Cefixime and ofloxacin tablets: the short answer
Cefixime and ofloxacin tablets (cefixime 200 mg + ofloxacin 200 mg) are a fixed-dose combination (FDC) approved by CDSCO on 26 April 2010 for exactly two indications in adults: typhoid fever and urinary tract infection.[1] It is not approved for bronchitis, pneumonia, gonorrhoea, or skin infections, whatever brand marketing may suggest.
The clinical picture has shifted since that 2010 approval. Pooled Indian surveillance data from 2015 onward puts fluoroquinolone resistance in Salmonella Typhi at 82%, against just 3% for third-generation cephalosporins.[5] In most Indian enteric-fever cases the ofloxacin component is the weaker half of this tablet, not the stronger one.
Cefixime is a Schedule H1 drug.[4] It is sold only against a registered medical practitioner’s prescription, and the pharmacy must record the sale in a separate H1 register.
Ceffon-OX at a glance
- CompositionCefixime IP 200 mg + Ofloxacin IP 200 mg
- Dosage formFilm-coated tablet
- Pack10 x 10 Alu-Alu
- MRPRs 199 per strip of 10
- ScheduleH1 (cefixime, entry 9)
- Marketed byLaafon Galaxy Pharmaceuticals
Ceffon-OX is Laafon Galaxy Pharmaceuticals’ brand of the cefixime and ofloxacin combination. Cefixime is a beta-lactam, which under WHO-GMP and Schedule M cross-contamination requirements must be made on a dedicated, segregated line. Ceffon-OX is therefore manufactured for Laafon Galaxy at Athens Life Sciences, Kala Amb, a WHO-GMP certified beta-lactam facility, rather than in-house.
Check the strip: the three-ingredient version is not an approved FDC
Several cefixime + ofloxacin brands in India add lactic acid bacillus (LAB) 60 million spores as a third ingredient. That three-ingredient combination has no CDSCO approval on record, and on 16 April 2025 the Drugs Controller General (India) wrote to all State and UT Drug Controllers directing that 35 unapproved FDCs not be manufactured, sold or distributed. The annexure to that communication (File No. 4-01/2023-DC (Misc. 3)) lists at item 8: “Cefixime IP 200mg + Ofloxacin IP 200mg + Lactic acid bacillus 60 million spores tablets”.[2][3]
The two-ingredient combination described on this page is a different product and is not affected: it holds a valid 2010 CDSCO approval[1] and does not appear on the consolidated list of FDCs prohibited under section 26A of the Drugs and Cosmetics Act.[12] If you are holding a strip, read the composition panel rather than the brand name.
What CDSCO actually approved, and what it did not
The approval record is specific, and it is narrower than the indication lists that circulate on retail and brand pages. CDSCO’s list of drugs approved between 1 January and 31 December 2010 carries the combination at entry 83.[1]
| Combination | Approved indication | Approval date |
|---|---|---|
| Cefixime 100/200 mg + Ofloxacin 100/200 mg tablets | Typhoid fever and urinary tract infection in adults | 26/04/2010 |
| Cefixime SR 200/400 mg + Ofloxacin SR 200/400 mg tablets | Additional strength of the above | 31/08/2010 |
| Cefixime + Ofloxacin + Lactic acid bacillus | No approval on record; named in the April 2025 halt directive | — |
Scroll the table sideways on a phone.
Indications commonly claimed but not approved for this FDC
Bronchitis, pneumonia, sinusitis, otitis media, skin and soft-tissue infections and gonorrhoea appear on many pages describing this combination. None of them is within the approved scope of the cefixime + ofloxacin FDC, which is confined to typhoid fever and adult UTI.[1] Cefixime as a single agent has its own broader approved uses; that is a different product with a different licence.
