Moxifloxacin Hydrochloride Tablets, 400 mg

MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG

Manufacturer: Novadoz Pharmaceuticals LLC

Score: 144.0

Quick Summary

Moxifloxacin hydrochloride is a fluoroquinolone antibacterial agent used to treat various infections, including community-acquired pneumonia, skin and skin structure infections, intra-abdominal infections, plague, acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis. It is essential to note the potential risks, including tendonitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis. The recommended dose is 400 mg once daily, with adjustments for special populations, such as geriatric patients and those with renal or hepatic impairment.

Key Clinical Findings and Indications

Community-acquired pneumonia
Skin and skin structure infections
Intra-abdominal infections
Plague
Acute bacterial sinusitis
Acute bacterial exacerbation of chronic bronchitis

Important Safety Information

Warning

Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis, tendon rupture, peripheral neuropathy, and central nervous system effects.

Contraindications

Known hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials

Adverse Reactions

Tendinitis and tendon rupture
Peripheral neuropathy
Central nervous system effects
Exacerbation of myasthenia gravis
Hypersensitivity reactions
Clostridium difficile-associated diarrhea
Blood glucose disturbances
Photosensitivity/phototoxicity

Dosing Recommendations

General Guidance

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Community-acquired pneumonia

Adult Dose

400 mg once daily for 7-14 days

Pediatric Dose

Not applicable

Skin and skin structure infections

Adult Dose

400 mg once daily for 7-21 days

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

Moxifloxacin hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether moxifloxacin is excreted in human milk.

Pediatric Use

Effectiveness in pediatric patients and adolescents less than 18 years of age has not been established.

Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders, including tendon rupture, when being treated with a fluoroquinolone such as moxifloxacin hydrochloride.