OMACIP 500/MG TAB 10/TAB

Indications

Approved Uses

Common approved indications for systemic ciprofloxacin include: complicated and uncomplicated urinary tract infections (including pyelonephritis), lower respiratory tract infections, acute bacterial sinusitis, skin/skin structure infections, bone and joint infections, complicated intra‑abdominal infections (with metronidazole), infectious diarrhea, typhoid fever, chronic bacterial prostatitis, inhalational anthrax (post‑exposure prophylaxis and treatment), and plague. (Gonorrhea is not reliably an approved/appropriate indication in many current guidelines due to resistance and is generally not recommended.)

Off-Label Uses

Commonly cited off‑label uses include traveler’s diarrhea (treatment; prophylaxis generally discouraged), certain sexually transmitted infections such as chancroid where susceptible/appropriate, and selected prophylaxis/treatment scenarios guided by local susceptibility (e.g., some neutropenia prophylaxis regimens historically, though practice varies). Tuberculosis and Crohn’s disease are not standard off‑label uses for ciprofloxacin in guidelines (TB requires multi‑drug regimens; Crohn’s use is limited/adjunctive and not a typical ciprofloxacin indication).

Dosage & Administration

Dosing by Condition

Typical adult oral immediate‑release dosing (guideline/label dependent): uncomplicated cystitis: 250 mg q12h for 3 days (where appropriate); complicated UTI/pyelonephritis: 500 mg q12h for 7-14 days; acute bacterial sinusitis: 500 mg q12h for ~10 days; lower respiratory tract infections: 500-750 mg q12h for 7-14 days; skin/skin structure: 500-750 mg q12h for 7-14 days; bone/joint: 500-750 mg q12h for 4-8 weeks; infectious diarrhea: 500 mg q12h for 3-5 (up to 7) days; typhoid fever: 500 mg q12h for 7-10 days; chronic bacterial prostatitis: 500 mg q12h for 28 days; complicated intra‑abdominal infection: 500 mg q12h for 7-14 days with metronidazole; inhalational anthrax PEP: 500 mg q12h for 60 days; plague: 500 mg q12h for 10-14 days.

Initial Dose

500mg every 12 hours

Maintenance Dose

250mg-750mg every 12 hours depending on infection severity

Maximum Dose

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

Children's Dosage

Not recommended for routine use in children under 18 years due to risk of arthropathy; exception: complicated UTI/pyelonephritis (1-17 years): 10-20mg/kg q12h (max 750mg/dose); inhalation anthrax: 15mg/kg q12h (max 500mg/dose)

Dose Adjustment Notes

Dose adjustment is required in renal impairment (e.g., reduce dose/extend interval when CrCl <50 mL/min; more significant adjustment when CrCl <30 mL/min). No routine dose adjustment is required for hepatic impairment. Use caution in older adults and those at higher risk of fluoroquinolone toxicities (tendinopathy, CNS effects, QT risk).

How to Take

Swallow the 500 mg film‑coated tablet whole with a full glass of water; may be taken with or without food. Avoid co-administration with polyvalent cations (antacids containing Mg/Al, sucralfate, iron, zinc, calcium supplements, multivitamins) and separate dosing (typically ciprofloxacin ≥2 hours before or ≥6 hours after these products). Do not take with dairy products or calcium‑fortified juices alone (they reduce absorption), though dairy as part of a meal is acceptable.

Side Effects

Common Side Effects

Common adverse effects: nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, dizziness, rash, and transient elevations in liver enzymes (ALT/AST).

Side Effect Frequency

Common (1-10%): nausea, diarrhea, vomiting, abdominal pain, headache, dizziness; rash and transaminase elevations are also reported; serious events (tendinopathy/rupture, peripheral neuropathy, seizures, QT prolongation, C. difficile colitis, anaphylaxis) are rare but clinically critical

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to ciprofloxacin/other quinolones; concomitant use with tizanidine. (Myasthenia gravis is a strong warning/avoid use, not an absolute contraindication in many labels.)

Warnings & Precautions

Precautions: reserve for appropriate infections when alternatives are unsuitable; stop immediately for tendon pain/swelling, neuropathy symptoms, or serious CNS effects; higher tendon-rupture risk in age >60, corticosteroid use, and transplant patients; avoid in myasthenia gravis; monitor QT risk (electrolytes, concomitant QT drugs); monitor glucose in diabetics; counsel on photosensitivity; assess for C. difficile diarrhea; maintain hydration to reduce crystalluria; use caution in patients with known aortic aneurysm or major risk factors.

