Folflox‑OZ is a fixed‑dose combination tablet containing ofloxacin 200 mg and ornidazole 500 mg, used mainly in adults for diarrhoea due to mixed bacterial–protozoal or aerobic–anaerobic infections and other selected mixed infections, under strict medical supervision and antimicrobial‑stewardship principles.

Composition and key product facts

Folflox‑OZ and similar “OZ” brands contain ofloxacin IP 200 mg (fluoroquinolone antibiotic) and ornidazole IP 500 mg (nitroimidazole antiprotozoal/anaerobic agent) per film‑coated tablet.
Cipla’s OFLOX‑OZ label specifies indication for diarrhoea of mixed infection in adults, with a recommended adult dose of one tablet twice daily; national and international generics use the same strength and positioning for mixed bacterial–parasitic infections.

Fixed‑dose ofloxacin–ornidazole tablets are widely marketed in India and other LMICs for diarrhea, dysentery, gynecological, abdominal, urinary, respiratory, dental and skin/soft tissue infections when mixed aerobic–anaerobic or bacterial–protozoal etiology is suspected.
However, this FDC is not approved by the US FDA and has been highlighted as an example of potentially inappropriate antibiotic combinations in stewardship literature.

Pharmacology of ofloxacin

Ofloxacin is a fluoroquinolone that inhibits bacterial DNA gyrase and topoisomerase IV, blocking DNA replication, transcription and repair, leading to rapid bactericidal activity.
It has broad Gram‑negative and some Gram‑positive activity and is indicated (as monotherapy) for respiratory tract infections, urinary tract infections, skin and soft‑tissue infections, pelvic inflammatory disease and certain sexually transmitted infections.

Oral ofloxacin is generally dosed 200–400 mg every 12 hours in adults, with treatment duration and renal dose adjustment based on the infection type and creatinine clearance.
Fluoroquinolones, including ofloxacin, carry important safety warnings for tendinitis/tendon rupture, peripheral neuropathy, CNS effects and dysglycaemia, and regulators recommend reserving them for patients with no suitable alternatives in some indications.

Pharmacology of ornidazole

Ornidazole is a nitroimidazole derivative with potent activity against anaerobic bacteria and protozoa such as Entamoeba histolytica, Giardia lamblia and Trichomonas vaginalis.
It is indicated for intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, bacterial vaginosis, anaerobic infections and peri‑operative prophylaxis in abdominal and genitourinary surgery.

Ornidazole exerts its effect by reductive activation within anaerobic organisms, generating reactive intermediates that damage DNA and other critical macromolecules, resulting in cell death.
Clinical data demonstrate high cure rates in protozoal infections such as trichomoniasis, with typical adult dosing 500–1000 mg/day in divided doses, adjusted to indication and duration.

Mechanism of action of the Folflox‑OZ combination

In Folflox‑OZ, ofloxacin provides coverage against aerobic Gram‑negative and selected Gram‑positive pathogens, while ornidazole covers anaerobes and protozoa.
The combination therefore offers broad‑spectrum activity against mixed infections where both enteric bacteria and protozoa, or mixed aerobic–anaerobic flora, are likely to be involved (for example, diarrhoea with suspected amoebiasis plus invasive enteric bacteria).

Fixed‑dose combinations also improve adherence compared with two separate tablets, but at the cost of reduced dosing flexibility and potential for irrational use when only one component is needed.
From a QA/pharmacist perspective, this means the product should be positioned only for situations where dual coverage is clinically justified and narrower single‑agent regimens are not appropriate.

Indications: when to use Folflox‑OZ tablet

1. Diarrhoea and dysentery due to mixed infections

Cipla’s OFLOX‑OZ SmPC indicates use in adults for “diarrhoea of mixed infection”, and several Indian and international references support use of ofloxacin–ornidazole for acute diarrhoea and dysentery where bacterial and protozoal or anaerobic etiologies coexist.

Typical scenarios include traveler’s diarrhoea or community‑acquired diarrhoea with blood/mucus and systemic features, where Shigella, invasive E. coli and Entamoeba histolytica or Giardia lamblia are suspected and local resistance patterns favour fluoroquinolone‐based therapy.

However, WHO diarrhoea treatment guidance clearly states that antibiotics should not be used routinely for acute watery diarrhoea and are reserved for cholera, dysentery (probable shigellosis) and selected high‑risk patients.
IDSA guidelines similarly emphasise that most infectious diarrhoea is self‑limited and that empiric antibiotics are mainly for severe or high‑risk presentations, typically with single agents such as ciprofloxacin or azithromycin.

2. Gastrointestinal and intra‑abdominal infections

Product‑level information and aggregator monographs list use of ofloxacin–ornidazole tablets in intra‑abdominal and gastrointestinal infections such as infective gastroenteritis, peritonitis, post‑operative abdominal infections and amoebic dysentery where mixed aerobic–anaerobic and protozoal pathogens are a concern.

In these settings the combination may serve as part of empirical therapy, but should be aligned with hospital antibiotic policies, local susceptibility data and, ideally, infectious‑disease consultation.

3. Gynecological and pelvic infections

Ofloxacin–ornidazole combinations are widely prescribed for pelvic inflammatory disease, bacterial vaginosis, post‑abortal or post‑operative pelvic sepsis and mixed vaginal infections where anaerobes and Trichomonas vaginalis may coexist with typical bacterial pathogens.

Regulators and guidelines, however, typically recommend standard regimens (e.g. cephalosporin plus doxycycline plus metronidazole) for PID, so the FDC should not replace evidence‑based protocols without strong local justification.

4. Urinary tract and genital infections

Monographs describe use for complicated or recurrent urinary tract infections and certain sexually transmitted infections when mixed aerobic–anaerobic or protozoal involvement is suspected, leveraging ofloxacin’s urinary penetration and ornidazole’s anaerobic/urogenital protozoal coverage.

Nevertheless, standard UTI and STI guidelines generally prefer narrower, guideline‑recommended regimens; fixed ofloxacin–ornidazole should be reserved for carefully selected, culture‑directed cases or local protocol‑approved indications.

5. Respiratory, dental, skin and soft‑tissue infections

Commercial references list use in lower respiratory tract infections, dental infections, skin and soft‑tissue infections, diabetic foot, and post‑surgical wound infections where mixed aerobic–anaerobic flora are suspected.

Here again, the combination may be considered only when dual coverage is clearly indicated and no better‑studied regimen exists, with strong preference for culture guidance and de‑escalation once pathogen profiles are available.

Dosage and administration (adult)

For OFLOX‑OZ and equivalent 200/500 mg tablets, the usual adult dose is one tablet twice daily for 5–10 days, adjusted to infection severity and clinical response.

Tablets should be swallowed whole with water, preferably with food to reduce gastrointestinal intolerance and to maintain steady plasma levels; patients should be instructed to complete the full prescribed course.

Dose adjustment is required in significant renal impairment because ofloxacin is renally excreted; reference labels for oral ofloxacin recommend reducing total daily dose or extending dosing interval when creatinine clearance is below about 50 mL/min.

In hepatic impairment, ornidazole clearance may be reduced, so close monitoring and potential dose reduction or alternative regimens should be considered in moderate–severe liver dysfunction.

Use in children and adolescents is generally not recommended for this FDC: OFLOX‑OZ is specifically indicated for adults, and systemic fluoroquinolones are usually avoided in patients under 18 years unless benefits clearly outweigh musculoskeletal risks.

Key safety profile and adverse effects

Common adverse effects

Across product labels and clinical monographs, the most frequent adverse effects with ofloxacin–ornidazole combinations include:

• Gastrointestinal: nausea, vomiting, abdominal pain, diarrhoea, dyspepsia.
• CNS: headache, dizziness, insomnia, fatigue or drowsiness.
• Dermatologic/others: pruritus, rash, vaginal inflammation, metallic taste, dry mouth.

Serious and fluoroquinolone‑class adverse reactions

Ofloxacin (like other fluoroquinolones) can cause serious, potentially irreversible adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, CNS effects (seizures, psychosis), dysglycaemia and exacerbation of myasthenia gravis.
Regulatory advisories emphasise immediate discontinuation at the first sign of tendon pain, neuropathic symptoms or severe CNS manifestations, and avoiding use in patients with known myasthenia gravis.

Fluoroquinolones have also been associated with QT interval prolongation and risk of torsades de pointes in predisposed patients, especially when combined with other QT‑prolonging agents or in electrolyte imbalance.
Like other broad‑spectrum antibiotics, ofloxacin can precipitate Clostridioides difficile‑associated diarrhoea; any new severe, persistent or bloody diarrhoea during or after therapy warrants urgent evaluation and discontinuation of the drug.

Ornidazole‑related reactions

Ornidazole commonly causes gastrointestinal upset, metallic taste, headache and dizziness, and can rarely lead to cholestatic hepatitis, pancreatitis, hematologic dyscrasias and severe cutaneous reactions.
Nitroimidazoles can provoke alcohol‑intolerance (disulfiram‑like) reactions, so patients should be advised to avoid alcohol during therapy and for at least 48–72 hours after the last dose.

