OFLOMED-200

OFLOMED – 200

 

COMPOSITION

Each film coated tablet contains :

-Ofloxacin…………………………………………………………200 mg

-Excipients : q.s. …………………………………one film coated tablet

THERAPEUTIC PROPERTIES :

Synthetic Antibiotic Belonging to the Fluoroquinolone Class.

INDICATIONS :

• The indications are limited in adults:
  • Treatment of urinary tract infections.
  • Treatment of severe infections in prostatic manifestations.
  • Treatment of gynecological infections.
  • Adjunct treatment for osteoarticular infections.
  • Treatment of bronchial suppuration.
  • Treatment of the following ENT infections:
  • Chronic sinusitis,
  • Acute exacerbations of chronic otitis (of any nature) and of air cavities,
  • Septicemia

CONTRAINDICATIONS :

• History of tendinopathy with a fluoroquinolone.
• Hypersensitivity to ofloxacin or to any other quinolone.
• Children until the end of the growth period.
• Pregnant or breastfeeding women.

IN CASE OF DOUBT, IT IS ESSENTIAL TO CONSULT

THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

WARNINGS AND PRECAUTIONS:

• Avoid exposure to sunlight and UV radiation during the treatment due to the risk of photosensitization.
• Ofloxacin’s activity against Mycobacterium tuberculosis can negatively affect the search for tuberculosis bacilli (BK), especially in pulmonary or osteoarticular tuberculosis.
• Ofloxacin should be used cautiously in patients with a history of seizures or factors that predispose to seizures (see side effects).
• Ofloxacin should be used cautiously in patients with myasthenia.

SIDE EFFECTS :

• Gastrointestinal issues: nausea, stomach pain, diarrhea, vomiting.
• Skin reactions: erythematous maculopapular rashes, vascular purpura.
• Musculoskeletal issues: muscle and/or joint pain, tendinitis, and Achilles tendon rupture, which may occur within the first 48 hours of treatment and can become bilateral (see contraindications, warnings, and precautions).

DOSAGE :

Oral route

Reserved for adults:

• In patients with normal renal function: 400 mg/day in two doses (one tablet in the morning and one in the evening).
• For the treatment of bronchial suppuration, the dosage is 400 mg/day in a single dose. This dose may be increased to 600 or 800 mg/day for patients with higher body weight or in cases of severe infection, especially in immunocompromised individuals.
• For the treatment of upper gynecological infections, the treatment duration should be 3 weeks.
• In patients with renal insufficiency: The dosage should be adjusted according to the degree of renal insufficiency by spacing out the doses:
  • Mild to moderate renal insufficiency (creatinine clearance above 20 mL/min): one 200 mg dose every 24 hours.
  • Severe renal insufficiency (creatinine clearance ≤ 20 mL/min): one 200 mg dose every 48 hours. It is recommended to monitor serum drug levels in patients with renal insufficiency or those undergoing hemodialysis.
• In elderly patients: The dosage should be adjusted based on the degree of renal insufficiency:
  • For creatinine clearance between 20 and 50 mL/min: the unit dose should be reduced by half, i.e., one 200 mg dose every 24 hours.
  • For creatinine clearance below 20 mL/min: one 200 mg dose every 48 hours.

CONSERVATION

 Store at a temperature below 30°C, protected from light and moisture.

 Keep out of the reach and sight of children.

 Do not use after the expiry date indicated on the packaging