Trade Names:Cetraxal- Solution, otic 0.2%
Trade Names:Ciloxan- Ointment, ophthalmic 3.33 mg/g (equivalent to 3 mg base)- Solution, ophthalmic 3.5 mg/mL (equivalent to 3 mg base)
Trade Names:Cipro- Tablets 100 mg- Tablets 250 mg- Tablets 500 mg- Tablets 750 mg- Microcapsules for oral suspension 250 mg per 5 mL (5%) (when reconstituted)- Microcapsules for oral suspension 500 mg per 5 mL (10%) (when reconstituted)
Trade Names:Cipro IV- Injection, solution, concentrate 10 mg/mL (1%)- Injection, solution 2 mg/mL (0.2%)
Trade Names:Cipro XR- Tablets, ER 500 mg- Tablets, ER 1,000 mg
Trade Names:Proquin XR- Tablets, ER 500 mgApo-Ciproflox (Canada)Cipro XL (Canada)CO Ciprofloxacin (Canada)Gen-Ciprofloxacin (Canada)PMS-Ciprofloxacin (Canada)RAN-Ciprofloxacin (Canada)ratio-Ciprofloxacin (Canada)Sandoz Ciprofloxacin (Canada)Taro-Ciprofloxacin (Canada)
Inhibits microbial DNA replication, transcription, repair, and recombination.
Rapidly and well absorbed. Bioavailability is about 70%. T max is 1 to 2 h (1 to 4 h for ER; 6 h for Proquin XR ). C max is 1.2 to 5.4 mcg/mL (250 to 1,000 mg for immediate-release); 1.59 to 3.11 mcg/mL (500 to 1,000 mg for ER); 0.82 mcg/mL ( Proquin XR ).IV
Following 200 and 400 mg IV infusions, C max is 2.1 to 4.6 mcg/mL, respectively.Otic
C max is anticipated to be less than 5 ng/mL.
20% to 40% protein bound. Widely distributed. Diffuses into the CSF, but concentrations are less than 10% of peak serum concentrations. Vd for IV is 2.1 to 2.7 L/kg.
Four metabolites have been identified that account for about 15% of the dose (11% for Proquin XR ); they are less active than the parent compound.IV
Three metabolites have been identified that account for about 10% of the dose.
About 40% to 50% is excreted unchanged in urine (30% for Proquin XR ); 20% to 35% is recovered in feces (43% for Proquin XR ). The serum elimination half-life is about 4 h (4.5 h for Proquin XR ). Cl is about 300 mL/min.IV
About 50% to 70% is excreted unchanged in urine; about 15% is recovered in feces. The half-life is about 5 to 6 h. Cl is about 35 L/h.
The half-life is prolonged.Hepatic Function Impairment
No changes in pharmacokinetics in patients with chronic liver cirrhosis. Acute hepatic function impairment has not been fully evaluated.Elderly
C max increased 16% to 40%, AUC increased about 20% to 30%, and half-life increased about 20%.
Treatment of acute sinusitis, acute uncomplicated cystitis in women, bone and joint infections, chronic bacterial prostatitis, complicated intra-abdominal infections, infectious diarrhea, lower respiratory tract infections, skin and skin structure infections, typhoid fever, uncomplicated cervical and urethral gonorrhea, UTIs, and inhalational anthrax (postexposure).Children (1 to 17 yr of age)
Treatment of complicated UTIs, pyelonephritis, and inhalation anthrax (postexposure).ER tablets Adults ( Cipro XR )
Treatment of uncomplicated UTIs, complicated UTIs, acute uncomplicated pyelonephritis.Adults ( Proquin XR )
Treatment of uncomplicated UTIs.IV ( Cipro IV ) Adults
Treatment of acute sinusitis, bone and joint infections, chronic bacterial prostatitis, complicated intra-abdominal infections, empirical therapy for febrile neutropenic patients, lower respiratory tract infections, nosocomial pneumonia, skin and skin structure infections, UTIs.Children (1 to 17 yr of age)
Treatment of complicated UTIs and pyelonephritis.Adults and children
Treatment of inhalational anthrax (postexposure).Ophthalmic use
Treatment of corneal ulcers (solution only) and conjunctivitis caused by susceptible organisms.Otic use
Treatment of acute externa caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus .
Multidrug-resistant tuberculosis; alternative regimen for tularemia; alternative regimen for cutaneous and GI anthrax; alternative therapy for plague; disseminated gonorrhea; cystic fibrosis and gastroenteritis in children; as part of combination therapy for treating atypical mycobacterial infections; traveler's diarrhea.
Coadministration with tizanidine; hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any component of the product.
PO 500 mg or IV 400 mg every 12 h for 10 days.Acute Uncomplicated Pyelonephritis ( Cipro XR )Adults
PO 1,000 mg every 24 h for 7 to 14 days.Bone and Joint InfectionsAdults Mild/Moderate
PO 500 mg or IV 400 mg every 12 h for at least 4 to 6 wk.Severe/Complicated
PO 750 mg every 12 h or IV 400 mg every 8 h for at least 4 to 6 wk.Chronic Bacterial ProstatitisAdults Mild/Moderate
PO 500 mg or IV 400 mg every 12 h for 28 days.Empirical Therapy for Febrile Neutropenic PatientsAdults Severe
IV ciprofloxacin 400 mg every 8 h plus piperacillin 50 mg/kg (not to exceed 24 g/day) every 4 h for 7 to 14 days.Infectious DiarrheaAdults Mild/Moderate/Severe
PO 500 mg every 12 h for 5 to 7 days.Inhalational Anthrax (Postexposure)Adults
PO 500 mg or IV 400 mg every 12 h for 60 days.Children
PO 15 mg/kg/dose (max, 500 mg dose) or IV 10 mg/kg/dose (max, 400 mg dose) every 12 h for 60 days.Intra-Abdominal InfectionsAdults Complicated
PO 500 mg or IV 400 mg every 12 h for 7 to 14 days in combination with metronidazole.Lower Respiratory Tract InfectionsAdults Mild/Moderate
PO 500 mg or IV 400 mg every 12 h for 7 to 14 days.Severe/Complicated
PO 750 mg every 12 h or IV 400 mg every 8 h for 7 to 14 days.Nosocomial PneumoniaAdults Mild/Moderate/Severe
IV 400 mg every 8 h for 10 to 14 days.Ocular InfectionsCorneal ulcers
Solution Day 1: 2 drops in affected eye every 15 min for 6 h, then 2 drops every 30 min for remainder of day 1. Day 2: 2 drops every hour. Days 3 through 14: 2 drops every 4 h. May continue treatment after 14 days if corneal re-epithelialization has not occurred.Conjunctivitis
Ointment Apply half-inch ribbon into conjunctival sac 3 times daily for the first 2 days, then twice daily for the next 5 days. Solution 1 to 2 drops every 2 h while awake for 2 days, then 1 to 2 drops every 4 h while awake for 5 days.Otitis ExternaAdults and Children 1 yr of age and older Otic
Instill the contents of 1 single-use container (deliverable volume, 0.25 mL) into the affected ear twice daily (approximately 12 h apart) for 7 days.Skin and Skin Structure InfectionsAdults Mild/Moderate
PO 500 mg or IV 400 mg every 12 h for 7 to 14 days.Severe/Complicated
PO 750 mg every 12 h or IV 400 mg every 8 h for 7 to 14 days.Typhoid FeverAdults Mild/Moderate
PO 500 mg every 12 h for 10 days.Urethral/Cervical Gonococcal InfectionsAdults Uncomplicated
PO 250 mg as a single dose.UTIsAdults Acute uncomplicated
PO 250 mg every 12 h for 3 days. For Cipro XR , PO 500 mg every 24 h for 3 days. For Proquin XR , PO 500 mg once daily for 3 days.Mild/Moderate
PO 250 mg or IV 200 mg every 12 h for 7 to 14 days.Severe/Complicated
PO 500 mg or IV 400 mg every 12 h for 7 to 14 days. For Cipro XR , PO 1,000 mg every 24 h for 7 to 14 days.Complicated UTI or PyelonephritisChildren 1 to 17 yr of age
PO 10 to 20 mg/kg every 12 h (max, 750 mg/dose, even in patients weighing more than 51 kg) or IV 6 to 10 mg/kg every 8 h (max, 400 mg/dose, even in patients weighing more than 51 kg) for 10 to 21 days.Renal Function ImpairmentAdults PO Immediate-release/oral suspension
Usual dosage for CrCl more than 50 mL/min; 250 to 500 mg every 12 h for CrCl 30 to 50 mL/min; 250 to 500 mg every 18 h for CrCl 5 to 29 mL/min; 250 to 500 mg every 24 h (after dialysis) for patients on peritoneal or hemodialysis.Cipro XR
Usual dosage for patients receiving 500 mg tablets; for CrCl less than 30 mL/min, max dose is 500 mg every 24 h. For patients on dialysis, administer dose after dialysis procedure is complete.Proquin XR
No dosage adjustment is needed for patients with mild to moderate renal function impairment.IV
Usual dosage for CrCl more than 30 mL/min; 200 to 400 mg every 18 to 24 h for CrCl 5 to 29 mL/min.
