Moxifloxacin Hydrochloride (6 brand names, 3 dosage forms, 3 routes)
Available dosage forms: TABLET, SOLUTION/DROPS, SOLUTION.
Routes of administration: ORAL, OPHTHALMIC, INTRAVENOUS.
Brand Names
- AVELOX
- AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
- MOXEZA
- MOXIFLOXACIN HYDROCHLORIDE
- MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
- VIGAMOX
Boxed Warning
Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)], including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] Peripheral neuropathy [see Warnings and Precautions (5.3)] Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue moxifloxacin hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]. Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)]. Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.14)], reserve moxifloxacin hydrochloride for use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis [see Indications and Usage (1.6)] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7)]
Contraindications
Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8)].
Adverse Reactions
The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1)] Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)] Peripheral Neuropathy [see Warnings and Precautions (5.3)] Central Nervous System Effects [see Warnings and Precautions (5.4)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5)] QT Prolongation [see Warnings and Precautions (5.6)] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7)] Hypersensitivity Reactions [see Warnings and Precautions (5.8)] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9)] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.10)] Blood Glucose Disturbances [see Warnings and Precautions (5.12)] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13)] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.14)]
Mechanism of Action
Moxifloxacin hydrochloride is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].
Overdosage
Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation. Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.