Sanbe Farma


Euro Asia Medico
Concise Prescribing Info
Severe infections in UTI, gonococcal & non-gonococcal urethritis, gonococcal & non-gonococcal cervicitis, lower resp tract infections, skin & soft tissue infections.
Dosage/Direction for Use
UTI 200-400 mg daily preferably in the morning, increase to 400 mg bd if necessary. Lower resp tract infections 400 mg daily preferably in the morning, increase to 400 mg bd if necessary. Skin & soft tissue infections 400 mg bd. Uncomplicated gonorrhoea 400 mg single dose. Non-gonococcal urethritis & cervicitis 400 mg daily in single or divided doses.
May be taken with or without food: Avoid antacids containing Al or Mg hydroxide 1 to 2 hr before or after ofloxacin.
Hypersensitivity to ofloxacin & quinolone derivatives. Pregnancy & lactation. Prepubertal childn.
Special Precautions
Discontinue use if hypersensitivity & shock-like symptoms occur. Patients w/ reduced renal function; known risk factors for QT interval prolongation eg, congenital long QT syndrome, concomitant use of known QT interval prolonging drugs, uncorrected electrolyte imbalance (eg, hypokalaemia, hypomagnesaemia), cardiac disease (eg, heart failure, MI, bradycardia). Concomitant use w/ antacid containing Al or Mg hydroxide. May exacerbate muscle weakness in persons w/ myasthenia gravis; avoid in patients w/ history of myasthenia gravis. Immediately discontinue if peripheral neuropathy symptoms occur; 1st signs or symptoms of any serious AR. Immediately consult an eye specialist if visual impairment or any effects on the eye is experienced. Increased risk of psychiatric AR including toxic psychosis, hallucinations or paranoia, depression or suicidal thoughts/acts, anxiety, agitation or nervousness, confusion, delirium, disorientation or attention disturbances, insomnia or nightmares, memory impairment. Carefully monitor blood glucose; discontinue use & initiate appropriate therapy if hypoglycaemic reaction occurs. Patients w/ positive family history of aneurysm or congenital heart valve disease, or in patients diagnosed w/ pre-existing aortic aneurysm &/or dissection or heart valve disease. Immediately consult a physician in case of sudden abdominal, chest or back pain; acute dyspnoea, new onset of heart palpitations, or development of oedema in abdomen or lower extremities. Fertile age. Elderly.
Adverse Reactions
Nausea, headache, dizziness, insomnia. Vomiting diarrhea, decreased appetite, abdominal pain, dry mouth; skin rash, pruritus.
Drug Interactions
Concomitant use w/ known QT interval prolonging drugs (eg, class IA & III antiarrhythmics, TCAs, macrolides, antipsychotics). May reduce absorption by Al or Mg hydroxide containing antacids.
MIMS Class
ATC Classification
J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Akilen film-coated tab 200 mg
3 × 10's
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