Community Pharm PCL


Community Pharm PCL
Full Prescribing Info
Each film-coated tablet contains Ofloxacin 100 mg or 200 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: Ofloxacin usually is bactericidal in action. Ofloxacin inhibits DNA synthesis in susceptible organisms via inhibition of the enzymatic activities of 2 members of the DNA topoisomerase class of enzymes, DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Pharmacokinetics: Ofloxacin is rapidly and almost completely absorbed from the GI tract following oral administration. The drug doses not undergo appreciable first-pass metabolism. The oral bioavailability of ofloxacin is 85-100% in healthy, fasting adults and peak serum concentrations of the drug generally are attained within 0.5-2 hours. Ofloxacin is widely distributed into body tissues and fluids following oral administration. The apparent volume of distribution of ofloxacin averages 1-2.5 L/kg. Ofloxacin is 20-32% bound to serum proteins; the drug is bound mainly to albumin. Ofloxacin crosses the placenta and is distributed into cord blood and amniotic fluid. The drug is distributed into milk following oral administration. The elimination half-life of ofloxacin is 4-8 hours. Elimination is mainly by renal excretion; 4% to 8% is excreted in the feces. Renal clearance of ofloxacin average 133-200 mL/min in adults with normal renal function.
For the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the following designated microorganisms in the infections listed.
Acute bacterial exacerbations of chronic bronchitis: Due to Haemophilus influenza or Streptococcus pneumonia.
Acute pelvic inflammatory disease (including severe infection): Due to Chlamydia trachomatis and/or Neisseria gonorrhoeae.
Acute, uncomplicated urethral and cervical gonorrhea: Due to N. gonorrhoeae.
Community-acquired pneumonia: Due to H. influenza or S. pneumonia.
Complicated urinary tract infections: Due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus, or Pseudomonas aeruginosa. Although treatment of infections due to C. diversus and P. aeruginosa in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
Mixed infections of the urethra and cervix: Due to C. trachomatis and N. gonorrhoeae.
Nongonococcal urethritis and cervicitis: Due to C. trachomatis.
Prostatitis: Due to E. coli.
Uncomplicated cystitis: Due to C. diversus, Enterobacter aerogenes, E. coli, K. pneumonia, P. mirabilis, or P. aeruginosa.
Uncomplicated skin and skin structure infections: Due to Staphylococcus aureus (methicillin-susceptible), S. pyogenes, or P. mirabilis.
Dosage/Direction for Use
Adults: Usual dosage: 200 mg to 400 mg orally every 12 hours. (See Table.)

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Mode of Administration: Ofloxacin is administered orally. While presence of food in the GI tract can decrease the rate and/or extent of absorption of ofloxacin, this is not usually considered clinically important and the manufacturer states that the drug can be given without regard to meals. Milk and yogurt do not appear to affect GI absorption of ofloxacin.
If acute overdosage of the ofloxacin occurs, the stomach should be emptied by inducing emesis or by gastric lavage. Supportive and symptomatic treatment should be observed carefully; adequate hydration should be maintained. Because ofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis, these procedures should not be relied on to enhance elimination of the drug from the body.
Ofloxacin is contraindicated in patients with a history of hypersensitivity to the drug or to other quinolones.
Special Precautions
Because fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all age groups, patients receiving ofloxacin should be informed of this potential adverse effect and the drug should be discontinued if pain, swelling, inflammation, or rupture of a tendon occurs.
Ofloxacin may cause CNS stimulation that potentially could result in tremor, restlessness, lightheadedness, mental confusion, hallucinations, and/or seizures, the drug should be used with caution in patients with known or suspected CNS disorders that predispose to seizures or lower the seizure threshold.
Use of ofloxacin should be avoided in patients with a history of QT interval prolongation, in those with uncorrected electrolyte disorders (e.g., hypokalemia) and in those receiving class IA or class III antiarrhythmic agents.
Patients receiving ofloxacin should be cautioned to avoid excessive exposure to direct sunlight or artificial ultraviolet light and to discontinue therapy if phototoxicity occurs.
Ofloxacin should be used with caution in patients with impaired renal or hepatic function since elimination of the drug may be reduced in these patients.
Use In Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Ofloxacin is distributed into milk. Because of the potential for serious adverse effects of ciprofloxacin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Adverse Reactions
Cardiovascular: Chest pain (1% to 3%), cardiac arrest, hypotension, vasodilation (less than 1%).
Central nervous system: Sleep disorders, nervousness (1% to 3%); anxiety, cognitive change, dream abnormality, euphoria, tremor, vertigo (less than 1%).
Dermatologic: Angioedema, urticaria, vasculitis (less than 1%).
Genitourinary: Vaginal discharge (1% to 3%); external genital pruritus in women (1% to 6%); burning/irritation/pain/rash of female genitalia, dysmenorrhea, dysuria, menorrhagia, urinary frequency/pain/retention (less than 1%).
Respiratory: Cough, rhinorrhea, respiratory arrest (less than 1%).
Special senses: Dysgeusia (1% to 3%), photophobia, tinnitus, decreased hearing acuity (less than 1%).
Miscellaneous: Decrease appetite, GI distress, pharyngitis, trunk pain (1% to 3%); hyperglycemia, hypoglycemia (1% or more); arthralgia, asthenia, diaphoresis, epistaxis, extremity pain, myalgia, pain, thirst, vasculitis, weight loss (less than 1%).
Drug Interactions
Concomitant administration of ofloxacin and antacids (magnesium, aluminium or calcium-containing) may decrease absorption of oral quinolones resulting in decreased serum and urine concentrations of the anti-infectives.
Concomitant use of ofloxacin and antiarrhythmic agents class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) may increase the risk of QT interval prolongation.
Coadministration of ofloxacin and corticosteroids may increase the risk of severe tendon disorders (e.g., tendinitis, tendon rupture), especially in geriatric patients older than 60 years of age.
Concomitant use of ciprofloxacin and nonsteroidal anti-inflamatory agents could increase the risk of CNS stimulation (e.g., seizure).
Concomitant use of ciprofloxacin and tizanidine may increase serum concentrations and AUC of tizanidine and potentiated the hypotensive and sedative effects of the drug.
Concomitant administration of ofloxacin and coumarin anticoagulant may increase prothrombin times.
Concomitant use of ofloxacin and theophylline may result in higher and prolonged serum theophylline concentrations and may increase the risk of theophylline-related adverse effects.
Store in well-closed containers at a temperature below 30°C and protect from light.
MIMS Class
ATC Classification
J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
FC tab 100 mg x 25 x 10's. 200 mg x 10 x 10's.
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