Moxiflox

Moxiflox

moxifloxacin

Manufacturer:

InnoGen Pharmaceuticals

Distributor:

InnoGen Pharmaceuticals
Full Prescribing Info
Contents
Moxifloxacin hydrochloride.
Description
Each film-coated tablet contains: Moxifloxacin (as hydrochloride) 400 mg.
Moxifloxacin is bactericidal/bacteriostat and acts by inhibiting the A subunit of DNA gyrase (topoisomerase which is essential in the reproduction of bacterial DNA. It has a broader spectrum of activity and is more potent in vitro than the non-fluorinated quinolone nalidixic acid, activity may be reduced in acid media.
Action
Pharmacology: Pharmacokinetics: Moxifloxacin is readily absorbed from the gastrointestinal tract following oral administration with an absolute bioavailability of about 90%. Moxifloxacin has an elimination half-life of approximately 12 hours, allowing once daily dosing. It is metabolized principally via sulfate and glucoronide conjugation.
Indications/Uses
Treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated and complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections caused by susceptible microorganisms.
Dosage/Direction for Use
Usual dose is 400 mg to be given once daily or as prescribed by the physician.
Contraindications
Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the formulation.
Special Precautions
Moxifloxacin should be used with caution in patients with epilepsy or history of CNS disorders. This should also not be used in children, adolescents, pregnant woman or breast-feeding mothers because it has been shown to cause degenerative changes in weight bearing joints of young animals. Treatment with moxifloxacin should be discontinued if patients experience tendon pain, inflammation or rupture. Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency or myasthenia gravis. An adequate fluid intake should be maintained during treatment with moxifloxacin and excessive alkalinity of the urine avoided because of the risk of crystalluria. Exposure to strong sunlight or sunlamps should be avoided. The ability to drive or operate machinery may be impaired by moxifloxacin, especially when alcohol is also taken.
Adverse Reactions
Adverse effects of moxifloxacin include gastrointestinal disturbances include nausea, vomiting, diarrhea, abdominal pain and dyspepsia. Pseudomembranous colitis has been reported rarely.
Headache, dizziness and restlessness are among the most common effects on the CNS. Others include tremor, drowsiness, insomnia, nightmares and visual and other sensory disturbances.
In addition, to rash and pruritis, hypersensitivity type reactions affecting the skin have included, rarely, vasculitis, erythema multiforme, Steven Johnson syndrome and toxic epidermal necrolysis.
Other adverse effects reported with moxifloxacin include transient increases in serum creatinine or blood urea, nitrogen and, occasionally, acute renal failure secondary to interstitial nephritis; crystalluria; elevated liver enzyme values, jaundice and hepatitis; hematological disturbances including eosinophilia, leucopenia, thrombocytopenia and, very rarely, hemolytic anemia or agranulocytosis, myalgia, gynecomastia and cardiovascular effects including tachycardia.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Quinolones
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Moxiflox FC tab 400 mg
Packing/Price
24's (P145/film-coated tab)
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