Concise Prescribing Info
Adults w/ complicated & uncomplicated UTI & prostatitis, uncomplicated gonorrhea & various GI infection caused by susceptible organisms.
Dosage/Direction for Use
Adult Complicated UTI 400 mg bid for at least 10-21 days. Uncomplicated UTI 400 mg bid for 3 days if caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis, or 7-10 days if caused by other susceptible organisms. Acute or chronic prostatitis caused by E. coli 400 mg bid for 28 days. Gastroenteritis 400 mg bid for 5 days or 3 days for some infections eg, shigellosis or some GI infections caused by E. coli. Traveler's diarrhea 400 mg bid for 3 days if severe or associated w/ fever or bloody stools or 1-2 days in some patients. Prophylaxis of traveler's diarrhea 400 mg once daily during risk period for up to 3 wk beginning at day of travel & continue for 1 or 2 days after leaving risk area. Gonorrhea & associated infections 80 mg as single dose. Renal impairment CrCl ≤30 mL/min/1.73 m2 400 mg once daily.
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals w/ a glass of water. Ensure adequate hydration. Do not take w/ dairy products.
Hypersensitivity to fluoroquinolones or quinolones. Tendinitis or tendon rupture associated w/ quinolone use. Patients receiving disopyramide, amiodarone & QTc-prolonging antiarrhythmics eg, quinidine, procainamide, sotalol.
Special Precautions
Hypersensitivity. Phototoxicity, convulsion, tendon rupture/tendinitis, pseudomembranous colitis, crystalluria, hemolytic reaction, myasthenia gravis. Patients should be well hydrated & drink fluids liberally. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Chest pain, MI, palpitation; myoclonus, tingling of fingers, anxiety, sleep disturbances; erythema multiforme, erythema, urticaria; hepatitis, pancreatitis, stomatitis, anorexia, rectal pain, loose stools, abdominal swelling, bitter taste, mouth ulcer, renal colic; arthralgia, back pain, bursitis; hyperhidrosis, asthenia, allergies, dysmenorrhea, pruritus ani.
Drug Interactions
Decreased absorption w/ antacid containing Mg- & Al-hydroxide. Additive or partially synergistic antibacterial activities w/ aminoglycosides. Prolonged prothrombin time w/ warfarin. Increased serum conc of cyclosporine. Severe hypoglycemia w/ glyburide. Interference of absorption w/ oral multivit & mineral supplements containing divalent & trivalent cations eg, Fe or Zn; sucralfate. Antagonized antibacterial activity w/ nitrofurantoin. Decreased urinary excretion w/ probenecid. Increased theophylline plasma conc.
MIMS Class
ATC Classification
J01MA06 - norfloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Janacin FC tab 400 mg
25 × 4's
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