OFCIN

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COMPOSITION:
Ofloxacin..................................... 200 mg
Excipients q.s.............................. 1 caplet
(Tapioca starch, lactose, magnesium stearate, sodium starch glycolate, aerosil, PVP K30, HPMC, PEG 6000, titanium dioxide, talc)
DOSAGE FORM: Film coated caplets.
PRESENTATION: Box of 2 blisters x 10 caplets.
PHARMACODYNAMICS: Ofcin contains the active ingredient Ofloxacin, a quinolone antibiotic, with a broad-spectrum antibacterial activity including Enterobacteriaceae, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria spp., Staphylococcus, Streptococcus pneumoniae and some other Gram-positive bacteria. Ofloxacin is more active than ciprofloxacin against Chlamydia trachomatis, Ureaplasma urealyticum, Mycoplasma pneumoniae. Ofloxacin is also active against Mycobacterium leprae as well as Mycobacterium tuberculosis and some other Mycobacterium spp. Ofloxacin has bactericidal action. Like other quinolones, ofloxacin inhibits DNA-gyrase which is an essential enzyme in the duplication, transcription and repair of bacterial DNA.
PHARMACOKINETICS: Ofloxacin is well and rapidly absorbed from the gastrointestinal tract. The oral bioavailability is about 100%. Absorption may be delayed by the presence of food, but the extent of absorption is not affected. The plasma half-life ranges from 5 to 8 hours; it is more prolonged in case of renal impairment, in which the dosage should be adjusted. Ofloxacin is widely distributed in body fluids, including cerebrospinal fluid and well penetrated into tissues. Approximately 25% of plasma concentrations is protein bound. The drug crosses the placenta and is excreted in breast milk. Relatively high concentrations are achieved in bile. Ofloxacin is mainly eliminated by the kidney.
INDICATIONS: Ofcin is used in the following cases: Pneumonia. Urethral and cervial Chlamydial infection with or without gonorrhea, uncomplicated gonorrhea, prostatitis. Skin and soft tissue infections. Bacterial colitis.
Uncomplicated urinary tract infections
Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients with uncomplicated urinary tract infection is self-limiting, reserve ofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
Acute exacerbation of chronic bronchitis
Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients with acute exacerbation of chronic bronchitis is self-limiting, reserve ofloxacin for treatment of acute exacerbation of chronic bronchitis in patients who have no alternative treatment options.
CONTRAINDICATIONS: Hypersensitivity to ofloxacin or other quinolones. Children aged less than 18 years.
WARNINGS AND PRECAUTIONS:
Disabling and potentially irreversible serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue ofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Patients with a known history of epilepsia or CNS disorders. Lower doses should be recommended to patients with renal impairment.
PREGNANCY AND LACTATION: Ofloxacin should not be indicated to pregnant women. Ofloxacin is excreted into human milk. If ofloxacin administration cannot be avoided in nursing mothers, breast-feeding should be temporarily discontinued.
VEHICLE DRIVERS AND MACHINERY OPERATORS: Cautions should be taken when driving vehicles and operating machinery.
INTERACTIONS:
Concurrent use of ofloxacin and NSAIDs (including aspirin, diclofenac, dipyrone, indomethacin, paracetamol) may lead to non-increased mental disorders (excitement, hysteria, neurosis). Concurrent use of ofloxacin and an aluminium and magnesium containing antacid may result in decreased ofloxacin serum concentrations.
ADVERSE EFFECTS:
Common: Digestive system: Nausea, vomiting, diarrhoea, abdominal pain, and gastrointestinal disturbances.
            Nerves: Headache, dizziness, fatigue, tremor, insomnia, nightmare, vision disorders.
            Skin: Pruritus, rash, hypersensitivity reactions.
Rare: Nerves: Hallucination, depression, convulsion.
       Skin: Vasculitis, Stevens-Johnson syndrome, toxic dermal necrolysis.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Inform your doctor immediately in case of overdose.
DOSAGE & ADMINISTRATION: Adults:
- Pneumonia: oral dose of 2 caplets twice daily for 10 days.
- Urethral and cervical Chlamydial infection: oral dose of 1½ caplets twice daily for 7 days.
- Uncomplicated gonorrhoea: oral dose of 2 caplets as a single dose.
- Prostatitis: oral dose of 1½ caplets twice daily for 6 weeks.
- Skin and soft tissue infections: oral dose of 2 caplets twice daily for 10 days.
- Acute exacerbation of chronic bronchitis: Oral dose of 2 caplets twice daily for 10 days.
- Urinary tract infections: Cystitis caused by E.coli or K.pneumoniae: oral dose of 1 caplet twice daily for 3 days.
       Cystitis caused by other bacteria: oral dose of 1 caplet twice daily for 7 days.
       Complicated urinary tract infections: oral dose of 1 caplet twice daily for 10 days.
In adults with impaired renal function: Creatinine clearance > 50 ml/min: the usual recommended unit dose, given twice daily.
          Creatinine clearance of 10 - 50 ml/min: the usual recommended unit dose, given once daily.
          Creatinine clearance < 10 ml/min: ½ the usual recommended unit dose, given once daily.
Or as directed by the physician.
Read the directions carefully before use.    Shelf-life: 36 months from the manufacturing date.
Consult the physician for more information.  Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
This drug is for prescriptions only.    Specifications: Manufacturer's.

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