Moxifloxacin (Oral)

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

Moxifloxacin belongs to a group of medicines called quinolone antibiotics. It works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

It is very important for your doctor to check your progress at regular visits while you are using this medicine to ensure it 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 you experience these symptoms, 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 taking this medicine.

Serious side effects can occur during treatment with this medicine and can sometimes happen 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 yellowing of the 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 with your doctor first. 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 (e.g., dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (e.g., rheumatoid arthritis), or have received an organ transplant (e.g., heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (e.g., 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, 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 sunblock product that has a sun protection factor (SPF) of at least 15. Some people may need 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.

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

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other drugs. As well inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of moxifloxacin in the elderly. Nevertheless, elderly patients are more likely to have age-related heart or kidney issues, or develop severe tendon problems (such as 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 medicine during breastfeeding. Weigh the potential benefits against the potential chances before using this medication while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician 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 using 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 drug with any of the following medicines is not advised. Your physician 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 drug with any of the following medications is typically not advised, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how frequently 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
• Etrasimod
• 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 medication 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 drugs are prescribed together, your doctor may change the dose or how frequently 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

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical problems may affect the use of this medication. Make sure you tell your clinician 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 issues (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 (such as cirrhosis) or
• Organ transplant (eg, heart, kidney, or lung), history of or
• Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause adverse effects to become worse.

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

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

Check with your doctor right away 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.

In the U.S.

• Avelox

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Moxifloxacin

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.