Cipro Zithromax Antibiotics Information
Cipro Oral Suspension, Cipro Tablets(Bayer)
DESCRIPTION
CIPRO® (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin *
) Oral Suspension are synthetic broad spectrum antimicrobial agents for oral
administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the
monohydrochloride monohydrate salt
CIPRO film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 mg
(ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to
slightly yellowish. The inactive ingredients are cornstarch, microcrystalline
cellulose, silicon dioxide, crospovidone, magnesium stearate, hydroxypropyl
methylcellulose, titanium dioxide, polyethylene glycol and water.
Ciprofloxacin Oral Suspension is available in 5% (5 g ciprofloxacin in 100
mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension
is a white to slightly yellowish suspension with strawberry flavor which may
contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules
and diluent which are mixed prior to dispensing (See instructions for USE/HANDLING).
The components of the suspension have the following compositions:
Microcapsules--ciprofloxacin, polyvinylpyrrolidone, methacrylic acid copolymer,
hydroxypropyl methylcellulose, magnesium stearate, and Polysorbate 20.
Diluent--medium-chain triglycerides, sucrose, lecithin, water, and strawberry
flavor.
* Does not comply with USP with regards to "loss on drying" and "residue
on ignition".
CLINICAL PHARMACOLOGY
Absorption: Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after oral administration. The absolute bioavailability
is approximately 70% with no substantial loss by first pass metabolism.
INDICATIONS AND USAGE section of the package insert for CIPRO (ciprofloxacin
hydrochloride)
Aerobic gram-positive microorganisms
Enterococcus faecalis (Many strains are only moderately susceptible.)
Staphylococcus aureus (methicillin-susceptible strains only)
Staphylococcus epidermidis (methicillin-susceptible strains only)
Staphylococcus saprophyticus
Streptococcus pneumoniae (penicillin-susceptible strains only)
Streptococcus pyogenes
Aerobic gram-negative microorganisms
Campylobacter jejuni
Citrobacter diversus
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marcescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei
Ciprofloxacin has been shown to be active against Bacillus anthracis both in
vitro and by use of serum levels as a surrogate marker (see INDICATIONS AND
USAGE and INHALATIONAL ANTHRAX--ADDITIONAL INFORMATION ).
The following in vitro data are available, but their clinical significance
is unknown .
Ciprofloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of
1 µg/mL or less against most (>/= 90%) strains of the following microorganisms;
however, the safety and effectiveness of ciprofloxacin in treating clinical
infections due to these microorganisms have not been established in adequate
and well-controlled clinical trials.
Aerobic gram-positive microorganisms
Staphylococcus haemolyticus
Staphylococcus hominis
Streptococcus pneumoniae (penicillin-resistant strains only)
Aerobic gram-negative microorganisms
Acinetobacter Iwoffi
Aeromonas hydrophila
Edwardsiella tarda
Enterobacter aerogenes
Klebsiella oxytoca
Legionella pneumophila
Pasteurella multocida
Salmonella enteritidis
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulnificus
Yersinia enterocolitica
Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia
are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides
fragilis and Clostridium difficile .
INDICATIONS AND USAGE
CIPRO is indicated for the treatment of infections caused by susceptible strains
of the designated microorganisms in the conditions listed below. Please see
DOSAGE AND ADMINISTRATION for specific recommendations.
Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae,
Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri,
Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas
aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus
faecalis .
Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus
saprophyticus . (See DOSAGE AND ADMINISTRATION .)
Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis
.
Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae,
Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus
influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae . Also,
Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of
first choice in the treatment of presumed or confirmed pneumonia secondary
to Streptococcus pneumoniae .
Acute Sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae,
or Moraxella catarrhalis .
Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae,
Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii,
Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus
aureus (methicillin-susceptible), Staphylococcus epidermidis , or Streptococcus
pyogenes .
Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens,
or Pseudomonas aeruginosa .
