Action and Spectrum

Moxifloxacin is from Fluoroquinolone/Quinolone antimicrobial Category. Moxifloxacin is used to treat infections caused by the following bacteria.

Aerobic, Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, and Streptococcus viridans group.a

Aerobic, Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilus influenzae, and Haemophilus parainfluenzae.Other microorganisms: Chlamydia trachomatis.

Aeromonas hydrophila, Bacillus anthracis, Bacteroides fragilis, Bacteroides the taiotaomicron, Campylobacter jejuni, Citrobacter, diversus, Citrobacter freundii, Clostridium perfringens, Escherichia coli, Enterobacter spp, Haemophilus influenzae, Hafnia alvei, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Mycobacterium pneumoniae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Peptostreptococcus spp, Proteus mirabilis, Proteus Vulgaris, Providencia spp, Pseudomonas aeruginosa, Salmonella typhi, Shigella spp, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus anginosus, Streptococcus constellatus, Streptococcus pneumoniae, Vibrio cholerae, Yersinia pestis.

First-line therapy: C jejuni; no unanimity on others (e.g., L pneumophila, M morganii)

Drug Interaction

Adverse Reaction

BRAND DISCONTINUED IN U.S

 CNS

Headache(4%),dizziness (3%),insomnia(2%)

Endocrine & Metabolic:Decrease serum glucose(>2%),hyperchloremia(>2%),increase serum albumin(>2%),hypokalemia(1%)

GIT

Nausea(7%),diarrhea(6%),decreased amylase(>2%),constipation(2%),vomiting(2%),abdominal pain(1-2%),dyspepsia(1%).

Hematologic and oncologic

Decreased basophils(>2%),Decreased RBC (>2%),eosinopenia(>2%),increase MCH(>2%),increase neutrophils(>2%),leukocytosis(>2%),prolonged prothrombin time (>2%),anemia(1%)

Hepatic

decrease serum bilirubin(>2%),increase serum bilirubin (>2%),increase alanine aminotransferase(1%).

Immunologic

Increased serum globulins(>2%)

Renal

Increase serum calcium(>2%)

Respiratory

Hypoxia(>2%)

Miscellaneous

Fever

Less than 1% postmarketing or case reports related with following adverse effect

Agitation,abdominal distention,abdominal distress,abnormal gait,abnormal liver function test,agranulocytosis,allergic dermatitis,anaphylaxis,anaphylactic shock,angina pectoris,angioedema,anorexiaaplastic,anemia,anxiety,asthma,ataxiaatrial fibrillation,auditory impairment,back pain,blurred vision,bronchospasm,candidiasis,cardiac puncture ,chest pain,chills,cholestatic hepatitis,CDAD,confusion,deafness,decrease appetite,dehydration,delirium,depression,disorientation,disturbance in attention,drowsiness,dysesthesia,dysgeusia,dyspnea,dysuria,edema,facial pain,fatigue,flatulence,fungal infection,gastritis,gastroenteritis ,hallucination,GIT reflux disease ,hemolytic anemia,hepatic failure,hepatic necrosis,hepatitis,hepatotoxicity (idiosyncratic),hyperglycemia,hyperhidrosis,hyperlipidemia,hypersensitivity pneumonitis,hypersensitivity reaction,hypertension,hypoesthesia,intracranial hypertension,increase amylase,increase blood urea nitrogen,increased gamma glutamyl transferase,, increase intracranial pressure,increase lactate dehydrogenase,increase serum creatinine,increased  alkaline phosphatase,serum aspartate aminotransferase, increased serum lipase,increased serum triglycerides,increased in uric acid,interstitial nephritis, jaundice,laryngeal edema,ethargy,leukopenia,limb pain,loss of consciousness,malaise,memory impairment,muscle spasm,musculoskeletal pain,myalgia,myasthenia,nervousness,neutropenia,nightmares,night sweats,pain,palpitations,pancytopenia,paranoid ideation,paresthesia,peripheral neuropathy,pharyngeal edema,phlebitis,phototoxicity,polyneuropathy,prolonged partial thromboplastine timeprolonged QT interval,renal failure syndrome, renal insufficiency,restlessness,rupture of tendon,seizure,serum sickness,skin photosensitivity,skin rash,Stevens johnson syndrome,suicidal thoughts,suicidal tendencies,syncope,tachycardia,tendinopathy,thrombocythemia,thrombocytopenia,thrombotic thrombocytopenic purpura,tingling sensation,tinnitus,torsades de pointes,toxic epidermal necrolysis,toxic psychosis,tremor ,urticaria,vaginal infection,vasculitis,ventricular tachyarrhythmia,vertigo,vision loss,vulvovaginal pruritus,wheezing,xerostomia.

