Finished product reference

Moxifloxacin

Solution, Drops · Ophthalmic · 0.5 % · 5 mL

List code
14266
Boxed warning

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together , including: o Tendinitis and tendon rupture o Peripheral neuropathy o C…

What it is and how it works

Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of antibacterial agents . Mechanism of Action The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination.

Indications

Moxifloxacin is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: • Community Acquired Pneumonia • Skin and Skin Structure Infections: Uncomplicated and Complicated • Complicated Intra-Abdominal Infections • Plague • Acute Bacterial Sinusitis • Acute Bacterial Exacerbation of Chronic Bronchitis To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin and other antibacterial drugs. Moxifloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Dosage and administration (summary)

Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia 400 mg 7-14 Uncomplicated Skin and Skin Structure Infections (SSSI) 400 mg 7 Complicated SSSI 400 mg 7-21 Complicated Intra-Abdominal Infections 400 mg 5-14 Plague 400 mg 10-14 Acute Bacterial Sinusitis 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg 5 • No dosage adjustment in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) • Moxifloxacin Hydrochloride in Sodium Chloride Injection: Slow intravenous infusion over 60 minutes. Avoid rapid or bolus intravenous injection. • Do not mix with other medications in intravenous bag or in an intravenous line.

Contraindications

Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials . Known hypersensitivity to moxifloxacin or other quinolones ( 4 , 5.8 )

Warnings and precautions

• Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin.

Pregnancy

Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm.

Storage and supply

Moxifloxacin Hydrochloride in Sodium Chloride Injection – Premix Bags Moxifloxacin hydrochloride in sodium chloride injection is available in ready-to-use 250 mL single-dose flexible bags containing moxifloxacin hydrochloride, USP (equivalent to 400 mg of moxifloxacin) in 0.8% sodium chloride aqueous solution.

Source: Moxifloxacin Hydrochloride (Moxifloxacin Hydrochloride) — US FDA prescribing information, 2026-03-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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