Axcel Ciprofloxacin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ciprofloxacin HCl

Indications/Uses

Uncomplicated & complicated resp tract infections; otitis media & sinusitis. Eyes, kidneys &/or efferent urinary tract, GIT, biliary tract, skin & soft tissue, bone & joint infections. Adnexitis, gonorrhoea & prostatitis; peritonitis; sepsis. Prophylaxis in immunocompromised patients. Selective intestinal decontamination in immunocompromised patients. Post-exposure anthrax inhalation in adults & childn.

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Dosage/Direction for Use

Adult Resp tract infection 500-750 mg bd for 7-14 days. Acute, uncomplicated UTI 250-500 mg bd for 7 days. Cystitis in women & acute, uncomplicated gonorrhea 500 mg single dose. Complicated UTI & adnexitis, prostatitis, epididymo-orchitis 500-750 mg bd for 7 days. Extragenital gonorrhea 250 mg bd for 7-14 days. Diarrhea, other infections & post-exposure anthrax inhalation 500 mg bd for 7-14 days. Severe, life-threatening infections caused by Pseudomonas, Staph or Strep 750 mg bd for at least 10 days. Prophylaxis of invasive infections due to Neisseria meningitides 500 mg single dose. CrCl 30-60 mL/min/1.73 m² Max daily dose: 1,000 mg. CrCl <30 mL/min/1.73 m² Max daily dose: 500 mg. Childn & adolescents Bronchopulmonary infection associated w/ P aeruginosa 20 mg/kg bd for 10-14 days. Max: 750 mg/dose. Complicated UTI & pyelonephritis 10-20 mg/kg bd for 10-21 days. Max: 750 mg/dose. Post-exposure anthrax inhalation 15 mg/kg bd. Max: 500 mg/dose.

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Overdosage

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Administration

May be taken with or without food: May be taken w/ meals to minimise GI discomfort. Do not take w/ antacids, Fe or dairy products.

Contraindications

Hypersensitivity to ciprofloxacin or other quinolones. Concurrent administration w/ tizanidine.

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Special Precautions

Discontinue use if severe anaphylactic/anaphylactoid reaction, severe & persistent diarrhoea, epilepsy, lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure/stroke, tendon swelling/inflammation or tendon rupture & photosensitisation occur. Kidney, heart & lung transplant recipients. History of myasthenia gravis. Avoid direct exposure to excessive sunlight or UV light. Concomitant use w/ CYP450 1A2 inhibitors (eg, theophylline, methylxanthines, caffeine, duloxetine, clozapine) & corticosteroids. May affect ability to drive & use machines. Not to be used during pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, diarrhea.

Drug Interactions

Reduced absorption w/ multivalent cation-containing drugs & mineral supplements (eg, Ca, Mg, Al, Fe), polymeric phosphate binders (eg, sevelamer), sucralfate or Mg-, Al-, or Ca-containing antacids & highly buffered drugs (eg, didanosine tab) & dairy products or mineral-fortified drinks (eg, milk, yoghurt, Ca-fortified orange juice). Reduced C_max& AUC w/ omeprazole. Increased serum theophylline conc. Provoked convulsions w/ certain NSAIDs (but not ASA). Transient rise in serum creatinine conc w/ cyclosporine. Intensified action of warfarin & glibenclamide. Increased serum conc by probenecid. Increased plasma levels of MTX. Accelerated absorption by metoclopramide. Increased tizanidine serum conc. Increased C_max & AUC of duloxetine & ropinirole. Reduced clearance of IV lidocaine. Increased serum conc of clozapine & N-desmethylclozapine.

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Storage

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Description

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Action

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MIMS Class

Quinolones

ATC Classification

J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Axcel Ciprofloxacin FC tab 250 mg

Packing/Price

10 × 10's

Form

Axcel Ciprofloxacin FC tab 500 mg

Packing/Price

10 × 10's

Axcel Ciprofloxacin

ciprofloxacin

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma