The fda has assigned these products an ab rating, which means they are considered equivalent to the brandname version. Moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin in 0. Pdf drug use evaluation of moxifloxacin avelox using a hand. Avelox 400 mg filmcoated tablets summary of product. Avoid avelox in patients with known history of myasthenia gravis see warnings and precautions 5. However, this medicine will not work for colds, flu, or other virus infections this medicine is available only with your doctors prescription.
If you have more questions, ask your doctor or pharmacist. Moxifloxacin is used to treat different types of bacterial infections of the skin, sinuses, lungs, or stomach fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible. Avelox 400 mg filmcoated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent e. In a drug safety communication pdf issued in august 20, the fda warned that peripheral neuropathy may arise at any time during treatment with avelox and may last for months, or even years. Moxifloxacin oral tablet is a prescription drug used to. It is used by mouth, by injection into a vein, or as an eye drop.
Dailymed avelox moxifloxacin hydrochloride injection. Moxifloxacin is a novel fluoroquinolone, the antimicrobial activity of which. Moxifloxacin should be used only for infections that cannot be treated with a safer. Selected from data included with permission and ed by first databank, inc. Tell your healthcare provider if you have a history of myasthenia gravis before. Patient information for avelox 400mg250ml solution for infusion including dosage instructions and possible side effects. I understand that this information is a copy of the summary of product characteristics and patient information leaflet for a medicine, which outline the conditions under which the medicine should be used and information on its known safety. Patient information for avelox 400 mg filmcoated tablets including dosage instructions and possible side effects. The dose of avelox is 400 mg orally or as an intravenous infusion once every 24 hours. Millions of americans might be eligible for rebates starting in 2012 under regulations released monday detailing the health care law. The usual adult dosage for avelox tablets for most infections is one 400 mg tablet once daily for 5 to 10 days.
Your doctor will determine the duration of time that you take the tablets depending on the type of infection you have. For the treatment of most infections, it is generally recommended to start with avelox 400 mg tablets one tablet, once a day. Moxifloxacin is a fluoroquinolone florokwinolone antibiotic that fights bacteria in the body. The length of time your healthcare recommends that you take avelox will depend on the type and severity of your infections. Nda 21085s057, avelox moxifloxacin hydrochloride tablets, 400 mg 2. Avelox 400 mg filmcoated tablets patient information. This includes pneumonia, conjunctivitis, endocarditis, tuberculosis, and sinusitis. Avelox 400 mg filmcoated tablets patient information leaflet pil by bayer plc. It works by killing bacteria or preventing their growth. Avelox tablets are not sufficient on their own for treating this kind of infection. Learn about side effects, warnings, dosage, and more.
The solution for infusion 250 ml contains 34 mmol sodium. Moxifloxacin serum concentrations were determined by a validated hplc procedure. Link can supply moxifloxacin actavis 400 mg filmcoated tablets registered and marketed in the united kingdom. Avelox tablets are available as filmcoated tablets containing moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin. Avelox 400mg filmcoated tablets moxifloxacin hydrochloride a salt imbalance in the blood especially low levels of potassium or magnesium in the blood a very slow heart rhythm called bradycardia a weak heart heart failure a history of abnormal heart rhythms or if you are taking other medicines that result in. The duration of therapy depends on the type of infection as described in.
This ed material has been downloaded from a licensed data provider and is not for distribution, except. Avelox tablets contain the active ingredient moxifloxacin, which is an antibiotic belonging to a group of medicines called fluoroquinolones. Avelox moxifloxacin oral uses, side effects, dosage. Due to regulatory changes, the content of the following patient information leaflet may vary from the one found in your medicine pack. Find patient medical information for avelox abc pack oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Prior avelox warnings misleadingly suggested that the nerve damage. Dailymed vigamox moxifloxacin hydrochloride solution. Common side effects include diarrhea, dizziness, and headache.
Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in australia of their safety or efficacy. The standard recommended avelox dosage is 400 mg once daily. When moxifloxacin single 400 mg tablet dose was administered two hours before, concomitantly, or 4 hours after an aluminummagnesiumcontaining antacid 900 mg aluminum hydroxide and 600 mg magnesium hydroxide as a single oral dose to 12 healthy volunteers there was a 26%, 60% and 23% reduction in the mean auc of moxifloxacin, respectively. Dailymed avelox moxifloxacin hydrochloride tablet, film. Fluoroquinolones like avelox may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. However, some types of infections may require longer treatment. The most common side effects leading to discontinuation with the oral dose were.
Each filmcoated tablet contains 400 milligram moxifloxacin as hydrochloride. Dailymed moxifloxacin hydrochloride tablets, 400 mg. Find patient medical information for avelox oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. It is used to treat community acquired pneumonia, plague, bacterial sinusitis, and chronic bronchitis with bacterial infection. Moxifloxacin is used to treat bacterial infections in many different parts of the body moxifloxacin belongs to the class of medicines known as quinolone antibiotics. Information on submitting spl files using elist may be found in the guidance for industry titled. Pdf icon download leaflet view the patient leaflet in pdf format.
Nda 21277s054, avelox moxifloxacin hydrochloride in nacl injection iv, 400 mg we also refer to our letter dated june 27, 20, notifying you, under section 505o4 of the fdca, of new safety information that we believe should be included in labeling for the systemic. Avelox is licensed to treat many bacterial infections, but what is 400 mg avelox used for, exactly. Worsening of myasthenia gravis a disease which causes muscle weakness. Moxifloxacin oral tablet comes as a generic drug and as the brandname drug avelox. The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide. Moxifloxacin, sold under the brandname avelox among others, is an antibiotic used to treat a number of bacterial infections. Be sure to finish your prescription, even if you start to feel better. The use of moxifloxacin avelox has increased at vancouver general hospital since its introduction onto the formulary in 2002. Generic avelox moxifloxacin is available as 400 mg tablets. However, generic avelox is allowed to have different inactive ingredients such as fillers or dyes, which may cause problems for people with certain allergies or. Avelox avehlocks moxifloxacin hydrochloride tablets.
Pharmacokinetics of consecutive oral moxifloxacin 400 mgday in. The importance of this question is emphasised by the case of. The analysis comprised all doubleblind and openlabel actively controlled clinical trials included in the clinical trial database of moxifloxacin 400 mg once daily and performed by the manufacturer as part of the phase iiiv programs that were initiated and completed between 1996 and 2010, with the exception of one exploratory phase ii study conducted in cirrhotic patients, most of. Avelox moxifloxacin is a fluoroquinolone floorokwinolone antibiotic that fights bacteria in the body. Avelox 400 mg filmcoated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin see sections 4.
Avelox 400 mg filmcoated tablets patient information leaflet pil. The final model was favorably applied to the measured plasma concentration data. The length of time that your healthcare recommends that you take avelox will depend on the type and severity of your infections. The duration of therapy depends on the type of infection as described. The duration of therapy depends on the type of infection as described in table 1. Moxifloxacin at the recommended dose of 400 mg once daily has been investigated in prospective, randomized, doubleblind clinical trials and metaanalyses in patients with mild, moderate, and. Please compare the leaflet preparedrevised date towards the end of the leaflet to establish if there have been any changes. As this emedtv resource explains, this medication is used for treating bronchitis, pneumonia, sinus infections, and various other infections. Moxifloxacin 400 mg was administered for an average of 6. Avelox is used to treat different types of bacterial infections of the skin, sinuses, lungs, or stomach. Stopping the drug too soon could lead to the development of antibioticresistant bacteria. Moxifloxacin in respiratory tract infections request pdf.
687 35 838 1072 1090 953 97 978 430 218 786 342 94 1162 1163 460 465 1116 450 1165 1551 818 1511 1156 885 464 1016 1550 1384 468 1548 920 1328 774 438 684 1267 993 1217 83