Product monograph · reviewed 31 Oct 2026
- Rx only · Schedule H
- Adults only
- Ofloxacin 200 mg + Ornidazole 500 mg
- Folflox-OZ MRP ₹108
Ofloxacin and ornidazole tablets: the short answer
Ofloxacin and ornidazole tablets (200 mg + 500 mg) combine a fluoroquinolone antibiotic with a nitroimidazole that acts on anaerobes and protozoa. In India this fixed-dose combination has one approved use: diarrhoea of mixed infection, approved by the Drugs Controller General of India on 20 January 2005 [1]. The labelled adult dose is one tablet twice daily [2].
It is not a tablet for ordinary loose motions. Indian guidance says antibiotics are not usually needed for acute watery diarrhoea in adults [3]. Because of its ofloxacin component, it must not be used in pregnancy, while breastfeeding, in children and growing adolescents, or in people with epilepsy [4][2].
Ofloxacin and ornidazole tablet uses: the one approved indication
The CDSCO list of fixed-dose combinations approved by DCG(I) records this product as serial 471: Ofloxacin (200 mg) + Ornidazole (500 mg) Tablets, for diarrhea of mixed infection, dated 20-01-2005 [1]. Other Indian brands of the same strength carry the same indication and the same dose of one tablet twice daily [2].
“Mixed infection” means a diarrhoeal illness where a bacterial cause that ofloxacin covers and an anaerobic or protozoal cause that ornidazole covers (for example Entamoeba histolytica or Giardia) are both reasonably suspected. That is a narrow clinical situation. ICMR’s antimicrobial guidelines set out how the common cases are handled [3]:
- Acute watery diarrhoea in adults: antimicrobials are not typically indicated. The exception is severe cholera in outbreak settings. Oral rehydration comes first.
- Bloody diarrhoea (dysentery): treat promptly with an antimicrobial effective against Shigella. The listed options are ciprofloxacin 500 mg twice daily for 3 days, or ceftriaxone 2 g IV as a single dose. Stool microscopy and culture should be sent.
- Amoebiasis: the listed regimen is metronidazole 500 mg three times daily for 5 days.
The fixed combination fits only where both kinds of cover are genuinely needed at once, and a stool test cannot settle the cause in time.
Uses outside the approval. Many websites list this combination for gynaecological, urinary, respiratory, dental and skin infections. Those uses are not part of the Indian approval for the 200/500 mg tablet [1], and this page does not recommend them. Single-ingredient products with their own approved indications exist for those infections.
How ofloxacin and ornidazole work together
Ofloxacin is a broad-spectrum fluoroquinolone that acts on both Gram-positive and Gram-negative bacteria [4]. It blocks bacterial DNA gyrase and topoisomerase IV, so the bacteria cannot copy their DNA.
Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria [5]. Its label covers amoebiasis, giardiasis, trichomoniasis and anaerobic infections.
One tablet covers aerobic bacteria and anaerobes or protozoa at once. That is convenient, but it brings three costs:
- No dose flexibility. Ofloxacin is adjusted for kidney function and ornidazole for liver function. A fixed tablet cannot change one without changing the other.
- Exposure to a drug that may not be needed. If only one cause is present, the patient still takes both drugs and carries both sets of side effects.
- Stewardship. In IQVIA sales data from 75 countries, 110 of 119 antibiotic fixed-dose combinations were not approved by the US FDA, and India marketed 80 of the 119 [6]. An Indian outpatient audit found ofloxacin + ornidazole among the most commonly prescribed antibiotics [7].