Black Box Warning

BRAND DISCONTINUED IN U.S

IRREVERSIBLE ADVERSE EFFECTS 

Fluoroquinolones have been associated with disabling and potentially irreversible severe adverse reaction that has occurred together with tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. 

Tendinitis/tendon rupture may occur during treatment or months after treatment is discontinued and risk all ages. 

Risk increased in older patients aged more than 60 years.

Strictly Avoided inpatient on Corticosteroids and Kidney/Heart/Lung transplant patients. 

Avoid in Myasthenia Gravis patients leads to exacerbating muscle weakness.

RESERVE USE FOR PATIENTS WITH NO ALTERNATIVE OPTIONS

ACUTE BACTERIAL SINUSITIS

 ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS

 UNCOMPLICATED UTI

Contraindication / Caution

Hypersensitivity to moxifloxacin or other members of the quinolones of antibiotic class. Fluoroquinolones show a permanent adverse severe reaction from different body systems in the patient. Discontinue the treatment immediately at the first sign or symptoms of following such as tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, hallucination, anxiety, depression, insomnia, severe headache confusion. 

Fluoroquinolones associated with an increase in the risk of tendinitis and tendon rupture in all ages include Achilles tendon, rotator cuff the shoulder, the hand, biceps, thumb.

Prolonged or repeated use of antibiotics leads to periodic evaluation of renal, hepatic, hematopoietic system function. 

Avoid excessive sunlight, which leads to a phototoxicity reaction. 

Peripheral neuropathy resulting in hypothesis, dysesthesias paresthesias, weakness reported with initial drug and potentially permanent. 

Hypoglycemia reported in patients without any clinical survey (Shows with gatifloxacin)Monitor glucose levels in patients with diabetes; discontinue therapy and use an alternative therapy. 

One of the side effects is QT interval prolongation which increases the risk of ventricular arrhythmias, torsade the pointes, acute myocardial ischemia, patients with hypomagnesemia or hypokalemia. 

Without infection of organism suspected; avoid using any antibiotic that produces resistance in the patients. 

IF clostridium difficile associated diarrhea is reported, an ongoing antibiotic, which is not directed for CDAD, stop the treatment. This condition requires the correct antibiotic treatment, fluid & electrolyte management, protein supplement, and surgical evaluation. 

Discontinue the treatment with the first sign of skin rash, hypersensitivity, and jaundice  

EFFECT ON CNS 

FQ shows an increased risk of CNS effects like intracranial pressure increase, convulsion, toxic. Psychosis, nervousness, insomnia, agitation, dizziness, confusion, tremors, hallucination, depression, suicidal ideation/thoughts, and self-injurious behavior such as attempted or completed suicide. If any of these reactions occur, discontinue treatment and consult your physician.FQ increase seizure or lower the seizure threshold. 

According to FDA safety alert issued in 12.20.2018 

After two months of use of fluoroquinolones in elderly patients with fluoroquinolones for systemic use IV OR oral, increase the rate of aortic aneurysm include peripheral atherosclerotic vascular disease, hypertension, some genetic disorder Marfan syndrome, Ehlers-Danlos. The patient immediately seeks medical help if any symptoms occur. Discontinue the treatment immediately .reserve the use of fluoroquinolones when no alternative drug is available. 

According to FDA safety alert issued in 07.10.2018 

The FDA warns prescribing FQ to the clinician, decreasing blood glucose and particularly adverse mental health. In elderly patients, hypoglycemia results in oral antidiabetic drugs or insulin coma. Instruct the elderly patients if symptoms of hypoglycemia occur. Safety alert affects systemic formulations like early signs, confusion, dizziness, unusual hunger, headache, irritability, pale skin, pounding heart or high-speed pulse, sweating, trembling, weakness or unusual anxiety, feeling shaky. This also included mental health issues like disturbances in attention, disorientation, agitation, nervousness, memory impairment, delirium. Immediately discontinue the treatment if any CNS-related adverse effects increase blood glucose level or potential risk of adverse psychiatric reactions after the initial dose. Consult your doctor for other antibiotic therapy.

Pregnancy / Lactation

Pregnancy Warning 

Moxifloxacin crosses the placenta. During pregnancy, physiologic changes occur, which alter the ADME of moxifloxacin in pregnant women. Moxifloxacin with multidrug-resistant tuberculosis does not require dose adjustment(off-label use) shoes adverse fetal outcome, intrauterine growth restriction, low birth weight, preterm birth, perinatal death, and mother also shows adverse effects like anemia and cesarean delivery. Based on susceptibility testing, moxifloxacin is used to treat multidrug-resistant tuberculosis during pregnancy when needed. 

Moxifloxacin is used off-label to reduce the incidence of disease progression of inhalational anthrax. Untreated anthrax infection during pregnancy shows preterm labor, fetal distress, fetal loss. Anthrax treatment is not recommended in pregnant patients as well as in postpartum patients. 

Breastfeeding Warnings

Data is not available until now for the use of moxifloxacin on breastfeeding mothers. Use alternative drugs to avoid side effects on infants.

Pharmacology

Mechanism Of Action.

Fluoroquinolones inhibit the enzyme bacterial DNA gyrase ( Primarily active in gram-negative bacteria), which nicks double-stranded DNA, introduces negative supercoils, and then reseals the neaked ends, needed to prevent supercoiling of strands. At the same time, they separate to permit replication or transcription.

The DNA gyrase Consists of Two A and Two B subunits: The A subunits carry nicking DNA, the B subunit introduces negative supercoils & then the A subunit reseals the strands. Fluoroquinolones bind to A subunits with high affinity and interfere with its strand cutting and resealing function.

In gram-positive bacteria, the primary target of   Fluoroquinolones action is a similar enzyme topoisomerase IV which nicks and DNA replicates & separates daughter DNA strands from it. Higher the topoisomerase IV affinity confer higher potency against gram-positive bacteria. The bactericidal action probably results from the digestion of DNA by exonucleases whose production is signaled by the damaged DNA. 

Absorption

Well absorbed; absorption is not affected by high-fat meal or yogurt

Bioavailability: 90% 

Distribution

Protein bound:30% to 50% 

Adult 

Vd: 1.7-2.7 L/kg; tissue concentrations often exceed plasma concentrations in respiratory tissues, alveolar macrophages, and sinus tissues 

Pediatric  

Infant more than 3 months of age and adolescents less than 13 years of age Vd:1.5 to 2.3L /kg

Metabolism

Metabolized in the liver via glucuronide (14%) and sulfate (38%) conjugation

Elimination

Adult

Half-life: PO, 12 hr; IV:8.2 to 15.4 hr

Excretion: Feces (25%), urine (20% as unchanged drug)

Sulfate conjugate metabolites are excreted in feces, glucuronide conjugate metabolites in urine

Pediatric patients Single dose IV 

Infant more than 3 months of age and children less than 2 years of age:5.9 to 6.8 hrs. 

Children more than 2 and less than 6 years of age:5.7 to 6 hrs 

Children more than 6 years and adolescents less than 13 years of age:6.2 to 7.9 hrs.

Adminstartion

IV Preparation

Dilution is not required for IV infusion.

