AVAILABLE COMPOSITION

NEFLOX-200 TABLETSEach film coated tablet contains Ofloxacin USP 200mg.

NEFLOX-400 TABLETSEach film coated tablet contains Ofloxacin USP 400mg.

OFLOXACIN TABLETS-200MGEach film coated tablet contains Ofloxacin USP 200mg.

OFLOXACIN TABLETS-400MGEach film coated tablet contains Ofloxacin USP 400mg.

OFLOXEL-200 TABLETSEach film coated tablet contains Ofloxacin USP 200mg.

OFLOXEL-400 TABLETSEach film coated tablet contains Ofloxacin USP 400mg.

 AVAILABLE COMPOSITIONNEFLOX-200 TABLETSEach film coated tablet contains Ofloxacin USP 200mg.NEFLOX-400 TABLETSEach film coated tablet contains Ofloxacin USP 400mg.OFLOXACIN TABLETS-200MGEach film coated tablet contains Ofloxacin USP 200mg.OFLOXACIN TABLETS-400MGEach film coated tablet contains Ofloxacin USP 400mg.OFLOXEL-200 TABLETSEach film coated tablet contains Ofloxacin USP 200mg.OFLOXEL-400 TABLETS Each film coated tablet contains Ofloxacin USP 400mg.

PHARMACOLOGICAL CLASSIFICATION:     A Broad spectrum antibiotic, Fluorinated quinolone antibacterial. 

MECHANISM OF ACTIONOFLOXACIN is bactericidal via its effects on DNA gyrase, an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription. Although human cells do not contain DNA gyrase, they do contain a topoisomerase enzyme that functions in the same manner. This mammalian enzyme is not affected by bactericidal concentrations of quinolones. It is unclear how inhibition of DNA gyrase leads to bacterial cell death. Both rapid and slow growing organisms are inhibited by fluoroquinolones. In addition, fluoroquinolones exhibit a prolonged post-antibiotic effect (PAE). Organisms may not resume growth for 2—6 hours after exposure to ofloxacin, despite undetectable drug levels.

Like other fluoroquinolones, OFLOXACIN is most effective against gram-negative organisms including Citrobacter diversus, C. freundii, Enterobacter cloacae, E. aerogenes, Escherichia coli, Klebsiella species, Morganella morganii, Proteus species, Salmonella species, Shigella species, and Yersinia enterocolitica. Ofloxacin is more potent against Serratia species than is Norfloxacin, and it is equipotent against Providencia species. Ofloxacin is less active against Pseudomonas aeruginosa but more potent against Xanthomonas maltophilia than is ciprofloxacin.

OFLOXACIN is effective in vitro against both negative and positive strains of Neisseria gonorrhoeae, N. meningitidis, Haemophilus ducreyi, Legionella pneumophila, and Vibrio cholerae. However, ciprofloxacin appears to be more effective against H. influenzae than is ofloxacin. Ofloxacin is moderately effective against Gardnerella vaginalis. OFLOXACIN exhibits in vitro activity against Chlamydia trachomatis and Mycoplasma pneumoniae. Additionally, the drug is more potent against Mycobacterium tuberculosis than are standard antituberculars, but M. intracellulare is less susceptible to OFLOXACIN, and higher levels of the drug may be required for infections caused by this organism. 

PHARMACOKINETICSOFLOXACIN is rapidly and well absorbed from the gastrointestinal tract. Oral bioavailability is almost 100% and a peak plasma concentration of 3 to 4 µg per ml is achieved 1 to 2 hours after a dose of 400 mg by mouth. Absorption may be delayed by the presence of food, but the extent of absorption is not substantially affected. The plasma half life range from 5 to 8 hours; in renal impairment values of 15 to 60 hours have been reported.         About 25% is bound to plasma proteins. OFLOXACIN is widely distributed in body fluids, including the CSF, and tissue penetration is good. It crosses the placenta and is distributed into breast milk relatively high concentrations are achieved in bile. There is limited metabolism to desmethyl and N-oxide metabolites; desmethyl ofloxacin has moderate antibacterial activity. Ofloxacin is eliminated mainly by the kidneys. Excretion is by tubular secretion and glomerular filtration and 75% to 80% of a dose is excreted unchanged in urine over 24 to 48 hours, resulting high urinary concentration. Less than 5% is excreted in the urine metabolites. From 4 to 8% of a dose may be excreted in the faeces.Only small amount of ofloxacin are removed by haemodialysis.

INDICATIONS:NEFLOX is indicated for the treatment of the following bacterial infections if these are due to OFLOXACIN-sensitive pathogens:i) Lower respiratory tract infections caused by Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis and Pseudomonas aeruginosa.ii) Infections of the urinary tract.iii) Sexually transmitted diseases; Acute uncomplicated urethral and cervical gonorrhoea, urethritis and cervicitis due to Chlamydia trachomatis. Mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoea.

 Patient information: Before taking NEFLOX Before taking NEFLOX make sure your doctor or pharmacist knows:

• if you are pregnant, trying for a baby or breast-feeding
• if you are under 18 years of age
• if you suffer from liver or kidney problems
• if you have diabetes
• if you have a history of tendon problems such as tendinitis
• if you suffer with epilepsy or any other condition that causes convulsions (fits)
• if you suffer from myasthenia gravis (muscle weakening disease)
• if you have ever suffered from mental health problems
• if you have glucose 6-phosphate dehydrogenase (G6PD) deficiency or if you have a family history of this condition
• if you have ever had an allergic reaction to this or any other medicine
• if you are taking any other medicines, including those available to buy without a prescription, herbal and complementary medicines especially non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac.

 HOW TO TAKE NEFLOX NEFLOX should be taken once as a single dose, or twice a day for 3 days to 6 weeks depending on the prescription. NEFLOX Tablets should be swallowed and may be taken with or without food. Try to take the tablets at the same times each day and drink fluids liberally.You may begin to feel better quickly; however, in order to make sure that all bacteria are killed, you should complete the full course of medication. Do not take more than the prescribed dose of NEFLOX even if you missed a dose by mistake. You should not take a double dose

.IF YOU MISS A DOSETake the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.TAKING OTHER MEDICINETaking warfarin together can further predispose you to the development of bleeding problems. If you take warfarin, be sure to tell your health care professional.Many antacids and multivitamins may interfere with the absorption of and may prevent it from working properly. You should take ofloxacin either 2 hours before or 2 hours after taking these products.It is important to let your health care professional know all of the medicines you are using. 

SIDE EFFECTSThe most common side effects caused by NEFLOX which are usually mild, include nausea, sleeplessness, headache, dizziness, diarrhea, vomiting, rash, itching, external genital itching in women, vaginitis, and impaired taste.Pain, swelling, and tears of Achilles, shoulder, or hand tendons have been reported in patients receiving fluoroquinolones. The risk for tendon effects is higher if you are over 65 years old and especially if you are taking corticosteroids. If you develop pain, swelling, or rupture of a tendon you should stop taking NEFLOX, avoid exercise and strenuous use of the affected area, and contact your health care provider.If you have diabetes and you develop a hypoglycemic reaction while on NEFLOX, you should stop taking NEFLOX and call your health care professional.Convulsions have been reported in patients receiving quinolone antibiotics. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.Quinolones, including NEFLOX may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts.If you notice any side effects not mentioned in this leaflet or you have concerns about the side effects you are experiencing, please inform your health care professional.

STORINGKeep all medicines out of the reach of children, Store in a cool, dry place, away from direct heat and light.Never keep out of date or unwanted medicines. Discard them safely out of the reach of children.