Please sign in so that we can notify you about a reply
Indications/Uses
Treatment of wide range of infections including inhalation anthrax, bacterial exacerbations bronchitis, bone and joint infections, infectious diarrhea, endocervical and urethral gonorrhea; intra-abdominal, lower respiratory tract, skin and soft tissue infections; bacterial prostatitis, acute sinusitis, typhoid fever, bacterial urinary tract infection.
Dosage/Direction for Use
Adult Inhalation anthrax: 500 mg (base) every 12 hour for 60 days.
Bone and joint infections: Mild to moderate 500 mg (base) every 12 hour for at least 4-6 week.
Severe or complicated infections: 750 mg (base) every 12 hour for at least 4-6 week.
Mild to moderate infectious diarrhea: 500 mg (base) every 12 hour for 5-7 days.
Endocervical and urethral gonorrhea: 250 mg (base) as single dose.
Intra-abdominal infections: 500 mg (base) every 12 hour for at least 7-14 days in combination with oral Metronidazole.
Lower respiratory tract, skin and soft tissue infections: Mild to moderate: 500 mg (base) every 12 hour for at least 7-14 days; severe or complicated: 750 mg (base) every 12 hour for 7-14 days.
Mild to moderate chronic prostatitis: 500 mg (base) every 12 hour for 28 days.
Mild to moderate sinusitis or typhoid fever: 500 mg (base) every 12 hour for 10 days.
Acute complicated urinary tract infection: 100 mg (base) every 12 hour for 3 days; mild to moderate: 250 mg (base) every 12 hour for 7-14 days; severe or complicated: 500 mg (base) every 12 hour for 7-14 days. Max: 1.5 g (base) daily.
Children up to 18 yr Given only when alternative therapy could not be used.
Inhalation anthrax: 15 mg/kg body weight dose (base). Max: 500 mg/dose, every 12 hour for 60 days.
Other infections: 10-15 mg (base)/kg body weight twice daily, up to 1.5 g/day.
Elderly: Adult dose.
Bone and joint infections: Mild to moderate 500 mg (base) every 12 hour for at least 4-6 week.
Severe or complicated infections: 750 mg (base) every 12 hour for at least 4-6 week.
Mild to moderate infectious diarrhea: 500 mg (base) every 12 hour for 5-7 days.
Endocervical and urethral gonorrhea: 250 mg (base) as single dose.
Intra-abdominal infections: 500 mg (base) every 12 hour for at least 7-14 days in combination with oral Metronidazole.
Lower respiratory tract, skin and soft tissue infections: Mild to moderate: 500 mg (base) every 12 hour for at least 7-14 days; severe or complicated: 750 mg (base) every 12 hour for 7-14 days.
Mild to moderate chronic prostatitis: 500 mg (base) every 12 hour for 28 days.
Mild to moderate sinusitis or typhoid fever: 500 mg (base) every 12 hour for 10 days.
Acute complicated urinary tract infection: 100 mg (base) every 12 hour for 3 days; mild to moderate: 250 mg (base) every 12 hour for 7-14 days; severe or complicated: 500 mg (base) every 12 hour for 7-14 days. Max: 1.5 g (base) daily.
Children up to 18 yr Given only when alternative therapy could not be used.
Inhalation anthrax: 15 mg/kg body weight dose (base). Max: 500 mg/dose, every 12 hour for 60 days.
Other infections: 10-15 mg (base)/kg body weight twice daily, up to 1.5 g/day.
Elderly: Adult dose.
Overdosage
Since there is no specific antidote for overdose of fluoroquinolone antibiotics, treatment should be symptomatic and supportive and may include the following: To decrease absorption: Induction of emesis or use of gastric lavage to empty the stomach.
Supportive care: Maintenance of adequate hydration. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Supportive care: Maintenance of adequate hydration. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Administration
May be taken with or without food: May be taken w/ meals to minimize GI discomfort. Do not take w/ antacids, Fe or dairy products.
