Floxsafe/Floxsafe IV Adverse Reactions

Floxsafe: Adverse reactions based on all clinical trials with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed as follows: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) (see Tables 4a and 4b).

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There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: hypernatraemia, hypercalcaemia, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions.
Floxsafe IV: Adverse reactions observed in clinical trials (total patients=17,951, sequential/I.V treatment study=4,583) with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [I.V/oral] and oral administration) sorted by frequencies (according to the CIOMS III classification) are listed as follows: Apart from nausea and diarrhea all adverse reactions were observed at frequencies below 3%. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) (see Tables 5a and 5b.)

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The following adverse reactions have a higher frequency category in the sub group of I.V treated patients with or without subsequent oral therapy: Common: Increased gamma-glutamyl-transferase. Uncommon: ventricular arrhythmia, hypotension, edema, antibiotic-associated colitis (in very rare cases associated with life-threatening complications), seizures with various clinical symptoms (including grand mal convulsions), hallucination, renal impairment, renal failure (by the dehydration in elderly patients with renal disorders).
Following changes may frequently occur regardless of moxifloxacin treatment: Hematocrit increased or decreased, White blood cell count increased, Red blood cell count increased or decreased, Blood glucose decreased, Hemoglobin decreased, ALP·AST·ALT increased, Blood urea increased, Creatinine increased, BUN increased. (It is unclear whether these symptoms occur by moxifloxacin treatment or in the course of therapy.)
Domestic Post-marketing surveillance: In domestic post-marketing surveillance including 1,343 patients for 6 years, adverse events have been reported in 6.48% (n:87/1,343) regardless of causality and 2,38% (n:32/1,343) have been investigated to have a causality with this drug. Nausea 0.67% (n:9) was most common of the reported adverse reactions, followed by headache 0.45% (n:6), diarrhea and fever 0.37% (n:5) respectively, vomiting and urticaria 0.30% (n:4), and pruritus and leukopenia 0.15% (n:2) respectively. Pneumonia, dyspepsia, chest pain, increased sweating, flare and edema at injection site have been reported in ≤0.1%.
As serious adverse reactions, pneumonia and exacerbation of pneumonia 0.67% (n:9) respectively, exacerbation of lung cancer 0.37% (n:5), respiratory failure 0.30% (n:4), dyspnea, respiratory distress syndrome and sepsis 0.22% (n:3) respectively, and bronchiectasis, asthma and exacerbation of tuberculosis 0.15% (n:2) respectively. GI bleeding, death, moniliasis, exacerbation of colorectal cancer, shock, exacerbation of heart failure, exacerbation of congestive heart failure, myocardial infarction, acidosis and tachycardia have been reported in ≤0.1%. Pneumonia (n:1) has been reported as drug adverse reaction, unable to exclude the causal relationship with this drug.
55 cases of unexpected adverse reactions have been reported in 47 patients (3.50%), including pneumonia 0.74% (n:10), exacerbation of pneumonia 0.67% (n:9), fever 0.52% (n:7), exacerbation of lung cancer 0.37% (n:5), respiratory distress syndrome 0.30% (n:4), infection and sepsis 0.22% (n:3), and bronchiectasis and exacerbation of tuberculosis 0.15% (n:2) respectively. Atelectasis, GI bleeding, death, exacerbation of colorectal cancer, exacerbation of heart failure, endocarditis, acidosis, and nephropyelitis have been reported in ≤0.1%. Fever 0.37% (n:5) and pneumonia 0.07% (n:1) have been investigated to be adverse reactions, unable to exclude the causal relationship with this drug.
The incidence rate of adverse events in the patients group with comorbidity has been statistically significantly higher than in the patients group without comorbidity.
The incidence rate of adverse events in the patients group without consecutive therapy after oral administration of antibiotics has been significantly higher than in the patients group with consecutive therapy after oral administration of antibiotics.