bulgaria