MOXIFLOXACIN (moxifloxacin hcl in sodium chloride,iso-osmotic/pf)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Conjunctivitis Keratitis Ocular itching Ocular pain Reduced visual acuity Subconjunctival hemorrhage	Conjunctival hyperemia

Rare/Very Rare
Acute bacterial otitis media Fever Hypersensitivity drug reaction Infection

There are 7 less severe adverse reactions.

More Frequent	Less Frequent
Dry eye Eye tearing	Ocular discomfort

Rare/Very Rare
Cough Pharyngitis Rhinitis Skin rash

Human data for moxifloxacin are insufficient to inform any drug-associated risk regarding use of the drug during pregnancy. Based on animal studies, moxifloxacin may cause fetal harm. Although moxifloxacin was not teratogenic when administered to pregnant rats, rabbits, and monkeys at exposures up to 2.5

times higher than human exposures reported with the usual dosage of the drug, embryofetal toxicity (e.g., decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), increased fetal loss) was observed when moxifloxacin was administered to pregnant rats or rabbits at dosages associated with maternal toxicity. Pregnant women should be advised of the potential risk to the fetus.

It is not known whether moxifloxacin is distributed into human milk; the drug is distributed into milk in rats. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for moxifloxacin and potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Approximately 23 or 42% of patients were 65 years of age or older and 9 or 23% of patients were 75 years of age or older in clinical studies of oral or IV moxifloxacin, respectively. No overall differences in safety or efficacy were observed between geriatric individuals and younger adults. The risk of developing severe tendon disorders, including tendon rupture, is increased in older adults (usually those older than 60 years of age).

This risk is further increased in those receiving concomitant corticosteroids. (See Tendinitis and Tendon Rupture under Warnings/Precautions: Warnings, in Cautions.) Caution is advised if moxifloxacin is used in geriatric adults, especially those receiving concomitant corticosteroids. The risk of QT interval prolongation may be increased in geriatric patients.

Concomitant use of moxifloxacin and class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents and use in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia) should be avoided. (See Prolongation of QT Interval under Warnings/Precautions: Warnings, in Cautions.) The risk of aortic aneurysm and dissection may be increased in geriatric patients. (See Risk of Aortic Aneurysm and Dissection under Warnings/Precautions: Other Warnings/Precautions, in Cautions.)