Store immediate-release tablets below 86°F. Store ER tablets at controlled room temperature (59° to 86°F). Store oral suspension below 77°F and protect from freezing. Store reconstituted suspension at room temperature below 86°F. Protect suspension from freezing. Discard any unused suspension after 14 days.Ophthalmic solution and ointment
Store at 36° to 77°F. Keep containers tightly closed.Otic solution
Store at 59° to 77°F. Store unused containers in pouch to protect from light.Injection
Store vials of injection concentrate between 41° and 86°F. Store flexible containers for IV infusion between 41° and 77°F. Protect from light, excessive heat, and freezing. Injection concentrate diluted in compatible IV infusion fluid is stable for up to 14 days in refrigerator (36° to 46°F) or at room temperature below 86°F.
May decrease oral absorption of fluoroquinolones. Stagger administration times.Antiarrhythmic agents (eg, amiodarone, disopyramide, quinidine)
The risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.Anticoagulants
May increase effect of warfarin; monitor PT.Antineoplastic agents (eg, cytarabine, doxorubicin)
Antineoplastic agents may decrease ciprofloxacin absorption by altering the intestinal mucosa.Beta-blockers (eg, metoprolol)
The pharmacologic effects of metoprolol and perhaps other beta-blockers may be increased.Caffeine
Caffeine Cl is reduced.Chloroquine
Coadministration may decrease absorption of ciprofloxacin.Clozapine
Clozapine plasma concentrations may be elevated, increasing the risk of adverse reactions.Corticosteroids
Coadministration of ciprofloxacin and corticosteroids may increase the risk of tendon rupture, especially in elderly patients.Cyclosporine
Nephrotoxic effects of cyclosporine may be increased; monitor renal function.Drugs primarily metabolized by CYP1A2 (eg, duloxetine, theophylline, tizanidine)
Ciprofloxacin is an inhibitor of hepatic CYP1A2, and plasma levels of drugs primarily metabolized by CYP1A2 may be elevated, resulting in increased adverse reactions and toxicity.Foscarnet
The risk of seizures may be increased.Glyburide
Coadministration has resulted in severe hypoglycemia. Fatalities have been reported.Lidocaine
Lidocaine plasma levels may be elevated, increasing the risk of toxicity.MAOIs
Plasma concentrations of MAOI may be increased; dose reduction may be required.Methadone
Methadone plasma concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.Methotrexate
Renal tubular transport of methotrexate may be inhibited, increasing methotrexate plasma levels.Metoclopramide
Rate of ciprofloxacin oral absorption may be accelerated; however, bioavailability is not affected.Mexiletine
Mexiletine plasma concentrations may be elevated and may produce an increase in adverse reactions.NSAIDs
Risk of convulsions may be increased in patients receiving high-dose ciprofloxacin.Olanzapine
Plasma concentrations may be elevated, increasing the risk of adverse reactions (eg, orthostatic hypotension, sedation).Omeprazole
AUC and C max of ciprofloxacin are reduced by 20% and 23%, respectively.Phenytoin
Plasma levels of phenytoin may be increased or decreased.Phosphodiesterase type-5 inhibitors (eg, sildenafil)
Plasma levels may be elevated by ciprofloxacin, increasing the risk of adverse reactions.Probenecid
Decreased ciprofloxacin renal Cl.Procainamide, ropivacaine
Plasma levels may be elevated by ciprofloxacin.Sevelamer
Bioavailability of ciprofloxacin may be reduced.Sucralfate
Coadministration may decrease the absorption of ciprofloxacin.Theophylline
Increased plasma levels of theophylline may result in toxicity and death; monitor theophylline level.Tizanidine
Plasma levels of tizanidine may be elevated 7-fold, increasing the risk of hypotension and sedation. Coadministration with ciprofloxacin is contraindicated.Vaccines, live
Ciprofloxacin may decrease the effectiveness of live vaccines when coadministered.
