Schedule H

Oral

• Tablets: 600 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Acute Uncomplicated Lower Urinary Tract Infections (Cystitis)

Parameter Recommendation

Starting dose 600 mg orally once daily

Titration Not applicable

Usual maintenance dose 600 mg once daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 3–5 days for uncomplicated cystitis

• Reserve for confirmed or suspected fluoroquinolone-sensitive uropathogens

• Not first-line therapy per ICMR antimicrobial stewardship recommendations

• Consider nitrofurantoin or fosfomycin as first-line alternatives where appropriate

⮞ Acute Exacerbation of Chronic Bronchitis

Parameter Recommendation

Starting dose 600 mg orally once daily

Titration Not applicable

Usual maintenance dose 600 mg once daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 7–10 days

• Use should be guided by local resistance patterns

• Not first-line per ICMR-AMR guidelines; reserve for resistant cases

• Consider amoxicillin-clavulanate or doxycycline as first-line alternatives

⮞ Community-Acquired Pneumonia (Mild to Moderate)

Parameter Recommendation

Starting dose 600 mg orally once daily

Titration Not applicable

Usual maintenance dose 600 mg once daily

Maximum dose 600 mg/day

Key Clinical Notes:

• Duration: 7–14 days depending on clinical response

• Avoid in patients at risk of QT prolongation

• Not first-line; reserve for beta-lactam allergy or resistant pathogens

• Covers typical and atypical respiratory pathogens

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

None documented in Indian guidelines.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

CONTRAINDICATED in children and adolescents below 18 years of age.

Fluoroquinolones are associated with risk of cartilage toxicity and tendon damage in the growing skeleton.

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

Not applicable.

Age Restriction Statement:

Use in patients below 18 years is contraindicated. Exceptional use may only be considered under paediatric infectious disease specialist direction with strong clinical justification and documented informed consent when no alternative exists.

• Known hypersensitivity to prulifloxacin, ulifloxacin, or any fluoroquinolone antibiotic

• History of tendon disorders (tendinitis, tendon rupture) associated with fluoroquinolone use

• Severe renal impairment (CrCl <30 mL/min)

• Children and adolescents below 18 years of age

• Pregnancy

• Lactation

• Known history of QT prolongation or congenital long QT syndrome

• Concurrent use with Class IA or Class III antiarrhythmics

• History of seizures or CNS disorders — fluoroquinolones may lower seizure threshold

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

• Electrolyte imbalances (hypokalaemia, hypomagnesaemia) — may exacerbate QT prolongation risk

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

• History of myasthenia gravis — may exacerbate muscle weakness; avoid if possible

• Concurrent corticosteroid use — increased tendon rupture risk

• G6PD deficiency — potential for haemolysis

• Dehydration — ensure adequate hydration during therapy

• Avoid excessive sun exposure — photosensitivity risk

• Diabetes mellitus — risk of dysglycaemia (both hypo- and hyperglycaemia)

Parameter Information

Risk category Contraindicated

Safety statement Risk of fetal arthropathy and cartilage damage observed in animal studies; avoid use

Preferred alternatives Nitrofurantoin (UTI — avoid at term); Cefixime; Amoxicillin-clavulanate (respiratory infections)

When to use Only if no alternative exists and benefit clearly outweighs risk — requires specialist decision

Monitoring If inadvertent exposure, monitor fetal musculoskeletal development

Parameter Information

Compatibility Not recommended

Drug level in milk Expected to be excreted; risk of cartilage damage in nursing infant

Preferred alternatives Cefuroxime, Amoxicillin, Azithromycin (depending on indication)

Infant monitoring If unavoidable, advise temporary cessation of breastfeeding during therapy and for 48 hours after last dose

• Starting dose: 600 mg once daily (no dose reduction, but use with caution)

• Titration: Not applicable

• Additional considerations:

• Increased risk of tendon rupture (especially Achilles tendon) — counsel patient

• Higher susceptibility to CNS effects (confusion, dizziness, hallucinations)

• Assess baseline renal function before initiation and during therapy

• QT prolongation risk is higher — consider baseline ECG

• Avoid concurrent corticosteroid use if possible

• Consider shorter treatment duration in frail elderly

Interacting Drug Effect Management

Theophylline Increased theophylline plasma levels; risk of seizures and cardiac arrhythmias Avoid combination if possible; if essential, monitor theophylline levels and reduce dose

Warfarin Enhanced anticoagulant effect; increased bleeding risk Monitor INR closely; adjust warfarin dose as needed

Class IA Antiarrhythmics (quinidine, procainamide) Additive QT prolongation; risk of Torsades de Pointes Avoid concurrent use