Complicated Intra-Abdominal Infections (used in combination with metronidazole)
caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella
pneumoniae, or Bacteroides fragilis. (See DOSAGE AND ADMINISTRATION .)
Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter
jejuni, Shigella boydii † , Shigella dysenteriae, Shigella flexneri or
Shigella sonnei † when antibacterial therapy is indicated.
Typhoid Fever (Enteric Fever) caused by Salmonella typhi .
NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid
carrier state has not been demonstrated.
Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae
.
Inhalational anthrax (post-exposure): To reduce the incidence or progression
of disease following exposure to aerosolized Bacillus anthracis .
Ciprofloxacin serum concentrations achieved in humans serve as a surrogate
endpoint reasonably likely to predict clinical benefit and provide the basis
for this indication. 4 (See also, INHALATIONAL ANTHRAX--ADDITIONAL INFORMATION
).
† Although treatment of infections due to this organism in this organ system
demonstrated a clinically significant outcome, efficacy was studied in fewer
than 10 patients.
If anaerobic organisms are suspected of contributing to the infection, appropriate
therapy should be administered. Appropriate culture and susceptibility tests
should be performed before treatment in order to isolate and identify organisms
causing infection and to determine their susceptibility to ciprofloxacin. Therapy
with CIPRO may be initiated before results of these tests are known; once results
become available appropriate therapy should be continued. As with other drugs,
some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly
during treatment with ciprofloxacin. Culture and susceptibility testing performed
periodically during therapy will provide information not only on the therapeutic
effect of the antimicrobial agent but also on the possible emergence of bacterial
resistance.
CONTRAINDICATIONS
CIPRO (ciprofloxacin hydrochloride) is contraindicated in persons with a history
of hypersensitivity to ciprofloxacin or any member of the quinolone class of
antimicrobial agents.
WARNINGS
THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS
(LESS THAN 18 YEARS OF AGE), -- EXCEPT FOR USE IN INHALATIONAL ANTHRAX (POST-
EXPOSURE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. (See
PRECAUTIONS : Pediatric Use, Pregnancy, and Nursing Mothers subsections.) The
oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological
examination of the weight-bearing joints of these dogs revealed permanent lesions
of the cartilage. Related quinolone-class drugs also produce erosions of cartilage
of weight-bearing joints and other signs of arthropathy in immature animals
of various species. (See ANIMAL PHARMACOLOGY .)
Convulsions, increased intracranial pressure, and toxic psychosis have been
reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin
may also cause central nervous system (CNS) events including: dizziness, confusion,
tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts.
These reactions may occur following the first dose. If these reactions occur
in patients receiving ciprofloxacin, the drug should be discontinued and appropriate
measures instituted. As with all quinolones, ciprofloxacin should be used with
caution in patients with known or suspected CNS disorders that may predispose
to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis,
epilepsy), or in the presence of other risk factors that may predispose to
seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction).
(See PRECAUTIONS : General , Information for Patients , Drug Interactions and
ADVERSE REACTIONS .)
SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT
ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE. These reactions have included
cardiac arrest, seizure, status epilepticus, and respiratory failure. Although
similar serious adverse effects have been reported in patients receiving theophylline
alone, the possibility that these reactions may be potentiated by ciprofloxacin
cannot be eliminated. If concomitant use cannot be avoided, serum levels of
theophylline should be monitored and dosage adjustments made as appropriate.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some
following the first dose, have been reported in patients receiving quinolone
therapy. Some reactions were accompanied by cardiovascular collapse, loss of
consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and
itching. Only a few patients had a history of hypersensitivity reactions. Serious
anaphylactic reactions require immediate emergency treatment with epinephrine.
Oxygen, intravenous steroids, and airway management, including intubation,
should be administered as indicated.
Severe hypersensitivity reactions characterized by rash, fever, eosinophilia,
jaundice, and hepatic necrosis with fatal outcome have also been rarely reported
in patients receiving ciprofloxacin along with other drugs. The possibility
that these reactions were related to ciprofloxacin cannot be excluded. Ciprofloxacin
should be discontinued at the first appearance of a skin rash or any other
sign of hypersensitivity.
Pseudomembranous colitis has been reported with nearly all antibacterial agents,
including ciprofloxacin, and may range in severity from mild to life-threatening.
Therefore, it is important to consider this diagnosis in patients who present
with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and
may permit overgrowth of clostridia. Studies indicate that a toxin produced
by Clostridium difficile is one primary cause of "antibiotic-associated
colitis."
After the diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to drug discontinuation alone. In moderate to severe cases, consideration
should be given to management with fluids and electrolytes, protein supplementation,
and treatment with an antibacterial drug clinically effective against C. difficile
colitis.
Achilles and other tendon ruptures that required surgical repair or resulted
in prolonged disability have been reported with ciprofloxacin and other quinolones.
Ciprofloxacin should be discontinued if the patient experiences pain, inflammation,
or rupture of a tendon.
Ciprofloxacin has not been shown to be effective in the treatment of syphilis.
Antimicrobial agents used in high dose for short periods of time to treat gonorrhea
may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea
should have a serologic test for syphilis at the time of diagnosis. Patients
treated with ciprofloxacin should have a follow-up serologic test for syphilis
after three months.
PRECAUTIONS
General: Crystals of ciprofloxacin have been observed rarely in the urine of
human subjects but more frequently in the urine of laboratory animals, which
is usually alkaline. (See ANIMAL PHARMACOLOGY .) Crystalluria related to ciprofloxacin
has been reported only rarely in humans because human urine is usually acidic.
Alkalinity of the urine should be avoided in patients receiving ciprofloxacin.
Patients should be well hydrated to prevent the formation of highly concentrated
urine.
Quinolones, including ciprofloxacin, may also cause central nervous system
(CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares
or paranoia. (See WARNINGS , Information for Patients , and Drug Interactions
.)
Alteration of the dosage regimen is necessary for patients with impairment
of renal function. (See DOSAGE AND ADMINISTRATION .)
Moderate to severe phototoxicity manifested as an exaggerated sunburn reaction
has been observed in patients who are exposed to direct sunlight while receiving
some members of the quinolone class of drugs. Excessive sunlight should be
avoided. Therapy should be discontinued if phototoxicity occurs.
As with any potent drug, periodic assessment of organ system functions, including
renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.
Information for Patients:
Patients should be advised:
that ciprofloxacin may be taken with or without meals and to drink fluids liberally.
As with other quinolones, concurrent administration of ciprofloxacin with magnesium/aluminum
antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets
or pediatric powder, or with other products containing calcium, iron or zinc
should be avoided. Ciprofloxacin may be taken two hours before or six hours
after taking these products. Ciprofloxacin should not be taken with dairy products
(like milk or yogurt) or calcium-fortified juices alone since absorption of
ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken
with a meal that contains these products.
that ciprofloxacin may be associated with hypersensitivity reactions, even
following a single dose, and to discontinue the drug at the first sign of a
skin rash or other allergic reaction.
to avoid excessive sunlight or artificial ultraviolet light while receiving
ciprofloxacin and to discontinue therapy if phototoxicity occurs.
to discontinue treatment; rest and refrain from exercise; and inform their
physician if they experience pain, inflammation, or rupture of a tendon.
that ciprofloxacin may cause dizziness and lightheadedness; therefore, patients
should know how they react to this drug before they operate an automobile or
machinery or engage in activities requiring mental alertness or coordination.
that ciprofloxacin may increase the effects of theophylline and caffeine. There
is a possibility of caffeine accumulation when products containing caffeine
are consumed while taking quinolones.
that convulsions have been reported in patients receiving quinolones, including
ciprofloxacin, and to notify their physician before taking this drug if there
is a history of this condition.
