(mox'' i flox' a sin)
P Â - Contraindicated in pregnancy
L Â - Contraindicated in lactation
|Indication & Dosage||Oral
Acute bacterialÂ sinusitis
Adult:Â 400 mg once daily for 10 days.
Acute bacterial exacerbation ofÂ chronic bronchitis
Adult:Â 400 mg once daily for 5-10 days.
Adult:Â 400 mg once daily for 7-14 days.
Skin and skin structure infections
Adult:Â Complicated: 400 mg once daily for 7-21 days; uncomplicated: 400 mg once daily for 7 days.Â
Acute bacterial sinusitis
Adult:Â 400 mg by IV infusion over 60 minutes every 24 hr for 10 days.
Acute bacterial exacerbation of chronic bronchitis
Adult:Â 400 mg by IV infusion over 60 minutes every 24 hr for 5-10 days.
Adult:Â 400 mg by IV infusion over 60 minutes every 24 hr for 7-14 days.
Skin and skin structure infections
Adult:Â Complicated: 400 mg once daily for 7-21 days; uncomplicated: 400 mg once daily for 7 days. Dose to be infused over 60 minutes.
Adult:Â 400 mg for 5-14 days. May change to oral therapy when clinically appropriate. Dose to be infused over 60 minutes.Â
Adult:Â As 0.5% ophthalmic solution: instil 1 drop in the affected eye tid for 7 days.
Child:Â >1 yr as 0.5% ophthalmic solution: instil 1 drop in the affected eye tid for 7 days.
|Administration||Should be taken on an empty stomach. Take on an
empty stomach for rapid effect. Do not take w/in 1 hr of antacids, milk or other dairy products.
|Overdosage||Stomach should be emptied and hydration maintained. Activated charcoal may be useful soon after oral overdosage. Treatment should be supportive, dialysis may be of some limited use.|
|Contraindications||Hypersensitivity; child, adolescent; pregnancy, lactation.|
|Special Precautions||Maintain adequate fluid intake; exposure to strong sunlight/sunlamp. Epilepsy, history of CNS disorders, DM. Not recommended in severe hepatic impairment. May worsen myasthenia gravis. Discontinue in case of tendon pain, inflammation or rupture. High level of resistance with S. aureus infections. Increased risk of tendon inflammation/rupture especially in elderly taking corticosteroids. Caution in patients with proarrhythmic conditions e.g. clinically significant bradycardia or acute MI. Existing QT prolongation, bradycardia, heart failure with reduced left ventricular ejection fraction; uncorrected hypokalaemia. Avoid concomitant usage with drugs that are known to prolong QT interval. Prolonged use may increase risk of fungal or bacterial superinfection.|
|Adverse Drug Reactions||GI disturbances, CNS effects, hypersensitivity-type reactions, reversible arthralgia, abnormal liver function tests, hepatitis, haematological disturbances, tachycardia, superinfection, pain and irritation at the Inj site, tendon damage, phloebitis and thrombophloebitis, peripheral neuropathy, photosensitivity, abdominal pain, headache, vaginitis.|
|Drug Interactions||Moxifloxacin should be taken 4 hr before or 8 hr after admin of
magnesium or aluminium containing antacids or iron and zinc containing products. Increased risk of CNS stimulation and convulsions with NSAIDs. May increase
adverse effects of corticosteroids when used together. May increase anticoagulant effect of coumarin derivatives. May reduce serum levels of mycophenolate.
Didanosine, sevelamer, sucralfate and quinalapril may reduce the absorption of orally-administered moxifloxacin.
Potentially Fatal:Â Risk of torsade de pointes with QT prolonging drugs e.g. class Ia or class III antiarrythmics, terfenadine, cisapride, astemizole.Â Please consult detailed drug interactions before prescribing.
Category (US FDA)
||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Intravenous:Â Store at 25Â°C.Â Ophthalmic:Â Store at 2-25Â°C.Â Oral:Â Store at 25Â°C.|
||Moxifloxacin inhibits the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription,
repair and recombination.
Absorption:Â Well absorbed from GI tract.
Distribution:Â Widely distributed throught the body. 30-50% protein bound.
Metabolism:Â Metabolised via glucuronide and sulfate conjugation.
Excretion:Â Excreted in urine and faeces as unchanged drug and metabolite. Elimination half life of around 12 hr.
|ATC Classification||J01MA14 - moxifloxacin; Belongs to the class of quinolones,
fluoroquinolone. Used in the treatment of systemic infections.Â
S01AX22 - moxifloxacin.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|EYEMOX||The Acme Laboratories Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.38 MRP|
|FLOMOX||Opso Saline Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.38 MRP|
|FLOROMOX||IBN SINA Pharmaceutical Industry Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|FLOXIMOX||Asiatic Laboratories Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|IVENTI||Square Pharmaceuticals Ltd.||Moxifloxacin Hydrochloride 400mg||Tablet||2x6's: 480.00 MRP|
|IVENTI 0.5%||Square Pharmaceuticals Ltd.||Moxifloxacin 0.5%||Eye Drops||5 ml: 100.68 MRP|
|IVENTI 400||Square Pharmaceuticals Ltd.||Moxifloxacin 400mg/250 ml||IV Infusion||250 ml: 175.53 MRP|
|MAXIFLOX||ACI Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|MFC||Nipa Pharmaceuticals Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|MOXIBAC||Popular Pharmaceuticals Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.38 MRP|
|MOXIBAC Inf.||Popular Pharmaceuticals Ltd.||Moxifloxacin 400mg in 250ml glass bottle||Infusion||250ml: 350.00 MRP|
|MOXIFLOX||Alco Pharma Ltd||Moxifloxacin INN 400mg||Tablet||8's: 680.00 MRP|
|MOXIKEM||Kemiko Pharmaceuticals Ltd||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|MOXIVINE EYE DROP||Healthcare Pharmacuticals Ltd.||Moxifloxacin 0.5% Eye Drops||Drop||5ml, MRP 100 Tk|
|MOXJGRAM||Apex Pharmaceuticals Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
|Moxquin 400||Incepta Pharmaceuticals Limited||Moxifloxacin 400 mg Tablet||Tablet||2x4's:MRP 680 Tk|
|Moxquin Eye||Incepta Pharmaceuticals Limited||Moxifloxacin 0.5% Eye Drops||Drop||5ml :MRP 100 Tk|
|OCUMOX||Reman Drug Laboratories Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.38 MRP|
|ODYCIN DROP||Beximco Pharmaceuticals Ltd||Moxifloxacin Hydrochloride INN eq. to Moxifloxacin 5mg/ml||Drop||5ml: 100.00 MRP|
|OPTIMOX||Aristopharma Ltd.||Moxifloxacin hydrochloride INN 5mg/ml||Eye Drop||5ml: 100.00 MRP|
Notice: Raised in the U.S. Market.
[Posted 08/15/2013]Â ISSUE: ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
BACKGROUND: The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.
RECOMMENDATION: Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy. Make sure your patients receive the Medication Guide with every prescription. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit the FDA website at:Â http://www.fda.gov/Safety/MedWatch/SafetyInformationÂ andÂ http://www.fda.gov/Drugs/DrugSafety.
Taking moxifloxacin increases the risk that you will develop tendinitis (swelling of fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone. If you experience any of the following symptoms of tendinitis, stop taking moxifloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking moxifloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move to or bear weight on affected area.
Taking moxifloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take moxifloxacin. If you have myasthenia gravis and your doctor tells you that you should take moxifloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking moxifloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with moxifloxacin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or check the manufacturer's website to obtain the Medication Guide.
Why is this medication prescribed?
Moxifloxacin is used to treat certain infections such as pneumonia, bronchitis, and sinus, skin, and abdominal (stomach area) infections caused by bacteria. Moxifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections. Antibiotics will not work against colds, flu, or other viral infections.
How should this medicine be used?Â
Moxifloxacin comes as tablet to take by mouth. It is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take moxifloxacin. Take moxifloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take moxifloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You should begin to feel better during the first few days of treatment with moxifloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take moxifloxacin until you finish the prescription, even if you feel better. Do not stop taking moxifloxacin unless you experience the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section or the symptoms of allergic reaction described in the SIDE EFFECTS section. If you stop taking moxifloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicineÂ
Moxifloxacin is also sometimes used to treat tuberculosis (TB) and endocarditis (infection of the heart lining and valves) when other medications cannot be used. Moxifloxacin also may be used to treat or prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air if other medications are not available for this purpose. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?Â
Before taking moxifloxacin,Â
- tell your doctor if you are allergic or have had a severe reaction to moxifloxacin, other quinolone or fluoroquinolone antibiotics such as ciprofloxacin, gatifloxacin , gemifloxacin, levofloxacin, lomefloxacin , nalidixic acid, norfloxacin, ofloxacin, and sparfloxacin , or any other medications.
- tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants Â such as warfarin; certain antidepressants; antipsychotics; nonsteroidal anti-inflammatory drugs Â such as ibuprofen Â and naproxen; cisapride ; diuretics; erythromycin; or certain medications for irregular heartbeat including amiodarone, disopyramide, procainamide, quinidine, and sotalol . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- take moxifloxacin at least 4 hours before or at least 8 hours after you take any of these medications: antacids containing magnesium or aluminum; didanosine; sucralfate or vitamin supplements that contain iron or zinc.
- tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or an irregular heartbeat, and if you have or have ever had nerve problems, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or mini-stroke), seizures, chest pain, a slow heartbeat, a low level of potassium in your blood, or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant or if you are breast-feeding. If you become pregnant while taking moxifloxacin, call your doctor.
- you should know that moxifloxacin may cause dizziness and lightheadedness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how moxifloxacin affects you.
- plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen. Moxifloxacin may make your skin sensitive to sunlight. Call your doctor if you develop skin redness or blisters during your treatment with moxifloxacin.
What special dietary instructions should I follow?Â
Make sure you drink plenty of water or other fluids every day during your treatment with moxifloxacin.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Moxifloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
loss of appetite
change in ability to taste food
sores in the mouth or on the tongue
white patches in the mouth
vaginal itching or burning
Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, stop taking moxifloxacin, and call your doctor immediately:Â
severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
difficulty breathing or swallowing
swelling of the face or throat
loss of consciousness
blistering or peeling skin
yellowing of the skin or eyes
muscle or joint pain
shortness of breath
unusual bruising or bleeding
fast, pounding or irregular heartbeat
not trusting others or feeling that others want to hurt you
thinking about harming or killing yourself
hallucinations (seeing things or hearing voices that do not exist)
difficulty falling asleep or staying asleep
uncontrollable shaking of a part of the body
pain, numbness, burning, tingling and/or weakness in the arms, hands, legs or feet
Moxifloxacin may cause problems with bones, joints, and tissues around joints in children. Moxifloxacin should not be given to children younger than 18 years old. Talk to your child's doctor about the risks of giving moxifloxacin to your child.
Moxifloxacin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose,Â consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref:Â Â U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.