Contraindications
Except under special circumstances, this medication should not be used when the following medical problems exist: Previous allergic reaction or hypersensitivity to fluoroquinolones or other chemically related quinolone derivatives.
History of tendinitis or tendon rupture (Fluoroquinolones have been reported to cause tendinitis or tendon rupture during or after treatment; other fluoroquinolones are not recommended for patients with these problems).
Risk-benefit should be considered when the following medical problems exist: Cerebral arteriosclerosis; Epilepsy; Other factors that predispose to seizures (Fluoroquinolones may cause CNS stimulation or toxicity; convulsions may occur within 3 to 4 days after the start of fluoroquinolone treatment and usually resolve with discontinuation of the fluoroquinolone; Fluoroquinolones should be used with caution in patients with confirmed or suspected CNS disorders).
Hepatic function impairment (patients with severe hepatic function impairment, such as cirrhosis with ascites, resulting in an increase in peak serum concentration and elimination half-life; patients with both hepatic and renal function impairment may require a reduction in the dosage of Ciprofloxacin).
Renal function impairment (in general, fluoroquinolones primarily are excreted renally; it is recommended that patients with impaired renal function be administered reduced doses of fluoroquinolones).
History of tendinitis or tendon rupture (Fluoroquinolones have been reported to cause tendinitis or tendon rupture during or after treatment; other fluoroquinolones are not recommended for patients with these problems).
Risk-benefit should be considered when the following medical problems exist: Cerebral arteriosclerosis; Epilepsy; Other factors that predispose to seizures (Fluoroquinolones may cause CNS stimulation or toxicity; convulsions may occur within 3 to 4 days after the start of fluoroquinolone treatment and usually resolve with discontinuation of the fluoroquinolone; Fluoroquinolones should be used with caution in patients with confirmed or suspected CNS disorders).
Hepatic function impairment (patients with severe hepatic function impairment, such as cirrhosis with ascites, resulting in an increase in peak serum concentration and elimination half-life; patients with both hepatic and renal function impairment may require a reduction in the dosage of Ciprofloxacin).
Renal function impairment (in general, fluoroquinolones primarily are excreted renally; it is recommended that patients with impaired renal function be administered reduced doses of fluoroquinolones).
Special Precautions
Carcinogenicity/Tumorigenicity: Long-term carcinogenicity studies (up to 2 years) in rats and mice with oral ciprofloxacin have shown no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects.
Mutagenicity: In vitro mutagenicity studies have shown both positive and negative results. Negative results were obtained in the Salmonella microsome test, Escherichia coli DNA repair test, Chinese hamster V79 cell HGPRT test, Syrian hamster embryo cell transformation assay, Saccharomyces cerevisiae point mutation assay. Positive results were obtained in the mouse lymphoma cell forward mutation assay and the rat hepatocyte DNA repair assay, micronucleus test in mice, and the dominant lethal test in mice.
Pediatrics: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in infants and children. Patients younger than 18 years of age usually have been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints.
Fluoroquinolones and other related quinolones have been reported to cause arthropathy in immature animals of various species; the effects vary with animal species and with quinolone treatment. The mechanism by which quinolones produce this cartilage damage is unknown.
Adolescents: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in adolescents. Patients younger than 18 years of age usually have not been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints. One clinical report of 1219 adolescent patients (74 of whom had cystic fibrosis) who received ciprofloxacin at least once did not reveal any cases of newly diagnosed acute arthritis or joint toxicity that were likely to have been caused by the medication. In general, arthralgias have been reported primarily in adolescent females who received fluoroquinolones; these arthralgias were not severe, were transient, and disappeared with either a dosage reduction or discontinuation of the medication.
Geriatrics: Studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluoroquinolones in the elderly. However, tendinitis or tendon rupture, central nervous system (CNS) effects (e.g., hallucinations), and other side effects may occur more frequently in the elderly. Elderly patients also are more likely to have an age-related decrease in renal function, which may require an adjustment of dosage in patients receiving any of these medications.
