Moxibac IV Infusion is indicated for the treatment of the following bacterial infections caused by susceptible strains:
- Bronchitis (acute exacerbations of chronic bronchitis)
- Pneumonia (community acquired)
- Sinusitis (acute)
- Complicated skin and skin structure infections (including diabetic foot infections)
- Complicated intra-abdominal infections including polymicrobial infections such as abscesses
Moxibac IV Infusion are indicated for the treatment of the following bacterial infections caused by susceptible strains: Uncomplicated pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis).
Dosage & Administration
The recommended dose for Moxibac IV Infusion is 400 mg once daily (250 ml IV infusion) for the above mentioned indications and should not be exceeded.
- Bronchitis: acute exacerbation of chronic bronchitis, 5 days
- Pneumonia: community acquired pneumonia (intravenous followed by oral therapy), 7-14 days
- Sinusitis: acute sinusitis, 7 days
- Complicated skin and skin structure infections total treatment duration for sequential therapy (intravenous followed by oral therapy): 7 - 21 days
- Complicated intra-abdominal infections total treatment duration for
sequential therapy (intravenous followed by oral therapy): 5-14 days. Moxibac IV Infusion can be administered intravenously for the entire treatment duration. Alternatively, therapy may be initial intravenous administration, followed by oral administration when clinically indicated. The recommended duration of treatment for the indication being treated should not be exceeded. The solution for infusion should be infused intravenously over 60 minutes. Elderly: No adjustment of dosage is required in the elderly. Children: Efficacy and safety of Moxibac IV Infusion in children and adolescents have not been established.
In some instances, the hypersensitivity and allergic reactions occurred after the first administration. Anaphylactic reactions in very rare instances can progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with Moxifloxacin IV must be discontinued, medical treatment (e.g. treatment for shock) is required. Moxifloxacin has been shown to prolong the QT interval of the
electrocardiogram in some patients. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval. The medicine should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalaemia and patients receiving class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the medicine in these patient populations. An additive effect of moxifloxacin and medicines that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants cannot be excluded; therefore moxifloxacin should be used with caution when given concurrently with these medicines. Moxifloxacin IV should be used with caution in patients with liver cirrhosis as pre-existing QT prolongation in these patients cannot be excluded. Moxifloxacin IV should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as clinically significant bradycardia, acute myocardial ischaemia. As the magnitude of QT prolongation may increase with increasing concentrations of the medicine, the recommended dose and the infusion rate (400 mg within 60 minutes) should not be exceeded. However, in patients suffering from pneumonia no correlation between plasma concentrations of moxifloxacin and QTc prolongation was observed. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in clinical studies with more than 9000 patients; however certain predisposing conditions may increase the risk for ventricular arrhythmias. Seizures may occur with quinolone therapy. Moxifloxacin IV should be used with caution in patients with known or suspected CNS disorders, which may predispose to seizures or lower the seizure threshold. Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment and rest the affected limb(s). Quinolones have been shown to cause photosensitivity reactions in patients. However, in specially designed preclinical and clinical studies photosensitivity has not been observed with moxifloxacin.
Use in Pregnancy & Lactation
The safe use of moxifloxacin in human pregnancy has not been established. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown. Consequently, the use of moxifloxacin during pregnancy is contraindicated. Preclinical evidence indicates that small amounts of moxifloxacin may be secreted in human milk. There is no data available in lactating or nursing women. Therefore, the use of moxifloxacin in nursing mothers is contraindicated.