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(moxifloxacin hydrochloride) Tablets and Intravenous Solution
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including AVELOX, have been
associated with disabling and potentially irreversible serious adverse
reactions that have occurred together [see WARNINGS AND
- Tendinitis and tendon rupture [see WARNINGS AND PRECAUTIONS]
- Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
- Central nervous system effects [see WARNINGS AND
Discontinue AVELOX immediately and avoid the use of fluoroquinolones, including AVELOX, in patients who experience any of these serious adverse reactions [see WARNINGS AND PRECAUTIONS].
- Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see WARNINGS AND PRECAUTIONS].
- Because fluoroquinolones, including AVELOX, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS], reserve AVELOX for use in patients who have no alternative treatment options for the following indications :
- Acute bacterial sinusitis [see INDICATIONS AND USAGE]
- Acute bacterial exacerbation of chronic bronchitis [see INDICATIONS AND USAGE]
AVELOX (moxifloxacin hydrochloride) is a synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1- cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4
- AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
- The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide.
- AVELOX Injection for intravenous use is available in ready-to-use 250 mL flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The flexibag is not made with natural rubber latex.
- The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability.
- The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment.
- AVELOX Injection contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.
What are the possible side effects of moxifloxacin (Avelox)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using moxifloxacin and call your doctor at once if you have a serious side effect such as:
- severe dizziness, fainting, fast or pounding heartbeats;
- sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
- diarrhea that is watery or bloody;
- confusion, hallucinations, depression, insomnia or nightmares, unusual...
What are the precautions when taking moxifloxacin hcl (Avelox)?
See also Warning section.
Before taking moxifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as recent heart attack), joint/tendon problems (such as tendonitis, bursitis), liver disease, myasthenia gravis, nerve problems (such as peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (such as brain/head injury, brain tumors, cerebral...
Last reviewed on RxList: 9/15/2016
This monograph has been modified to include the generic and brand name in many instances.
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