Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Avelox Iv. If you are concerned about side effects, discuss the risks and benefits of Avelox Iv with your doctor.

The following side effects have been reported by at least 1% of people taking Avelox Iv. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness or lightheadedness
• headache
• indigestion
• mild Diarrhea
• nausea
• nightmares
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• anxiety
• confusion or changes in thought patterns
• hallucinations (seeing, hearing, or feeling things that are not there)
• muscle or joint pain
• muscle weakness
• nervousness
• numbness, tingling, or weakness
• pain, swelling, or rupture of a tendon
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• swelling, redness, or other irritation at the place of injection (for intravenous only)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
• symptoms of liver problems (e.g., abdominal pain, dark urine, yellowing of the skin or eyes, nausea, pale stools)
• tremors
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• diarrhea (watery and severe; may also be bloody)
• fainting
• irregular or fast heart rate
• seizures
• signs of a Anaphylaxis (severe allergic reaction) (e.g.: Hives, difficulty breathing, or swelling of the face, tongue, or throat)
• skin rash, especially if skin is blistering, loosening, or peeling
• thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Avelox Iv.

Tablets

Each oblong, dull red film-coated tablet, engraved "BAYER" on one side and "M400" on the other, contains moxifloxacin HCl equivalent to 400 mg of moxifloxacin. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, red ferric oxide, and titanium dioxide.

Intravenous Injection

Each premixed, ready-to-use 250 mL minibag contains moxifloxacin HCl equivalent to 400 mg of moxifloxacin in 0.8% saline, with pH ranging from 4.1 to 4.6. The appearance of the intravenous solution is yellow and is not affected by, or indicative of, product stability. Nonmedicinal ingredients: sodium chloride, USP, and water for injection, USP. It may also contain hydrochloric acid and/or sodium hydroxide for pH adjustment. No further dilution of this product is necessary.

Do not use Avelox Iv if you:

• are allergic to moxifloxacin or any ingredients of the medication
• are allergic to other quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin)

There may be an interaction between moxifloxacin and any of the following:

• acetylsalicylic acid (Asa)
• Amiodarone
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide): take moxifloxacin 4 hours before or 8 hours after these medications
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• bacillus Calmette-Guérin (BCG)
• chloroquine
• Cholera vaccine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Degarelix
• dofetilide
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Rosiglitazone)
• Disopyramide
• Domperidone
• Dronedarone
• Fingolimod
• Flecainide
• Indacaterol
• iron supplements (e.g., ferrous fumarate, ferrous gluconate, ferrous sulphate): take moxifloxacin 4 hours before or 8 hours after these medications
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• magnesium supplements (e.g., magnesium citrate, magnesium hydroxide, magnesium oxide)
• Methadone
• mifepristone
• multivitamin/mineral supplements
• mycophenolate
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Diclofenac, Ibuprofen, Ketorolac, Naproxen)
• pentamidine
• Porfimer
• procainamide
• Propafenone
• Romidepsin
• Quinapril
• quinidine
• quinine
• other quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, Ofloxacin)
• rilpivirine
• saquinavir
• selective serotonin reuptake inhibitors (SSRIS; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• sevelamer
• sodium picosulfate
• Sotalol
• sucralfate (take moxifloxacin 4 hours before or 8 hours after Avelox Iv)
• Tetrabenazine
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• typhoid vaccine
• tyrosine kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib)
• Varenicline
• vilanterol
• Warfarin
• zinc

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Avelox Iv. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Avelox Iv.

Bacterial resistance: Misuse of an antibiotic such as moxifloxacin may lead to the growth of resistant bacteria that will not be killed by the antibiotic. If this happens, the antibiotic may not work for you in the future. Although you may begin to feel better when you first start taking moxifloxacin, you need to take all the medication exactly as directed by your doctor to finish ridding your body of the infection and to prevent resistant bacteria from taking hold. Do not take moxifloxacin or other antibiotics to treat a viral infection such as The Common Cold; antibiotics do not kill viruses, and using them to treat viral infections can lead to the growth of resistant bacteria.

Allergic reactions: In rare cases, some people may develop a severe allergic reaction to Avelox Iv. Signs of a severe reaction include a severe rash, swollen face, or difficulty breathing. If these occur, get immediate medical attention.

Antibiotic-related diarrhea: As with other antibiotics, moxifloxacin can cause a severe form of diarrhea associated with the condition called pseudomembranous colitis. If you develop severe diarrhea while taking Avelox Iv, contact your doctor as soon as possible.

Behaviour and movement changes: Rarely, Avelox Iv can cause movement disorders or behaviour changes such as agitation, anxiety, confusion, depression, tremors, hallucinations, and other mood changes. If you experience any of these, or notice them in a family member who is taking Avelox Iv, stop taking Avelox Iv and contact your doctor immediately.

Diabetes: Moxifloxacin may cause changes in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Avelox Iv.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Avelox Iv may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Avelox Iv, and whether any special monitoring is needed.

Driving and operating heavy machinery: Moxifloxacin may cause dizziness and drowsiness, impairing your ability to drive or operate machinery, especially when combined with alcohol. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Avelox Iv.

Liver problems: Liver disease or reduced liver function may cause Avelox Iv to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Avelox Iv may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Avelox Iv, and whether any special monitoring is needed.

Avelox Iv may cause liver problems that in rare cases can be fatal. If you experience symptoms of liver problems (e.g., yellowing of the skin and eyes, abdominal pain, dark urine, pale stools, loss of appetite, itchy skin) while taking Avelox Iv, contact your doctor immediately. People with a severe reduction in liver function should not use Avelox Iv.

Neuromuscular disorders: Moxifloxacin, like other antibiotics in this family, can cause increased muscle weakness, including difficulty breathing, for people with Myasthenia Gravis (an autoimmune disorder that causes muscle weakness). If you have myasthenia gravis, discuss with your doctor how Avelox Iv may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Avelox Iv, and whether any special monitoring is needed. Generally, moxifloxacin is not recommended for people with myasthenia gravis.

Palpitations and fainting spells: See a doctor as soon as possible if you experience palpitations (irregular or rapid heartbeat) or fainting spells while taking moxifloxacin.

Peripheral Neuropathy: Although rare, moxifloxacin may affect the nerves of the skin and limbs. If you start to feel pain, burning, tingling, numbness, or weakness, stop taking Avelox Iv and contact your doctor immediately.

QT prolongation: Avelox Iv can lengthen heartbeat as shown on an electrocardiogram test, also known as QT prolongation. Very rare cases of abnormal heartbeat have been reported in people while on moxifloxacin, but these reports generally involved people who had conditions that predisposed them to abnormal heartbeat, or who have been taking other medications that can increase the risk of developing an abnormal heartbeat.

You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or if you are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Avelox Iv may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Avelox Iv, and whether any special monitoring is needed.

Seizures: Seizures may rarely occur with Avelox Iv. If you have a medical condition that increases the risk of seizures, discuss with your doctor how Avelox Iv may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Avelox Iv, and whether any special monitoring is needed.

If you have a seizure while taking Avelox Iv, stop taking the medication and get immediate medical attention.

Sun sensitivity: People who take moxifloxacin may be more likely to experience Sunburn. While taking moxifloxacin, avoid excessive sunlight or artificial ultraviolet light exposure (e.g., sun beds, sunlamps). Stop taking the medication and contact your doctor if sun sensitivity occurs.

Tendonitis: Moxifloxacin may increase the chance of tendon injury. Injury occurs more commonly for seniors who are also taking corticosteroid medications. If there is any new pain in the tendons or joints, stop taking moxifloxacin, avoid physical exercise, and consult your doctor.

Pregnancy: Avelox Iv should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Avelox Iv, stop taking it immediately and contact your doctor.

Breast-feeding: It is not known if moxifloxacin passes into breast milk. If you are a breast-feeding mother and are taking Avelox Iv, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Avelox Iv have not been established for children under 18 years of age.