Ofloxacin 2 mg/mL

(Sterile, Pyrogen Free, Single Dose)

Indication

Ofloxacin is used in the treatment of a wide range of infections including complicated urinary tract infections, lower respiratory tract infections, septicemia, skin and soft tissue infections, gonorrhoea, gastro-enteritis, Legionnaires’ disease, pneumonia, bladder infection, and Traveler’s diarrheo...read more

Dosage and Administration

Adult recommended dose of Ofloxacin is as follow:

Complicate urinary tract infections: 200 mg daily, increased to 400 mg twice daily for severe or complicated infections; to be given over at least 30 minutes for each 200 mg.

Lower respiratory tract infection and Septicaemia: 200 mg twice daily, increased to 400 mg twice daily for severe or complicated infections; to be given over at least 30 minutes for each 200 mg.

Skin and soft tissue infections: 400 mg twice daily, to be given over at least 30 minutes for each 200 mg. Ofloxacin is not indicated in children or growing adolescents.

Composition

Each 100 mL contains:

Ofloxacin USP ... 200 mg

Water for Injection B.P ... q.s.

Description

Ofloxacin is quinolone antibiotics. It is useful for the treatment of a number of bacterial infections. Its chemical formula is C18H20FN3O4 and molecular weight is 361.368.

Clinical Pharmacology

Mechanism of Action

Ofloxacin is a broad-spectrum antibiotic that is active against both gram-positive and gram-negative bacteria. It is a DNA gyrase inhibitor. DNA gyrase is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA...read more

Pharmacological Action

Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50%of its mirror image or enantiomer dextrofloxacin. It is extremely active against Gram negative organisms and less active against Gram positive organism. Antimicrobial Spectrum

Organisms susceptible to ofloxacin in vitro and in clinical situations include Chlamydia trachomatis, Citrobacter diversus, Enterobacter aerogenes, E. coli, Haemophilus influenza, Klebsiella pneumonia, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus, Streptoco...read more

Gram positive - Enterococcus faecalis, Staphylococcus epidermidis including methicillin resistant strains, Staphylococcus saprophyticus, Streptococcus agalactiae;

Gram negative - Aeinetobacter spp, Aeromonas hydrophila, Camphylobacter jejuni, Citrobacter freundii, Enterobacter cloacae, Haemophilus parainfluenzae, Klebsiella oxytoca, Branhamella catarrhalis, Morganella morganii, Neisseria meningitidis, Proteus valgaris, Provedencia rettgeri, Salmonella spp, Se...read more

Anaerobes - Bacteroides fragilis, Clostridium spp, Gardnerella vaginalis, Peptostreptococci;

Other organisms - Legionella pneumophila, Mycoplasma pneumoniae, Myco-bacterium tuberculosis, M. leprae, Ureaplasma urealyticum.

Pharmacokinetics

About 25% of ofloxacin is bound to plasma protein. It is widely distributed in body fluids, including cerebrospinal fluid and tissue penetration is good. It crosses the placenta and is excreted in breast milk. Relatively high concentrations are achieved in bile. There is limited metabolism to desmet...read more

Contraindication

Hypersensitivity to ofloxacin or other members of the quinolone group; or any component of the medication.

Warning and Precaution

It is used with caution in patients with epilepsy or other CNS disease which could predipose seizures and then use with caution in patients with renal impairment, failure to respond to an ophthamic antibiotic after 2 - 3 days may indicate in the presence of Warning and Precaution resistant organism ...read more

Overdose

Acute overdosage with ofloxacin has been very rare. It occurs; the excess drug should be removed by a stomach pump. The patient should be well hydrated and alkalinization of urine should be avoided. Patient should be careful and given symptomatic therapy as required. Headache, vomiting and blurred v...read more

Drug Interaction

Azlocillin, cimetidine and probenecid may increase serum levels. Forcarnet and NSAIDs have been associated with the increased risk of seizures with some quinolones. Serum levels of some quinolones are increased by loop diuretic administration. The hypoprothrombinemic effects of warfarin is enhanced ...read more

Storage

Should be stored in cool and dark place. Avoid freezing.

Do not remove inner container form carton box until ready for use.