Ofloxacin and ornidazole tablets dosage for adults
| Situation | What the labels say |
|---|---|
| Adults, usual dose | One tablet (ofloxacin 200 mg + ornidazole 500 mg) twice daily. Duration depends on the severity of infection and is set by the prescriber [2]. |
| Timing with antacids, iron, zinc, sucralfate | Take ofloxacin 2 hours before these products, which reduce its absorption [4]. |
| Kidney impairment | Ofloxacin maintenance dose: 100 to 200 mg/day at creatinine clearance 20 to 50 mL/min, and 100 mg/day below 20 mL/min [4]. |
| Liver impairment | Ofloxacin: no more than 400 mg/day in severe hepatic dysfunction [4]. Ornidazole: double the dosing interval in marked hepatic impairment [5]. |
| Children and adolescents (age limit) | Not for use under 18. Ofloxacin is contraindicated in children and growing adolescents [4]. |
| Maximum course | Ofloxacin treatment should not exceed 2 months [4]. Diarrhoea courses are far shorter; review if there is no improvement. |
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Practical point: when a patient needs a kidney or liver dose adjustment, the fixed tablet stops being a good fit. Separate ofloxacin and ornidazole products let each drug be dosed on its own label.
Before prescribing or dispensing: a 5-question safety check
For doctors, pharmacists and stockists. Answer all five to see where a patient stands against the labels cited on this page. It does not replace clinical judgement.
1. What kind of diarrhoea is it?
2. Is the patient pregnant or breastfeeding?
3. Is the patient under 18?
4. Epilepsy or seizures, a past tendon problem with any fluoroquinolone, or allergy to a quinolone or nitroimidazole?
5. Takes warfarin, an antidiabetic, theophylline, an NSAID or a QT-prolonging drug, or has diabetes, myasthenia gravis, heart-rhythm, kidney or liver disease?
Answer all five questions
The result appears here.
Is ofloxacin and ornidazole safe in pregnancy and breastfeeding?
No. The current UK ofloxacin label states that ofloxacin must not be used during pregnancy, and that breastfeeding should be stopped during treatment [4]. An Indian prescribing information for the same 200/500 mg combination lists pregnant and breastfeeding women as contraindicated [2]. The ornidazole label adds that ornidazole should not be prescribed in early pregnancy or to nursing mothers unless absolutely necessary [5].
A pregnant or breastfeeding woman with infective diarrhoea needs a regimen chosen for pregnancy by her doctor, not this combination.
Ofloxacin and ornidazole tablets side effects
Common, usually mild
- From ofloxacin: dizziness, headache, abdominal pain, diarrhoea, nausea, vomiting, insomnia, agitation, itching and rash. The label classes these as uncommon, affecting 1 in 1,000 to 1 in 100 patients [4].
- From ornidazole: bitter or metallic taste, nausea, diarrhoea, stomach discomfort, dry mouth, loss of appetite, headache, dizziness, sleepiness and tiredness [5].
Serious: stop the tablet and seek care
Fluoroquinolones can cause prolonged, disabling and potentially irreversible reactions affecting several body systems at once [4]. The US FDA advised in 2016 that fluoroquinolones be reserved for patients with no alternative in acute sinusitis, acute bronchitis and uncomplicated urinary infection [8].
- Tendons: tendinitis and tendon rupture. Stop at the first sign of tendon pain [4].
- Aorta and heart valves: aortic aneurysm, dissection and valve regurgitation. Sudden chest, abdominal or back pain needs emergency care [4].
- Nerves and brain: peripheral neuropathy, seizures, and worsening of myasthenia gravis [4]. Ornidazole also needs caution in epilepsy and multiple sclerosis [5].
- Heart rhythm: QT prolongation [4].
- Blood sugar: both high and low blood sugar, especially in people on antidiabetic drugs [4].
- Skin and sun: photosensitivity. Avoid strong sunlight and UV during treatment and for 48 hours after [4].
- Gut: Clostridioides difficile diarrhoea. Severe or bloody diarrhoea during or after the course needs urgent review [4].
- Liver and blood: liver injury with ofloxacin [4]. Occasional leucopenia with ornidazole; leukocyte counts should be checked before and after therapy [5].
Reactions reported with this exact combination
Indian case reports describe acute pancreatitis with a positive rechallenge after an ofloxacin-ornidazole tablet bought over the counter [9], and fixed drug eruptions, including in a patient who repeatedly self-treated diarrhoea with different fluoroquinolone-nitroimidazole combinations [10][11]. Several of these patients had self-medicated, which is one more reason this is a prescription-only product.
Ofloxacin and ornidazole can both cause dizziness or drowsiness, so patients should not drive until they know how the tablet affects them [4][5].
Alcohol with ofloxacin and ornidazole: what the labels actually say
Many pages warn of a “disulfiram-like” reaction (flushing, vomiting, palpitations) with ornidazole. That warning belongs to metronidazole and tinidazole. The ornidazole label says that, unlike other nitroimidazoles, ornidazole does not inhibit aldehyde dehydrogenase, and that no disulfiram-like reaction has been reported with alcohol [5].
The advice is still to avoid alcohol, for two label-based reasons:
Drug interactions to check
| Medicine | Which component | What to do |
|---|---|---|
| Antacids, sucralfate, iron, zinc, mineral multivitamins | Ofloxacin | Absorption falls. Take ofloxacin 2 hours before them [4][2]. |
| Warfarin and other coumarin anticoagulants | Both | Both components can raise the anticoagulant effect. Monitor clotting tests [4][5]. |
| Glibenclamide, insulin and other antidiabetics | Ofloxacin | Risk of low blood sugar. Monitor glucose closely [4][2]. |
| Theophylline, NSAIDs | Ofloxacin | Seizure threshold may fall markedly [4]. |
| QT-prolonging drugs (class IA and III antiarrhythmics, tricyclics, macrolides, antipsychotics) | Ofloxacin | Use with caution [4]. |
| Probenecid, cimetidine, furosemide, methotrexate | Ofloxacin | Compete for renal tubular secretion. Use with caution [4]. |
| Vecuronium (anaesthesia) | Ornidazole | Muscle-relaxant effect is prolonged [5]. |
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Who should not take ofloxacin and ornidazole tablets
- Hypersensitivity to ofloxacin, ornidazole, any quinolone or any nitroimidazole [2][5].
- History of tendinitis or tendon disorders linked to a fluoroquinolone [4][2].
- Epilepsy or a lowered seizure threshold [4][2].
- Pregnancy and breastfeeding [4][2].
- Children and growing adolescents [4].
- G6PD deficiency: contraindicated on the UK ofloxacin label [4] and listed as a caution in Indian combination prescribing information [2].
Use with caution and monitoring in myasthenia gravis, diabetes, heart-rhythm disorders, psychiatric illness, peripheral neuropathy, kidney or liver impairment, and in older patients [4][2].
Regulatory status of ofloxacin + ornidazole in India
| Product | Status |
|---|---|
| Ofloxacin 200 mg + ornidazole 500 mg tablets | Approved by DCG(I) on 20-01-2005 for diarrhoea of mixed infection [1]. |
| Ofloxacin + ornidazole injection | Prohibited as irrational by S.O. 1852(E), 8 June 2017 [12]. |
| Ofloxacin 50 mg + ornidazole 125 mg + racecadotril 15 mg syrup | On CDSCO’s April 2025 list of 35 unapproved FDCs whose manufacture and sale were ordered stopped [13]. |
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Neither the injection ban nor the 2025 syrup order covers the 200/500 mg tablet. Both ofloxacin and ornidazole are listed in Schedule H of the Drugs Rules, so the tablet is sold only on a registered medical practitioner’s prescription. Neither drug is in Schedule H1 (the H1 fluoroquinolones are balofloxacin, gemifloxacin, levofloxacin, moxifloxacin, prulifloxacin and sparfloxacin). For the wider history of combination bans, see the 2024 list of 156 banned FDCs.
Folflox-OZ: Laafon Galaxy’s ofloxacin + ornidazole tablet
Ofloxacin and Ornidazole Tablets · Rx only
| Brand | Folflox-OZ Tablet |
|---|---|
| Generic name | Ofloxacin and Ornidazole Tablets |
| Each tablet | Ofloxacin IP 200 mg + Ornidazole IP 500 mg |
| Approved use | Diarrhoea of mixed infection in adults |
| MRP | ₹108 |
| Schedule | Schedule H · Rx only |
| Marketed by | Laafon Galaxy Pharmaceuticals |
| Manufactured at | A third-party WHO-GMP certified facility |
| Storage | Store in a cool, dry and dark place. Keep out of reach of children. |
Distributors, stockists and chemists
For Folflox-OZ rates, availability and supply to your area, message the Laafon Galaxy team directly.
Folflox-OZ enquiry on WhatsAppOther ofloxacin products in the Laafon range
ओफ़्लॉक्सासिन और ऑर्निडाज़ोल गोलियाँ (फ़ॉलफ़्लॉक्स-OZ): हिंदी में संक्षेप
- भारत में यह संयोजन (ओफ़्लॉक्सासिन 200 mg + ऑर्निडाज़ोल 500 mg) केवल एक उपयोग के लिए स्वीकृत है: वयस्कों में मिश्रित संक्रमण से होने वाला दस्त।
- साधारण पानी जैसे दस्त में आमतौर पर एंटीबायोटिक की ज़रूरत नहीं होती। पहले ORS दें और डॉक्टर से सलाह लें।
- वयस्कों की सामान्य खुराक: डॉक्टर के निर्देश अनुसार एक गोली दिन में दो बार।
- गर्भावस्था, स्तनपान, 18 वर्ष से कम उम्र और मिर्गी में यह दवा नहीं लेनी चाहिए।
- एंटासिड, आयरन या ज़िंक की दवा से कम से कम 2 घंटे पहले लें।
- टेंडन (एड़ी की नस) में दर्द, हाथ-पैर में झुनझुनी, सीने या पीठ में अचानक दर्द, या खूनी दस्त हो तो दवा बंद करके तुरंत डॉक्टर को दिखाएँ।
- यह Schedule H की दवा है: केवल पंजीकृत डॉक्टर के पर्चे पर मिलती है।
Frequently asked questions
In India the 200 mg + 500 mg tablet is approved for one use: diarrhoea of mixed infection in adults, where both a bacterial cause and an anaerobic or protozoal cause are suspected. It is not approved for ordinary watery diarrhoea or for other infections, and it is a prescription-only medicine.
The labelled adult dose is one tablet twice daily, for a duration set by the doctor according to severity. Kidney or liver impairment changes the safe dose of each ingredient differently, so in those patients single-ingredient products are usually a better fit than the fixed tablet.
No. The ofloxacin label says it must not be used during pregnancy and that breastfeeding should be stopped during treatment, and Indian prescribing information for the combination lists pregnant and breastfeeding women as contraindicated. A doctor should choose a pregnancy-appropriate regimen instead.
Take one tablet twice a day, roughly 12 hours apart, exactly as prescribed. If the patient also uses antacids, sucralfate, iron or zinc, the tablet should be taken at least 2 hours before them, because those products reduce ofloxacin absorption.
Yes. The tablet is for adults only. Ofloxacin is contraindicated in children and growing adolescents and should not be given to anyone under 18.
Avoid it. The ornidazole label states that ornidazole does not cause the disulfiram-like reaction seen with metronidazole, but it still advises against alcohol, and alcohol can worsen the dizziness and drowsiness ofloxacin may cause.
The 200 mg + 500 mg tablet is not banned: DCG(I) approved it in January 2005 for diarrhoea of mixed infection. The ofloxacin + ornidazole injection was prohibited in June 2017, and a syrup combining ofloxacin, ornidazole and racecadotril was on CDSCO’s April 2025 stop list of unapproved FDCs.
