Epicoflocin® (Ofloxacin) 200 mg Film-Coated Tablets
1. Disclaimer
This medication information is intended for healthcare professionals and is provided for educational and reference purposes only. It does not replace the approved Egyptian product information, the prescribing physician’s clinical judgment, local antimicrobial-resistance data, or patient-specific assessment. Ofloxacin is a fluoroquinolone associated with potentially serious, disabling, and sometimes persistent adverse reactions; therefore, its use should be limited to appropriate indications and guided by the current official product information and applicable antimicrobial-treatment guidelines.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Epicoflocin® contains ofloxacin, a fluoroquinolone antibacterial agent. The product listed by EIPICO is an oral 200 mg film-coated tablet. Ofloxacin has high oral bioavailability and is eliminated predominantly by the kidneys. Because fluoroquinolones can cause serious and potentially irreversible adverse reactions, ofloxacin should generally be reserved for bacterial infections for which alternative antibacterial agents are inappropriate or unsuitable, in accordance with the applicable official product information and treatment guidelines.
3. Brand Name
Epicoflocin®
Current Egyptian market listing supplied for this product: Epicoflocin 200 mg 10 f.c. tablets.
4. Category
Antibacterial; Fluoroquinolone (quinolone) antibiotic.
ATC classification for ofloxacin: J01MA01.
5. Active Ingredient
Each tablet contains:
Ofloxacin 200 mg
6. Pharmaceutical Form & Strength
Pharmaceutical form: Film-coated tablet, scored.
Strength: 200 mg ofloxacin per tablet.
Route: Oral.
The currently identified Egyptian product presentation is 10 film-coated tablets.
7. Manufacturer & Marketing Authorization Holder
Manufacturer / Product company: Egyptian International Pharmaceutical Industries Co. (EIPICO), Egypt.
EIPICO’s official product information identifies Epicoflocin as its ofloxacin product. The available public EIPICO page confirms the product and company, but does not separately state a distinct marketing-authorization-holder entity; therefore, no separate MAH is stated here beyond the identified EIPICO product company.
8. Mechanism of Action
Ofloxacin inhibits bacterial DNA replication by interfering with bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes required for DNA supercoiling, replication, transcription, repair, and segregation. The antibacterial effect is concentration-dependent and results in inhibition of bacterial growth and cell death.
9. Spectrum of Activity
Ofloxacin has in-vitro and/or clinical activity against susceptible strains of a range of Gram-negative and Gram-positive organisms, including organisms such as Escherichia coli, Haemophilus influenzae, Klebsiella spp., Proteus spp., Neisseria spp., Pseudomonas aeruginosa, Staphylococcus aureus, and selected other susceptible urinary, respiratory, genital, and enteric pathogens.
Its activity is organism- and susceptibility-dependent, and resistance to fluoroquinolones is clinically important. Therefore, an organism should not be assumed to be susceptible solely because it is listed as potentially susceptible, and local susceptibility data and microbiological testing should be considered when appropriate. Ofloxacin should not be used empirically for gonorrhea merely on the basis of historical susceptibility claims because fluoroquinolone-resistant N. gonorrhoeae is widespread.
10. Pharmacokinetics
Ofloxacin is rapidly and well absorbed after oral administration. Absolute oral bioavailability is approximately 98%, with maximum serum concentrations generally reached within 1–2 hours. Approximately 32% of circulating drug is plasma-protein bound. Food does not materially reduce overall exposure, although it can delay the time to peak concentration.
Ofloxacin undergoes relatively little metabolism. Approximately 65–80% of an oral dose is excreted unchanged in the urine within 48 hours, and a smaller fraction is excreted in feces. Renal clearance is therefore a major determinant of exposure, and dose adjustment is required in significant renal impairment.
The pharmacokinetic half-life is approximately 4–5 hours for the principal early elimination phase, with a longer terminal phase contributing little to the overall exposure; accumulation at steady state is commonly characterized using an effective half-life of approximately 9 hours.
11. Indications
According to current EIPICO product information, Epicoflocin/ofloxacin is indicated for infections caused by organisms susceptible to ofloxacin, including:
- Uncomplicated acute cystitis, when commonly recommended antibacterial agents are inappropriate.
- Acute pyelonephritis.
- Complicated urinary tract infections.
- Acute exacerbations of chronic obstructive pulmonary disease, including chronic bronchitis.
- Community-acquired pneumonia, when commonly recommended antibacterial agents are inappropriate.
- Gonococcal urethritis/cervicitis due to susceptible Neisseria gonorrhoeae.
- Nongonococcal urethritis and cervicitis.
Because of serious fluoroquinolone adverse effects, contemporary product information advises using ofloxacin only when other commonly recommended antibacterial agents are inappropriate, such as because of resistance, contraindication, intolerance, or treatment failure.
Important current guideline point: CDC guidance does not recommend routine empiric ofloxacin therapy for uncomplicated gonorrhea. The current CDC-recommended treatment is ceftriaxone 500 mg intramuscularly as a single dose for persons weighing <150 kg, or 1 g for persons weighing ≥150 kg.
12. Administration
Ofloxacin tablets should be swallowed whole with sufficient liquid and may be taken before or during meals. Doses should be taken at approximately regular intervals.
Do not take ofloxacin within 2 hours before or 2 hours after preparations containing aluminum, magnesium, iron, or zinc, mineral antacids, sucralfate, or certain buffered/chewable didanosine preparations because these products can substantially reduce absorption.
Patients should maintain adequate hydration unless fluid restriction is medically required.
13. Method of Preparation
No preparation or reconstitution is required.
This is a ready-to-use oral film-coated tablet. It should be swallowed whole with liquid. It should not be crushed or chewed unless specifically permitted by the current product labeling or a healthcare professional.
14. Contraindications
Ofloxacin is contraindicated in patients with:
- Hypersensitivity to ofloxacin, other fluoroquinolones, or relevant excipients.
- A previous fluoroquinolone-associated serious adverse reaction for which re-exposure is contraindicated according to the applicable product labeling.
- A history of fluoroquinolone-associated tendon disorder, where specified by the applicable product information.
- Children and growing adolescents where contraindicated by the approved product information.
- Pregnancy and breastfeeding where contraindicated by the applicable product information.
- Epilepsy or certain CNS disorders associated with a lowered seizure threshold, where stated in the applicable SmPC.
- Glucose-6-phosphate dehydrogenase deficiency where the approved product information lists this as a contraindication because of the potential for hemolysis.
The exact regulatory wording can vary between jurisdictions; the locally approved Egyptian product information should take precedence.
15. Warnings & Precautions
Ofloxacin carries important fluoroquinolone-class safety warnings. Serious, disabling, and potentially irreversible adverse reactions may involve several organ systems and may include tendinitis/tendon rupture, peripheral neuropathy, and central nervous system or psychiatric effects. Treatment should be discontinued and medical assessment obtained if a serious adverse reaction develops.
Particular attention should be given to:
- Tendon injury: Risk is increased in older adults, patients receiving systemic corticosteroids, patients with renal impairment, and certain transplant recipients. Tendon rupture can occur during treatment or months afterward.
- Peripheral neuropathy: Pain, burning, tingling, numbness, or weakness may occur and can potentially persist.
- CNS/psychiatric effects and seizures: Use cautiously in patients with seizure risk or other CNS disorders.
- Myasthenia gravis: Fluoroquinolones may worsen muscle weakness and should generally be avoided in known myasthenia gravis.
- Aortic aneurysm/dissection: Fluoroquinolones have been associated with an increased risk, particularly in susceptible or older patients. A sudden severe abdominal, chest, or back pain requires urgent medical attention.
- QT prolongation: Use cautiously in patients with known QT prolongation, significant electrolyte abnormalities, bradycardia, cardiac disease, or concomitant QT-prolonging medicines.
- Dysglycemia: Hypoglycemia and hyperglycemia may occur, particularly in patients with diabetes receiving insulin or sulfonylureas.
- Severe hypersensitivity: Serious anaphylactic and severe cutaneous reactions can occur, sometimes after the first dose.
- Hepatic injury: Rare severe hepatic reactions, including acute liver failure, have been reported.
- Clostridioides difficile-associated diarrhea: Significant antibiotic-associated diarrhea/colitis can occur during or after treatment.
- Photosensitivity: Excessive sunlight and artificial UV exposure should be avoided during treatment and for the period specified by the current product information.
Renal function should be assessed when clinically appropriate because ofloxacin is predominantly eliminated by the kidneys.
16. Drug Interactions
Clinically relevant interactions include:
- Antacids and mineral preparations: Aluminum, magnesium, calcium-containing products, iron, zinc, and sucralfate can reduce absorption; separate administration by at least 2 hours before or after ofloxacin.
- Didanosine buffered/chewable formulations: May reduce ofloxacin absorption.
- Warfarin and other vitamin-K antagonists: May increase anticoagulant effect; monitor PT/INR or the appropriate coagulation parameter.
- Insulin and oral antidiabetic medicines: Increased risk of dysglycemia; blood glucose monitoring is recommended.
- NSAIDs: May increase CNS stimulation and seizure risk.
- Theophylline: May increase theophylline exposure and toxicity in some patients; monitoring may be required.
- QT-prolonging medicines: Additive QT effects may occur.
- Drugs affecting renal tubular secretion, including some medicines such as probenecid, methotrexate, cimetidine, and furosemide, may require caution depending on the clinical situation.
17. Side Effects
Common or relatively frequent adverse effects include:
- Nausea, vomiting, diarrhea, abdominal discomfort/pain, and dyspepsia.
- Headache, dizziness, insomnia, and other sleep disturbance.
- Pruritus, rash, and photosensitivity.
- Vaginitis or genital irritation in women.
- Taste or other sensory disturbances.
Clinically important serious or potentially prolonged adverse reactions include tendinitis/tendon rupture, peripheral neuropathy, CNS/psychiatric reactions, severe hypersensitivity, QT prolongation/arrhythmia, dysglycemia, severe hepatic injury, severe skin reactions, C. difficile-associated diarrhea/colitis, and renal injury.
18. Use in Special Populations
Pregnancy: Ofloxacin should generally be avoided during pregnancy unless its use is specifically justified by the treating clinician and permitted by the applicable approved labeling. Current product information does not support routine use during pregnancy.
Breastfeeding: Ofloxacin passes into breast milk. Some product information contraindicates use during breastfeeding, while other regulatory labels advise an individualized risk-benefit decision because of potential serious adverse reactions in the breastfed infant. The locally approved Egyptian labeling should be followed.
Children/adolescents: Routine use is not established and is contraindicated in growing children/adolescents in the cited product information because of musculoskeletal toxicity concerns.
Elderly patients: No age-only dose adjustment is generally required, but renal function should be considered. Elderly patients have a higher risk of tendon disorders, particularly with corticosteroid therapy.
Renal impairment: Dose reduction is required when renal clearance is substantially reduced. One current 200-mg SmPC recommends, after an appropriate initial dose, approximately 100–200 mg/day for creatinine clearance 20–50 mL/min and 100 mg/day when creatinine clearance is <20 mL/min, with additional considerations for dialysis. Exact dosing should follow the locally approved product information because renal-dose tables differ by formulation and jurisdiction.
Hepatic impairment: Caution is advised because elimination may be reduced in severe hepatic dysfunction; some product information recommends limiting the total daily dose in severe hepatic impairment.
19. Storage Conditions
Store according to the approved package labeling. A commonly specified condition for ofloxacin tablets is 20–25°C, while the supplied Epicoflocin information states storage at a temperature not exceeding 30°C. For the Egyptian product, the package/locally approved labeling should be regarded as authoritative. Keep out of the reach of children.
20. Additional Sections
Antimicrobial Stewardship
Ofloxacin should be used only for proven or strongly suspected susceptible bacterial infections and should not be used for viral infections. Unnecessary use increases the risk of antimicrobial resistance and exposes patients to avoidable fluoroquinolone toxicity.
Current Status of STI Use
Historical ofloxacin regimens for gonorrhea, chlamydia, epididymitis, or PID should not be treated as current universal recommendations. Current CDC recommendations use different first-line regimens; for example, doxycycline is the preferred treatment for uncomplicated chlamydial infection, and ceftriaxone is the recommended treatment for uncomplicated gonorrhea. Fluoroquinolone-containing regimens are generally not recommended empirically for gonorrhea because of resistance.
Missed Dose
Take the missed dose when remembered unless it is close to the time of the next scheduled dose. If it is nearly time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.
Duration of Therapy
Treatment duration depends on the confirmed infection, severity, organism susceptibility, renal function, and the applicable current treatment guideline. Therapy should not be unnecessarily prolonged.
21. Frequently Asked Questions (FAQ)
Is Epicoflocin an antibiotic?
Yes. It contains ofloxacin, a fluoroquinolone antibacterial.
Can Epicoflocin be used for a common cold or influenza?
No. It does not treat viral infections.
Can it be taken with food?
Yes. Food does not materially reduce total ofloxacin exposure, although it may delay peak concentrations.
Can it be taken with antacids or iron supplements?
Not at the same time. Separate ofloxacin from aluminum/magnesium antacids, iron, zinc, sucralfate, and relevant mineral-containing products by at least 2 hours.
Is ofloxacin still recommended for gonorrhea?
Not as routine empiric treatment under current CDC guidance. Ofloxacin may only have a role where a susceptible isolate has been demonstrated and the applicable local guidance supports its use.
What is the most important symptom requiring urgent attention?
Important warning symptoms include tendon pain or swelling, sudden severe chest/abdominal/back pain, new numbness or burning sensations, severe neurologic or psychiatric symptoms, severe allergic reactions, significant hypoglycemia, or severe/persistent diarrhea.
Does kidney impairment matter with ofloxacin?
Yes. Because most ofloxacin is eliminated unchanged through the kidneys, clinically significant renal impairment requires dosage adjustment.
Can I stop the medicine when I feel better?
Treatment should be taken exactly as prescribed. However, if a serious suspected fluoroquinolone adverse reaction occurs, medical advice should be sought immediately and the drug may need to be stopped.
22. References
- EIPICO – Epicoflocin Product Prescribing Information / Therapeutic Indications. Egyptian International Pharmaceutical Industries Co.
- DailyMed – Ofloxacin Tablets, USP. Current U.S. labeling, including boxed warnings, pharmacokinetics, interactions, precautions, and adverse reactions. The cited label was updated in 2024; a newer DailyMed ofloxacin label was also identified in June 2026.
- Ofloxacin 200 mg Tablets – Summary of Product Characteristics (SmPC). Electronic Medicines Compendium (emc), including current dosing, renal adjustment, contraindications, warnings, interactions, and adverse effects.
- CDC – Clinical Treatment of Gonorrhea. Updated July 11, 2024; current treatment recommendations.
- CDC – Sexually Transmitted Infections Treatment Guidelines. Chlamydial infection, gonorrhea, epididymitis, and pelvic inflammatory disease recommendations.
- CDC – STI Treatment Guidelines 2021 / current CDC STI guidance pages. Used to distinguish historical fluoroquinolone regimens from current recommended therapy.
- Vademecum – Epicoflocin Film-Coated Tablet 200 mg, Egypt. Product identification, pharmaceutical form, route, and ATC classification.