Mutagenicity: In vitro mutagenicity studies have shown both positive and negative results. Negative results were obtained in the Salmonella microsome test, Escherichia coli DNA repair test, Chinese hamster V79 cell HGPRT test, Syrian hamster embryo cell transformation assay, Saccharomyces cerevisiae point mutation assay. Positive results were obtained in the mouse lymphoma cell forward mutation assay and the rat hepatocyte DNA repair assay, micronucleus test in mice, and the dominant lethal test in mice.
Pediatrics: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in infants and children. Patients younger than 18 years of age usually have been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints.
Fluoroquinolones and other related quinolones have been reported to cause arthropathy in immature animals of various species; the effects vary with animal species and with quinolone treatment. The mechanism by which quinolones produce this cartilage damage is unknown.
Adolescents: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in adolescents. Patients younger than 18 years of age usually have not been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints. One clinical report of 1219 adolescent patients (74 of whom had cystic fibrosis) who received ciprofloxacin at least once did not reveal any cases of newly diagnosed acute arthritis or joint toxicity that were likely to have been caused by the medication. In general, arthralgias have been reported primarily in adolescent females who received fluoroquinolones; these arthralgias were not severe, were transient, and disappeared with either a dosage reduction or discontinuation of the medication.
Geriatrics: Studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluoroquinolones in the elderly. However, tendinitis or tendon rupture, central nervous system (CNS) effects (e.g., hallucinations), and other side effects may occur more frequently in the elderly. Elderly patients also are more likely to have an age-related decrease in renal function, which may require an adjustment of dosage in patients receiving any of these medications.
Use In Pregnancy & Lactation
Pregnancy: Ciprofloxacin crosses the placenta.
Studies in rats and mice given doses of up to six times the usual daily human dose have not shown that ciprofloxacin causes adverse effects on the fetus. Studies in rabbits given oral doses of 30 and 100 mg/Kg have shown that ciprofloxacin causes gastrointestinal disturbances, resulting in maternal weight loss and an increased incidence of abortion. However, these studies have not shown that ciprofloxacin is teratogenic at either dose. Studies using intravenous doses of up to 20 mg/Kg have not shown that ciprofloxacin causes maternal toxicity, embryotoxicity, or teratogenic effects.
Breastfeeding: Ciprofloxacin is known to be distributed into breast milk. Fluoroquinolones have been shown to cause permanent lesions of the cartilage of weight-bearing joints, as well as other signs of arthropathy, in immature animals. Therefore, if an alternative antibiotic cannot be prescribed and a fluoroquinolone must be administered, breastfeeding is not recommended.
Fertility: Adequate and well controlled studies in humans have not been done. Studies in rats and mice given doses of up to six times the usual daily human dose have not shown that ciprofloxacin causes adverse effects on fertility.
Studies in rats and mice given doses of up to six times the usual daily human dose have not shown that ciprofloxacin causes adverse effects on the fetus. Studies in rabbits given oral doses of 30 and 100 mg/Kg have shown that ciprofloxacin causes gastrointestinal disturbances, resulting in maternal weight loss and an increased incidence of abortion. However, these studies have not shown that ciprofloxacin is teratogenic at either dose. Studies using intravenous doses of up to 20 mg/Kg have not shown that ciprofloxacin causes maternal toxicity, embryotoxicity, or teratogenic effects.
Breastfeeding: Ciprofloxacin is known to be distributed into breast milk. Fluoroquinolones have been shown to cause permanent lesions of the cartilage of weight-bearing joints, as well as other signs of arthropathy, in immature animals. Therefore, if an alternative antibiotic cannot be prescribed and a fluoroquinolone must be administered, breastfeeding is not recommended.
Fertility: Adequate and well controlled studies in humans have not been done. Studies in rats and mice given doses of up to six times the usual daily human dose have not shown that ciprofloxacin causes adverse effects on fertility.
Adverse Reactions
Those indicating need for medical attention: Incidence less frequent: Phototoxicity (blisters; sensation of skin burning; skin itching, rash, or redness; swelling).
Incidence rare: Arthralgia (joint pain); CNS stimulation (acute psychosis; agitation; confusion; hallucinations; tremors); cardiovascular reactions such as palpitation (fast or irregular heartbeat); vasodilation (dizziness; faintness; feeling of warmth or heat; flushing or redness of skin especially on face and neck; headache; lightheadedness; sweating; weakness); or tachycardia (fainting; fast, pounding, or irregular heartbeat or pulse); hematuria (blood in urine); hepatoxicity (dark or amber urine; loss of appetite; pale stools; stomach pain; unusual tiredness or weakness; yellow eyes or skin); hypersensitivity reactions (skin rash, itching, or redness; shortness of breath; swelling of face or neck; vasculitis); interstitial nephritis (bloody or cloudy urine; fever; skin rash; swelling of feet or lower legs).
Those indicating need for medical attention only if they continue or are bothersome: Incidence more frequent: CNS toxicity (dizziness or lightheadedness; headache; nervousness; drowsiness; insomnia); gastrointestinal reactions (abdominal or stomach pain or discomfort, mild; diarrhea, mild; nausea or vomiting).
Incidence less frequent or rare: Back pain; change in sense of taste; dream, abnormal; dysuria (difficulty in urination); headache; moniliasis, oral (sore mouth or tongue; white patches in mouth and/or tongue); moniliasis, vaginal (vaginal yeast infection); myalgia (muscle pain); photosensitivity (increased sensitivity of skin to sunlight); vision, abnormal.
Note: Some patients note a reduced incidence of nausea and taste perversion if the dose is administered in the evening. Photosensitivity reactions generally appear within a few days of the start of fluoroquinolone treatment but can occur up to 3 weeks after discontinuation. The reactions usually subside within 1 month of discontinuation.
Those indicating possible phototoxicity, pseudomembranous colitis, or tendinitis or tendon rupture and the need for medical attention if they occur after medication is discontinued: Abdominal or stomach cramps and pain, severe; abdominal tenderness; blisters; diarrhea, watery and severe, which may also be bloody; fever; pain in calves, radiating to heels; sensation of skin burning; skin rash, itching, or redness; swelling of calves or lower legs.
Incidence rare: Arthralgia (joint pain); CNS stimulation (acute psychosis; agitation; confusion; hallucinations; tremors); cardiovascular reactions such as palpitation (fast or irregular heartbeat); vasodilation (dizziness; faintness; feeling of warmth or heat; flushing or redness of skin especially on face and neck; headache; lightheadedness; sweating; weakness); or tachycardia (fainting; fast, pounding, or irregular heartbeat or pulse); hematuria (blood in urine); hepatoxicity (dark or amber urine; loss of appetite; pale stools; stomach pain; unusual tiredness or weakness; yellow eyes or skin); hypersensitivity reactions (skin rash, itching, or redness; shortness of breath; swelling of face or neck; vasculitis); interstitial nephritis (bloody or cloudy urine; fever; skin rash; swelling of feet or lower legs).
Those indicating need for medical attention only if they continue or are bothersome: Incidence more frequent: CNS toxicity (dizziness or lightheadedness; headache; nervousness; drowsiness; insomnia); gastrointestinal reactions (abdominal or stomach pain or discomfort, mild; diarrhea, mild; nausea or vomiting).
Incidence less frequent or rare: Back pain; change in sense of taste; dream, abnormal; dysuria (difficulty in urination); headache; moniliasis, oral (sore mouth or tongue; white patches in mouth and/or tongue); moniliasis, vaginal (vaginal yeast infection); myalgia (muscle pain); photosensitivity (increased sensitivity of skin to sunlight); vision, abnormal.
Note: Some patients note a reduced incidence of nausea and taste perversion if the dose is administered in the evening. Photosensitivity reactions generally appear within a few days of the start of fluoroquinolone treatment but can occur up to 3 weeks after discontinuation. The reactions usually subside within 1 month of discontinuation.
