OGB

 

Warning:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patient taking corticosteroid drugs, and in patient with kidney, heart or lung transplants.

Composition:
Each ml infusion contains:
Ofloxacin 2 mg

Pharmacology:
Ofloxacin is a fluoroquinolone anti-infective agent, which is active against many gram-positive and gram-negative aerobic bacteria. Ofloxacin inhibits DNA topoisomerase (ATP-hydrolizing) enzyme, type II DNA topoisomerase which known as DNA gyrase.

Indications:
Ofloxacin is indicate for infections caused by susceptible microorganism:
- Acute exacerbations of chronic bronchitis.
- Community-acquired pneumonia (CAP).
- Uncomplicated skin and skin structure infections.
- Acute, uncomplicated urethral and/or cervical gonorrhea.
- Nongonococcal urethritis and cervicitis.
- Mixed urethral and/or cervical infections.
- Uncomplicated cystitis.
- Complicated urinary tract infections.
- Prostatitis.
Prior to initiation of ofloxacin therapy, appropriate specimens should be obtained for identification of the causative organism(s) and in vitro susceptibility tests. Ofloxacin therapy may be started pending results of susceptibility tests, but should be discontinued and other appropriate anti-infective therapy substituted if the organism is found to be resistant to the drug. In vitro susceptibility test should be repeated periodically during ofloxacin therapy to assess effectiveness of the drug and to detect emergence of ofloxacin-resistant strains, which may develop during therapy with the drug.

Contraindications:
Ofloxacin IV should not be used in patients known hypersensitive to ofloxacin or other quinolones.
Ofloxacin IV is contraindicated in epileptics.
Ofloxacin IV should not be used in patients with pre-existing CNS-lesions involving a lowered convulsion threshold, e.g., after cerebrocranial injuries, inflammations in the region of the CNS, or stroke.
In children or adolescent in the growth phase and in pregnant or breast-feeding women, ofloxacin IV is not indicated because the safe use in such patients has not yet been sufficiently documented and judging from animal experiments, the risk of damage to the cartilage of joints in the growing organism cannot be altogether excluded.
Patients with latent or actual effects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.

Dosage and administration:
Ofloxacin IV should only be administered by IV infusion. It is not for intramuscular, intrathecal, intraperitoneal or subcutaneous administration. Caution: rapid or bolus IV infusion must be avoided. Ofloxacin IV should be infused intravenously slowly over a period of not less than 60 minutes. Single-use vials require dilution prior to administration. The usual dose of ofloxacin IV is 200-400 mg administered by slow infusion over 60 minutes every 12 hours.
These recommendations apply to patients with mild to moderate infection and normal renal function (i.e., creatinine clearance >50 ml/min). For patients with altered renal function (i.e., creatinine clearance <50 ml/min), see the patients with impaired renal function dosing.
- Patients with normal renal function: table-1
Because there are no safety data presently available to support the use of the IV formulations of ofloxacin for more than 10 days, therapy after 10 days should be switched to the oral tablet formulation or other appropriate therapy.
Patients with impaired renal function: dosage should be adjusted for patients with a creatinine clearance <50 ml/min. After a normal initial dose, dosage should be adjusted.
Patients with cirrhosis: the excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded.
Ofloxacin IV should be used as soon as the infusion bottle has been opened. If its compatibility with other infusion solutions has not been proven, ofloxacin IV should, as a rule, be applied separately.