The resistance problem that changed this combination’s value
When this FDC was approved in 2010, adding a fluoroquinolone to a third-generation cephalosporin was a defensible hedge. Indian surveillance since then has moved decisively in one direction. A 2026 systematic review and meta-analysis in PLOS Neglected Tropical Diseases pooled 188 studies of culture-confirmed Salmonella Typhi isolates from India covering 1977 to 2024.[5]
| Antimicrobial class | Pooled resistance, isolates from 2015 onward | Direction of travel |
|---|---|---|
| Fluoroquinolones (ofloxacin, ciprofloxacin) | 82% (95% CI 74–87) | Rose from 2% in 1990–94 to 85% in 2015–19, then declined slightly |
| Third-generation cephalosporins (cefixime, ceftriaxone) | 3% (95% CI 2–4) | Below 5% throughout the study period |
| Azithromycin | 3% (95% CI 1–6) | Below 8% throughout |
| Carbapenems | Below 2% | Negligible |
| Multidrug resistance (chloramphenicol, ampicillin, co-trimoxazole) | Near 0% from 2020 | Fell from a 1990–94 peak of 65% |
Source: pooled meta-analysis of Indian isolates. The authors note that many isolates came from major cities, so national generalisation warrants caution, and resistance varies markedly between states.[5]
Read plainly: in roughly four of five Indian S. Typhi isolates the ofloxacin in this tablet contributes little. The cefixime component is doing the work. That does not make the FDC useless, but it does undercut the common marketing claim that combination therapy is now the only workable option for typhoid in India. Two independent guidance sources say the opposite of that claim:
- US CDC clinical guidance for typhoid and paratyphoid fever, last reviewed 18 April 2024, states directly: “Do not use fluoroquinolones for empiric treatment.” It positions ceftriaxone and azithromycin as the appropriate empiric options for most countries.[6]
- The Indian Academy of Pediatrics Standard Treatment Guidelines for enteric fever make cefixime 20 mg/kg/day the first-line outpatient choice and ceftriaxone 100 mg/kg/day the choice for hospitalised patients, with treatment continued for at least 7 days after fever settles or 14 days in total, whichever is longer. They state that quinolones are contraindicated in the paediatric age group and should not be used for enteric fever, and they do not recommend a cefixime + ofloxacin combination at all.[7]
Is a cefixime + ofloxacin FDC a reasonable choice here?
An orientation aid for pharmacy and prescribing context. It does not replace culture, sensitivity testing or clinical judgement.
1. Patient age
2. Indication under consideration
3. Culture and sensitivity result
The two molecules, separately
Cefixime — third-generation cephalosporin
Cefixime is a beta-lactam that kills bacteria by disrupting synthesis of the bacterial cell wall.[8] It is taken every 12 or 24 hours, with or without food, at about the same time each day.[8]
Cautions worth stating to the patient: cefixime may reduce the effectiveness of hormonal contraceptives, so a backup method is advised. Report any allergy to cephalosporins or penicillins, and any history of colitis, gastrointestinal disease, kidney disease or liver disease.[8]
Common effects: diarrhoea, nausea, vomiting, abdominal pain, gas, heartburn. Seek care urgently for: watery or bloody stools with cramps or fever; rash, itching or hives; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips or eyes.[8]
Ofloxacin — fluoroquinolone, and it carries boxed warnings
Ofloxacin acts on bacterial DNA replication and repair. Its safety profile is the reason regulators have progressively narrowed fluoroquinolone use, and it is the part of this tablet that deserves the most attention.[9]
- Tendinitis and tendon rupture — risk persists during treatment and for up to several months afterwards, and is highest above age 60.[9]
- Peripheral neuropathy — nerve damage can begin soon after the first doses and may not resolve after stopping the drug.[9]
- Central nervous system effects — seizures, tremor, hallucinations, mood change and sleep disturbance, possible after the first dose.[9]
- Myasthenia gravis — may worsen muscle weakness with severe breathing difficulty or death; the condition is a contraindication.[9]
Practical points: separate the dose from antacids and from aluminium, calcium, magnesium, iron or zinc supplements by at least two hours. Use caution alongside NSAIDs and in patients with cardiac history. Not for use under 18 years. Photosensitivity is common, so advise sun protection.[9]
Dosage and administration
This is a Schedule H1 prescription medicine and dosing is set by the treating physician against the individual patient, the organism and its sensitivity pattern. This page deliberately does not publish a self-administration dosing table.
For orientation, the Indian Academy of Pediatrics enteric-fever guidance sets cefixime at 20 mg/kg/day (maximum 1,200 mg/day) for outpatient management and ceftriaxone at 100 mg/kg/day (maximum 4 g/day) where the patient is hospitalised, with therapy continued at least 7 days beyond defervescence or 14 days in total, whichever is longer.[7] Completing the full course matters: stopping when the fever settles is a common cause of relapse and contributes to the resistance picture described above.
Schedule H1 dispensing obligations
Cefixime is entry 9 in Schedule H1 of the Drugs and Cosmetics Rules, inserted by G.S.R. 588(E) under the Drugs and Cosmetics (Fourth Amendment) Rules, 2013.[4] The pharmacist must retain a copy of the prescription, record the sale in a separate register with the patient’s and prescriber’s details and the quantity supplied, keep that register for three years, and dispense from a pack bearing the prescribed H1 warning box with a red vertical band. See our Schedule H1 drug list and register rules for the full compliance detail.
