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Antibiotics

Ofloxacin STADA® 200 mg

 

Pack size:

Box of 2 blisters x 10 film-coated tablets.


Composition:

Each film-coated tablet contains ofloxacin 200 mg.


Shelf-life:

48 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.
 

 

 
  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

For treatments of the following infections when caused by sensitive organisms:

  • Prostatitis.
    300 mg every 12 hours for 6 weeks.
  • Uncomplicated urethral and cervical gonorrhoea.
    A single dose of 400 mg.
  • Non - gonococcal urethritis and cervicitis.
    400 mg daily in single or divided doses.
  • Skin and soft tissue infections.
    400 mg twice daily.
  • Uncomplicated urinary tract infections:
    Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Precautions) and for some patients uncomplicated urinary tract infection is self-limiting, reserve ofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
    Lower urinary tract infection: 200 - 400 mg daily.
    Upper urinary tract infection: 200 - 400 mg daily increasing, if necessary, to 400 mg twice a day.
  • Acute bacterial exacerbations of chronic bronchitis (ABECB):
    Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Precautions) and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options.
    400 mg daily increasing, if necessary, to 400 mg twice daily.
  • Acute bacterial sinusitis (ABS):
    Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see PRECAUTIONS) and for some patients ABS is self-limiting, reserve ofloxacin for treatment of ABS in patients who have no alternative treatment options.
  • Impaired renal function:
    Following a normal initial dose, dosage should be reduced in patients with impairment of renal function.
  • Children:
    Ofloxacin is not indicated for use in children or growing adolescents.
    Duration of treatment is dependent on the severity of the infection and the response to treatment. The usual treatment period is 5 - 10 days except in uncomplicated gonorrhoea, where a single dose is recommended.
    Treatment should not exceed 2 months duration.

    Ofloxacin STADA®  200 mg  is administered orally.
  • The dose of ofloxacin is determined by the type and severity of the infection.
  • The dosage range for adults: 200 mg to 800 mg daily.
  • Oral doses up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses.
  • Generally, individual doses are to be given at approximately equal intervals.


Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to 4-quinolone antibacterials or to any ingredient of the drug.
  • Patients with a past history of tendinitis.
  • Patients with a history of epilepsy or with a lowered seizure threshold.
  • Children or growing adolescents, and in pregnant or breast-feeding women, since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.
  • Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.

     

Common

  • Nausea, vomiting, diarrhoea, abdominal pain and dyspepsia.
  • Headache, dizziness, restlessness, tremor, drowsiness, insomnia, bad dreams and visual disturbances.
  • Rash, pruritus, hypersensitivity type reactions affecting the skin.

Rare

  • Hallucination, psychotic reaction, depression, convulsions.
  • Vasculitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.

     

  • Ofloxacin, like other quinolones, can cause serious, potentially fatal hypersensitivity reactions, occasionally following the initial dose. Patients should be advised of this possibility and instructed to discontinue the drug and contact their physician at the first sign of rash, urticaria, or other skin reactions or any other sign of hypersensitivity such as rapid heartbeat, difficulty in swallowing or breathing, or any swelling indicative of angioedema (e.g., swelling of the lips, tongue, face; tightness of the throat; hoarseness).
  • Patients receiving ofloxacin should be advised to discontinue the drug and inform their clinician if they experience pain, inflammation, or rupture of a tendon and to rest and refrain from exercise until a diagnosis of tendinitis or tendon rupture is excluded.
  • Ofloxacin should be used with caution in patients with a history of psychotic disorder or in patients with psychiatric disease.
  • Administration of antibiotics, especially of prolonged, may lead to proliferation of resistant micro-organisms. The patient's condition must therefore be check at regular intervals. If a secondary infection occurs, appropriate measures must be taken.
  • Disabling and potentially irreversible serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, 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 fluoroquinolones. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue this medicine immediately at the first signs or symptoms of any serious adverse reactions. In addition, avoid the use of fluoroquinolones, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
  • Pregnancy: There are no adequate and controlled studies to date using ofloxacin in pregnant women. Since the drug, like most other fluoroquinolones, causes arthropathy in immature animals, ofloxacin should not be used in pregnant women.
  • Lactation: Ofloxacin is distributed into milk. Because of the potential for serious adverse effects of ofloxacin 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.
  • Effects on ability to drive and use machines: Since there have been occasional reports of somnolence, impairment of skills, dizziness and visual disturbances, patients should know how they react to ofloxacin before they drive or operate machinery. These effects may be enhanced by alcohol.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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