None well documented.
Angina pectoris, arrhythmias, atrial flutter, cardiac murmur, cardiopulmonary arrest, CV collapse, cerebral thrombosis, hypertension, hypotension, MI, palpitation, phlebitis, postural hypotension, syncope, tachycardia, torsades de pointes, vasculitis, ventricular ectopy (postmarketing).
Headache, insomnia, (3%); dizziness (2%); restlessness (more than 1%); abnormal gait, agitation, anxiety, ataxia, confusion, convulsive seizures, delirium, depression, drowsiness, dysphasia, hallucinations, hyperesthesia, hypesthesia, hypertonia, lethargy, light-headedness, malaise, manic reaction, migraine, nightmares, paranoia, paresthesia, peripheral neuropathy, phobia, psychosis, restlessness, tonic-clonic convulsion, toxic psychosis, tremor, twitching, unresponsiveness, weakness (postmarketing).
Application-site pain (2% to 3%); rash (1%); candidiasis (cutaneous), erythema multiforme, erythema nodosum, exfoliative dermatitis, fixed eruption, hyperpigmentation, petechiae, purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicles (postmarketing).
Ocular crystalline precipitates (17%); conjunctival hypermia, foreign body sensation, itching, lid margin crusting (more than 1% to less than 10%); nasopharyngitis, rhinitis (3%); fungal ear superinfection (2% to 3%); eye discomfort, keratopathy (2%); anosmia, blurred vision, burning, chromatopsia, decreased visual acuity, diplopia, discomfort, epistaxis, hearing loss, nystagmus, visual disturbances (postmarketing).
Bad taste after ocular instillation (less than 10%); nausea (4%); diarrhea, vomiting (2%); dyspepsia (1%); C. difficile –associated diarrhea, constipation, dry mouth, dyspepsia, dysphagia, GI bleeding, ileus, intestinal perforation, oral ulcers, pancreatitis, pseudomembranous colitis, taste loss (postmarketing).
Micturition urgency, vaginal moniliasis (2%); albuminuria, breast pain, candiduria, crystalluria, cylindruria, gynecomastia, hematuria, hemorrhagic cystitis, interstitial nephritis, nephritis, polyuria, renal calculi, renal failure, urethral bleeding, urinary retention, vaginal candidiasis, vaginal pruritus (postmarketing).
Eosinophilia (more than 1%); agranulocytosis, anemia, bleeding diathesis, decreased or increased PT, hemolytic anemia, immature WBCs, leukocytosis, leukopenia, marrow depression, methemoglobinemia, pancytopenia, purpura, serum sickness (postmarketing).
Elevations of ALT and AST (2%); acute hepatic necrosis or failure, cholestatic jaundice, hepatitis, jaundice (postmarketing).
Allergic reactions ranging from urticaria to anaphylactic reactions, angioedema (postmarketing).
