"LONDON, UK â€” The European Commission (EC) has followed the recommendation last year from its Committee for Medicinal Products for Human Use (CHMP) for an additional indication for the oral platelet inhibitor ticagrelor (Brilique, AstraZe"...
(gemifloxacin mesylate) Tablets
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones, including FACTIVE®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (See WARNINGS) including:
- Tendinitis and tendon rupture
- Peripheral neuropathy
- Central nervous system effects
Discontinue FACTIVE immediately and avoid the use of fluoroquinolones, including FACTIVE, in patients who experience any of these serious adverse reactions (See WARNINGS)
- Fluoroquinolones, including FACTIVE, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid FACTIVE in patients with known history of myasthenia gravis (See WARNINGS).
- Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions (See WARNINGS), reserve FACTIVE for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis (See INDICATIONS AND USAGE).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine3-carboxylic acid.
The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Gemifloxacin is considered freely soluble at neutral pH (350 µg/mL at 37°C, pH 7.0). Its empirical formula is C18H20FN5O4•CH4O3S and its chemical structure is:
Each white to off-white, oval, film-coated FACTIVE tablet has breaklines and GE 320 debossed on both faces and contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. The inactive ingredients are crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide.
What are the possible side effects of gemifloxacin (Factive)?
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 gemifloxacin and call your doctor at once if you have a serious side effect such as:
- severe dizziness, fainting, fast or pounding heartbeat;
- 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, unusual thoughts or...
What are the precautions when taking gemifloxacin mesylate (Factive)?
Before using gemifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., 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 (e.g., slow/fast/irregular heartbeat, chest pain, recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, myasthenia gravis, nerve problems (such as peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors, cerebral...
Last reviewed on RxList: 8/9/2016
This monograph has been modified to include the generic and brand name in many instances.
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