Moxifloxacin

Moxifloxacin is a prescription medication used to treat Acute Bacterial Sinusitis, Community-Acquired Pneumonia, Acute Exacerbation of Chronic Bronchitis, Skin and Skin Structure Infections, Intra-abdominal Infections, Pneumonic and Septicemic Plague.

• Moxifloxacin is available under the following different brand names: Avelox, Moxifloxacin Systemic

Adult dosage

Injectable solution

• 400mg/250mL

Tablet

• 400mg

Acute Bacterial Sinusitis

Adult dosage

• 400 mg orally/IV once daily for 5-10 days

Community-Acquired Pneumonia

Adult dosage

• 400 mg orally/IV once daily for 7-14 days

Acute Exacerbation of Chronic Bronchitis

Adult dosage 

• 400 mg orally/IV once daily for 5 days

Skin and Skin Structure Infections

Adult dosage

• Uncomplicated: 400 mg orally/IV every day for 7 days
• Complicated: 400 mg orally/IV every day for 7-21 days

Intra-abdominal Infections 

Adult dosage

• Complication: 400 mg orally/IV once daily for 5-14 days

Pneumonic and Septicemic Plague

Adult dosage

• 400 mg orally/IV once daily for 10-14 days

Pediatric dosage not available

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Moxifloxacin include:

• nausea, 
• diarrhea, 
• dizziness, and
• headache

Serious side effects of Moxifloxacin include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• fever, 
• sore throat, 
• burning in the eyes, 
• skin pain, 
• red or purple skin rash that spreads and causes blistering and peeling, 
• headache, 
• hunger, 
• sweating, 
• irritability, 
• dizziness, 
• nausea, 
• fast heart rate, 
• anxiety, 
• shakiness, 
• numbness, weakness, tingling, or burning pain in hands, arms, legs, or feet, 
• nervousness, 
• confusion, 
• agitation, 
• paranoia, 
• hallucinations, 
• memory problems, 
• trouble concentrating, 
• thoughts of self-harm, 
• sudden pain, 
• swelling, 
• bruising,
• tenderness, 
• stiffness, 
• movement problems, 
• snapping or popping sound in any of the joints, 
• severe and constant pain in the chest, stomach, or back, 
• severe stomach pain, 
• diarrhea that is watery or bloody, 
• fast or pounding heartbeats, 
• fluttering in the chest, 
• shortness of breath, 
• sudden dizziness, 
• muscle weakness, 
• breathing problems, 
• seizure, 
• skin rash (no matter how mild), 
• severe headache, 
• ringing in ears, 
• vision problems, 
• pain behind the eyes, 
• upper stomach pain, 
• loss of appetite, 
• dark urine, 
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Rare side effects of Moxifloxacin include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Moxifloxacin has severe interactions with the following drugs:
  • disopyramide
  • ibutilide
  • indapamide
  • pentamidine
  • pimozide
  • procainamide
  • quinidine 
  • sotalol
• Moxifloxacin has serious interactions with at least 95 other drugs.
• Moxifloxacin has moderate interactions with at least 152 other drugs:
• Moxifloxacin has minor interactions with at least 24 other drugs:

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to Moxifloxacin or any member of the quinolone class of antibacterials. 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Moxifloxacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Moxifloxacin?”

Cautions

• Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient; adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); discontinue treatment immediately at the first signs or symptoms of any serious adverse reaction; avoid use in patients who have experienced any of these serious adverse reactions
• Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages; adverse reaction most frequently involve the Achilles tendon and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons (see Black Box Warnings)
• In prolonged therapy, perform periodic evaluations of organ system function (eg, renal, hepatic, hematopoietic); superinfections may occur with prolonged or repeated antibiotic therapy
• Phototoxicity reactions may occur; avoid excessive sunlight
• Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent
• Serious, sometimes fatal hypoglycemia reported including in patients without a history of hypoglycemia (common with gatifloxacin, which is no longer marketed); monitor glucose levels closely in patients with diabetes; if a hypoglycemic reaction occurs, discontinue therapy and initiate appropriate therapy immediately
• Avoid use in presence of drugs or conditions that prolong QT interval, patients with known prolongation of the QT interval, patients with ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia or patients with hypokalemia or hypomagnesemia
• In immature dogs, oral administration of moxifloxacin caused lameness; related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species
• Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190
• Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
• Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
• Serious anaphylactic reactions reported in patients receiving fluoroquinolone therapy; discontinue treatment at the first appearance of a skin rash or any other sign of hypersensitivity
• Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology have been reported; reactions may be severe and generally occur following the administration of multiple doses; discontinue treatment immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures

CNS effects

• Fluoroquinolones have been associated with an increased risk of CNS effects, including convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
• May also cause CNS events including nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
• Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

FDA MedWatch Safety Alert

• Issued 12-20-2018
• An increase in the rate of aortic aneurysm and dissection was reported within two months following the use of fluoroquinolones, particularly in elderly patients
• May occur with fluoroquinolones for systemic use (IV or orally)
• Patients who have an aortic aneurysm or are at risk for an aortic aneurysm (e.g., patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions [e.g., Marfan syndrome, Ehlers-Danlos syndrome], elderly patients)
• Prescribe fluoroquinolones to these patients only when no other treatment options are available
• Advise patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm
• Stop treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection

FDA MedWatch Safety Alert

• Issued July 10, 2018
• The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
• Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or diabetic patients taking oral hypoglycemic medicine or insulin
• Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
• This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
• Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
• Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
• Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible

Pregnancy and Lactation

• No available human data are establishing a drug-associated risk; however, when moxifloxacin was administered to rats during pregnancy and throughout lactation at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed
• Advise pregnant women of the potential risk to the fetus
• Not known if moxifloxacin is present in human milk
• Based on animal studies in rats, moxifloxacin may be excreted in human milk
• Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drugs or the underlying maternal condition