Side effects:
Effects on the gastrointestinal tract: stomach upsets, abdominal pain, loss of appetite, nausea, vomiting, diarrhoea. In the event of severe and persistent diarrhoea during or after treatment with ofloxacin IV, the possibility of antibiotic-induced inflammatory intestinal disease (pseudomembranous colitis) should be considered, as it is a potentially life-threatening condition. In such cases, ofloxacin IV should immediately be discontinued and appropriate therapy instituted (e.g., vancomycin oral 250 mg 4-times daily). Medicines that inhibit intestinal motility must not be used in such cases.
Effects on the nervous system: headache, giddiness, sleep disorders, unsteadiness of gait, tremor (disorder of muscular coordination), convulsions, numbness, and tingling in the limbs (paraesthesiae), visual disorders such as double vision and abnormal colour vision, disorders of taste and smell, hearing and equilibrium, vivid dreaming sometimes amounting to nightmares, psychotic reactions such as restlessness, agitation, anxiety, depression, mental confusion and hallucination. In some instances, these reactions have occured already after the first use. Any such reactions should be reported to the doctor.
Effects on the cardiovascular system: there may be a temporary fall in blood pressure during the infusion. In the event of a serious decrease in blood pressure, the infusion of ofloxacin IV should be discontinued.
Hypersensitivity reactions: cutaneous reactions such as skin eruptions (vesicular in individual cases), itching, skin manifestations associated with exposure to strong sunlight (photosensitivity), erythema multiforme, fleabite-like haemorrhages (petechiae), blistering with bleeding into the blisters (haemorrhagic bullae) and small nodules (papules) with crust formation indicating vessel involvement (vasculitis), fever, swelling of the face, tongue and/or larynx, difficult breathing sometimes progressing to life-threatening shock, in some cases even after the first use. In the event of such reactions, ofloxacin IV should be discontinued immediately, medical treatment (e.g., therapy for shock) is imparative.
Effects on the blood picture: reduction in the numbers of red and white blood cells and platelets (leukopenia, agranulocytosis, anaemia, thrombocytopenia).
Effects on the kidney, urinary tract and reproductive organs: impairment of renal function, for example, increases kidney (such as creatinine) or acute inflammation of the kidney (interstitial nephritis).
Miscellaneous effects: weakness, muscle and joint symptoms such as pain, rapid heart bead (tachycardia), inflammatory irritation of the vein wall at the infusion site, e.g., pain and reddening, thrombophlebitis. Experience to date has shown that the adverse reaction to ofloxacin treatment resolve on discontinuation of the preparation with very rare exceptions (e.g., isolated cases of smell, taste and hearing disoders).
Traffic warning: even if used in accordance with the directions, this medicine may affect alertness and reaction time to such an extent that ability to drive, cross the road safely or operate machinery may be impaired. Concurent use of alcohol increases this risk.

Warnings and precautions:
If the patient report any pain, swelling, tendinitis and tendon rupture during administration of fluoroquinolone, thus:
a. Stop the drug immediately.
b. Consult the doctor immediately for alternate drug replacement.
c. Avoid exercise and any other activity with affected tendon.
Serious, potentially fatal hypersensitivity reaction, occasionally following the initial dose, thus patient should be instructed to discontinue the drug at the first sign of rash or other hypersensitivity reactions.
Photosensitivity reaction have been reported, thus the patients should be cautioned to avoid excessive exposure to direct sunlight or UV rays. If photosensitivity occur, the drug should be discontinued.
Should be used with caution in patients with impaired renal or hepatic function since elimination of the drug may be reduced in these patients. The patients should be monitored carefully and appropriate laboratory studies should be performed prior to and during therapy with the drug.
Renal, hepatic, and hematologic systems should be evaluated periodically during prolonged ofloxacin therapy.
Patients should be instructed to drink sufficient quantities of fluids to ensure proper hydration and adequate urinary output during therapy.
Longterm therapy may result in overgrowth of nonsusceptible organisms.
In the absence of vomiting or other factors interfering with the absorption of orally administered drug, patients receiving essentially the same systemic antimicrobial therapy after equivalent doses of ofloxacin administered by either the oral or the IV route. Therefore, the IV formulation does not provide a higher degree of efficacy or more potent antimicrobial activity than an equivalent dose of the oral formulation of ofloxacin.
Ofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high doses for short period of time to treat gonorrhoea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhoea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ofloxacin should have a follow-up serologic test for syphilis after 3 months.
As with other quinolones, disturbances of blood glucose including symptomatic hyper- and hypoglicemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hipoglycemic agents or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in patient being treated with ofloxacin, discontinue ofloxacin immediately and consult a physician.

Drug interactions:
If ofloxacin IV is administered at the same time as drugs with hypotensive effects, there may be a sudden fall in blood pressure. In such cases, or if the drug is given concomitantly with barbiturate-containing anaesthetics, cardiovascular function should be monitored.
Prolongation of bleeding time has been occured during concomitant administration of ofloxacin and anticoagulants.
NSAIDs: the concomitant administration of these drugs with quinolone including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
As with some other quinolones, concomitant administration of ofloxacin may prolong the half-life of theophylline, elevate serum theophylline levels and may increase the risk of theophylline-related adverse reactions. Theophylline levels should be closely monitored and theophylline dosage adjustment made, if appropriate when ofloxacin is co-administered.

Overdose:
The most important signs to be expected following acute overdosage are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures, as well as gastrointestinal reactions such as nausea and mucosal erosions. Elimination of ofloxacin may be increased by forced diuresis.

Presentation and registration number:
Infusion bottle @ 100 ml;

ON MEDICAL PRESCRIPTION ONLY

STORE AT TEMPERATURE BELOW 30'C, PROTECT FROM LIGHT.

Manufactured by:
PT Ferron Par Pharmaceuticals

Cikarang-Indonesia

For:
PT Dexa Medica