Ofloxacin IP 200 mg tablet

Clostridium difficile - associated disease:

Diarrhoea, particularly if severe and/or persistent, occuring during treatment or in the initial weeks following treatment with ofloxacin or with various other antibiotics, but especially broad spectrum antibiotics, may be sympomatic of Clostridium difficile-associated disease, the most severe form of which is pseudo-membranous colitis.

If a diagnosis of pseudomembranous colitis is suspected, ofloxacin should be stopped immediately and appropriate specified antibiotic therapy should be started without delay (e.g. vancomycin or metronidazole).

Tendinitis, less frequently observed, may occasionally lead to rupture, involving more particularly Achilles tendon, and occurring especially in elderly patients. Rupture seems to be favoured by treatment with corticosteroids. The onset of signs of tendinitis requires to stop the treatment, to rest both Achilles tendons by appropriate immobilisation or special heel pieces, and to take orthopaedic advice.

Ofloxacin may aggravate myasthenia gravis.Ofloxacin may negativate the isolation of Mycobacterium tuberculosis, giving falsenegative results, in the bacteriological diagnosis of tuberculosis.
The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and haemodialysis patients. Although this has not been reported, the possibility cannot be ruled out that fluoroquinolones may trigger an attack of porphyria in predisposed patients.

Hypersensitivity to ofloxacin or related chemotherapeutic agents of the quinolonederivative group.

It should not be administered to pregnant or lactating women.
It should not be administered to patients with cerebral convulsive disorders.ATMOFLOX is contra-indicated in epileptics. Tablet must not be used in patients with pre existing central nervous system lesions involving a lowered convulsant threshold e.g. after cerebrocranial injuries, inflammations in the region of the central nervous system, or stroke.
In children or adolescents in the growth phase

In patients with a history of tendon disorders related to floroquinolone adminstration.

Some of other side effects are -

Diarrhea

Upset stomach

Vomiting

Mild skin rash

Oral

Disclaimer:To be taken only after consulting with the doctor.

Ofloxacin is a quinolone carboxylic acid derivative which has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative bacteria. Ofloxacin exerts its effect by inhibiting the bacterial DNA gyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication.The mode of action, range of activities, duration of action and MIC levels have been established mainly by means of in vitro studies using bacterial isolates. Ofloxacin is readily absorbed and excreted mainly unchanged in the urine. The serum elimination half-life is approximately 6 to 8 hours.
Following oral administration, ofloxacin peak serum concentrations are reached within one to two hours. The plasma level usually achieved by the recommended dosage regimens (3 to 4 micrograms/mL) is in excess of the average MIC which is 1 to 2 micrograms/mL, for susceptible organisms. Ofloxacin has a low (9,4%) plasma protein binding. Ofloxacin has a bactericidal effect. In vitro tests show that strains in which the sensitivity varies include pneumococci and ureaplasma urealyticum.
Strains that are normally resistant are:
Peptococcus, Peptostreptococcus, Eubacterium spp., Fusobacterium spp. and Treponema pallidum.

WHAT OTHER DRUGS WILL AFFECT OFLOXACIN?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ofloxacin, especially:
• Theophylline
• A diuretic or "water pill"
• Heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others
• Medicine to treat depression or mental illness--amitriptylline, clomipramine, clozapine, desipramine, duloxetine, iloperidone, imipramine, nortriptyline, ziprasidone, and others
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

• Ofloxacin is usually taken every 12 hours. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
• Take this medicine with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking ofloxacin.
• You may take ofloxacin with or without food. Take the medicine at the same time each day.
• Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ofloxacin will not treat a viral infection such as the common cold or flu.
• If you are being treated for gonorrhea, your doctor may also have you tested for syphilis, another sexually transmitted disease.
• Do not share this medicine with another person (especially a child), even if they have the same symptoms you have.
• This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking ofloxacin.
• Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, a fluorinated carboxyquinolone, is the racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The chemical structure is:

C18H20FN3O4 M.W. 361.4

Ofloxacin is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin at room temperature, as defined by USP nomenclature, indicate that ofloxacin is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu+2 > Ni+2 > Pb+2 > Zn+2 > Mg+2 > Ca+2 > Ba+2.