CIPROGRAM 250/MG FC TAB 10/FC TAB

Indications

Approved Uses

Ciprofloxacin is indicated (depending on local label) for susceptible infections such as urinary tract infections (including pyelonephritis), lower respiratory tract infections, skin/skin-structure infections, bone and joint infections, infectious diarrhea/enteric infections (including typhoid fever), certain gonococcal infections, and inhalational anthrax post-exposure prophylaxis/treatment; other uses (e.g., sinusitis, intra-abdominal infection, plague) are label- and region-dependent and should not be assumed for this specific SFDA product without the local SmPC.

Dosage & Administration

Initial Dose

250-500 mg every 12 hours depending on indication and severity

Children's Dosage

Not recommended for routine use in children under 18 years due to risk of arthropathy; approved for specific indications: complicated UTI/pyelonephritis 10-20 mg/kg q12h (max 750 mg/dose), anthrax post-exposure 15 mg/kg q12h (max 500 mg/dose)

Side Effects

Common Side Effects

Common adverse effects include nausea, diarrhea, vomiting, abdominal pain/dyspepsia, headache, dizziness, and rash (with possible mild transaminase elevations).

Side Effect Frequency

Common (1-10%): nausea, diarrhea (also vomiting/abdominal pain in some sources), headache/dizziness, rash; Uncommon (0.1-1%): insomnia/agitation/restlessness, dyspepsia/flatulence, photosensitivity; Rare (<0.1%): tendinitis/tendon rupture, peripheral neuropathy, seizures/CNS effects, severe hypersensitivity, QT prolongation, severe hepatotoxicity, C. difficile-associated diarrhea

Safety & Warnings

Warnings & Precautions

Warnings/precautions: tendonitis/tendon rupture risk (higher in >60 years, 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 drugs), C. difficile diarrhea, dysglycemia (esp. diabetics), photosensitivity, aortic aneurysm/dissection risk, and crystalluria-maintain hydration and avoid excessive sun.

Age Restriction

Generally avoid routine use in patients <18 years; may be used only when benefits outweigh risks for specific approved/accepted pediatric indications (e.g., complicated UTI/pyelonephritis, inhalational anthrax post-exposure, plague) and when no suitable alternatives exist.

Drug Interactions

Drug Interactions

Key interactions: tizanidine (contraindicated); polyvalent cations/antacids/iron/zinc/calcium, sucralfate, and didanosine-buffered products (↓ absorption-separate dosing); theophylline and caffeine (↑ levels/toxicity via CYP1A2 inhibition); warfarin (↑ INR/bleeding-monitor); QT-prolonging drugs (additive QT risk); NSAIDs (may ↑ seizure risk); probenecid (↑ ciprofloxacin levels); methotrexate (↓ clearance/↑ toxicity); cyclosporine (possible ↑ nephrotoxicity/SCr); clozapine/ropinirole (↑ levels).

Interaction Severity

MAJOR/Contraindicated: tizanidine. MAJOR/Clinically significant: theophylline (toxicity risk), QT-prolonging drugs (additive QT risk in susceptible patients), and warfarin (INR elevation-often managed with close monitoring rather than absolute avoidance). MODERATE: antacids/sucralfate/iron/zinc/calcium (reduced absorption), NSAIDs (CNS stimulation/seizure risk), cyclosporine (nephrotoxicity), methotrexate (reduced clearance/toxicity), caffeine (increased effects).

Special Populations

Children

Not recommended for routine use in children under 18 years due to risk of arthropathy; approved for specific indications: complicated UTI/pyelonephritis 10-20 mg/kg q12h (max 750 mg/dose), anthrax post-exposure 15 mg/kg q12h (max 500 mg/dose)

Kidney Impairment

Adjust by creatinine clearance: CrCl 30-50 mL/min: usual dose q12h; CrCl 5-29 mL/min: extend interval to about q18-24h; hemodialysis/peritoneal dialysis: dose q24h and administer after dialysis.

Storage & Patient Advice

Stopping the Medicine

Complete the prescribed course unless significant adverse effects occur; stop and seek urgent medical advice if serious reactions develop (e.g., tendon pain/rupture, neuropathy symptoms, severe CNS effects, severe diarrhea, anaphylaxis).

Product Information

Available Dosage Forms

For ciprofloxacin as an active ingredient, common dosage forms include immediate-release oral tablets (including film-coated), oral suspension, and IV infusion; ophthalmic and otic solutions exist as separate topical products. Extended-release tablets and ophthalmic ointment exist in some markets but are not universal.

Composition per Dose

Each film-coated tablet: 250 mg ciprofloxacin as ciprofloxacin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for all fluoroquinolone antibiotics

Spectrum

Broad-spectrum.

Antibiotic Class

Fluoroquinolone

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