Pronunciation:

mox-i-FLOX-a-sin hye-droe-KLOR-ide

Brand Names:

• Avelox

Dosage Forms:

• Tablet

Warnings:

Fluoroquinolones, including moxifloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue moxifloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of moxifloxacin for patients with no alternative treatment options for acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis. Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Moxifloxacin

Uses of This Medicine:

Moxifloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat and prevent plague (including pneumonic and septicemic plague).

Moxifloxacin belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of moxifloxacin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of moxifloxacin in the elderly. However, elderly patients are more likely to have age-related heart or kidney problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving moxifloxacin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Adagrasib
• Albiglutide
• Alfuzosin
• Alogliptin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Betamethasone
• Budesonide
• Buprenorphine
• Bupropion
• Buserelin
• Canagliflozin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Corticotropin
• Cortisone
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Dulaglutide
• Ebastine
• Efavirenz
• Empagliflozin
• Encorafenib
• Entrectinib
• Eribulin
• Ertugliflozin
• Erythromycin
• Escitalopram
• Exenatide
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fludrocortisone
• Fluocortolone
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glimepiride
• Glipizide
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocortisone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lixisenatide
• Lofexidine
• Lumefantrine
• Macimorelin
• Magnesium Sulfate
• Mefloquine
• Metformin
• Methadone
• Methotrexate
• Methylprednisolone
• Metronidazole
• Mifepristone
• Miglitol
• Mirtazapine
• Mizolastine
• Mobocertinib
• Nafarelin
• Nateglinide
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pioglitazone
• Pipamperone
• Pitolisant
• Ponesimod
• Porfimer
• Posaconazole
• Pramlintide
• Prednisolone
• Prednisone
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Repaglinide
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Rosiglitazone
• Saxagliptin
• Selpercatinib
• Semaglutide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolazamide
• Tolbutamide
• Tolterodine
• Toremifene
• Trazodone
• Triamcinolone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voglibose
• Voriconazole
• Vorinostat
• Warfarin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Aminolevulinic Acid
• Didanosine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Iron
• Lanthanum Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Rifampin
• Sucralfate
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aortic aneurysm (bulge in the wall of the largest artery) or
• Diabetes or
• Diarrhea or
• Heart disease or
• Heart rhythm problems (eg, bradycardia, prolonged QT interval), or family history of or
• Hypoglycemia (low blood sugar) or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected or
• Mental illness, history of or
• Seizures (epilepsy), or history of—Use with caution. May make these conditions worse.

• Brain disease (eg, hardening of the arteries) or
• Kidney disease or
• Liver disease (including cirrhosis) or
• Organ transplant (eg, heart, kidney, or lung), history of or
• Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.

• Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with a glass of water. Do not split, crush or chew it. This medicine may be taken with or without food.

Take this medicine at the same time each day.

Drink plenty of fluids with this medicine to help prevent some unwanted effects.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 4 hours before or 8 hours after taking moxifloxacin. These medicines may keep moxifloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For infections:
    • Adults—400 milligrams (mg) once every 24 hours.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is 8 hours or more until your next dose, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 8 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses of this medicine to make up for a missed dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are using this medicine to make sure this medicine is working properly. Blood and urine tests are needed to check for any unwanted effects.

If you have low potassium levels in the blood, moxifloxacin may increase your risk of having a fast, slow or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

Serious side effects can occur during treatment with this medicine and can sometimes occur without warning. Possible warning signs include black, tarry stools, blistering, peeling, or loosening of the skin, bloody or cloudy urine, chills, decreased urination, diarrhea, fever, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, or yellow skin or eyes. Check with your doctor immediately if you notice any of these warning signs.

Moxifloxacin may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Moxifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

Moxifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Tell your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.

This medicine may increase your risk for aortic aneurysm (bulge in the wall of the largest artery). Check with your doctor right away if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness.

Moxifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

Some people who take moxifloxacin may become more sensitive to sunlight than normal. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, or skin rash, redness, itching, or discoloration. When you begin using this medicine:

• Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor right away.

For diabetic patients: This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Black, tarry stools

bleeding gums

blisters

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

chills

clay-colored stools

cough

crying

dark urine

deep or fast breathing with dizziness

diarrhea, watery and severe, which may also be bloody

difficult or labored breathing

difficulty with moving

difficulty with swallowing

discouragement

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

excessive muscle tone

fast, irregular, pounding, or racing heartbeat or pulse

feeling of unreality

feeling of warmth or heat

feeling sad or empty

fever

fruit-like breath odor

headache

increased hunger

increased sensitivity of the skin to sunlight

increased thirst

increased urination

irregular heartbeat, recurrent

irritability

itching, skin rash

joint pain, stiffness, or swelling

lack of coordination

loss of appetite

loss of interest or pleasure

lower back, side, or stomach pain

mood or mental changes

muscle cramps, pains, stiffness, tension, or tightness

nausea

nervousness

noisy breathing

numbness of the feet, hands, and around the mouth

pain in the pelvis

pain, warmth, or burning in the fingers, toes, and legs

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

problems with speech or speaking

problems with vision or hearing

quick to react or overreact emotionally

rapid weight gain

rapidly changing moods

redness or other discoloration of the skin

restlessness

seeing, hearing, or feeling things that are not there

seizures

sensation of the skin burning

sense of detachment from self or body

severe sunburn

shakiness in the legs, arms, hands, or feet

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramps or tenderness

sweating

swelling of the feet or lower legs

swelling or puffiness of the face

swollen glands

thick, white vaginal discharge with no odor or with a mild odor

tingling of the hands or feet

trouble concentrating

trouble sleeping

unexplained weight loss

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

vomiting of blood

white patches in the mouth or on the tongue

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

burning, numbness, tingling, or painful sensations

change in the ability to see colors, especially blue or yellow

difficulty with chewing or talking

double vision

drooping eyelids

eye pain

general feeling of tiredness or weakness

hives

hoarseness

irregular or slow heart rate

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of consciousness

muscle weakness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

red skin lesions, often with a purple center

severe headache

severe tiredness

stomach pain, continuing

unsteadiness or awkwardness

unusual behavior, including disorientation to time or place, failure to recognize people, hyperactivity, or restlessness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Bad, unusual, or unpleasant (after) taste

belching

burning feeling in the chest or stomach

change in sense of smell

change in taste

changes in vision

continuing ringing or buzzing or other unexplained noise in the ears

difficulty having a bowel movement

excess air or gas in the stomach or bowels

fear or nervousness

feeling of constant movement of self or surroundings

full feeling

general feeling of discomfort or illness

hearing loss

heartburn

impaired vision

indigestion

itching of the vagina or genital area

lack or loss of strength

loss of memory

pain during sexual intercourse

passing of gas

problems with memory

redness, swelling, or soreness of the tongue

sensation of spinning

sleepiness or unusual drowsiness

sore mouth or tongue

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.