Decreases in BUN, hematocrit, hemoglobin, leukocyte counts, platelet count, serum albumin, total serum protein, and uric acid; elevated cholesterol; elevated triglycerides; increases in alkaline phosphatase, amylase, atypical lymphocyte count, blood monocytes, BUN, LDH, lipase, platelet count sedimentation rate, serum bilirubin, serum calcium, serum CPK, serum creatinine, serum gamma-glutamyl transpeptidase, serum uric acid, and triglycerides (postmarketing).
Local IV-site reactions (more than 1%).
Acidosis, decreased blood glucose, elevated blood glucose, hyperkalemia, hypokalemia, lymphadenopathy (postmarketing).
Arthralgia, flare-up of gout, hypertonia, joint stiffness, myalgia, myasthenia, myasthenia gravis, myoclonus, tendon rupture, tendonitis (postmarketing).
Asthma (2%); bronchospasm, dyspnea, hemoptysis, pleural effusion; pulmonary embolism, respiratory arrest, respiratory distress (postmarketing).
Accidental injury, fungal infections (3%); fever (2%); aches, chills, edema, fever, increased perspiration, pain, photosensitivity, phototoxicity (postmarketing).
Ciprofloxacin has been associated with an increased risk of tendonitis and tendon rupture in patients of all ages. The risk is increased in patients older than 60 yr of age, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants.
Ensure CBC (including platelets and differential), renal function, and liver enzymes are evaluated before starting therapy and periodically thereafter during prolonged therapy. Monitor patient's response to therapy. Periodically assess organ system function with prolonged therapy.
Category C .
Excreted in breast milk.
Not drug of first choice in children because of increased incidence of adverse reactions related to joints and surrounding tissue. Do not use ciprofloxacin tablets, oral suspension, or injection in children younger than 18 yr of age, except for listed indications. Do not use ophthalmic solution or otic solution in children younger than 1 yr of age, ophthalmic ointment in children younger than 2 yr of age, or ER tablets in children younger than 18 yr of age.
Because of the risk of reduced renal function, take care in dose selection; renal function monitoring may be useful. Elderly patients may be more susceptible to effects on QT interval or tendons.Ophthalmic
No overall differences in safety and efficacy have been observed between elderly and younger patients.
Serious and potentially fatal reactions have occurred. Discontinue drug if allergic reaction occurs.
Adjust dose downward accordingly.
Use of antibiotics may result in bacterial or fungal overgrowth.
Moderate to severe reactions have occurred with some fluoroquinolones; avoid excessive sunlight and discontinue therapy if phototoxicity occurs.
Consider possibility in patients with diarrhea.
Seizures, increased intracranial pressure, and toxic psychosis have been reported. May also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and rarely, suicidal thoughts or acts. Discontinue therapy and institute appropriate measures if these reactions occur. Use with caution in patients with known or suspected CNS disorders or other risk factors (eg, drug therapy, renal function impairment) that may predispose to seizures or lower the seizure threshold.
An ocular white crystalline precipitate in superficial portion of corneal defect may occur.
Has been reported rarely. Avoid alkalinity of the urine and keep patient well hydrated.
Ensure that ER tablets are not used to treat infections other than UTIs.
Sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, and weakness has been rarely reported. To prevent development of an irreversible condition, discontinue therapy if patient experiences symptoms of neuropathy.
Clinical manifestations of serious and sometimes fatal reactions that have been reported with ciprofloxacin include acute hepatic necrosis or failure, acute renal insufficiency or failure, agranulocytosis, allergic pneumonitis, anemia (including hemolytic and aplastic), arthralgia, fever, hepatitis, interstitial nephritis, jaundice, leukopenia, myalgia, pancytopenia, rash, serum sickness, Stevens-Johnson syndrome, thrombocytopenia (including thrombotic thrombocytopenic purpura), toxic epidermal necrolysis, and vasculitis.
Not effective in treatment of syphilis. All patients with gonorrhea should have a serologic test for syphilis at time of diagnosis and 3 mo after treatment with ciprofloxacin.
Achilles and other tendon ruptures requiring surgical repair and prolonged disability have been reported. Risk increased with concomitant corticosteroid therapy, especially in elderly patients. Discontinue use if patient experiences pain, inflammation, or rupture of tendon.
Acute renal failure.
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