References
- Central Drugs Standard Control Organisation. Fixed dose combinations approved by DCG(I) since 1961 to 28th June 2019 [S.No. 471: Ofloxacin (200 mg) + Ornidazole (500 mg) tablets, for diarrhea of mixed infection, 20-01-2005]. New Delhi: CDSCO; 2019. Available from: cdsco.gov.in. Accessed Oct 2026.
- Torrent Pharmaceuticals Ltd. CHANGE (Ofloxacin 200 mg and Ornidazole 500 mg Tablets): abbreviated prescribing information [IN/CHANGE/FEB 2015/01/AbPI]. Ahmedabad: Torrent Pharmaceuticals; 2015 Feb. Available from: torrentpharma.com. Accessed Oct 2026.
- Indian Council of Medical Research. Guidelines for antimicrobial use. Chapter 5: Acute diarrhea treatment [Internet]. New Delhi: ICMR; date not stated. Available from: amrtg.icmr.org.in. Accessed Oct 2026.
- Viatris UK Healthcare Ltd. Ofloxacin 200 mg Tablets: Summary of Product Characteristics [Internet]. Electronic Medicines Compendium; revised Aug 2026. Available from: medicines.org.uk/emc/product/8481/smpc. Accessed Oct 2026.
- Aristo Pharmaceuticals Pvt Ltd. ORNIDA (Ornidazole Tablets 500 mg): Summary of Product Characteristics. Addis Ababa: Ethiopian Food and Drug Authority; revised 2023 Jul 5. Available from: efda.gov.et. Accessed Oct 2026.
- Bortone B, Jackson C, Hsia Y, Bielicki J, Magrini N, Sharland M. High global consumption of potentially inappropriate fixed dose combination antibiotics: analysis of data from 75 countries. PLoS One. 2021;16(1):e0241899. doi: 10.1371/journal.pone.0241899.
- Kankanala S, Joshi KP, Khan MN, Dixit R, Gunasekaran R, Gupta T, et al. Digital platform for prescription analytics and antibiotic surveillance in an outpatient department setup. Indian J Pharmacol. 2025;57(1):27-32. doi: 10.4103/ijp.ijp_201_25.
- US Food and Drug Administration. FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together [Internet]. Silver Spring (MD): FDA; 2016 May 12. Available from: fda.gov. Accessed Oct 2026.
- Bush N, Sharma V, Chandrahasan K, Patil AN. Ofloxacin-ornidazole fixed-dose combination medication-induced pancreatitis with positive rechallenge. J Family Med Prim Care. 2020;9(6):3157-9. doi: 10.4103/jfmpc.jfmpc_531_20.
- Sarkar MK, Dey S. A fixed-dose combination of ofloxacin-ornidazole induced fixed drug eruption: a case report. Cureus. 2023;15(3):e35630. doi: 10.7759/cureus.35630.
- Pal A, Sen S, Das S, Biswas A, Tripathi SK. A case of self-treatment induced recurrent fixed drug eruptions associated with the use of different fixed dose combinations of fluoroquinolone-nitroimidazole. Iran J Med Sci. 2014;39(6):584-8. Available from: PubMed 25429184.
- Ministry of Health and Family Welfare. S.O. 1852(E): prohibition of the fixed dose combination of Ofloxacin + Ornidazole injection. Gazette of India, Extraordinary; 2017 Jun 8. Available from: cdsco.gov.in. Accessed Oct 2026.
- Medical Dialogues. Govt bans 35 combination drugs, see full list [reporting CDSCO letter F.No. 4-01/2023-DC (Misc. 3), April 2025; entry 32] [Internet]. 2025 Apr. Secondary source. Available from: medicaldialogues.in. Accessed Oct 2026.
Disclaimer: This page is technical and educational information for healthcare professionals and trade buyers. It is not medical advice and does not replace a prescriber’s judgement or the product’s own label. Ofloxacin + ornidazole is a Schedule H prescription medicine; use it only as a registered medical practitioner directs. Indian statutory instruments and product labels change; check the current versions before relying on any figure here.