Moxifloxacin Hydrochloride (Page 5 of 12)

8.2 Lactation

Risk Summary

It is not known if moxifloxacin is present in human milk. Based on animal studies in rats, moxifloxacin may be excreted in human milk (see Data).

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin hydrochloride and any potential adverse effects on the breastfed child from moxifloxacin hydrochloride or from the underlying maternal condition.

Data

In lactating rats given a single oral dose of 4.59 mg/kg moxifloxacin (approximately 9 times less than the recommended human dose based on body surface area) 8 days postpartum, there was very low excretion of substance-related radioactivity into the milk, amounting to approximately 0.03% of the dose.

8.4 Pediatric Use

Effectiveness in pediatric patients and adolescents less than 18 years of age has not been established. Moxifloxacin hydrochloride causes arthropathy in juvenile animals. Limited information on the safety of moxifloxacin hydrochloride in 301 pediatric patients is available from the cIAI trial [see Boxed Warning, Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

Active Controlled Trial in Complicated Intra-Abdominal Infection (cIAI)

The safety and efficacy of moxifloxacin hydrochloride in pediatric patients for the treatment of cIAI has not been demonstrated.

Pediatric patients 3 months to <18 years of age (mean age of 12 ± 4 years) were enrolled in a single randomized, double-blind, active controlled trial in cIAI including appendicitis with perforation, abscesses and peritonitis.

Pediatric patients were randomized (2:1) to receive either moxifloxacin hydrochloride or comparator. This study enrolled 451 patients who received study medication, 301 treated with moxifloxacin, and 150 with comparator. Of the 301 pediatric patients treated with moxifloxacin hydrochloride, 15 were below the age of 6 years and 286 were between the ages of 6 to <18 years.

Patients received sequential intravenous/oral moxifloxacin hydrochloride or comparator (intravenous ertapenem followed by oral amoxicillin/clavulanate) for 5 to 14 days (mean duration was 9 days with a range of 1 to 24 days).

The overall adverse reaction profile in pediatric patients was comparable to that of adult patients. The most frequently occurring adverse reactions in pediatric patients treated with moxifloxacin hydrochloride were QT prolongation 9.3% (28/301), vomiting, 6.6% (20/301), diarrhea 3.7% (11/301), arthralgia 3.0% (9/301), and phlebitis 2.7% (8/301) (see Table 5). Discontinuation of study drug due to an adverse reaction was reported in 5.3% (16/301) of moxifloxacin hydrochloride-treated patients versus 1.3% (2/150) of comparator-treated patients. The adverse reaction profile of moxifloxacin hydrochloride or comparator was similar across all age groups studied.

Musculoskeletal adverse reactions were monitored and followed up to 5 years after the end of study treatment. The rates of musculoskeletal adverse reactions were 4.3% (13/301) in the moxifloxacin hydrochloride-treated group versus 3.3% (5/150) in the comparator-treated group. The majority of musculoskeletal adverse reactions were reported between 12 and 53 weeks after start of study treatment with complete resolution at the end of the study [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2)].

Table 5 Incidence (%) of Selected Adverse Reactions in ≥2.0% of Pediatric Patients Treated with Moxifloxacin Hydrochloride in cIAI Clinical Trial

System Organ Class Adverse Reactions Moxifloxacin Hydrochloride N = 301 (%) Comparator N = 150 (%)
Gastrointestinal disorders Abdominal pain 8 (2.7) 3 (2.0)
Diarrhea 11 (3.7) 1 (0.7)
Vomiting 20 (6.6) 12 (8.0)
General disorders and administration site conditions Pyrexia 6 (2.0) 4 (2.7)
Investigations Aspartate aminotransferase increased 2 (0.7) 3 (2.0)
Electrocardiogram QT prolonged 28 (9.3) 4 (2.7)
Musculoskeletal and connective tissue disorders Arthralgia 9 (3.0) 2 (1.3)
Nervous system disorders Headache 6 (2.0) 2 (1.3)
Vascular disorders Phlebitis 8 (2.7) 0 (0)

Clinical response was assessed at the test-of-cure visit (28 to 42 days after end of treatment). The clinical response rates observed in the modified intent to treat population were 83.9% (208/248) for moxifloxacin hydrochloride and 95.5% (127/133) for comparator; see Table 6.

Table 6: Clinical Response Rates at 28 to 42 Days After End of Treatment in Pediatric Patients with cIAI

Moxifloxacin Hydrochloride n (%) Comparator n (%) Difference2 (95% CI)
mITT Population1 N=248 N=133
Cure 208 (83.9) 127 (95.5) -12.2 (-17.9, -6.4)
Failure 17 (6.9) 3 (2.3)
Indeterminate 21 (8.5) 3 (2.3)
Missing 2 (0.8) 0

1 The modified intent-to-treat (mITT) population is defined as all subjects who were treated with at least one dose of study medication and who have at least one pre-treatment causative organism from the intra-abdominal site of infection or from blood cultures.

2 Difference in clinical cure rates (moxifloxacin hydrochloride — Comparator) and 95% confidence intervals, presented as percentages, are based on stratified analysis by age group using Mantel-Haenszel methods.

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