Generic Name

Composition

Therapeutic Category

Division

Ofloxacin

Ofloxacin 200mg Tablets

Ofloxacin 400mg Tablets

Ofloxacin 50mg/5ml Dry Syrup

Fluoroquinolone Antibiotic

NEXUS

    BRAND COMPOSITION DESCRIPTION
     OFROX 200  Each film coated tablet contains:
    Ofloxacin USP                                200mg
    OFROX 200 is a yellow oblong film coated tablet with 'T' imprinted on one side.
    OFROX 400

    Each film coated tablet contains:

    Ofloxacin USP                               400mg

    OFROX 400 is a yellow oblong film coated tablet with break line on one side.
    OFROX Suspension

    Each 5 ml contains:

    Ofloxacin USP                               50mg
    OFROX suspension contains yellow coloured flavoured suspension filled in amber coloured PET bottle.
    PHARMACOLOGY

    Pharmacotherapeutic Group: Fluoroquinolone antibiotics

    Pharmacodynamic properties:

    Ofloxacin is a fluoroquinolone which inhibits bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination. It has activity against a wide range of gram-negative and gram-positive microorganisms.

    Pharmacokinetic properties:

    Absorption:Rapidly and well absorbed from the GI tract (oral), peak plasma concentrations after 0.4-2 hr. Rate, but not extent delayed by the presence of food.  Bioavailability: 98%

    Distribution: Widely distributed into the body fluids, CSF, tissues, bile (high concentrations), crosses the placenta and enters the breast milk. Protein binding: 20-32%

    Metabolism:

    Excretion:  Via urine within 24-48 hr by tubular secretion and glomerular filtration (75-80% as unchanged,

    INDICATIONS

    Chronic bronchitis, community acuired pneumonia, SSTI, gonorrhoea, nongonococcal urethritis, cervcitis, typhoid fever, UTI

     DOSE

    Adult: 200-400 mg every 12 to 24 hr for 7-14 days

     

    PATIENT INFORMATION

     Administration:

    • May be taken with or without food.

    Food Interaction: 

    • Reduced absorption with multivitamins.

    Pregnancy:   Category C

    Nursing Mothers:

    Ofloxacin can pass into breast milk and may harm a nursing baby. Do not breast-feed while using ofloxacin.

    Storage: Store tablets at room temperature.

    Missed dose: Take the missed dose as soon as you remember

    • Skip the missed dose if it is almost time for your next scheduled dose
    • Do not take extra medicine to make up the missed dose.
    CONTRAINDICATIONS

    Hypersensitivity to ofloxacin or other quinolones, severe hepatic or renal impairment, past history of tendinitis, History of epilepsy or lowered seizure threshold. Children or growing adolescents, history of myasthenia gravis, pregnancy & lactation.

     SPECIAL PRECAUTIONS

    Renal impairment, psychiatric patients or history of psychiatric disease. Avoid excessive exposure to sunlight & UV rays

     ADVERSE DRUG REACTIONS

    Severe AEs: Anaphylaxis; rarely seizures

    Common AEs: GI disturbances, headache, dizziness, sleep disorders, restlessness, tachycardia, rash, itch, nausea

     DRUG INTERACTIONS

    Probenecid decreases elimination. Antacids may reduce ofloxacin absorption, avoid for 2 hr either side of administration. Cimetidine may increase ofloxacin concentrations. Monitor blood glucose in patients on antidiabetic medication

    PRESENTATION

    OFROX 200: Each box is supplied with 10 strips of 10 tabs packed in blisters.

    OFROX 400: Each box is supplied with 10 strips of 10 tabs packed in blisters.

    OFROX suspension: Each phial is supplied with 60 ml suspension.