FDC‑specific safety concerns

Case reports document serious adverse drug reactions, including acute pancreatitis and severe cutaneous eruptions, linked specifically to ofloxacin–ornidazole FDCs, and highlight that such FDCs are often used contrary to guideline recommendations.
Pharmacovigilance and policy analyses note that most antibiotic FDCs marketed in some countries are not FDA‑approved and may be discordant with WHO Essential Medicines List, underscoring the need for stricter regulation and stewardship.

Contraindications and precautions

Folflox‑OZ–type combinations are contraindicated in patients with:

• Known hypersensitivity to ofloxacin, ornidazole, other quinolones or nitroimidazoles.
• History of tendon disorders related to fluoroquinolone use.
• Documented or suspected myasthenia gravis (risk of exacerbation).

Use requires special caution in patients with epilepsy or other seizure disorders, significant CNS disease, severe renal or hepatic impairment, known QT prolongation, uncorrected electrolyte disturbances, diabetes (risk of dysglycaemia) and in the elderly.

Pregnancy and breastfeeding use should be avoided unless no safer alternative exists, because systemic fluoroquinolones and nitroimidazoles have limited safety data and potential fetal/neonatal risks; product information and standard references recommend against routine use in these populations.

Rational use in diarrhoea:

WHO diarrhoea guidelines and paediatric antibiotic reviews consistently advise against routine antibiotic use for acute watery diarrhoea; management should prioritise ORS, zinc (in children), nutrition and assessment of dehydration.

Antibiotics are reserved mainly for dysentery (Shigella), suspected cholera with severe dehydration, and selected high‑risk groups such as patients with severe malnutrition, immunosuppression or systemic sepsis.

IDSA infectious diarrhoea guidelines suggest empiric antimicrobial therapy (usually ciprofloxacin or azithromycin, not FDCs) only for adults with severe or inflammatory diarrhoea, high fever, dysentery or significant traveller’s diarrhoea, again emphasising culture‑guided de‑escalation.

Despite this, Indian and LMIC data show heavy community use of ofloxacin–ornidazole FDCs for uncomplicated diarrhoea, increasing cost, adverse events and antimicrobial resistance without clear benefit.

For prescribers, pharmacists and QA teams, positioning Folflox‑OZ strictly for adult diarrhoea of mixed infection and other well‑defined mixed infections, rather than routine “loose motion”, is essential to align with stewardship and regulatory expectations.

Practical prescribing and counselling points

From a professional standpoint, key points when using Folflox‑OZ or equivalent OZ tablets include:

• Advise strict avoidance of alcohol during treatment and for at least 48–72 hours after the last dose because of ornidazole’s potential disulfiram‑like reaction and hepatotoxicity risks.
• Confirm clinical probability of mixed bacterial–protozoal or aerobic–anaerobic infection before selecting the FDC; avoid for simple viral or non‑inflammatory diarrhoea.
• Use adult dosing of one tablet twice daily for 5–10 days, with adjustment for renal/hepatic impairment and de‑escalation based on culture and clinical response.
• Review concomitant QT‑prolonging drugs, antidiabetics, NSAIDs, steroids (tendon risk) and antiepileptics; document drug–drug interaction assessment.
• Counsel patients about tendon pain, neuropathic symptoms, severe diarrhoea, rash or jaundice, and instruct them to stop the drug and seek urgent care if these occur.

Short Description product:

• Brand/INN: Folflox‑OZ (representative of ofloxacin 200 mg + ornidazole 500 mg tablets).
• Dosage form: Film‑coated oral tablets, typically in 10‑tablet blisters, often packed as 10×10 strips per carton.
• Composition: Ofloxacin IP 200 mg + Ornidazole IP 500 mg, with conventional tablet excipients.
• Therapeutic indication (core label): Diarrhoea of mixed infection in adults; many generics also describe use in other mixed bacterial–protozoal infections (GI, GU, respiratory, dental, skin/soft‑tissue) in line with local protocols.
• Posology (adults): One tablet twice daily for 5–10 days, or as directed by the physician, with dose adjustments in renal/hepatic dysfunction.
• Special warnings: Reserve fluoroquinolone use where benefits clearly outweigh risks; monitor for tendon disorders, neuropathy, CNS events, severe diarrhoea and hepatotoxicity.

FAQs

References

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Reviewed by;

Dr. Yogesh Chaudhary (B. Pharma)

Senior Pharmacist at S.N. Medical College, Agra-(UP)

Disclaimer:

Disclaimer: All the information and articles available on this site are for educational purposes only. The information given here should not be used for the diagnosis or treatment of any health problem or disease without expert advice. The advice of a qualified medical practitioner should always be sought for medical examination and treatment.