Class III Antiarrhythmics (amiodarone, sotalol) Additive QT prolongation; risk of fatal arrhythmias Avoid concurrent use

Antacids (Al/Mg/Ca-containing) Chelation reduces fluoroquinolone absorption significantly Separate administration by at least 2 hours (prulifloxacin before or 4–6 hours after antacid)

Sucralfate Markedly reduced absorption Avoid concurrent use or separate by at least 2 hours

Interacting Drug Effect Management

NSAIDs Increased risk of CNS stimulation and seizures Use with caution; monitor for neurological symptoms

Corticosteroids Increased risk of tendon rupture, especially in elderly Avoid combination if possible; counsel patient about tendon symptoms

Iron preparations Reduced fluoroquinolone bioavailability via chelation Separate administration by at least 2 hours

Zinc/Multivitamins with minerals Reduced absorption Separate administration by at least 2 hours

Cyclosporine Possible increased cyclosporine levels Monitor renal function and cyclosporine levels

Metformin Possible altered glucose control; dysglycaemia risk Monitor blood glucose closely

Caffeine Reduced caffeine metabolism; CNS stimulation Advise limiting caffeine intake

• Nausea

• Diarrhoea

• Dizziness

• Headache

• Abdominal pain/discomfort

• Dyspepsia

• Skin rash

• Insomnia

• Photosensitivity

Adverse Effect Clinical Notes

Tendon rupture Especially Achilles tendon; risk increased in elderly and those on corticosteroids; discontinue immediately if tendon pain occurs

QT prolongation / Torsades de Pointes Potentially fatal; obtain ECG if symptoms (palpitations, syncope) develop; avoid in predisposed patients

Seizures Risk in patients with CNS disorders or on concomitant NSAIDs/theophylline; discontinue if seizures occur

Peripheral neuropathy May be irreversible; discontinue at first sign of paraesthesia, pain, or weakness

Stevens-Johnson Syndrome / TEN Rare; discontinue immediately and refer urgently

Hepatotoxicity Monitor LFTs; discontinue if significant elevation occurs

C. difficile-associated diarrhoea Suspect with severe or persistent diarrhoea; discontinue and treat appropriately

Aortic aneurysm/dissection Rare; avoid in patients with aortic disease or risk factors

Dysglycaemia Both hypoglycaemia and hyperglycaemia reported; monitor in diabetics

Phase Parameters

Baseline Serum creatinine; LFTs (if hepatic disease); ECG (if cardiac history or concurrent QT-prolonging drugs); blood glucose (in diabetics)

During therapy Clinical assessment for GI symptoms, CNS effects, signs of tendinopathy, neuropathy; INR if on warfarin

Long-term use Not recommended for prolonged therapy; if essential, monitor LFTs, renal function, and CBC periodically

• Urifast (Lupin)

• Megapril (Macleods)

• Pruliflox (Zydus Cadila)

• Profloxin (Micro Labs)

• Pruliga (Glenmark)

• Multiple generic preparations available

Note: Not included in NLEM; not NPPA price-controlled; not part of central government supply chains.

1. Prodrug mechanism: Prulifloxacin is an ester prodrug that is rapidly hydrolysed in the body to the active metabolite ulifloxacin; this improves oral bioavailability.

1. Not first-line therapy: Due to rising fluoroquinolone resistance in India, reserve prulifloxacin for documented susceptible infections or when first-line agents fail/are contraindicated.

1. Chelation interaction: Do not co-administer with calcium, iron, zinc, magnesium, or aluminium-containing products — separate doses by at least 2 hours to ensure adequate absorption.

1. Tendon warning: Counsel all patients, especially elderly and those on corticosteroids, to report any tendon pain immediately and discontinue the drug if symptoms develop.

1. Single daily dosing advantage: Once-daily dosing may improve adherence compared to other fluoroquinolones requiring multiple daily doses.

1. QT prolongation screening: Avoid in patients with known QT prolongation; consider baseline ECG in elderly or those with cardiac history before initiating therapy.

Prulifloxacin; fluoroquinolone; antibiotic; UTI; urinary tract infection; respiratory infection; pneumonia; bronchitis; QT prolongation; tendon toxicity; pregnancy-contraindicated; paediatric-contraindicated; Schedule H

RxIndia v1.0 — 10 Jan 2025

• CDSCO Product Information

• Indian Pharmacopoeia

• ICMR Antimicrobial Treatment Guidelines (2022)

• API Textbook of Medicine

• AIIMS Drug Formulary

• Product inserts (Lupin, Zydus Cadila, Macleods)

• NLEM 2022 (for reference: Prulifloxacin not listed)

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics