Schedule H

Oral, Intravenous, Ophthalmic, Otic

Form Strengths

Film-coated Tablets 250 mg; 500 mg; 750 mg

Extended-release Tablets 500 mg; 1000 mg

Oral Suspension 250 mg per 5 mL (limited availability)

IV Infusion 100 mg/50 mL; 200 mg/100 mL; 400 mg/200 mL

Eye Drops 0.3% w/v (5 mL, 10 mL)

Ear Drops 0.3% w/v (5 mL, 10 mL)

Eye Ointment 0.3% w/w

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Uncomplicated Urinary Tract Infection (Acute Cystitis)

Adults:

Parameter Recommendation

Starting dose 250 mg orally every 12 hours

Titration Not applicable

Usual maintenance dose 250–500 mg orally every 12 hours

Maximum dose 500 mg every 12 hours

Duration 3 days (women); 7 days (men)

Clinical Note: NOT first-line for uncomplicated UTI due to high resistance rates in India. Reserve for culture-confirmed susceptible organisms or when first-line agents (nitrofurantoin, fosfomycin) are contraindicated or have failed.

1. Complicated Urinary Tract Infection / Pyelonephritis

Adults — Oral:

Parameter Recommendation

Starting dose 500 mg orally every 12 hours

Titration Increase to 750 mg every 12 hours for severe infections

Usual maintenance dose 500–750 mg orally every 12 hours

Maximum dose 750 mg every 12 hours

Duration 7–14 days

Adults — Intravenous (Severe/Hospitalised):

Parameter Recommendation

Starting dose 400 mg IV every 12 hours

Titration May increase frequency to every 8 hours for severe infections

Usual maintenance dose 400 mg IV every 8–12 hours

Maximum dose 400 mg IV every 8 hours (1200 mg/day)

Duration 7–14 days; step-down to oral when clinically stable

1. Enteric Fever (Typhoid/Paratyphoid) — Only If Susceptible

Adults:

Parameter Recommendation

Starting dose 500 mg orally every 12 hours

Titration May increase to 750 mg every 12 hours for severe cases

Usual maintenance dose 500–750 mg orally every 12 hours

Maximum dose 750 mg every 12 hours

Duration 7–10 days (uncomplicated); 10–14 days (complicated)

Clinical Note: High fluoroquinolone resistance (>80% in many regions of India) limits empiric use. Use ONLY when culture and sensitivity confirms susceptibility. Azithromycin or ceftriaxone preferred for empiric therapy per ICMR guidelines.

1. Acute Bacterial Diarrhoea (Invasive — Shigella, Salmonella, Campylobacter)

Adults:

Parameter Recommendation

Starting dose 500 mg orally every 12 hours

Titration Not applicable

Usual maintenance dose 500 mg every 12 hours

Maximum dose 500 mg every 12 hours

Duration 3–5 days

Clinical Note: Reserve for moderate-severe invasive diarrhoea with systemic features. Azithromycin increasingly preferred due to quinolone resistance in enteric pathogens.

1. Skin and Soft Tissue Infections (Gram-Negative Susceptible Organisms)

Adults — Oral:

Parameter Recommendation

Starting dose 500 mg orally every 12 hours

Titration Increase to 750 mg every 12 hours for severe infections

Usual maintenance dose 500–750 mg orally every 12 hours

Maximum dose 750 mg every 12 hours

Duration 7–14 days

Adults — Intravenous:

Parameter Recommendation

Starting dose 400 mg IV every 12 hours

Titration Increase to every 8 hours for severe/complicated infections

Usual maintenance dose 400 mg IV every 8–12 hours

Maximum dose 400 mg IV every 8 hours

Duration 7–14 days

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

General Principle: Ciprofloxacin is NOT routinely recommended in children <18 years due to risk of cartilage toxicity (arthropathy). Use ONLY when no suitable alternative exists and benefits outweigh risks. Requires specialist supervision.

1. Enteric Fever (MDR Typhoid) — Culture-Confirmed Susceptibility

Children ≥1 year:

Parameter Recommendation

Starting dose 10–15 mg/kg orally every 12 hours

Titration Not applicable

Usual maintenance dose 10–15 mg/kg every 12 hours

Maximum single dose 500 mg

Maximum daily dose 1000 mg

Duration 7–10 days

Clinical Note: Use only for culture-confirmed fluoroquinolone-susceptible strains when ceftriaxone/azithromycin not suitable.

