Safety profile of oral and intravenous moxifloxacin: Cumulative data from clinical trials and postmarketing studies

Ball, Peter; Stahlmann, Ralf; Kubin, R; Choudhri, Shurjeel; Owens, Robert C.

doi:10.1016/s0149-2918(04)90170-1

Cited by 100 publications

(62 citation statements)

References 40 publications

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“…Mineral supplements such as iron and zinc, or antacids might decrease the bioavailability of MFX as well [10], but after a daily dose of 400 mg MFX in combination with food or calcium supplements, the MFX AUC is not significantly affected [10].…”

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Evaluation of moxifloxacin for the treatment of tuberculosis: 3 years of experience

Pranger

Altena

Aarnoutse

et al. 2011

European Respiratory Journal

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Moxifloxacin (MFX) is a powerful second-line anti-tuberculosis (TB) agent, but the optimal dose has not yet been established and long-term safety data are scarce.We retrospectively reviewed the medical charts of TB patients treated at the Tuberculosis Centre Beatrixoord, University Medical Centre Groningen (Haren, the Netherlands) receiving MFX 400 mg once daily as part of their TB treatment between January 1 2006 and January 1 2009. Safety data and drug-drug interactions were evaluated. Efficacy was predicted based on the area under the concentration-time curve up to 24 h post-dosage (AUC 0-24h )/minimal inhibitory concentration (MIC) ratio.89 patients were treated with a median dose of 6.9 mg?kg -1 MFX once daily for a median period of 74 days. Discontinuation of therapy occurred in only three patients due to gastrointestinal sideeffects and hypersensitivity. Pharmacokinetic analysis showed an AUC 0-24h /MIC ratio ,100 in eight out of 16 patients. A large variation in protein binding affected the unbound AUC 0-24h considerably. These data show that MFX treatment was well tolerated in 89 patients receiving a dose of 400 mg once daily for a prolonged period. Considering the variability in (un)bound AUC 0-24h /MIC ratio, therapeutic drug monitoring is recommended in selected patients (i.e. rifampicin comedication; MIC o0.25 mg?L -1 ) to assess optimal therapy.

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confidence: 99%

Evaluation of moxifloxacin for the treatment of tuberculosis: 3 years of experience

Pranger

Altena

Aarnoutse

et al. 2011

European Respiratory Journal

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“…Furthermore, the properties of MXF are favorable both pharmacokinetically (high bioavailability, long half-life, and good tissue penetration) and pharmacodynamically (MXF is bactericidal at concentrations two-to fourfold higher than the MIC) (26). The most common drug-related adverse effects involve the gastrointestinal tract and the central nervous system and were usually transient and mild in severity (4). Its lack of significant drug interactions in target groups makes it an option in diabetic patients and elderly individuals, as well as in those with renal dysfunction or with mild to moderate hepatic impairment (4).…”

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confidence: 99%

“…The most common drug-related adverse effects involve the gastrointestinal tract and the central nervous system and were usually transient and mild in severity (4). Its lack of significant drug interactions in target groups makes it an option in diabetic patients and elderly individuals, as well as in those with renal dysfunction or with mild to moderate hepatic impairment (4). MXF appears to be tolerated by patients with hypersensitivity reactions to beta-lactam antibiotics (7).…”

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confidence: 99%

Comparative Efficacies of Amoxicillin, Clindamycin, and Moxifloxacin in Prevention of Bacteremia following Dental Extractions

Dios

Tomás

Limeres

et al. 2006

Antimicrob Agents Chemother

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We evaluated the efficacies of oral prophylactic treatment with amoxicillin (AMX), clindamycin (CLI), and moxifloxacin (MXF) in the prevention of bacteremia following dental extractions (BDE). Two hundred twentyone adults who required dental extractions under general anesthesia were randomly assigned to a control group, an AMX group, a CLI group, and an MXF group (the individuals in the drug treatment groups received 2 g, 600 mg, and 400 mg, respectively, 1 to 2 h before anesthesia induction). Venous blood samples were collected from each patient at the baseline and 30 s, 15 min, and 1 h after the dental extractions. The samples were inoculated into BACTEC Plus aerobic and anaerobic blood culture bottles and were processed in a BACTEC 9240 instrument. Subculture and the further identification of the isolated bacteria were performed by conventional microbiological techniques. The prevalences of BDE in the control group, AMX group, CLI group, and MXF group were 96, 46, 85, and 57%, respectively, at 30 s; 64, 11, 70, and 24%, respectively, at 15 min; and 20, 4, 22, and 7%, respectively, at 1 h. Streptococcus spp. were the most frequently identified bacteria in all groups (44 to 68%), with the lowest percentage being detected in the AMX group (44%). AMX and MXF prophylaxis showed high efficacies in reducing the prevalence and duration of BDE, but CLI prophylaxis was noneffective. As a consequence, MXF prophylaxis is a promising antibiotic alternative for the prevention of BDE when beta-lactams are not indicated.

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“…An estimated 140 million prescriptions have been issued for moxifloxacin worldwide, and the drug is included as an effective alternative in guidelines and/or recommendations for each of these indications. [1][2][3][4][5][6][7][8][9][10] The clinical efficacy of moxifloxacin has been unambiguously demonstrated, [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] and its safety profile has been analyzed periodically on the basis of pre-marketing studies, [21,[31][32][33][34][35] including populations with risk factors, [36,37] such as the elderly [38,39] and those with hepatic or renal insufficiency. [37,40] These data did not show significantly higher toxicity of moxifloxacin compared with commonly used antibiotics if the contraindications and precautions of use mentioned in the Summary of Product Characteristics [41][42][43] are taken into account.…”

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confidence: 99%

Moxifloxacin Safety

2012

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Background: Moxifloxacin, a fluoroquinolone antibiotic, is used for the treatment of respiratory tract, pelvic inflammatory disease, skin, and intra-abdominal infections. Its safety profile is considered favorable in most reviews but has been challenged with respect to rare but potentially fatal toxicities (e.g. hepatic, cardiac, or skin reactions). Objective: To analyze and compare the safety profile of moxifloxacin versus comparators in the entire clinical database of the manufacturer. Setting: Data on the valid-for-safety population from phase II-IV actively controlled studies (performed between 1996 and 2010) were analyzed. Studies were either double blind (n = 22 369) or open label (n = 7635) and included patients with indications that have been approved in at least one country [acute bacterial sinusitis, acute exacerbation of chronic bronchitis, communityacquired pneumonia, uncomplicated pelvic inflammatory disease, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections] (n = 27 824) and patients with other indications (n = 2180), using the recommended daily dose (400 mg) and route of administration (oral, intravenous/oral, intravenous only). The analysis included patients at risk (age ‡65 years, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, or body mass index <18 kg/m

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Safety profile of oral and intravenous moxifloxacin: Cumulative data from clinical trials and postmarketing studies

Cited by 100 publications

References 40 publications

Evaluation of moxifloxacin for the treatment of tuberculosis: 3 years of experience

Evaluation of moxifloxacin for the treatment of tuberculosis: 3 years of experience

Comparative Efficacies of Amoxicillin, Clindamycin, and Moxifloxacin in Prevention of Bacteremia following Dental Extractions

Moxifloxacin Safety

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