PROXEN 500/MG FC TAB 20/FC TAB

Indications

Approved Uses

Ciprofloxacin oral is indicated for susceptible infections including: urinary tract infections (uncomplicated/complicated) and pyelonephritis; lower respiratory tract infections; skin/skin structure infections; bone and joint infections; infectious diarrhea; typhoid fever; intra‑abdominal infections (typically in combination with metronidazole); chronic bacterial prostatitis; and inhalational anthrax (post‑exposure prophylaxis and treatment).

Dosage & Administration

Dosing by Condition

Typical adult oral dosing (susceptible organisms; adjust for renal function and local guidance): Uncomplicated cystitis: 250 mg every 12 hours for 3 days. Complicated UTI/pyelonephritis: 500 mg every 12 hours for 7-14 days. Lower respiratory tract infections: 500-750 mg every 12 hours for 7-14 days. Skin/skin structure: 500-750 mg every 12 hours for 7-14 days. Bone/joint: 500-750 mg every 12 hours for ~4-6 (up to 8) weeks. Infectious diarrhea: 500 mg every 12 hours for 5-7 days. Typhoid fever: 500 mg every 12 hours for 7-10 days. Chronic bacterial prostatitis: 500 mg every 12 hours for 28 days. Inhalational anthrax (PEP/treatment): 500 mg every 12 hours for 60 days.

Initial Dose

500mg every 12 hours

Maintenance Dose

500mg-750mg every 12 hours depending on infection severity

Maximum Dose

1500mg per day (750mg twice daily for severe infections)

Children's Dosage

10-20mg/kg every 12 hours (max 750mg per dose); approved for complicated UTI and pyelonephritis in children 1-17 years, and anthrax prophylaxis/treatment. Not recommended for routine use in children due to arthropathy risk

Dose Adjustment Notes

Dose adjustment is required in renal impairment (reduce dose and/or extend interval based on creatinine clearance). No routine adjustment is required for hepatic impairment.

How to Take

Swallow the 500 mg film‑coated tablet whole with water; may be taken with or without food. Avoid coadministration with polyvalent cations (antacids containing Mg/Al, sucralfate, iron, zinc, calcium supplements) by separating doses (typically ciprofloxacin ≥2 hours before or ≥6 hours after these agents). Dairy products/calcium-fortified juices can reduce absorption if taken alone with the dose; they may be consumed as part of a meal.

Side Effects

Side Effect Frequency

Common (≥1% to <10%): nausea, diarrhea (also commonly reported: vomiting, abdominal pain/discomfort, headache, dizziness, rash, and transaminase elevations). Uncommon/Rare: tendinitis/tendon rupture, peripheral neuropathy, seizures/CNS effects, QT prolongation, photosensitivity, hypersensitivity including anaphylaxis, and C. difficile-associated diarrhea/colitis.

Safety & Warnings

Contraindications

Contraindications: (1) hypersensitivity to ciprofloxacin/other quinolones; (2) concomitant use with tizanidine.

Warnings & Precautions

Warnings/precautions: tendinitis/tendon rupture risk (higher in age >60, corticosteroid use, transplant); peripheral neuropathy (stop if symptoms); CNS effects/seizure risk; exacerbation of myasthenia gravis (avoid); QT prolongation risk (avoid with known QT prolongation/hypokalemia or QT-prolonging drugs); C. difficile diarrhea; aortic aneurysm/dissection risk in at-risk patients; photosensitivity; maintain hydration to reduce crystalluria; use only when benefits outweigh risks for uncomplicated infections.

Age Restriction

Not routinely recommended in patients <18 years; may be used in pediatrics only for specific approved/accepted indications (e.g., complicated UTI/pyelonephritis, inhalational anthrax post-exposure, plague) with specialist oversight.

Drug Interactions

Drug Interactions

Key interactions: tizanidine (contraindicated); polyvalent cations/antacids/sucralfate/iron/zinc/calcium and dairy (reduced absorption-separate dosing); warfarin (↑INR/bleeding risk); theophylline (↑levels/toxicity); QT-prolonging drugs (additive QT risk); probenecid (↑ciprofloxacin levels); cyclosporine (possible ↑nephrotoxicity/SCr); methotrexate (reduced clearance/↑toxicity); clozapine (↑levels); NSAIDs may increase CNS stimulation/seizure risk in susceptible patients.

Food Interaction

Food has minimal effect on overall exposure, so it may be taken with or without food; however, avoid taking the dose with dairy products or calcium-fortified juices alone, and separate from antacids/sucralfate or mineral supplements containing calcium, magnesium, aluminum, iron, or zinc (ciprofloxacin ≥2 hours before or ≥6 hours after).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Not assigned (Risk Summary: Use only if potential benefit justifies potential risk to fetus)

Children

10-20mg/kg every 12 hours (max 750mg per dose); approved for complicated UTI and pyelonephritis in children 1-17 years, and anthrax prophylaxis/treatment. Not recommended for routine use in children due to arthropathy risk

Elderly

Use standard adult dosing but with caution; increased risk of tendon rupture, QT prolongation, and CNS effects; adjust for renal function as renal clearance decreases with age

Kidney Impairment

CrCl 30-50 mL/min: 250-500 mg every 12 hours; CrCl 5-29 mL/min: 250-500 mg every 18 hours; hemodialysis/peritoneal dialysis: 250-500 mg every 24 hours (dose after dialysis).

Liver Impairment

No dosage adjustment is generally required for hepatic impairment; use caution/monitoring in severe hepatic disease especially if concurrent renal impairment is present.

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed course unless a serious adverse reaction occurs (e.g., tendon pain/rupture, neuropathy, severe CNS effects, severe allergy), in which case stop and seek urgent medical advice.

Patient Counseling

Take exactly as prescribed and complete the full course. Swallow with water and maintain hydration. Separate from antacids/sucralfate and mineral supplements (Ca/Mg/Al/Fe/Zn) by taking ciprofloxacin ≥2 hours before or ≥6 hours after; avoid taking with dairy/calcium-fortified juice alone. Stop and seek care urgently for tendon pain/swelling, sudden joint pain, numbness/tingling or weakness (neuropathy), severe/persistent diarrhea, severe rash/allergic reaction, or significant mood/CNS changes; limit excessive sun/UV exposure and use protection.

Monitoring Requirements

Monitor renal function when clinically indicated (especially in renal impairment/elderly), and monitor for tendon pain/rupture, peripheral neuropathy/CNS effects, severe diarrhea (C. difficile), hypersensitivity, and dysglycemia in diabetics; consider LFTs if symptoms or underlying hepatic disease.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination, leading to bacterial cell death

Half-Life

Approximately 4 hours (typical range ~3.5-5 hours in adults with normal renal function).

Bioavailability

Approximately 70% oral bioavailability.

Excretion

Primarily renal: ~40-50% excreted unchanged in urine; remainder via feces/biliary excretion (roughly ~20-35%) plus metabolites.

Protein Binding

20-40%.

Product Information

Available Dosage Forms

Film-coated tablet, Oral suspension, Intravenous infusion, Ophthalmic solution, Otic solution

Composition per Dose

Each film-coated tablet: 500mg ciprofloxacin (as ciprofloxacin hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Pain Type

General

Nsaid

No

Opioid

No

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