1. Complicated Urinary Tract Infection / Pyelonephritis

Children ≥1 year:

Parameter Recommendation

Starting dose 10 mg/kg orally/IV every 12 hours

Titration Not applicable

Usual maintenance dose 10–15 mg/kg every 12 hours

Maximum single dose (Oral) 500 mg

Maximum single dose (IV) 400 mg

Duration 7–14 days

1. Pseudomonal Infections (Cystic Fibrosis, Immunocompromised)

Children ≥1 year:

Parameter Recommendation

Starting dose 15 mg/kg orally/IV every 12 hours

Titration May increase to 20 mg/kg every 12 hours for severe infections

Usual maintenance dose 15–20 mg/kg every 12 hours

Maximum single dose (Oral) 750 mg

Maximum single dose (IV) 400 mg

Duration As per indication and specialist guidance

1. Ophthalmic Infections (Bacterial Conjunctivitis, Corneal Ulcer)

All ages (including neonates for topical use):

Parameter Recommendation

Starting dose 1–2 drops every 2 hours while awake

Titration Reduce frequency as infection improves

Usual maintenance dose 1–2 drops every 4–6 hours

Duration 7–14 days

1. Otitis Externa / Chronic Suppurative Otitis Media

Children ≥1 year:

Parameter Recommendation

Starting dose 3 drops into affected ear twice daily

Usual maintenance dose 3 drops twice daily

Duration 7–14 days

Secondary Indications — Paediatrics (Off-label, if any)

Indication Dose Duration Notes

Febrile Neutropenia (when IV not feasible) 10–15 mg/kg orally every 12 hours (max 500 mg/dose) Until neutrophil recovery OFF-LABEL. Specialist oncology supervision only. In combination with amoxicillin-clavulanate for outpatient low-risk neutropenia

Age Restrictions and Safety Monitoring

Age Group Recommendation

<1 year Avoid systemic use; topical ophthalmic/otic may be used with caution

1–18 years Systemic use only when no alternative exists; specialist supervision mandatory

18 years Adult dosing applicable

Safety Monitoring in Paediatrics:

• Monitor for musculoskeletal symptoms (joint pain, swelling, tendon pain) — discontinue if occurs

• Baseline and periodic assessment of joints in prolonged therapy

Dose adjustment required based on creatinine clearance:

CrCl (mL/min) Oral Dosing IV Dosing

50 No adjustment No adjustment

30–50 250–500 mg every 12 hours 200–400 mg every 12 hours

10–29 250–500 mg every 18–24 hours 200–400 mg every 18–24 hours

<10 250–500 mg every 24 hours 200–400 mg every 24 hours

Haemodialysis 250–500 mg every 24 hours (dose after dialysis on dialysis days) 200–400 mg every 24 hours (dose after dialysis)

CAPD 250–500 mg every 24 hours 200–400 mg every 24 hours

CRRT 200–400 mg every 12 hours (adjust per effluent rate) As per clinical response

• Known hypersensitivity to ciprofloxacin or any fluoroquinolone antibiotic

• Concurrent use with tizanidine — risk of severe hypotension and excessive sedation (pharmacokinetic interaction via CYP1A2 inhibition)

• History of tendon disorder related to fluoroquinolone use (tendinitis, tendon rupture)

• Myasthenia gravis — risk of severe exacerbation including respiratory failure

• History of epilepsy or conditions predisposing to seizures — lowers seizure threshold

• Pre-existing QT prolongation or concurrent use of QT-prolonging drugs

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency — haemolytic reactions reported

• Diabetes mellitus — risk of severe hypoglycaemia or hyperglycaemia

• Elderly patients — increased risk of tendon rupture, QT prolongation, and CNS effects

• Concurrent corticosteroid use — significantly increased tendon rupture risk

• Renal impairment — requires dose adjustment

• History of peripheral neuropathy

• Aortic aneurysm or dissection risk factors — emerging data on association with aortic events

Parameter Recommendation

Overall safety Generally AVOID; potential risk of fetal cartilage damage based on animal studies

Risk category Category C (US legacy); Not recommended in pregnancy per Indian practice

Preferred alternatives Cephalosporins (ceftriaxone, cefixime), nitrofurantoin (for UTI — avoid near term), azithromycin (for typhoid)

When it may be used Only when no safer alternative available and maternal benefit clearly outweighs fetal risk; specialist decision

Monitoring Fetal growth; maternal adverse reactions; avoid in first trimester if possible

Parameter Recommendation

Compatibility Use with caution; excreted in breast milk

Drug levels in milk Low to moderate; infant receives small amounts

Preferred alternatives Amoxicillin, cephalosporins, azithromycin

Infant monitoring Observe for diarrhoea, oral thrush, feeding difficulties; theoretical concern for cartilage effects (not proven in humans)

Note: If ciprofloxacin essential, consider temporary interruption of breastfeeding during treatment course.

Parameter Recommendation

Starting dose Lower end of dosing range (250–500 mg orally or 200–400 mg IV every 12 hours)

Titration Cautious; assess renal function before escalating

Renal consideration Age-related decline in renal function common; calculate CrCl and adjust dose accordingly

Specific risks Significantly increased risk of: Achilles tendon rupture (especially with concurrent steroids); QT prolongation and arrhythmias; CNS effects (confusion, hallucinations, delirium); hypoglycaemia (especially in diabetics on sulfonylureas/insulin)

Monitoring ECG if cardiac risk factors; blood glucose in diabetics; tendon symptoms; mental status

Drug Interaction Recommendation

Tizanidine CYP1A2 inhibition by ciprofloxacin causes 10-fold increase in tizanidine levels → severe hypotension, excessive sedation CONTRAINDICATED — do not co-administer

Theophylline/Aminophylline CYP1A2 inhibition → increased theophylline levels → toxicity (seizures, arrhythmias, nausea) Reduce theophylline dose by 30–40%; monitor levels closely

QT-prolonging drugs (Amiodarone, Sotalol, Haloperidol, Ondansetron, Erythromycin) Additive QT prolongation → risk of torsades de pointes Avoid combination if possible; if essential, baseline and follow-up ECG; correct electrolytes

Warfarin/Acenocoumarol Enhanced anticoagulant effect via CYP1A2 inhibition and gut flora alteration Monitor INR closely (within 3–5 days of starting ciprofloxacin); adjust anticoagulant dose

Methotrexate Reduced renal clearance of methotrexate → increased toxicity Monitor for methotrexate toxicity; consider dose reduction or avoid combination

Duloxetine CYP1A2 inhibition → increased duloxetine levels → serotonin syndrome risk Avoid combination; if essential, use lowest duloxetine dose and monitor

Phenytoin Altered phenytoin levels (increased or decreased) Monitor phenytoin levels; adjust dose as needed

Drug Interaction Recommendation

Antacids (Aluminium/Magnesium hydroxide), Iron, Calcium, Zinc, Sucralfate Form chelation complexes → significantly reduced ciprofloxacin absorption Administer ciprofloxacin 2 hours before or 6 hours after these products

Dairy products / Calcium-fortified foods Reduced absorption (less than antacids but still significant) Avoid taking ciprofloxacin with dairy; may take with food otherwise

Sulfonylureas (Glibenclamide, Glimepiride) / Insulin Risk of severe hypoglycaemia or hyperglycaemia Monitor blood glucose closely; counsel patient about symptoms

Cyclosporine Increased cyclosporine nephrotoxicity; ciprofloxacin levels may also increase Monitor renal function and cyclosporine levels

NSAIDs Potential increased risk of CNS stimulation and seizures Use with caution, especially in patients with seizure history

Rifampicin May reduce ciprofloxacin levels via enhanced metabolism Monitor clinical efficacy; consider ciprofloxacin dose increase

Clozapine CYP1A2 inhibition → increased clozapine levels → toxicity Monitor clozapine levels and for adverse effects; dose reduction may be needed

Probenecid Reduced renal clearance of ciprofloxacin → increased levels Monitor for ciprofloxacin toxicity

• Nausea and vomiting

• Diarrhoea

• Abdominal pain/discomfort

• Headache

• Dizziness

• Rash and pruritus

• Photosensitivity

• Transient elevation of liver enzymes

• Insomnia

• Injection site reactions (IV use)

Adverse Effect Clinical Notes

Tendinitis / Tendon rupture Most commonly Achilles tendon; risk highest in elderly, those on corticosteroids, and renal transplant recipients. Discontinue immediately if tendon pain occurs; avoid exercise

QT prolongation / Torsades de pointes Risk increased with electrolyte disturbances, concurrent QT-prolonging drugs, cardiac disease. ECG monitoring recommended in at-risk patients

Severe hypoglycaemia / Hyperglycaemia Can be life-threatening; more common in diabetics on glucose-lowering therapy. Discontinue if severe dysglycaemia occurs

CNS toxicity (Seizures, Toxic psychosis, Hallucinations, Encephalopathy) Risk increased in elderly, those with CNS disorders, renal impairment. Discontinue immediately

Peripheral neuropathy May be irreversible; presents as pain, burning, tingling, numbness. Discontinue at first symptoms

Clostridioides difficile-associated diarrhoea (CDAD) May occur during or after therapy. Discontinue and treat appropriately if confirmed

Anaphylaxis / Severe allergic reactions Discontinue immediately; manage with adrenaline and supportive care

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Very rare; discontinue immediately; hospitalisation required

Hepatotoxicity (including fulminant hepatic failure) Rare; discontinue if jaundice or significant LFT elevation

Aortic aneurysm / Dissection Emerging association; use with caution in patients with risk factors (Marfan syndrome, elderly, hypertension)

Exacerbation of myasthenia gravis May cause life-threatening respiratory failure

Phase Parameters

Baseline Serum creatinine/eGFR, LFTs, blood glucose (diabetics), ECG (if cardiac risk factors or concurrent QT-prolonging drugs), allergy history

During treatment Clinical response; tendon symptoms (pain, swelling — counsel patient to report); CNS symptoms; blood glucose in diabetics; signs of C. difficile infection

Prolonged therapy (>7–14 days) LFTs weekly; renal function; CBC if indicated; reassess clinical need for continuation

High-risk patients ECG monitoring for QT; enhanced glucose monitoring

Ciplox Cipla Tablets, IV, Eye/Ear drops

Cifran Sun Pharma Tablets, IV

Ciprobid Zydus Tablets

Quintor Torrent Tablets

Zoxan FDC Tablets

Alcipro Alkem Tablets, IV

Ciprofloxacin (Generic) Multiple All forms

Fixed-Dose Combinations (Note: Use rational combinations only):

Regulatory Note: Listed under NLEM 2022 (select formulations). NPPA price-controlled. Available through government supply at lower rates.

1. Resistance is the major issue: Fluoroquinolone resistance in enteric pathogens exceeds 80% in many parts of India. NEVER use empirically for typhoid — always obtain culture/sensitivity. Azithromycin or ceftriaxone preferred for empiric enteric fever treatment.

1. Dairy and antacid timing: Ciprofloxacin absorption significantly reduced by dairy, antacids, iron, and calcium supplements. Administer 2 hours before or 6 hours after these products to ensure therapeutic levels.

1. Tendon rupture warning: Educate all patients, especially elderly and those on corticosteroids, to immediately stop ciprofloxacin and rest the affected limb if tendon pain occurs. Risk persists for months after stopping the drug.

1. QT risk assessment: Before prescribing, check for concurrent QT-prolonging medications (common in India: azithromycin, ondansetron, antipsychotics). Consider baseline ECG in elderly or those with cardiac history.

1. Diabetic caution: Both severe hypoglycaemia and hyperglycaemia reported. Counsel diabetic patients on sulfonylureas or insulin to monitor glucose closely and recognise warning symptoms.

1. Not for routine use in children: Systemic ciprofloxacin in children should be an exception, not routine. Document indication and lack of alternatives. Topical ophthalmic/otic use is generally safe.

ciprofloxacin; fluoroquinolone; antibiotic; UTI; typhoid; pseudomonas; tendon-rupture-risk; QT-prolongation; resistance-concern; paediatric-restricted; NLEM-India; Schedule-H

RxIndia v1.0 — 03 May 2025

• CDSCO Drug Database and Product Inserts

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Antimicrobial Resistance Surveillance Network Reports

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes

• AIIMS Antimicrobial Policy and Treatment Guidelines

• NCDC Typhoid and Enteric Fever Treatment Modules

• IAP Textbook of Paediatric Infectious Diseases

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine (21st Edition)