AVELOX IV (moxifloxacin hcl/sodium chloride, iso-osmotic)

There are 8 contraindications. Absolute contraindication.

Contraindication List
Aortic aneurysm
Congenital long QT syndrome
Dissection of aorta
Ehlers-danlos syndrome
Loeys-dietz syndrome
Marfan syndrome
Myasthenia gravis
Torsades de pointes

There are 16 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bradycardia
Cardiac arrhythmia
Cardiac transplantation
Clostridioides difficile infection
Drug-induced hepatitis
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Hypokalemia
Idiopathic intracranial hypertension
Intracranial hypertension
Lung transplantation
Myocardial ischemia
Prolonged QT interval
Renal transplant
Tendon rupture
Tendonitis

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Disease of liver
Hepatic cirrhosis
Hypoglycemic disorder
Lower seizure threshold
Peripheral neuropathy
Seizure disorder
Severe cerebral arteriosclerosis

There are 57 severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal hepatic function tests

Rare/Very Rare

Abnormal ECG Acute hepatic failure Acute renal failure Agranulocytosis Anaphylaxis Anemia Angioedema Aortic aneurysm Aplastic anemia Arterial dissection Asthma Atrial fibrillation Cholestatic hepatitis Clostridioides difficile infection Dissection of aorta Drug-induced psychosis Eosinophilia Hallucinations Hearing loss Hepatic necrosis Hepatitis Hypersensitivity drug reaction Hypersensitivity pneumonitis Hypoglycemic disorder Hypotension Interstitial nephritis Intracranial hypertension Laryngeal edema Leukopenia Neuromuscular blockade Non-traumatic rupture of achilles tendon Obstructive hyperbilirubinemia Pancytopenia Peripheral edema Peripheral motor neuropathy Peripheral neuropathy Prolonged QT interval Rhabdomyolysis Rotator cuff tendon rupture Seizure disorder Serum sickness Severe diarrhea Stevens-johnson syndrome Suicidal ideation Tachycardia Tendon rupture Tendon rupture extensor of hand and wrist Tendon rupture flexor of hand and wrist Tendonitis Thrombocytopenic disorder Thrombotic thrombocytopenic purpura Torsades de pointes Toxic epidermal necrolysis Valvular regurgitation Ventricular tachycardia Vision impairment

There are 61 less severe adverse reactions.

More Frequent	Less Frequent
Abdominal pain with cramps Diarrhea Dizziness Headache disorder Nausea	Constipation Dysgeusia Dyspepsia Fever Vomiting

Rare/Very Rare

Abdominal distension Acute cognitive impairment Agitation Anorexia Arthralgia Arthritis Ataxia Back pain Candidiasis Chest pain Delirium Depression Disturbance of attention Drowsy Dyspnea Edema Flatulence Gait abnormality Gastritis Gastroesophageal reflux disease General weakness Hyperglycemia Hyperhidrosis Hyperlipidemia Hypertension Hyperuricemia Insomnia Malaise Memory impairment Muscle weakness Myalgia Nervousness Oral candidiasis Pain Pain in extremities Palpitations Paresthesia Peripheral sensory neuropathy Pruritus of skin Skin photosensitivity Skin rash Symptoms of anxiety Syncope Tinnitus Tremor Urticaria Vaginitis Vertigo Visual changes Vulvovaginal candidiasis Xerostomia

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.)