IV Administration

Avoid infusion of two drugs in the same tubing simultaneously infuse over 1 hr.

Patient Information Leaflet

Generic Name: Moxifloxacin( Oral) 

Pronounced: mox- is- flox’ a sin 

Why do we use Moxifloxacin?

Moxifloxacin is used in bacterial infections, pneumonia, skin infection, and abdominal infections. Moxifloxacin treats and prevents plague, bronchitis, or sinus infection. 

Warning  

Moxifloxacin may cause a severe permanent effect on tendon-like tendon rupture, tendonitis, nerve problem in the leg & arm ( peripheral neuropathy), and nervous system problem like depression seizures. Contact your physician if you are on Ciprofloxacin and observe the following symptoms: Pain/numbness/burning/tingling/weakness in arms/hands/legs/feet, changes in senses touch, pain, temperature, vibration, body position, severe or lasting headache, vision changes, shaking ( tremors), mental/mood changes like agitation, anxiety, confusion, hallucination, depression, rare thoughts of suicide. If you observe any sign like pain or swelling in joints/muscles, stop exercising, take a rest and seek medical help. Avoid patients with age more than 60yr and patients taking prednisolone ( Corticosteroids), patients with transplant (kidney, heart, lung), which leads to increased tendon problems. Ciprofloxacin worsens Myasthenia gravis condition. Consult your doctor if you have new or worsening muscle weakness such as drooping eyelids, unsteady walk, or trouble breathing. Talk to the doctor before using this medicine.

HOW TO USE 

Moxifloxacin is usually taken with or without food once a day for 5 to 21 days. Duration of treatment depends upon the type and severity of infection decided by the physician/Doctor. Take medicine at the same time. If you don’t understand any part of moxifloxacin use, please consult a doctor/Pharmacist. Follow doctor instructions taking medication. Call your doctor if you should begin to feel better during the first few days of treatment with Moxifloxacin or symptoms do not improve. Do not stop medication even you feel better. It’s always better to complete a course of antibiotics to avoid resistance to antibiotics. 

OTHER USES FOR THIS MEDICINE

Moxifloxacin is used to treat T.B., sexually transmitted diseases, endocarditis, anthrax when no alternative medicine is available. This drug is also used for salmonella infection, which causes diarrhea, shigella infection, which causes severe diarrhea in HIV patients. Tell your doctor about risk conditions for using this medicine. If you need information about the drug, ask your doctor/Pharmacist. 

SIDE EFFECT

Avoid Moxifloxacin in children younger than 18 years old, which leads to a problem in bones, joints, and tissues around joints in children. If you find other side effects that are not mentioned, contact your doctor/pharmacist or directly report the side effects to the manufacturing company or FDA official website. 

Severe diarrhea watery or blood in stools occur with or without fever and stomach cramps occur up to 2 months or more after treatment, rash, itching, peeling or blistering of the skin, fever, hives, swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet ankles, hoarseness or sore throat, difficulty breathing or swallowing, yellow skin or eyes, pale skin, dark urine or light color stool, powerful thrust or hunger, fast or fluttering heartbeat, frequent urination, trembling, blurred vision, loss of consciousness unusual anxiety, fainting, decreased urination, unusual bruising or bleeding, sudden pain in the chest, stomach or back, nausea, vomiting, stomach pain, diarrhea. If you observe this symptom, immediately stop the drug and call your doctor. 

PRECAUTIONS 

Tell your doctor/Pharmacist to show allergic reaction to moxifloxacin or other quinolones other fluoroquinolones like Cipro, delafloxacin, Gemifloxacin, levofloxacin, ofloxacin, nutritional, vitamins, other supplements, the herbal product you are taking or plan to take. Glipizide, glyburide, tolazamide, and tolbutamide, for irregular heartbeat including amiodarone such as Nexterone, Pacerone disopyramide like Norpace, procainamide, quinidine, and sotalol such as Betapace, Betapace AF, Sorine, Sotylize in this condition your doctor need to change doses of medication, monitor, carefully. If you’re taking an antacid like aluminum or magnesium or didanosine, sucralfate, administer Moxifloxacin at least 4 hrs before or 8hrs after this medication.

IMPORTANT WARNING  

Anticoagulants such as warfarin, Coumadin, Jantoven, Antidepressants, antipsychotics, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen as Advil, Motrin, others and naproxen as Aleve, Naprosyn, others; cisapride as Propulsid, diuretics, erythromycin, insulin or other medicine to treat diabetes such as chlorpropamide, glimepiride glipizide, glyburide, tolazamide, and tolbutamide; certain medications for irregular heartbeat including amiodarone Nexterone, Pacerone, disopyramide, procainamide, quinidine, and sotalol. Consult your doctor immediately for changing doses of your medicine and monitor to prevent side effects.

Tell your doctor if you or your family history of prolonged QTc interval means any heart-related diseases or rare heart problem or sudden death, irregular heartbeat, aortic aneurysm, B.P., peripheral vascular disease, Marfan syndrome, Ehlers-Danlos syndrome, low potassium or magnesium level, diabetes or low sugar level, liver condition. 

Before administering Moxifloxacin, tell your doctor if you are pregnant or nursing an infant or toddler to avoid risk in infants or infants.

Avoid driving, machine operator, or any other activity that needs alertness or coordination until you know how Moxifloxacin affects you. Also, unnecessary exposure to sunlight or U.V. light, wear protective clothes, sunglasses, sunscreen because Moxifloxacin shows phototoxicity as a side effect. 

DRUG-DRUG INTERACTION  

Drug-drug interaction may change how your medications work, increase your risk of severe side effects, or require patient monitoring. This document does not claim all possible drug-drug interactions. Before visiting the doctor, keep a list of all products you use, including prescribed drugs, OTC, and herbal products; share this with your doctor or Pharmacist. Don’t stop, change, or start the medicine without your doctor’s approval. Some products like acenocoumarol, warfarin, strontium may interact with Ciprofloxacin.Many drugs like amiodarone,dofetilide,quinidine,procainamidesotalol prolonged QTc interval besides ciprofloxacin . Drugs like duloxetine, flibanserin, lomitapide, pirfenidone, tasimelteon, tizanidine removal of this drug slow down by Ciprofloxacin. Avoid caffeine intake, OTC product that contains caffeine; this medicine increases the effect of caffeine. 

OVERDOSE

The patient overdosed and has severe passing symptoms or breathing; in the U.S., call 911 and call a poison control center immediately. Other countries call an ambulance and are admitted to the hospital. 

NOTES 

Do not share your medicine with others. Medicine selection depends upon types of microorganism, site of infection, the severity of infection decision, lab test, CBC, cultures, kidney function taken by doctors only. This medicine is prescribed only for the present condition, so do not administer it for future use, producing resistance against microorganisms. This should be monitored closely for progress or to check the side effects. Consult your doctor for more details about the medication. Don’t change the brand of medicine without consulting the doctor; not all brands have the same effects. 

OTHER INFORMATION  

Visit a doctor and the laboratory regularly. Sometimes the doctor may order another test to see how your body reacts to Moxifloxacin. If you have diabetes and taking the antidiabetic drug or insulin, talk to your doctor about that and constantly monitor sugar levels in the body when on Moxifloxacin.

Do not share your medicine with others. Your dose is not refillable. If there is no improvement in the symptoms, immediately talk to your doctor. 

Always keep a list of prescribed, nonprescribed OTC drugs supplement or plan to be on treatment when you visit a clinic or at the time of hospital admission. This will be helpful for a doctor in an emergency condition. 

MISSED DOSE 

If you miss a dose, If it’s less than 6 hours before the next dose, skip the missed dose. Do not double the dose to level up the missed dose. Take the next dose at the regular time.

STORAGE

Keep the medicine in an air-tight container at room temperature and out of reach of children and pets. Avoid storing at the place of excess heat or moisture. Before discarding, consult the doctor/physician if you have any doubts or queries.