Drug Interactions: As with some other quinolones, concurrent administration
of ciprofloxacin with theophylline may lead to elevated serum concentrations
of theophylline and prolongation of its elimination half-life. This may result
in increased risk of theophylline-related adverse reactions. (See WARNINGS
.) If concomitant use cannot be avoided, serum levels of theophylline should
be monitored and dosage adjustments made as appropriate.
Some quinolones, including ciprofloxacin, have also been shown to interfere
with the metabolism of caffeine. This may lead to reduced clearance of caffeine
and a prolongation of its serum half-life.
Concurrent administration of a quinolone, including ciprofloxacin, with multivalent
cation-containing products such as magnesium/aluminum antacids, sucralfate,
Videx® (didanosine) chewable/buffered tablets or pediatric powder, or products
containing calcium, iron, or zinc may substantially decrease its absorption,
resulting in serum and urine levels considerably lower than desired. (See DOSAGE
AND ADMINISTRATION for concurrent administration of these agents with ciprofloxacin.)
Histamine H 2 -receptor antagonists appear to have no significant effect on
the bioavailability of ciprofloxacin.
Altered serum levels of phenytoin (increased and decreased) have been reported
in patients receiving concomitant ciprofloxacin.
The concomitant administration of ciprofloxacin with the sulfonylurea glyburide
has, on rare occasions, resulted in severe hypoglycemia.
Some quinolones, including ciprofloxacin, have been associated with transient
elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Quinolones have been reported to enhance the effects of the oral anticoagulant
warfarin or its derivatives. When these products are administered concomitantly,
prothrombin time or other suitable coagulation tests should be closely monitored.
Probenecid interferes with renal tubular secretion of ciprofloxacin and produces
an increase in the level of ciprofloxacin in the serum. This should be considered
if patients are receiving both drugs concomitantly.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Eight in vitro mutagenicity
tests have been conducted with ciprofloxacin, and the test results are listed
below:
Salmonella/Microsome Test (Negative)
E. coli DNA Repair Assay (Negative)
Mouse Lymphoma Cell Forward Mutation Assay (Positive)
Chinese Hamster V 79 Cell HGPRT Test (Negative)
Syrian Hamster Embryo Cell Transformation Assay (Negative)
Saccharomyces cerevisiae Point Mutation Assay (Negative)
Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
Rat Hepatocyte DNA Repair Assay (Positive)
Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo
test systems gave negative results:
Rat Hepatocyte DNA Repair Assay
Micronucleus Test (Mice)
Dominant Lethal Test (Mice)
Long-term carcinogenicity studies in mice and rats have been completed. After
daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered
for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic
or tumorigenic effects in these species.
Results from photo co-carcinogenicity testing indicate that ciprofloxacin does
not reduce the time to appearance of UV-induced skin tumors as compared to
vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours
five times every two weeks for up to 78 weeks while concurrently being administered
ciprofloxacin. The time to development of the first skin tumors was 50 weeks
in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately
equal to maximum recommended human dose based upon mg/m 2 ), as opposed to
34 weeks when animals were treated with both UVA and vehicle. The times to
development of skin tumors ranged from 16-32 weeks in mice treated concomitantly
with UVA and other quinolones. 3
In this model, mice treated with ciprofloxacin alone did not develop skin or
systemic tumors. There are no data from similar models using pigmented mice
and/or fully haired mice. The clinical significance of these findings to humans
is unknown.
Fertility studies performed in rats at oral doses of ciprofloxacin up to 100
mg/kg (0.8 times the highest recommended human dose of 1200 mg based upon body
surface area) revealed no evidence of impairment.
Pregnancy: Teratogenic Effects. Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women. An expert
review of published data on experiences with ciprofloxacin use during pregnancy
by TERIS--the Teratogen Information System--concluded that therapeutic doses
during pregnancy are unlikely to pose a substantial teratogenic risk (quantity
and quality of data=fair), but the data are insufficient to state that there
is no risk. 7
A controlled prospective observational study followed 200 women exposed to
fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures)
during gestation. 8 In utero exposure to fluoroquinolones during embryogenesis
was not associated with increased risk of major malformations. The reported
rates of major congenital malformations were 2.2% for the fluoroquinolone group
and 2.6% for the control group (background incidence of major malformations
is 1-5%). Rates of spontaneous abortions, prematurity and low birth weight
did not differ between the groups and there were no clinically significant
musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed
children.
Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone
exposure (93% first trimester exposures). 9 There were 70 ciprofloxacin exposures,
all within the first trimester. The malformation rates among live-born babies
exposed to ciprofloxacin and to fluoroquinolones overall were both within background
incidence ranges. No specific patterns of congenital abnormalities were found.
The study did not reveal any clear adverse reactions due to in utero exposure
to ciprofloxacin.
No differences in the rates of prematurity, spontaneous abortions, or birth
weight were seen in women exposed to ciprofloxacin during pregnancy. 7,8 However,
these small postmarketing epidemiology studies, of which most experience is
from short term, first trimester exposure, are insufficient to evaluate the
risk for less common defects or to permit reliable and definitive conclusions
regarding the safety of ciprofloxacin in pregnant women and their developing
fetuses. Ciprofloxacin should not be used during pregnancy unless the potential
benefit justifies the potential risk to both fetus and mother (see WARNINGS
).
Reproduction studies have been performed in rats and mice using oral doses
up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon
body surface area, respectively) and have revealed no evidence of harm to the
fetus due to ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally)
produced gastrointestinal disturbances resulting in maternal weight loss and
an increased incidence of abortion, but no teratogenicity was observed at either
dose. After intravenous administration of doses up to 20 mg/kg, no maternal
toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity
was observed. (See WARNINGS .)
Nursing Mothers: Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin
absorbed by the nursing infant is unknown. Because of the potential for serious
adverse reactions in infants nursing from mothers taking ciprofloxacin, a decision
should be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients and adolescents
less than 18 years of age have not been established, except for use in inhalational
anthrax (post-exposure). Ciprofloxacin causes arthropathy in juvenile animals.
(See WARNINGS .)
For the indication of inhalational anthrax (post-exposure), the risk-benefit
assessment indicates that administration of ciprofloxacin to pediatric patients
is appropriate. For information regarding pediatric dosing in inhalational
anthrax (post-exposure), see DOSAGE AND ADMINISTRATION and INHALATIONAL ANTHRAX--ADDITIONAL
INFORMATION.
Short-term safety data from a single trial in pediatric cystic fibrosis patients
are available. In a randomized, double-blind clinical trial for the treatment
of acute pulmonary exacerbations in cystic fibrosis patients (ages 5-17 years),
67 patients received ciprofloxacin I.V. 10 mg/kg/dose q8h for one week followed
by ciprofloxacin tablets 20 mg/kg/dose q12h to complete 10-21 days treatment
and 62 patients received the combination of ceftazidime I.V. 50 mg/kg/dose
q8h and tobramycin I.V. 3 mg/kg/dose q8h for a total of 10-21 days. Patients
less than 5 years of age were not studied. Safety monitoring in the study included
periodic range of motion examinations and gait assessments by treatment-blinded
examiners. Patients were followed for an average of 23 days after completing
treatment (range 0-93 days). This study was not designed to determine long
term effects and the safety of repeated exposure to ciprofloxacin.
In the study, injection site reactions were more common in the ciprofloxacin
group (24%) than in the comparison group (8%). Other adverse events were similar
in nature and frequency between treatment arms. Musculoskeletal adverse events
were reported in 22% of the patients in the ciprofloxacin group and 21% in
the comparison group. Decreased range of motion was reported in 12% of the
subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia
was reported in 10% of the patients in the ciprofloxacin group and 11% in the
comparison group. One of sixty-seven patients developed arthritis of the knee
nine days after a ten day course of treatment with ciprofloxacin. Clinical
symptoms resolved, but an MRI showed knee effusion without other abnormalities
eight months after treatment. However, the relationship of this event to the
patient's course of ciprofloxacin can not be definitively determined, particularly
since patients with cystic fibrosis may develop arthralgias/arthritis as part
of their underlying disease process.
Geriatric Use: In a retrospective analysis of 23 multiple-dose controlled clinical
trials of ciprofloxacin encompassing over 3500 ciprofloxacin treated patients,
25% of patients were greater than or equal to 65 years of age and 10% were
greater than or equal to 75 years of age. No overall differences in safety
or effectiveness were observed between these subjects and younger subjects,
and other reported clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity of some older
individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known
to be substantially excreted by the kidney, and the risk of adverse reactions
may be greater in patients with impaired renal function. No alteration of dosage
is necessary for patients greater than 65 years of age with normal renal function.
However, since some older individuals experience reduced renal function by
virtue of their advanced age, care should be taken in dose selection for elderly
patients, and renal function monitoring may be useful in these patients. (See
CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION .)
ADVERSE REACTIONS
During clinical investigation with the tablet, 2,799 patients received 2,868
courses of the drug. Most of the adverse events reported were described as
only mild or moderate in severity, abated soon after the drug was discontinued,
and required no treatment. Ciprofloxacin was discontinued because of an adverse
event in 3.5% of patients treated.
The most frequently reported events, drug related or not, were nausea (5.2%),
diarrhea (2.3%), vomiting (2.0%), abdominal pain/discomfort (1.7%), headache
(1.2%), restlessness (1.1%), and rash (1.1%).
Additional events that occurred in less than 1% of ciprofloxacin patients are
listed below.
BODY AS A WHOLE: foot pain
CARDIOVASCULAR: palpitation, atrial flutter, ventricular ectopy, syncope, hypertension,
angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis
CENTRAL NERVOUS SYSTEM: dizziness, lightheadedness, insomnia, nightmares, hallucinations,
manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy,
drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression,
paresthesia (See above.) (See PRECAUTIONS .)
GASTROINTESTINAL: painful oral mucosa, oral candidiasis, dysphagia, intestinal
perforation, gastrointestinal bleeding (See above.) Cholestatic jaundice has
been reported.
HEMIC/LYMPHATIC: lymphadenopathy
MUSCULOSKELETAL: arthralgia or back pain, joint stiffness, achiness, neck or
chest pain, flare up of gout
RENAL/UROGENITAL: interstitial nephritis, nephritis, renal failure, polyuria,
urinary retention, urethral bleeding, vaginitis, acidosis, breast pain
RESPIRATORY: dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemoptysis,
bronchospasm, pulmonary embolism
SKIN/HYPERSENSITIVITY: pruritus, urticaria, photosensitivity, flushing, fever,
chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous
candidiasis, hyperpigmentation, erythema nodosum (See above.)
Allergic reactions ranging from urticaria to anaphylactic reactions have been
reported. (See WARNINGS .)
SPECIAL SENSES: blurred vision, disturbed vision (change in color perception,
overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus,
hearing loss, bad taste
In several instances nausea, vomiting, tremor, irritability, or palpitation
were judged by investigators to be related to elevated serum levels of theophylline
possibly as a result of drug interaction with ciprofloxacin.
In randomized, double-blind controlled clinical trials comparing ciprofloxacin
tablets (500 mg BID) to cefuroxime axetil (250 mg-500 mg BID) and to clarithromycin
(500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated
a CNS adverse event profile comparable to the control drugs.
Post-Marketing Adverse Events: Additional adverse events, regardless of relationship
to drug, reported from worldwide marketing experience with quinolones, including
ciprofloxacin, are:
agitation, agranulocytosis, albuminuria, anaphylactic reactions, anosmia, candiduria,
cholesterol elevation (serum), confusion, constipation, delirium, dyspepsia,
dysphagia, erythema multiforme, exfoliative dermatitis, flatulence, glu- cose
elevation (blood), hemolytic anemia, hepatic necrosis, hypotension (postural),
jaundice, methemoglobinemia, myalgia, myasthenia gravis (possible exacerbation),
myoclonus, nystagmus, pancreatitis, phenytoin alteration (serum), potassium
elevation (serum), prothrombin time prolongation, pseudomembranous colitis
(The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial
treatment.), psychosis (toxic), renal calculi, Stevens-Johnson syndrome, taste
loss, tendinitis, tendon rupture, toxic epidermal necrolysis, triglyceride
elevation (serum), vaginal candidiasis, and vasculitis. (See PRECAUTIONS .)
Adverse Laboratory Changes: Changes in laboratory parameters listed as adverse
events without regard to drug relationship are listed below:
Hepatic -Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase
(0.8%), LDH (0.4%), serum bilirubin (0.3%).
Hematologic -Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets
(0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%).
Renal -Elevations of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA,
AND HEMATURIA HAVE BEEN REPORTED.
Store below 30°C (86°F).
(ciprofloxacin * ) ORAL SUSPENSION
This section contains important patient information about CIPRO (ciprofloxacin
hydrochloride) Tablets and CIPRO (ciprofloxacin * ) Oral Suspension and should
be read completely before you begin treatment. This section does not take the
place of discussion with your doctor or health care professional about your
medical condition or your treatment. This section does not list all benefits
and risks of CIPRO. If you have any concerns about your condition or your medicine,
ask your doctor. Only your doctor can determine if CIPRO is right for you.
What is CIPRO?
CIPRO is an antibiotic used to treat bladder, kidney, prostate, cervix, stomach,
intestine, lung, sinus, bone, and skin infections caused by certain germs called
bacteria. CIPRO kills many types of bacteria that can infect these areas of
the body. CIPRO has been shown in a large number of clinical trials to be safe
and effective for the treatment of bacterial infections.
Sometimes viruses rather than bacteria may infect the lungs and sinuses (for
example the common cold). CIPRO, like all other antibiotics, does not kill
viruses. You should contact your doctor if your condition is not improving
while taking CIPRO.
CIPRO Tablets are white to slightly yellow in color and are available in 100
mg, 250 mg, 500 mg and 750 mg strengths. CIPRO Oral Suspension is white to
slightly yellow in color and is available in concentrations of 250 mg per teaspoon
(5%) and 500 mg per teaspoon (10%).
How and when should I take CIPRO?
CIPRO Tablets:
Unless directed otherwise by your physician, CIPRO should be taken twice a
day at approximately the same time, in the morning and in the evening. CIPRO
can be taken with food or on an empty stomach. CIPRO should not be taken with
dairy products (like milk or yogurt) or calcium-fortified juices alone; however,
CIPRO may be taken with a meal that contains these products.
You should take CIPRO for as long as your doctor prescribes it, even after
you start to feel better. Stopping an antibiotic too early may result in failure
to cure your infection. Do not take a double dose of CIPRO even if you miss
a dose by mistake.
CIPRO Oral Suspension:
Take CIPRO Oral Suspension in the same way, as above. In addition, remember
to shake the bottle vigorously each time before use for approximately 15 seconds
to make sure the suspension is mixed well. Be sure to swallow the required
amount of suspension. Do not chew the microcapsules. Close the bottle completely
after use. The product can be used for 14 days when stored in a refrigerator
or at room temperature. After treatment has been completed, any remaining suspension
should be discarded.
Who should not take CIPRO?
You should not take CIPRO if you have ever had a severe reaction to any of
the group of antibiotics known as "quinolones".
CIPRO is not recommended during pregnancy or nursing, as the effects of CIPRO
on the unborn child or nursing infant are unknown. If you are pregnant or plan
to become pregnant while taking CIPRO talk to your doctor before taking this
medication.
In general, CIPRO is not recommended for persons less than 18 years of age.
What are the possible side effects of CIPRO?
CIPRO is generally well tolerated. The most common side effects, which are
usually mild, include nausea, diarrhea, vomiting, and abdominal pain/discomfort.
If diarrhea persists, call your health care professional.
Rare cases of allergic reactions have been reported in patients receiving quinolones,
including CIPRO, even after just one dose. If you develop hives, difficulty
breathing, or other symptoms of a severe allergic reaction, seek emergency
treatment right away. If you develop a skin rash, you should stop taking CIPRO
and call your health care professional.
Some patients taking quinolone antibiotics may become more sensitive to sunlight
or ultraviolet light such as that used in tanning salons. You should avoid
excessive exposure to sunlight or ultraviolet light while you are taking CIPRO.
You should be careful about driving or operating machinery until you are sure
CIPRO is not causing dizziness. Convulsions have been reported in patients
receiving quinolone antibiotics including ciprofloxacin. Be sure to let your
physician know if you have a history of convulsions. Quinolones, including
ciprofloxacin, have been rarely associated with other central nervous system
events including confusion, tremors, hallucinations, and depression.
CIPRO has been rarely associated with inflammation of tendons. If you experience
pain, swelling or rupture of a tendon, you should stop taking CIPRO and call
your health care professional.
If you notice any side effects not mentioned in this section, or if you have
any concerns about side effects you may be experiencing, please inform your
health care professional.
What about other medications I am taking?
CIPRO can affect how other medicines work. Tell your doctor about all other
prescription and non-prescription medicines or supplements you are taking.
This is especially important if you are taking theophylline. Other medications
including warfarin, glyburide, and phenytoin may also interact with CIPRO.
Many antacids, multivitamins, and other dietary supplements containing magnesium,
calcium, aluminum, iron or zinc can interfere with the absorption of CIPRO
and may prevent it from working. Other medications such as sulcrafate and Videx® (didanosine)
chewable/buffered tablets or pediatric powder may also stop CIPRO from working.
You should take CIPRO either 2 hours before or 6 hours after taking these products.
What if I have been prescribed CIPRO for possible anthrax exposure?
CIPRO has been approved to reduce the chance of developing anthrax infection
following exposure to the anthrax bacteria. In general, CIPRO is not recommended
for children; however, it is approved for use in patients younger than 18 years
old for anthrax exposure. If you are pregnant, or plan to become pregnant while
taking CIPRO, you and your doctor should discuss if the benefits of taking
CIPRO for anthrax outweigh the risks.
CIPRO is generally well tolerated. Side effects that may occur during treatment
to prevent anthrax might be acceptable due to the seriousness of the disease.
You and your doctor should discuss the risks of not taking your medicine against
the risks of experiencing side effects.
CIPRO can cause dizziness, confusion, or other similar side effects in some
people. Therefore, it is important to know how CIPRO affects you before driving
a car or performing other activities that require you to be alert and coordinated
such as operating machinery.
Your doctor has prescribed CIPRO only for you. Do not give it to other people.
Do not use it for a condition for which it was not prescribed. You should take
your CIPRO for as long as your doctor prescribes it; stopping CIPRO too early
may result in failure to prevent anthrax.
Remember:
Do not give CIPRO to anyone other than the person for whom it was prescribed.
Take your dose of CIPRO in the morning and in the evening.
Complete the course of CIPRO even if you are feeling better.
Keep CIPRO and all medications out of reach of children.
*Does not comply with USP with regards to "loss on drying" and "residue
on ignition".
Cipro Zithromax Antibiotics Information
| Amoxil | Biaxin | Cefzil | Cipro | Doxycycline | Levaquin | Minocycline | Tetracycline | Zithromax |