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Oloxin

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Ofloxacin

PRESENTATION: Tablet 200mg x 10’s

DESCRIPTION

OLOXIN® (ofloxacin tablets) Tablets is 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.

Its empirical formula is C 18 H 20 FN 3 O 4 , and its molecular weight is 361.4.

 

INDICATIONS AND USAGE

OLOXIN (ofloxacin tablets) Tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible microorganisms in the infections listed below.

Acute bacterial exacerbations of chronic bronchitis, Community-acquired Pneumonia, Uncomplicated skin and skin structure infections, Acute, uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis and cervicitis, Mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae, Acute pelvic inflammatory disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae, Uncomplicated cystitis, Complicated urinary tract infections, Prostatitis. Biliary tract infections, Typhoid fever, Peritonitis & Septicemia. Ophthalmic infections and ENT infections

 

CONTRAINDICATIONS

OLOXIN (ofloxacin) is contraindicated in persons with a history of hypersensitivity associated with the use of ofloxacin or any member of the quinolone group of antimicrobial agents.

 

PRECAUTIONS

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

In lactating females, a single oral 200-mg dose of ofloxacin resulted in concentrations of ofloxacin in milk that were similar to those found in plasma. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients and adolescents below the age of 18 years have not been established.

 

ADVERSE REACTIONS

Gastrointestinal: nausea, vomiting, diarrhea, anorexia

Neurological: headache, dizziness, insomnia, visual disturbance

Allergic reaction: pruritus, fever, rash

 

DOSAGE AND ADMINISTRATION

The usual dose of OLOXIN (ofloxacin tablets) Tablets is 200 mg to 400 mg daily usually for 5-7 days depending on the severity and the nature of infection.

Doses greater than 400mg should be given in two divide doses. It is recommended that treatment be continued for at least 3 days after the body temperature has returned to normal and the symptoms have subsided. It may be necessary to increase the dose up to two 400mg tablets daily in severe infections or in those suspected to be caused by the Streptococcus group of pathogens. Uncomplicated UTI – 200mg daily. Uncomplicated gonorrhoea – 200mg single dose. Prostatitis – 300mg twice a day up to 6 weeks.

Patients with Impaired Renal Function: No dosage adjustment is needed if creatinine clearance >50mL/min. In patients with impaired renal function, after a normal initial dose, dosage should be adjusted as follows: Creatinine clearance – 20 to 50mL/min – 100 to 200mg every 24 h, <20mL/min – 100mg every 24h.


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