Age Restriction

Generally avoid routine use in patients <18 years; use only when benefits outweigh risks for specific pediatric indications (e.g., complicated UTI/pyelonephritis, inhalational anthrax post-exposure, plague) per local labeling/guidelines.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: tizanidine (contraindicated); polyvalent cations/antacids/sucralfate/iron/zinc/calcium (reduced absorption-separate dosing); theophylline/caffeine (↑ levels via CYP1A2 inhibition); warfarin (↑ INR/bleeding-monitor); antidiabetic agents esp. sulfonylureas/insulin (dysglycemia); QT-prolonging drugs (additive QT risk); NSAIDs (↑ CNS stimulation/seizure risk); probenecid (↑ ciprofloxacin levels); clozapine/ropinirole/sildenafil (possible ↑ levels); methotrexate (reduced clearance/toxicity risk); cyclosporine (possible ↑ nephrotoxicity/SCr).

Interaction Severity

MAJOR/Contraindicated: tizanidine. MAJOR: strong risk interactions include theophylline (↑ levels/toxicity), QT‑prolonging drugs in high‑risk patients (additive QT risk), and warfarin (clinically significant INR increase-requires close monitoring). MODERATE: antidiabetic agents (dysglycemia), NSAIDs (↑ CNS stimulation/seizure risk), cyclosporine (↑ nephrotoxicity risk), clozapine (↑ levels), methotrexate (↓ clearance), caffeine (↑ effects). ABSORPTION interaction (manage by separation, not “severity” toxicity): antacids/sucralfate/iron/zinc/calcium/multivitamins and dairy/calcium-fortified products.

Food Interaction

May be taken with or without food; food may improve GI tolerability. Avoid taking with dairy products or calcium‑fortified juices alone and separate from antacids/sucralfate/iron/zinc/calcium/multivitamins (commonly ciprofloxacin ≥2 hours before or ≥6 hours after) to prevent reduced absorption.

Special Populations

Pregnancy

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

Breastfeeding

Caution

Children

Not recommended for routine use in children under 18 years due to risk of arthropathy; exception: complicated UTI/pyelonephritis (1-17 years): 10-20mg/kg q12h (max 750mg/dose); inhalation anthrax: 15mg/kg q12h (max 500mg/dose)

Elderly

Use standard adult dosing with caution; increased risk of tendon rupture (especially with concurrent corticosteroid use), QT prolongation, and CNS adverse effects. Monitor renal function and adjust dose accordingly

Kidney Impairment

Dose adjustment required: CrCl 30-50 mL/min: 250-500 mg every 12 hours; CrCl 5-29 mL/min: 250-500 mg every 18-24 hours; hemodialysis/peritoneal dialysis: 250-500 mg every 24 hours, give after dialysis.

Liver Impairment

No routine dose adjustment required in hepatic impairment (including stable cirrhosis); use caution if severe hepatic disease coexists with renal impairment because dosing is primarily renal.

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep in original packaging. Keep out of reach of children.

Missed Dose

Take as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not take a double dose.

Stopping the Medicine

Complete the prescribed course; do not stop early unless a clinician advises or serious adverse effects occur (e.g., tendon pain, neuropathy, severe allergy, severe diarrhea).

Overdose

Overdose may cause GI upset, CNS toxicity (dizziness, tremor, seizures), QT prolongation, and renal impairment/crystalluria; management is supportive (consider activated charcoal if early, maintain hydration, monitor ECG/renal function); no specific antidote and dialysis removes only a small amount-seek urgent medical care.

Patient Counseling

Complete the full prescribed course; take with a full glass of water and stay well hydrated. May take with or without food, but separate from antacids/sucralfate/iron/zinc/calcium/multivitamins and avoid dairy/calcium-fortified juices alone around dosing (follow ≥2 hours before or ≥6 hours after rule). Avoid excessive sun/UV exposure (photosensitivity). Stop and seek care urgently for tendon pain/swelling, sudden tendon rupture, peripheral neuropathy symptoms (numbness/tingling/burning), severe mood/CNS effects, severe/persistent diarrhea, or allergic reaction. Use caution with driving if dizzy. Inform clinician about history of seizures, QT prolongation/arrhythmias, myasthenia gravis, kidney disease, and interacting drugs (notably warfarin, theophylline, tizanidine).

Monitoring Requirements

No routine labs are required for all patients, but monitor as clinically indicated: renal function (especially if impaired/elderly or prolonged therapy), INR if on warfarin, blood glucose in diabetics, and monitor for tendinopathy, peripheral neuropathy, CNS effects, severe diarrhea (C. difficile), and consider ECG/QT risk assessment in susceptible patients.

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.

Onset of Action

Oral absorption is rapid with peak concentrations about 1-2 hours after dosing; clinical improvement in infection is typically seen within 24-72 hours if the pathogen is susceptible.

Duration of Effect

Approximately 12 hours for immediate‑release oral ciprofloxacin (supports q12h dosing).

Product Information

Available Dosage Forms

Ciprofloxacin is available (by market) as: immediate‑release oral tablets (film‑coated), extended‑release oral tablets, oral suspension, IV infusion/solution for infusion, and ophthalmic solution (eye drops); otic formulations exist in some markets (often as combinations).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative-ciprofloxacin/fluoroquinolones are prescription-only (SFDA legal status: Prescription).

Spectrum

Broad-spectrum

Antibiotic Class

Fluoroquinolone

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