Those indicating possible phototoxicity, pseudomembranous colitis, or tendinitis or tendon rupture and the need for medical attention if they occur after medication is discontinued: Abdominal or stomach cramps and pain, severe; abdominal tenderness; blisters; diarrhea, watery and severe, which may also be bloody; fever; pain in calves, radiating to heels; sensation of skin burning; skin rash, itching, or redness; swelling of calves or lower legs.
Drug Interactions
Aminophylline, oxtriphylline, theophylline, magnesium and aluminum antacids, iron sulfate, zinc, sucralfate, phenytoin, cyclosporine, didanosine, warfarin.
Storage
Store at a temperature not exceeding 30°C.
Action
Pharmacology: Bactericidal; fluoroquinolones act intracellularly by inhibiting topoisomerase II (DNA gyrase) and/or topoisomerase IV. Topoisomerases are essential bacterial enzymes that are critical catalysts in the duplication, transcription, and repair of bacterial DNA.
Pharmacokinetics: Distribution: Fluoroquinolones are widely distributed to most body fluids and tissues; high concentrations are attained in the kidneys, gallbladder, liver, lungs, gynecologic tissue, prostatic tissue, phagocytic cells, urine, sputum, and bile. Ciprofloxacin is also distributed to skin, fat, muscle, bone, and cartilage. Ciprofloxacin has been found to penetrate into the cerebrospinal fluid (CSF). CSF concentrations of ciprofloxacin reach 10% of the peak serum concentration with noninflamed meninges, and 30% to 50% with inflamed meninges.
Bioavailability: 70-80%.
Half-life (hr): Normal renal function: 4; Impaired renal function- 6-8.
Time to peak serum concentration: 1-2 hr.
Peak serum concentration after dose: 1.2-1.4 mcg/mL; Dose: 250 mg, 2.4-4.3 mcg/mL; Dose: 500 mg, 3.4-4.3 mcg/mL; Dose: 750 mg, 5.4 mcg/mL; Dose: 1000 mg.
Peak urine concentration after dose: >200 mcg/mL; Dose: 250 mg.
Protein binding: 20-40%.
Renal excretion (% unchanged/hrs): 40-50/24.
Metabolism: 20%.
Biliary excretion: 20-35%. VolD: 2 liter/Kg.
Removal by dialysis: HD - <10%; PD - <10%.
Pharmacokinetics: Distribution: Fluoroquinolones are widely distributed to most body fluids and tissues; high concentrations are attained in the kidneys, gallbladder, liver, lungs, gynecologic tissue, prostatic tissue, phagocytic cells, urine, sputum, and bile. Ciprofloxacin is also distributed to skin, fat, muscle, bone, and cartilage. Ciprofloxacin has been found to penetrate into the cerebrospinal fluid (CSF). CSF concentrations of ciprofloxacin reach 10% of the peak serum concentration with noninflamed meninges, and 30% to 50% with inflamed meninges.
Bioavailability: 70-80%.
Half-life (hr): Normal renal function: 4; Impaired renal function- 6-8.
Time to peak serum concentration: 1-2 hr.
Peak serum concentration after dose: 1.2-1.4 mcg/mL; Dose: 250 mg, 2.4-4.3 mcg/mL; Dose: 500 mg, 3.4-4.3 mcg/mL; Dose: 750 mg, 5.4 mcg/mL; Dose: 1000 mg.
Peak urine concentration after dose: >200 mcg/mL; Dose: 250 mg.
Protein binding: 20-40%.
Renal excretion (% unchanged/hrs): 40-50/24.
Metabolism: 20%.
Biliary excretion: 20-35%. VolD: 2 liter/Kg.
Removal by dialysis: HD - <10%; PD - <10%.
MedsGo Class
Quinolones
Features
Brand
CICLODIN
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Ciprofloxacin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Ciprofloxacin Hcl
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY44015
Drug Classification
Prescription Drug (RX)