Imexpharm Pharmaceutical Joint Stock Company – Binh Duong High-Tech Plant – Vietnam

Imexpharm Pharmaceutical Joint Stock Company

Moxifloxacin (as moxifloxacin hydrochloride)

400 mg / 250 mL

24 months

Solution for infusion

Box of 10 bags × 1 bottle × 250 mL

893115027624

January 30, 2024

January 30, 2029

Antibacterial

Moxifloxacin IMP 400 mg / 250 mL solution for infusion is indicated for the treatment of:
- Community-acquired pneumonia.
- Complicated skin and skin structure infections, including diabetic foot infections.
- Complicated intra-abdominal infections, including polymicrobial infections such as abscesses.
- Uncomplicated urinary tract infections.*
- Acute bacterial exacerbation of chronic bronchitis.*
- Acute bacterial sinusitis.*
*Because fluoroquinolones, including Moxifloxacin IMP 400 mg / 250 mL, are associated with serious adverse reactions (see Warnings and Precautions), and uncomplicated urinary tract infections, acute bacterial exacerbations of chronic bronchitis, and acute bacterial sinusitis may be self-limiting in some patients, Moxifloxacin IMP 400 mg / 250 mL should be reserved only for patients who have no alternative treatment options.

Recommended adult dosage: Moxifloxacin 400 mg administered by intravenous infusion once daily.
Duration of Therapy:
The duration of treatment should be guided by the severity of the infection and the clinical response.
The recommended treatment durations for respiratory tract infections and other indications are outlined below.
Therapy may be initiated with intravenous infusion and subsequently switched to an oral formulation when clinically indicated.
The recommended total duration of treatment (initial intravenous infusion followed by oral switch) is:
- Community-acquired pneumonia: 7–14 days
- Complicated skin and skin structure infections: 7–21 days
- Complicated intra-abdominal infections: 5–14 days
- Acute exacerbation of chronic bronchitis: 5 days
- Acute sinusitis: 10 days
Special Populations:
- Geriatric patients: No dosage adjustment is required in elderly patients.
- Children and adolescents: The safety and efficacy of moxifloxacin in pediatric patients and growing adolescents have not been established (see Contraindications).
- Ethnic groups: No dosage adjustment is necessary across different ethnic groups.
- Hepatic impairment: No dosage adjustment is required in patients with hepatic impairment (see Warnings and Precautions).
- Renal impairment: No dosage adjustment is necessary in patients with any degree of renal impairment (including creatinine clearance ≤ 30 mL/min/1.73 m²), nor in patients on chronic dialysis, such as hemodialysis or continuous ambulatory peritoneal dialysis.