Pricing and DPCO status
The two products are treated differently under price control, which is worth knowing before setting or comparing an MRP.
- Cefixime as a single ingredient is a scheduled formulation. It appears in the National List of Essential Medicines 2022 at 6.2.1.8 as tablet 200 mg, tablet 400 mg and oral liquid 50 mg/5 mL, which brings it within Schedule I of DPCO 2013 and under an NPPA ceiling price.[10]
- The cefixime + ofloxacin FDC is not. Neither ofloxacin nor this combination appears in NLEM 2022, so the FDC sits outside Schedule I.[10] Under paragraph 20 of DPCO 2013 a non-scheduled formulation carries no ceiling price, but its MRP may not be increased by more than 10% in any preceding twelve months.[11]
Ceffon-OX is priced at Rs 199 per strip of 10 tablets. For a like-for-like comparison of plain cefixime brands against the NPPA ceiling, see our comparison of the top cefixime tablet brands in India with NPPA pricing and Schedule H1 status.
Other cefixime products from Laafon Galaxy
| Brand | Composition | Form | Details |
|---|---|---|---|
| Ceffon-OX | Cefixime 200 mg + Ofloxacin 200 mg | Tablet | This page |
| Ceffon-200 | Cefixime 200 mg | Tablet | View product details |
| Ceffon Dry Syrup | Cefixime oral suspension IP | Dry syrup | View product details |
Brand names ending in “-OX” are used by several Indian manufacturers for different cefixime combinations. They are not interchangeable by name; always read the composition panel on the strip.
Frequently asked questions
No. The two-ingredient combination of cefixime and ofloxacin was approved by CDSCO on 26 April 2010 for typhoid fever and urinary tract infection in adults, and it does not appear on the consolidated list of fixed-dose combinations prohibited under section 26A of the Drugs and Cosmetics Act. The three-ingredient version that adds lactic acid bacillus is a different matter: it has no approval on record and was named in the DCGI’s 16 April 2025 directive to State and UT Drug Controllers covering 35 unapproved FDCs.
The cefixime component remains effective. Pooled Indian data from 2015 onward shows third-generation cephalosporin resistance in Salmonella Typhi at 3%, while fluoroquinolone resistance stands at 82%. The ofloxacin component therefore adds little in most Indian isolates. The US CDC advises against fluoroquinolones for empiric treatment of typhoid, and Indian paediatric guidance places cefixime, not a combination, as the first-line outpatient option. Treatment should follow culture and sensitivity results wherever they are available.
No. Ofloxacin is not for use under 18 years, and Indian Academy of Pediatrics guidance states that quinolones are contraindicated in the paediatric age group and should not be used to treat enteric fever. Paediatric cefixime is given as a separate single-ingredient preparation at a weight-based dose determined by the treating physician.
Against Salmonella Typhi in India, cefixime. Pooled surveillance of isolates collected from 2015 onward puts resistance to third-generation cephalosporins such as cefixime at 3%, while resistance to fluoroquinolones such as ofloxacin sits at 82%. The two drugs are not interchangeable in general, because they act on different bacterial targets and cover different organisms, but for enteric fever specifically the cephalosporin is the component carrying the treatment. Sensitivity testing should decide in any individual case.
Taking them together is licensed: CDSCO approved the two as a fixed-dose combination in 2010, so co-administration in this form is not off-label. The safety questions attach to the ofloxacin component rather than the pairing. Fluoroquinolones carry warnings for tendinitis and tendon rupture, for peripheral nerve damage that may not resolve after stopping, and for central nervous system effects including seizures, and they can worsen muscle weakness dangerously in myasthenia gravis. Those risks apply whether ofloxacin is given alone or in a combination, and they are the reason a prescriber should be satisfied the fluoroquinolone is genuinely needed.
Cefixime may be taken with or without food, every 12 or 24 hours, at about the same time each day. What matters more than meals is spacing: keep the dose at least two hours away from antacids and from supplements containing aluminium, calcium, magnesium, iron or zinc, because these bind the ofloxacin component and reduce how much of it is absorbed. Follow the timing your prescriber has specified on the prescription.
No. Cefixime as a single ingredient is in the National List of Essential Medicines 2022 and so carries an NPPA ceiling price, but the cefixime plus ofloxacin combination is not in NLEM 2022 and sits outside Schedule I of DPCO 2013. As a non-scheduled formulation its MRP is uncapped in absolute terms, but paragraph 20 of DPCO 2013 limits any increase to 10% over the preceding twelve months.
Because cefixime is a Schedule H1 drug, entry 9, inserted by G.S.R. 588(E) under the Drugs and Cosmetics (Fourth Amendment) Rules, 2013. The pharmacist must retain a copy of the prescription and enter the supply in a dedicated Schedule H1 register recording the patient and prescriber details and the quantity dispensed, keeping that register for three years.
Sourcing cefixime and ofloxacin tablets
Pharmaceutical companies and distributors evaluating this molecule can review pack options, documentation and compliance requirements for cefixime and ofloxacin third-party manufacturing, or the terms for a PCD pharma franchise across our anti-infective range. Beta-lactam products in this range, including this combination, are made at Athens Life Sciences, Kala Amb, a WHO-GMP certified facility, on the dedicated segregated line that Schedule M and WHO-GMP cross-contamination rules require for this drug class.
References
- Central Drugs Standard Control Organisation. List of approved drugs from 01.01.2010 to 31.12.2010 (entry 83: Cefixime 100mg/200mg + Ofloxacin 100mg/200mg tablets, approved 26/04/2010; entry 163: Cefixime SR + Ofloxacin SR, 31.08.2010). Government of India; 2010. Available from: cdsco.gov.in. Accessed September 2026.
- Central Drugs Standard Control Organisation. Communication to all State and UT Drug Controllers regarding unapproved fixed-dose combinations, File No. 4-01/2023-DC (Misc. 3), dated 16 April 2025. Government of India; 2025. Available from: cdsco.gov.in. Accessed September 2026.
- Medical Dialogues. Govt bans 35 combination drugs, see full list. 2025. Available from: medicaldialogues.in. Accessed September 2026. (Reproduces the annexure to reference 2, which is published as a scanned document.)
- Ministry of Health and Family Welfare. Drugs and Cosmetics (Fourth Amendment) Rules, 2013, G.S.R. 588(E), inserting Schedule H1 to the Drugs and Cosmetics Rules, 1945 (cefixime at entry 9). Government of India; 2013.
- Mogasale VV, Zhang P, John J, Farooqui HH, Ray A, Mogasale V, Parry CM, Dhoubhadel BG, Edmunds WJ, Clark A, Abbas K. Burden of antimicrobial resistance in culture-confirmed Salmonella Typhi isolates in India from 1977 to 2024: a systematic review and meta-analysis. PLoS Negl Trop Dis. 2026;20(4):e0014206. Available from: doi.org/10.1371/journal.pntd.0014206. Accessed September 2026 via PubMed (PMID 41990105).
- Centers for Disease Control and Prevention. Clinical guidance for typhoid fever and paratyphoid fever. Last reviewed 18 April 2024. Available from: cdc.gov. Accessed September 2026.
- Indian Academy of Pediatrics. Standard treatment guidelines: enteric fever (Chapter 8). IAP; 2022. Available from: iapindia.org. Accessed September 2026.
- MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US); Cefixime. Available from: medlineplus.gov. Accessed September 2026.
- MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US); Ofloxacin. Available from: medlineplus.gov. Accessed September 2026.
- Ministry of Health and Family Welfare. National List of Essential Medicines 2022 (cefixime at 6.2.1.8). Government of India; 2022. Available from: cdsco.gov.in. Accessed September 2026.
- Ministry of Chemicals and Fertilizers, Press Information Bureau. NPPA monitors the prices of scheduled as well as non-scheduled medicines under DPCO, 2013. 30 July 2024. Available from: pib.gov.in. Accessed September 2026.
- Directorate of Food and Drugs Administration, Government of Goa. Banned drugs list (FDCs) dated 02.08.2024, consolidating prohibitions notified under section 26A of the Drugs and Cosmetics Act, 1940. Available from: goa.gov.in. Accessed September 2026.
Disclaimer. This page is technical and educational content for pharmacy, healthcare and pharmaceutical-industry readers. It is not medical advice and must not be used to diagnose or treat any condition without a qualified prescriber. Cefixime is a Schedule H1 drug and is to be supplied only against a registered medical practitioner’s prescription.
Indian statutory instruments, CDSCO approval status, NLEM listings and NPPA notifications change frequently, and Schedule H1 is amended by gazette notification. Verify the current position against the primary source before relying on any regulatory statement here. Antimicrobial resistance data reflects pooled published surveillance and varies by state and by institution.
